The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 14 April 2022 is covered.
On mobile, the table is best viewed by scrolling sideways.
For regulatory status prior to 14 April 2022, please visit:
- post 1 of 3 for regulatory status between 8 May 2020 – 23 September 2021
- post 2 of 3 for regulatory status between 24 September – 13 April 2022
Other news including on vaccines, treatments, trials and side effects, here.
This page is no longer being updated.
| Company(ies)/ Organisation | Product | Issuing regulatory agency/Organisation | Regulatory status update | Date |
|---|---|---|---|---|
| Novavax CZ a.s., Czechia | Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) | MHRA/UK | Approval has been granted by the MHRA for an adapted Novavax COVID-19 vaccine that targets the Omicron XBB 1.5 subvariant. This vaccine has been approved for use in individuals from 12 years of age. This new authorisation granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. | 9 Feb 2024 |
| BioNTech Manufacturing GmbH | Comirnaty Omicron XBB.1.5 30 micrograms/dose (single-dose vials) | MHRA/UK | This approval enables the thawing and re-labelling of the vaccine by a manufacturer outside of the NHS, that has been authorised by the MHRA and confirmed to meet the globally recognised Good Manufacturing Practice standards. The vaccine needs to be stored at ultra-low temperatures of -80 ºC and then thawed before use. Until now, the thawing and distribution of the vaccine has been centrally managed by the NHS. | 9 Feb 2024 |
| Pfizer Inc. | Paxlovid | FDA/US | Today, FDA announced a revision to the Paxlovid emergency use authorization (EUA), stating that Paxlovid manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date. However, the Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with the NDA (NDA-labeled Paxlovid) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. | 29 Jan 2024 |
| MODERNA BIOTECH SPAIN, S.L. | Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection | MHRA (UK) | The following updates were made to the SmPCs for single dose and multi dose vials (but no changes were made to the PIL):• Section 4.4 was updated to remove the warning about use in immunocompromised individuals • Section 4.8 was updated to to include safety data in organ transplant recipients • Section 5.2 was updated to include immunogenicity data in organ transplant recipients | 19 Jan 2024 |
| MODERNA BIOTECH SPAIN, S.L. | Spikevax XBB.1.5 0.1 mg/mL dispersion for injection | MHRA (UK) | The following updates were made to the SmPC • Section 4.4 was updated to remove the warning about use in immunocompromised individuals • Section 4.8 was updated to to include safety data in organ transplant recipients • Section 5.2 was updated to include immunogenicity data in organ transplant recipients | 19 Jan 2024 |
| Zalika Farmacêutica Ltda | Covid-19 Vaccine ( recombinant) | Anvisa/Brazil | Approved for the prevention of Covid-19 in individuals aged 12 years and over. | 8 Jan 2024 |
| Pfizer | Comirnaty vaccine | Anvisa/Brazil | Approval of post-registration changes aimed at updating the registration of the monovalent Comirnaty vaccine against Covid-19 for the XBB 1.15 variant. The vaccine is indicated for active immunization to prevent Covid-19 and can be used by people over 5 years of age, as a single dose, and regardless of the stage of vaccination, that is, both for vaccinated people and for people unvaccinated. | 19 Dec 2023 |
| Future Health Pharma GmbH has announced on behalf of the manufacturer Novavax | NUVAXOVID against Omicron sub-variant XBB.1.5. | Swissmedic | Future Health Pharma GmbH has withdrawn the application for authorisation of the protein-based vaccine Nuvaxovid submitted to Swissmedic on 30 August 2023. | 18 Dec 2023 |
| Novavax Inc | NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine (Recombinant protein, Adjuvanted) Suspension for intramuscular injection | Health Canada | Approved for Active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in individuals 12 years of age and older. | 5 Dec 2023 |
| AstraZeneca UK Limited | Vaxzevria, suspension for injection COVID-19 Vaccine (ChAdOx1 S [recombinant]) | MHRA/UK | SmPC and PIL updates – Update to section 4.4 of the SmPC and section 2 of the PIL text to include a warning about acute disseminated encephalomyelitis (ADEM) – Update to section 4.8 of the SmPC and section 4 of the PIL to revise the frequency of the possible side effects dizziness, pyrexia and abdominal pain – Update to sections 4.8 and 5.1 of the SmPC regarding updated analyses for clinical studies | 22 Nov 2023 |
| Novavax CZ a.s. | Nuvaxovid dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) | MHRA/UK | To include a homologous booster recommendation for adolescents | 17 Nov 2023 |
| Novavax CZ a.s. | Nuvaxovid dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) | MHRA/UK | To add new pack sizes of multidose vials (approved 16/11/23) | 16 Nov 2023 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)/dose for age 6moths to 4 years of age | MHRA/UK | Section 6.3 Shelf-life of SmPC updated to reflect an update to the product shelf-life from 18 months to 2 years. | 16 Nov 2023 |
| Novavax CZ, a.s. | Nuvaxovid XBB.1.5-adapted COVID-19 vaccine | EMA/EU | The CHMP has recommended the authorising of an adapted targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus. The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12 years of age. | 31 Oct 2023 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection | MHRA/UK | Update to SmPC sections 4.4 and 4.8 and PIL sections 2 and 4 on myocarditis and pericarditis Update to SmPC section 4.4 on use in immunocompromised individuals – Update to SmPC section 4.8 and PIL section 4 to include mechanical urticaria as an adverse event | 20 Oct 2023 |
| Janssen-Cilag Ltd | COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant]) | MHRA/UK | – Update to sections 4.4 and 4.8 of SmPC and sections 2 and 4 of the PIL text to include a warning about myocarditis and pericarditis and include myocarditis and pericarditis as a possible side effect. – Update to section 4.8 of the SmPC and section 4 of the PIL to revise the frequency of some possible side effects. – Update to section 5.1 of SmPC to update the ATC code. | 19 Oct 2023 |
| Moderna | Spikevax vaccine | HSA/Singapore | Updated vaccine authorised to be used for the prevention COVID-19 in individuals aged 6 months and above. | 13 Oct 2023 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) | MHRA/UK | SmPC and PIL for the product updated for use in infants and children aged 6m to 4 years following approval of the Comirnaty Omicron XBB.1.5 vaccines and to update information on myocarditis. | 13 Oct 2023 |
| Novavax, Inc., Gaithersburg, MD, USA | Novavax COVID-19 Vaccine, Adjuvanted suspension for injection, for intramuscular use. | FDA/US | FDA amended the EUA of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula. | 3 Oct 2023 |
| Novavax CZ a.s. | Nuvaxovid dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) | MHRA/UK | The following changes were approved: 1) Conversion of the Conditional Marketing Authorisation to a full Marketing Authorisation 2) To increase the shelf-life from 9 to 12 months when stored at 2 °C – 8 °C 3) To include additional guidance for in-use stability | 2 Oct 2023 |
| BioNTech Manufacturing GmbH | Pfizer-BioNTech Comirnaty®Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine | Health Canada | Authorised for individuals six months of age and older. | 28 Sep 2023 |
| Pfizer | Comirnaty XBB.1.5 vaccine | Swissmedic | Approved for persons aged 12 and over. | 22 Sep 2023 |
| Moderna | Spikevax XBB.1.5 | MHRA/UK | An adapted version of the vaccine that targets the Omicron XBB 1.5 subvariant has been authorised for use in individuals from 6 months of age. This new line extension was approved via the National licensing route. | 15 Sep 2023 |
| Moderna Biotech Spain, S.L. | Spikevax XBB.1.5 | EMA/EU | The CHMP has recommended authorising the adapted vaccinee to be used for preventing COVID-19 in adults and children from 6 months of age. | 15 Sep 2023 |
| BioNTech Manufacturing GmbH | Comirnaty (COVID-19 Vaccine, mRNA) (the updated vaccine comprises a monovalent (single) component that corresponds to the Omicron XBB.1.5 variant) | HSA/Singapore | Authorised for the prevention of Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and above. | 12 Sep 2023 |
| BioNTech Manufacturing GmbH | Comirnaty (COVID-19 Vaccine, mRNA) | FDA/US | Approval of vaccine to include the 2023-2024 formula, and a change to a single dose for individuals 12 years of age and older. Comirnaty was previously approved as a two-dose series for individuals 12 years of age and older. Further information here. | 11 Sep 2023 |
| Pfizer Inc. | Pfizer-BioNTech COVID-19 Vaccine Omicron variant XBB.1.5 | FDA/US | Authorization of vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets. Further information here. | 11 Sep 2023 |
| Spikevax (COVID-19 Vaccine, mRNA) | FDA/US | Approval of vaccine to include the 2023-2024 formula, a change to a single dose for individuals 18 years of age and older, and approval of a single dose for individuals 12 through 17 years of age. Spikevax was previously approved as a two-dose series for individuals 18 years of age and older. Further information here. | 11 Sep 2023 | |
| Moderna COVID-19 Vaccine | FDA/US | Authorization of vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula and lower the age eligibility for receipt of a single dose from 6 years to 5 years of age. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets. Further information here. | 11 Sep 2023 | |
| BioNTech Manufacturing GmbH | Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) | MHRA/UK | Approval granted for an adapted vaccine that targets the Omicron XBB 1.5 subvariant. The vaccine has been approved for use in individuals from 6 months of age. This new line extension granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. SmPC and PIL updated to reflect: 1. A variation to reflect new posology for primary immunisation. The updates affect all the Comirnaty Original Products. | 4 Sep 2023 |
| Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) | MHRA/UK | First authorisation granted. GB only | 31 Aug 2023 | |
| Comirnaty – adapted COVID-19 vaccine targeting Omicron XBB.1.5 | EMA/EU | EMA’s human medicines committee (CHMP)recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. | 30 Aug 2023 | |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified | MHRA/UK | SmPC and PIL updated to reflect: A variation to reflect new posology for primary immunisation and a variation to extend the shelf-life. The updates affect all Comirnaty Original/Omicron BA.4-5 products. | 24 Aug 2023 |
| BioNTech Manufacturing GmbH | Comirnaty 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) | MHRA/UK | A variation to extend the shelf-life was approved. The updates affect the Comirnaty Original 10 microgram/dose and 3 microgram/dose products. | 24 Aug 2023 |
| Hipra Human Health, S.L.U., SPain | BIMERVAX emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted) | MHRA/UK | The Marketing Authorisation is valid in Great Britain only authorised via the European Commission (EC) Decision Reliance Route. | 1 Aug 2023 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injection | MHRA/UK | Updated SmPC and PIL of bivalent Original/Omicron BA.4/5 multi-dose vial ‘ to reflect extension to children from 6 months of age and new posology for primary immunisation. | 1 Aug 2023 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) for ages 5 – 11 years | MHRA/UK | Updated safety and immunogenicity information has been added to the product information based on six months post-booster dose follow-up data in recipients aged 16 years and older. | 6 Jun 2023 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) from age 12+ yrs | MHRA/UK | Updated safety and immunogenicity information has been added to the product information based on six months post-booster dose follow-up data in recipients aged 16 years and older. | 6 Jun 2023 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) for age 12+years | MHRA/UK | Updated safety and immunogenicity information has been added to the product information based on six months post-booster dose follow-up data in recipients aged 16 years and older. | 6 Jun 2023 |
| SK Chemicals GmbH | SKYCovion suspension and emulsion for emulsion for injection. | MHRA/ UK | SKYCovion is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The Marketing Authorisation granted by the MHRA is valid in Great Britain only. | 26 May 2023 |
| Moderna Biotech Spain, S.L. | Spikevax 0.1mg/mL dispersion for injection | MHRA/UK | Vaccine authorised in new age group for use in children aged 6 months to 5 years. | 9 May 2023 |
Roche Registration GmbH | Ronapreve 300 mg + 300 mg solution for injection/infusion | EMA/ EU | EMA’s CHMP recommended an extension of indication to include people aged 12 and older with a negative antibody test who are receiving Oxygen. | 26 Apr 2023 |
Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.4-5 | EMA/EU | EMA’s CHMP recomended an extension of indication for Spikevax to include use of its adapted BA.4-5 version as a booster in children aged 6 to 11 | 26 Apr 2023 |
| Moderna | SPIKEVAX (elasomeran) | TGA/Australia | Transition approved from provisional to full registration. | 21 Apr 2023 |
| Sanofi Pasteur, France | VidPrevtyn Beta solution and emulsion for emulsion for injection | MHRA/UK | MHRA comments on the handling of handling of VidPrevtyn Beta and the need for observation of vaccines post-injection, have been added on this page. | 20 Apr 2023 |
| Moderna TX Inc. | Moderna COVID-19 bivalent mRNA vaccine (original and omicron BA.4/BA.5 strains) | FDA/US | EUA amended so that the vaccine is to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. | 18 Apr 2023 |
| BioNTech Manufacturing GmbH | Pfizer-BioNTech COVID-19 bivalent mRNA vaccine (original and omicron BA.4/BA.5 strains) | FDA/US | EUA amended so that the vaccine is to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. | 18 Apr 2023 |
| Janssen-Cilag Ltd | COVID-19 Vaccine Janssen suspension for injection | MHRA/UK | Sections 4.8 and 5.1 of the SmPC updated to include safety and immunogenicity data following a booster (second dose). | 17 Apr 2023 |
| Pfizer Ltd. | Adapted Bivalent Comirnaty Original / Omicron BA.4-5 mRNA vaccine (tozinameran / famtozinameran) booster | Swissmedic | Approved for use for adults aged 12 and over who have already been administered Comirnaty Original as basic vaccination or a first booster dose. The approved vaccine is an adapted version of Pfizer Ltd. COVID-19 vaccine Comirnaty. | 11 Apr 2023 |
| InflaRx GmbH, Germany | Gohibic (vilobelimab) injection for IV use | FDA/US | EUA issued for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support). | 4 Apr 2023 |
| AstraZeneca UK Limited | Vaxzevria, suspension for injection | MHRA/UK | SMPC and PIL & updated to reflect: – Update to sections 4.2,4.4, 4.8 and 5.1 regarding homologous booster – Update to section 4.8 paraesthesia, hypoesthesia and cutaneous vasculitis – Update to section 6.3 to extend self-life to 9 months | 4 Apr 2023 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection | MHRA/UK | SmPC and PIL updated due to change to the shelf-life of the product. No further specifics provided. | 31 Mar 2023 |
| HIPRA Human Health S.L.U. | Bimervax (previously COVID-19 Vaccine HIPRA) | EMA/EU | Vaccine authorised as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine. Further information is available here. | 30 Mar 2023 |
| Pfizer AG | Comirnaty COVID-19 vaccines | Swissmedic | Swissmedic has approved applications to have the company’s COVID-19 vaccines – until now authorised temporarily subject to special conditions – authorised for five years. | 27 Mar 2023 |
| Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose and Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) and Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) | MHRA/UK | SPCs and PILs updated for all Comirnaty products, to include: the uncommon side effect ‘dizziness’ & longer-term clinical trial follow-up data in 5-11 year olds. | 17 Mar 2023 | |
| BioNTech Manufacturing GmbH | Comirnaty 3 micrograms/dose (Maroon cap), Comirnaty 30 micrograms/dose (purple cap) and Comirnaty 10 micrograms/dose (orange cap) concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) | MHRA/UK | SPCs and PILs updated for all Comirnaty products, to include: the uncommon side effect ‘dizziness’ & longer-term clinical trial follow-up data in 5-11 year olds. | 17 Mar 2023 |
| Moderna | Spikevax bivalent Original / Omicron BA.4-5 mRNA | Swissmedic | Unlimited authorisation granted for use as a booster for persons aged 18 and over, who have received a primary vaccine cycle and/or previous booster dose of Spikevax or another authorised vaccine. | 8 Mar 2023 |
| Roche Registration GmbH | Ronapreve 300 mg + 300 mg solution for injection/infusion (casirivimab + imdevimab) | EMA/EU | Sections 4.1, 4.4 and 5.1 of the SmPC updated in order to update information on the in vitro neutralization activity of casirivimab/imdevimab against the SARS-CoV-2 B.1.1.529 (Omicron) variant. | 7 Mar 2023 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection | MHRA/UK | An extension of indication to include children aged 6 to 11 years old granted. SmPC and PIL have been updated. | 6 Mar 2023 |
| Pfizer Europe MA EEIG | Paxlovid 150 mg + 100 mg film-coated tablets (nirmatrelvir + ritonavir) | EMA/EU | Conditional marketing authorisation replaced with a marketing authorisation not subject to specific obligations. | 24 Feb 2023 |
| Valneva Austria GmbH | COVID-19 Vaccine (inactivated, adjuvanted) Valneva suspension for injection | EMA/EU | EMA’s CHMP recommended authorising the vaccine as a booster in adults aged 18 to 50 | 23 Feb 2023 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injection | MHRA/UK | This new line extension has been granted an authorisation for use as a booster in individuals aged 12 years and above. It ids valid only in GB and was authorised via the European Commission (EC) Decision Reliance Route. | 21 Feb 2023 |
| Janssen-Cilag Ltd | COVID-19 Vaccine Janssen suspension for injection | MHRA/UK | SmPC and PIL updated to reflect conversion to a full marketing authorisation. | 20 Feb 2023 |
| Moderna | Spikevax Bivalent Original/Omicron BA.4-5 (elasomeran and davesomeran ) | TGA/Australia | Provisional approval granted for use as a booster dose in individuals aged 12 years and older. | 20 Feb 2023 |
| Adium SA | Version of the bivalent vaccine for Covid-19 developed by Moderna and marketed by Adium SA | Anvisa/Brazil | Request for Emergency Use Authorisation submitted. | 17 Feb 2023 |
Valneva Austria GmbH | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | EMA/ EU | The SmPC (Annex I) and the Package Leaflet (Annex IIIB) have been updated to reflect the change in shelf life to 21 months when stored at 5°C ± 3°C | 17 Feb 2023 |
| Pfizer | Bivalent Comirnaty vaccines BA.1 and BA.4/BA.5, produced by the company Pfizer. | Anvisa/Brazil | The expiry date of vaccines has been extended from 12 to 18 months. | 9 Feb 2023 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine | MHRA/UK | PI added for a new, age-appropriate presentation of the bivalent version of the vaccine which is for use in children aged 5 to 11 years. Minor, consequential updates were made to the product information for the Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose and Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose. | 3 Feb 2023 |
| Merck Sharp & Dohme LLC | Lagevrio | FDA/US | FDA revised the Letter of Authorization for the EUA to remove the requirement for positive test results to prescribe this products. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. | 1 Feb 2023 |
| Pfizer Inc. | Paxlovid (nirmatrelvir co-packaged with ritonavir) | FDA/US | FDA revised the Letter of Authorization for the EUA to remove the requirement for positive test results to prescribe this products. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. | 1 Feb 2023 |
| Pfizer | bivalent Comirnaty vaccine BA.4 /BA.5 ( Covid-19 vaccine ) | Anvisa/Brazil | Registration application submitted, including a request for the extension of the authorization for use in children between 5 and 11 years old. Product has already been authorised for emergency use since Nov 2022 as a booster for those aged over 12 years of age. | 30 Jan 2023 |
| Pfizer | Paxlovid (Nirmatrelvir (150mg) and Ritonavir (100mg)) | SAHPRA/South Africa | Registered for the treatment of mild to moderate COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19. | 30 Jan 2023 |
| AstraZeneca Pharmaceuticals LP | Evusheld (tixagevimab co-packaged with cilgavimab) | FDA/US | FDA revised the EUA for the product to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency. | 26 Jan 2023 |
| AstraZeneca UK Limited | Vaxzevria, suspension for injection | MHRA/UK | SmPC and PIL updated to add tinnitus as an uncommon side effect | 26 Jan 2023 |
| Pfizer Manufacturing Deutschland GmbH | Paxlovid 150 mg + 100 mg film-coated tablets (150 mg of nirmatrelvir + 100 mg of ritonavir) | EMA/EU | Shelf life of the finished product extended from ’18 months’ to ‘2 years’ (section 6.3 of the SmPC). Storage conditions changed from ‘Do not store above 25 °C. Do not refrigerate or freeze.’ to ‘This medicinal product does not require any special storage conditions.’ | 25 Jan 2023 |
| Zodiac Pharmaceuticals. | COVID-19 vaccine Moderna | Anvisa/Brazil | Application for registration filed. | 20 Jan 2023 |
| Pfizer | COMIRNATY Original/Omicron BA.4-5 COVID-19 vaccine (COVID-19 bivalent booster vaccine dose) | TGA/Australia | Provisional approval granted for use as a booster dose in individuals aged 12 years and older. | 20 Jan 2023 |
| Moderna Australia Pty Ltd | Spikevax | TGA/Australia | TGA has commenced evaluation of the vaccine for potential transition to full registration. | 20 Jan 2023 |
| Janssen-Cilag International NV | JCOVDEN suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant]) | EMA/EU | The European Commission authorised the conversion of the conditional marketing authorisation to a standard marketing authorisation | 9 Jan 2023 |
| Janssen-Cilag Ltd | COVID-19 Vaccine Janssen suspension for injection | MHRA/UK | Section 4.8 of the SmPC and section 4 of the PIL updated to add: – facial paralysis (including Bell’s palsy) as a rare ADR – cutaneous small vessel vasculitis as an ADR of unknown frequency | 29 Dec 2022 |
| Paxlovid 150 mg + 100 mg film-coated tablets | Paxlovid 150 mg + 100 mg film-coated tablets | EMA/EU | An application for a group of variations was made, which resulted in updates to sections 4.3, 4.4, 4.5, 4.8, 5.1 and of the SmPC, the details of which can be viewed in this document. | 22 Dec 2022 |
| BioNTech Manufacturing GmbH | Comirnaty 30 µg Concentrate for dispersion for injection | EMA/EU | Shelf life extension of the finished product from 15 months to 18 months when stored at -90 to -60°C. | 22 Dec 2022 |
| Hoffmann-La Roche, Ltd. | Actemra (tocilizumab) | FDA/US | Supplemental application approved for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. | 21 Dec 2022 |
| Sanofi Pasteur | VidPrevtyn Beta solution and emulsion for emulsion for injection COVID-19 vaccine (recombinant, adjuvanted | MHRA/UK | Authorised for use in those aged 18 and over, as a heterologous booster dose, given as a single injection. This means that those who received a different vaccine (mRNA or viral-vectored) as a primary course, can receive this vaccine as a booster. The Marketing authorisation valid in Great Britain only. | 21 Dec 2022 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.1 (12.5 μg elasomeran/12.5 μg davesomeran) | EMA/EU | Extension of indication to include a booster dose of Spikevax bivalent Original/Omicron BA.1 (12.5 μg elasomeran/12.5 μg davesomeran) in children aged 6 to 11 years. | 16 Dec 2022 |
Moderna Biotech Spain, S.L. | Spikevax (25 μg elasomeran) | EMA/EU | Extension of indication to include a booster dose of Spikevax (25 μg elasomeran) in children aged 6 to 11 years. | 16 Dec 2022 |
| AstraZeneca | Evusheld®️ (tixagevimab + cilgavimab) | Anvisa/Brasil | Inclusion of the therapeutic indication for the treatment of pediatrics (from 12 years old with weight minimum of 40 kg) and adults with Covid-19 who do not require supplemental oxygen and who demonstrate an increased risk of progression to severe disease. | 16 Dec 2022 |
| Eli Lilly Nederland B.V. | Olumiant | EMA/EU | EMA stopped the evaluation of Olumiant as a COVID-19 treatment after the developer, Eli Lilly, withdrew withdrew its application for the use of Olumiant in the treatment of patients hospitalised with COVID-19. | 16 Dec 2022 |
| Janssen-Cilag International NV | Jcovden | EMA/EU | EMA’s CHMP recommended converting the conditional marketing authorisation for Jcovden to standard marketing authorisation | 15 Dec 2022 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original/Omicron BA.1 vaccine | EMA/EU | EMA’s CHMP recommended authorising the vaccine’s adapted BA.1 version for use as a booster in children aged 6 to 11 years | 15 Dec 2022 |
| Moderna Biotech Spain, S.L. | Spikevax vaccine | EMA/EU | EMA’s CHMP recommended authorising both Spikevax for use as a booster in children aged 6 to 11 years | 15 Dec 2022 |
Moderna Biotech SPAIN, S.L. | Spikevax bivalent Original/Omicron BA.1 | MHRA/UK | SmPC and PIL updated as follows: 1) to extend the indication for booster dose to the 12+ years age group (previously 18+ years) 2) to include urticaria, extensive swelling of the vaccinated limb and heavy menstrual bleeding as adverse events Minor change to the text on myo/pericarditis | 14 Dec 2022 |
| Janssen-Cilag Ltd | COVID-19 Vaccine Janssen suspension for injection | MHRA/UK | Section 4.2 of the SmPC and section 3 of the PIL updated to include information about a homologous booster dose in individuals aged 18 years and over Section 4.4 of the SmPC and Section 2 of the PIL updated to add information on the risk of very rare events after a booster dose. | 13 Dec 2022 |
| Moderna US, Inc. | bivalent Moderna COVID-19 vaccine | FDA/US | EUA of the updated (bivalent) vaccine updated to include use in children down to 6 months of age. | 8 Dec 2022 |
| BioNTech Manufacturing GmbH | bivalent Pfizer-BioNTech COVID-19 vaccine | FDA/US | EUA of the updated (bivalent) vaccine updated to include use in children down to 6 months of age. | 8 Dec 2022 |
| BioNTech Manufacturing GmbH | Pfizer/BioNTech COVID-19 vaccine (Comirnaty) | MHRA/UK | Authorisation granted for new line extension (a new presentation of the vaccine) valid in GB only or use in infants and children aged 6 months to 4 years. | 6 Dec 2022 |
| Eli Lilly | Bebtelovimab | FDA/US | The FDA announced that bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data included in the Health Care Provider Fact Sheet. | 30 Nov 2022 |
| Merck Sharp & Dohme (UK) Limited | Lagevrio 200 mg hard capsules | MHRA/UK | Section 6.3 of the SmPC been updated as the shelf life of the product has been extended from 18 to 30 months from initial manufacture. | 28 Nov 2022 |
| Valneva Austria GmbH | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | EMA/EU | The SmPC and the Package Leaflet have been updated to reflect the change in shelf life to 18 months when stored at 5°C ± 3°C. | 25 Nov 2022 |
| Pfizer | Pfizer (Comirnaty ) Bivalent BA4/BA5 – protects against the original variant as well as the Omicron BA4/BA5 variant | Anvisa/Brazil | Temporary and emergency use of bivalent vaccine approved for use as a booster dose in the population from 12 years old | 22 Nov 2022 |
| Pfizer | Pfizer (Comirnaty ) Bivalent BA1 – protects against the original variant as well as the Omicron BA1 variant | Anvisa/Brazil | Temporary and emergency use of bivalent vaccine approved for use as a booster dose in the population from 12 years old | 22 Nov 2022 |
Gilead Sciences Farmaceutica DO Brasil LTDA. | Veklury (Remdesivir) | Anvisa/Brazil | Extension of the use of the antiviral drug for pediatric use in the treatment of Covid-19 approved for the following populations: – infants and children from 28 days and weighing 3 kg or more with pneumonia requiring supplemental oxygen administration (low- or high-flow oxygen, or other non-invasive ventilation at the start of treatment); – children weighing ≥ 40 kg who do not require supplemental oxygen administration and who are at increased risk of progressing to severe Covid-19. | 21 Nov 2022 |
| Neuronic Mexicana SA de CV and Instituto Finlay de Vacunas | Sovereign recombinant domain protein SARS-CoV-2 virus receptor binding (RBD) conjugated to tetanus toxoid) | Cofepris/Mexico | Emergency use authorisation granted. Indicated for the prevention of symptomatic disease caused by the Sars-COV-2 virus for primary vaccination in the adult population. | 19 Nov 2022 |
| Neuronic Mexicana SA de CV and Instituto Finlay de Vacunas | Sovereign PL recombinant SARS-CoV-2 virus receptor binding domain (RBD) protein. | Cofepris/Mexico | Emergency use authorisation granted. Indicated for the prevention of symptomatic disease caused by the Sars-COV-2 virus for primary vaccination in the adult population. | |
| Pfizer | Paxlovid (nirmatrelvir + ritonavir) | Anvisa/Brazil | Extension of the Shelf -life of the medicine medicine from 12 months to 18 months approved. | 21 Nov 2022 |
| Moderna Switzerland GmbH | COVID-19 bivalent vaccine (contains both mRNA from the original Moderna COVID-19 vaccine (Spikevax) and mRNA coding for the spike protein of Omicron variants BA.4 and BA.5). | Swissmedic | Application submitted to Swissmedic for authorisation of a further bivalent COVID-19 vaccine. | 18 Nov 2022 |
| Pfizer Australia Pty Ltd | COVID-19 bivalent (Comirnaty bivalent omicron BA.4/BA.5) booster dose vaccine | TGA/Australia | Provisional determination granted. The vaccine is proposed use as a booster for active immunisation to prevent COVID-19 in individuals aged 12 years and older. | 16 Nov 2022 |
| Pfizer | Comirnaty Ready To Use Adult Vaccine | SAHPRA/South Africa | Registered under the terms of Section 15 (6a) of the Medicines and Related Substance Act (Act 101 of 1965 as amended), with conditions i.e. granted full registration and indicated for active immunisation to prevent COVID-19 in individuals 12 years and above. | 15 Nov 2022 |
| Pfizer | Comirnaty Dilue To Use Paediatric vaccine | SAHPRA/South Africa | Registered under the terms of Section 15 (6a) of the Medicines and Related Substance Act (Act 101 of 1965 as amended), with conditions i.e. granted full registration and indicated for active immunisation against SARS-CoV-2 and may contribute to protection against COVID-19 in individuals 5 – 11 years of age | 15 Nov 2022 |
| AstraZeneca UK Limited | Evusheld (tixagevimab/cilgavimab) | MHRA/ UK | The SmPC and PIL were updated to reflect the approval of the product for the treatment adults who are at risk of progressing to severe COVID-19. It seems that sections 4.1 and 5.1 of the SmPC and section 1 of the PIL have been updated. A new section on breakthrough infection or treatment failure due to antiviral resistance was added. It seems that Section 4.4 of the SmPC and section 2 of the PIL have been updated. | 15 Nov 2022 |
| Sanofi Pasteur, | COVID-19 vaccine | EMA/EU | Vaccine authorised for use as a booster in adults vaccinated with an mRNA or adenoviral vector vaccine. | 10 Nov 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | EMA/EU | EMA’s CHMP recommended authorising an adapted version of Comirnaty as a booster for children aged 5 to 11 | 10 Nov 2022 |
| Novavax CZ a.s. | Nuvaxovid COVID-19 vaccine | MHRA/UK | The vaccine has been approved for use as an adult booster for those aged 18 and above. The product information has also been updated to add information on additional side effects. | 9 Nov 2022 |
| BioNTech Manufacturing GmbH | Comirnaty 10 micrograms concentrate for dispersion for injection ((one of the licensed Comirnaty vaccines produced by Pfizer/BioNTech)) | MHRA/UK | Approved as a booster for 5- to 11-year-olds. There has also been an update to the product information for the Comirnaty vaccines on myocarditis and pericarditis after a third dose and in the age group 5-11 years. This update reflects the most up to date information about these known side effects. | 9 Nov 2022 |
| BioNTech Manufacturing GmbH? | Bivalent COVID-19 booster vaccine (targets both the Original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants) | MHRA/UK | The vaccine (a new line extension and the second bivalent COVID-19 booster from Pfizer/BioNTech) has been approved for use in GB only as a booster dose in individuals aged 12 years and above. | 9 Nov 2022 |
| Astrazeneca AB. | Vaxzevria | EMA/EU | The European Commission authorised the conversion of a conditional authorisation to a standard marketing authorisation via a commission implementing decision. The updated Annexes can be viewed here. | 31 Oct 2022 |
| Pfizer Australia Pty Ltd. | COMIRNATY Original/Omicron BA.1 ( bivalent COVID-19 vaccine, tozinameran and riltozinameran ) | TGA/Australia | Provisionally approved or use as a booster dose in adults 18 years and over. | 28 Oct 2022 |
| Moderna Biotech Spain, S.L. | Spikevax | EMA/EU | EMAs PRAC has recommended that heavy menstrual bleeding should be added to the product information as side effect of unknown frequency | 28 Oct 2022 |
| BioNTech Manufacturing GmbH | Comirnaty | EMA/EU | EMAs PRAC has recommended that heavy menstrual bleeding should be added to the product information as side effect of unknown frequency | 28 Oct 2022 |
| Pfizer Limited | Paxlovid | MHRA/UK | The shelf-life of the product has been extended from 18 to 24 months and section 6.3 Shelf-life of the SmPC has been updated accordingly. | 26 Oct 2022 |
| Novavax, Inc. | Novavax COVID-19 Vaccine, Adjuvanted | FDA/US | EUA granted for use as a first booster dose for individuals 18 & older at least 6 months after completion of primary vaccination with an FDA-approved or authorized COVID-19 vaccine. | 21 Oct 2022 |
| Moderna | Spikevax COVID-19 vaccine | TGA/Australia | Provisionally approved for use as a booster dose in individuals aged 12 years and older. | 19 Oct 2022 |
| Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine An adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. This is the second adapted Spikevax vaccine that EMA has recommended for approval. An adapted Spikevax vaccine targeting Omicron BA.1 and the original strain was authorised in September 2022. | EMA/EU | The CHMP has recommended authorising approval of an adapted Spikevax vaccine. The vaccine is recommended for adults and children from 12 years of age who have already had a primary vaccination course against COVID-19. | 19 Oct 2022 |
| Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine | EMA/EU | The CHMP has recommended extending use of the product, including use in children aged 6 months to 5 years. | 19 Oct 2022 |
BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | EMA/EU | The CHMP has recommended extending the use of the product, including use in children aged 6 months to 4 years. | 19 Oct 2022 |
| AstraZeneca AB | Vaxzevria COVID-19 vaccine | EMA/EU | EMA’s CHMP recommended converting the conditional marketing authorisation for Vaxzevria to a standard marketing authorisation | 14 Oct 2022 |
| AstraZeneca AB | Vaxzevria COVID-19 vaccine | EMA/EU | Shelf-life of finished product extended from 6 months to 9 months. Section 6.3 of the SmPC updated accordingly. You can view the updated PI here. | 12 Oct 2022 |
| BioNTech Manufacturing GmbH | Pfizer-BioNTech COVID-19 Vaccine, Bivalent Includes an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages | FDA/US | EUA amended so that the vaccine is authorized for administration at least two months following completion of primary or booster vaccination in children down to 5years of age. The bivalent vaccine is authorized for use as a single booster dose in individuals 5 years of age and older. | 12 Oct 2022 |
| Moderna US, Inc. | Moderna COVID-19 Vaccine, Bivalent Includes an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages | FDA/ US | EUA amended so that the vaccine is authorized for administration at least two months following completion of primary or booster vaccination in children down to 6 years of age. The bivalent vaccine is authorized for use as single booster dose in individuals 6 years of age and older. | 12 Oct 2022 |
| Pfizer/BioNTech | Comirnaty Bivalent (Original/Omicron BA.4/5) | HSA/Singapore | Interim authorisation granted under the Pandemic Special Access Route (PSAR). | 11 Oct 2022 |
| BioNTech Manufacturing GmbH | Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) | EMA/EU | Commission implementing decision replacing the conditional marketing authorisation with a marketing authorisation not subject to specific obligations i.e. a standard marketing authorisation. Updated Annexes can be viewed here. | 10 Oct 2022 |
| Pfizer | Comirnaty Bivalent Original / Omicron BA.1 (tozinameran / riltozinameran) | Swissmedic | Swissmedic has temporarily authorised the bivalent vaccine booster from age 18 onwards. | 10 Oct 2022 |
| BioNTech Manufacturing GmbH | Comirnaty Original & Omicron BA.4/BA.5 Tozinameran, famtozinameran suspension for injection | Health Canada | Bivalent booster (ages 12 years and over) for the prevention of COVID-19 caused by SARS-CoV-2 Food and Drug Regulations Authorized with terms and conditions | 7 Oct 2022 |
Pfizer Europe MA EEIG | Paxlovid | EMA/EU | EMA published updated product information for COVID-19 treatment Paxlovid, with an increase in its approved shelf life from 12 months to 18 months. | 4 Oct 2022 |
| Moderna Biotech Spain, S.L. | Spikevax 0.2 mg/mL dispersion for injection Spikevax 0.1 mg/mL dispersion for injection Spikevax 50 micrograms dispersion for injection in pre-filled syringe | EMA/EU | Commission implementing decision replacing the conditional marketing authorisation with a marketing authorisation not subject to specific obligations i.e. a standard marketing authorisation. Updated Annexes can be viewed here. | 4 Oct 2022 |
BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine adapted. | EMA/EU | EMA has started a rolling review for the use of an adapted version of the vaccine in children aged 5 to 11 | 3 Oct 2022 |
| AstraZeneca Pharmaceuticals LP | Evusheld (tixagevimab co-packaged with cilgavimab) | FDA/US | FDA has added important information (namely detailed neutralization data) to the revised, authorized Fact Sheet for Healthcare Providers (HCPs) . to inform HCPs and individuals receiving Evusheld, of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld. HCPs should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive. | 3 Oct 2022 |
| Pfizer | Bivalent COVID-19 vaccine Comirnaty (contains the subvariant BA.4/BA.5, in addition to the original strain) | Anvisa/Brazil | Request received for emergency use authorisation of new bivalent vaccine for Covid-19 which is intended to provide greater protection against the Omicron variant. | 30 Sept 2022 |
| Moderna Australia Pty Ltd. | Spikevax bivalent original/omicron BA.4/BA.5 (elasomeran and davesomeran) | TGA/Australia | Provisional determination granted for use of vaccine as a booster for active immunisation to prevent COVID-19. | 30 Sept 2022 |
| Pfizer | Comirnaty COVID-19 vaccine | HSA/Singapore | Authorised for the prevention of COVID-19 in children aged 6 months through 4 years. | 29 Sept 2022 |
| Pfizer Australia Pty Ltd. | COVID-19 vaccine Comirnaty (tozinameran) | TGA/Australia | Paediatric dose provisionally approved, for children aged 6 months to less than 5 years. | 29 Sept 2022 |
| Valneva Austria GmbH | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | EMA/EU | Sections 6.3 and 6.6 of the SmPC (Annex I), section 9 of Labelling (Annex IIIA), and the Package Leaflet (Annex IIIB) have been updated to reflect the change in the in-use shelf life after first opening to “either up to 6 hours when stored below 25°C or up to 48 hours when stored at 2-8°C with a maximum time of 2.5 hours at room temperature. The updated PI can be viewed here. | 27 Sept 2022 |
Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine adapted version | EMA/EU | EMA’s CHMP started evaluating an application for the authorisation of an additional adapted version of Spikevax | 26 Sept 2022 |
| Pfizer AG | Bivalent Comirnaty COVID-19 vaccine The ready to use dispersion for injection contains both messenger RNA (mRNA) from the original Pfizer/BioNTech COVID-19 vaccine (Comirnaty®) and mRNA coding for the spike protein of Omicron variants BA.4 and BA.5. | Swissmedic | Application submitted for authorisation of a further bivalent COVID-19 vaccine. Swissmedic is evaluating the data being submitted on an ongoing basis in a rolling submission procedure. | 21 Sept 2022 |
| Pfizer Australia Pty Ltd | COVID-19 vaccine, COMIRNATY (tozinameran) | TGA/Australia | Provisional approved granted Pfizer’s for use as a booster dose in individuals 5 years to 11 years. | 20 Sept 2022 |
| MC Pharma (Pty) Ltd., India | COVID-19 vaccine MC Pharma | SAHPRA/ South Africa | Approval of additional indication of the use of the vaccine in the age group 3 to 17 years. the product has a full registrations. | 16 Sept 2022 |
| Pfizer | Comirnaty vaccine | Anvisa/Brazil | Extension of the use of the vaccine for immunization against Covid-19 in children between 6 months and 4 years of age approved. | 16 Sept 2022 |
| Gilead Sciences Ireland UC | Veklury (remdesivir) | EMA/EU | EMA’s CHMP recommended extending the use of the product to include treating children with COVID-19 needing supplemental oxigen, or risking severe disease | 16 Sept 2022 |
| AstraZeneca AB | Evusheld (tixagevimab and cilgavimab) | EMA/EU | EMA’s CHMP recommended extending the use of the product to include treating adults and adolescents with COVID-19 who do not require supplemental oxygen. | 16 Sept 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | EMA/EU | EMA’s CHMP recommended authorising the use of the vaccine as a booster dose for children aged 5 to 11 | 16 Sept 2022 |
| BioNTech Manufacturing GmbH | Comirnaty | EMA/EU | The CHMP has recommended converting the conditional marketing authorisation vaccine a into standard marketing authorisation. | 16 Sept 2022 |
| Moderna Biotech Spain, S.L. | Spikevax | EMA/EU | The CHMP has recommended converting the conditional marketing authorisation vaccine a into standard marketing authorisation | 16 Sept 2022 |
| Moderna | Spikevax Bivalent Original/Omicron COVID-19 vaccine | HSA/Singapore | Interim authorisation granted under the Pandemic Special Access Route (PSAR) for bivalent COVID-19 vaccine for use as a booster vaccine in individuals aged 18 years and above, who have received primary series vaccination with COVID-19 vaccines. | 14 Sept 2022 |
| Valneva Austria GmbH | COVID-19 vaccine Valneva | EMA/EU | EMA’s CHMP approved a new manufacturing site for the active substance of COVID-19 Vaccine Valneva in Dessau-Rosslau, Germany | 13 Sept 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine This vaccine is an adapted version of the mRNA COVID-19 vaccine Comirnaty (Pfizer/BioNTech). | EMA/EU | European Commission authorised an adapted version of COVID-19 vaccine COmirnaty. | 13 Sept 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval | EMA/EU | EMA’s CHMP recommended authorising an additional adapted version of Comirnaty in vaccinated peopple aged 12 and over | 12 Sept 2022 |
| BioNTech Manufacturing GmbH | Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) Tozinameran (mRNA vaccine, BNT162b2) suspension for injection | Health Canada | To extend the indication of Comirnaty to include active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 6 months to 4 years of age Food and Drug Regulations Authorized with terms and conditions | 9 Sept 2022 |
Novavax CZ, a.s. | Nuvaxovid dispersion for injection COVID-19 vaccine | EMA/EU | Update of sections 4.2, 4.8 and 5.1 of the SmPC in order to include a third dose for Nuvaxovid, to boost individuals who have previously completed a primary vaccination series with Nuvaxovid (homologous booster dose) or with an mRNA or adenoviral vector vaccine (heterologous booster dose). The updated PI can be viewed here. | 6 Sept 2022 |
| Bharat Biotech | COVID-19 recombinant nasal vaccine (BBV154) | CDSCO/India | Approved for restricted use in emergency situations for primary immunisation of those aged 18 years and above | 6 Sept 2022 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine In each dose of the booster vaccine, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). | MHRA/UK | Conditional Marketing Authorisation (valid in GB only) granted for “Bivalent” vaccine as a booster, approved for use in individuals aged 12 years and above. | 3 Sept 2022 |
| Future Health Pharma GmbH | Nuvaxovid | Swissmedic | Vaccine now approved for young people aged 12 and over with immediate effect. The vaccine can also be used as a booster following basic vaccination, for people aged 18 and over. Both applications were submitted on 6 Jul 2022. | 2 Sept 2022 |
| Novavax CZ, a.s. | Nuvaxovid | EMA/EU | EMA’s CHMP recommended authorising the use of the vaccine as a booster dose for adults who have received the same or another COVID-19 vaccine for their initial vaccination | 1 Sept 2022 |
| Moderna Biotech Spain, S.L. | Spikevax Bivalent Original/Omicron BA.1 This vaccine is an adapted version of the original vaccine to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2. | EMA/EU | The EMA has recommend ed authorising this adapted vaccine for use in people aged 12 years and above who have received at least primary vaccination against COVID-19. This is to provide broader protection against COVID-19 | 1 Sept 2022 |
| BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.1 This vaccine is an adapted version of the original vaccine to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2. | EMA/EU | The EMA has recommend ed authorising this adapted vaccine for use in people aged 12 years and above who have received at least primary vaccination against COVID-19. This is to provide broader protection against COVID-19 | 1 Sept 2022 |
| Moderna TX Inc. | Moderna COVID-19 Vaccine | FDA/US | EUA amended to authorize an updated formulation of the vaccine for use as a single booster dose in individuals 18 years of age and older. This bivalent vaccine, as contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one from the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. | 31 Aug 2022 |
| Pfizer Inc. | Pfizer-BioNTech COVID-19 Vaccine | EUA amended to authorize an updated formulation of the vaccine for use as a single booster dose in individuals 12 years of age and older. This bivalent vaccine, as contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one from the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 | 31 Aug 2022 | |
| Moderna | SPIKEVAX Bivalent Original/Omicron (COVID-19 vaccine, elasomeran/imelasomeran) | TGA/Australia | Provisionally approved for use as a booster dose in adults 18 years and over. The adapted vaccine triggers an immune response against two different COVID-19 variants: the original virus and the BA.1 Omicron variant. | 29 Aug 2022 |
| Moderna Switzerland GmbH | Spikevax Bivalent Original/Omicron (mRNA-1273.214) vaccine booster | Swissmedic | Temporary authorisation for use from age 18 onwards. Application to extend the authorisation to a bivalent vaccine was submitted on 24 June 2022. | 29 Aug 2022 |
| Novavax CZ a.s. | Nuvaxovid | MHRA/UK | The vaccine has been granted an extension to its existing UK approval, for 12- to 17-year-olds. The Conditional Marketing Authorisation (CMA) extension granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route | 26 Aug 2022 |
| Pfizer AG | Comirnaty® 30microgram/dose (PURPLE cap) | Swissmedic | Shelf-life updated for the frozen vials, from 12 months to 15 months. Storage conditions remain unchanged at -90°C to -60°C. Within the 15 month shelf life, unopened vials can be stored at -25°C to -15°C for can be stored and transported for a total of 2 weeks and can be brought back once to the recommended storage temperature of -90°C to -60°C. Once thawed vaccine must not be frozen again. | 24 Aug 2022 |
| Moderna | Spikevax COVID-19 Vaccine | HSA/Singapore | Authorisation extended for the vaccine via the Pandemic Special Access Route (PSAR) to the younger Population Aged 6 Months to 17 Years Old. | 24 Aug 2022 |
| Adjutor Healthcare Pty Ltd | sabizabulin | TGA/Australia | Provisional determination granted for the treatment of COVID-19. | 22 Aug 2022 |
| Pfizer/BioNtech | Comirnaty ? | Anvisa/Brazil | Request received by the agency for emergency use authorization for a new booster vaccine against Covid-19 for those over 12 years of age. The new vaccine is of the bivalent type i.e. it acts against two strains of the virus. In this case, the vaccine consists of a mixture of the original strain used in the Comirnaty vaccine and the Ômicron strain, subvariant BA.1. | 19 Aug 2022 |
| Pfizer-BioNTech | Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) Tozinameran (mRNA vaccine, BNT162b2) suspension for injection | Health Canada | First booster dose (ages 5-11 years) Food and Drug Regulations Authorized with terms and conditions. Details on page 2 at link above. | 19 Aug 2022 |
| SK Chemicals GmbH | Skycovion COVID-19 vaccine | EME/EU | Review started for a conditional marketing authorisation | 18 Aug 2022 |
| Cipla (Pty) Ltd., India | Covovax vaccine | SAHPRA/ South Africa | Approved for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The product has a full registration. | 16 Aug 2022 |
Moderna Biotech Spain, S.L. | Spikevax | EMA/EU | Various updates include: Update of sections 4.2 and 4.4 of the SmPC and PIL to introduce a 50 µg booster dose (via a pre-filled syringe) individuals 12 years of age and older. SMPC also updated to included information based on the fact that the PRAC considers that a causal relationship between elasomeran and extensive swelling of vaccinated limb is at least a reasonable possibility. | 16 August 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVDI-19 vaccine | MHRA/UK | SmPC and PIL of both formulations updated to include information about receiving a heterologous booster dose in individuals aged 18 years and over. (Although not delineated by the MHRA, It seems that sections 4.2 and 4.8 of the SmPC of the purple cap formulation and section 3 of the PIL have been modified. For the orange cap formulation, it seems that section 4.8 of the SmPC has been modified) SmPC section 6.3 and section 5 of the PIL for the purple cap product shelf-life and transportation storage time information updated. | 16 Aug 2022 |
| Moderna Biotech Spain, S.L. | Spikevax bivalent Original / Omicron 0.1 mg/mL dispersion for injection | MHRA (UK) | An updated version of the vaccine that targets two coronavirus variants has been granted a Conditional Marketing Authorisation valid in GB only. It is indicated as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. An emergency use authorisation has been granted for Northern Ireland to ensure access across the whole of the UK. | 12 Aug 2022 |
| Pfizer Limited. | Paxlovid | MHRA/UK | Product shelf-life increased from 12 monthsto 18 months. | 12 Aug 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | EMA/EU | EMA started a rolling review for a version of Comirnaty adapted to the original SARS-CoV-2 virus and to its Omicron subvariants BA.4/5 | 9 Aug 2022 |
| AstraZeneca AB | Vaxzevria COVID-19 vaccine | EMA/EU | In line with the conclusions of PRAC (as per Annex 4 of document), Section 4.8 of the SmPC and section 4 of the Package leafet have been updated to add tinnitus, paraesthesia and hypoaesthesia as undesirable effects. | 8 Aug 2022 |
| Gilead Sciences Ireland UC | Veklury (remdesivir) | EMA/EU | Conditional marketing authorisation replaced with a marketing authorisation not subject to specific obligations. | 8 Aug 2022 |
| Pfizer Inc. | Paxlovid (nirmatrelvir and ritonavir) | FDA/US | EUA revised to include additional post-authorization requirements in Condition O of this letter for Pfizer to conduct a clinical trial in patients with “COVID-19 rebound” and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to moderate COVID-19. The Fact Sheet for Patients, Parents, and Caregivers was also revised to include additional clarifying information on how to take PAXLOVID, which now includes pictures of packaging and tablets for both dosing presentations. | 5 Aug 2022 |
| – Eli Lilly and Compan | Bebtelovimab | FDA/US | EUA revised with revisions to the scope of authorization no longer requiring directed distribution of bebtelovimab by the United States Government. | 5 Aug 2022 |
| Merck Sharp & Dohme LLC | Lagevrio (molnupiravir) | FDA/US | EUA revised. to update the post-authorization requirements as detailed in Condition O of this letter. The Fact Sheet for Healthcare Providers was also revised to include additional virology information and to identify Veklury (remdesivir) as an approved alternative to Lagevrio | 5 Aug 2022 |
| Pfizer AG | COVID-19 vaccine Comirnaty | Swissmedic | An application (to be examined on a rolling basis) has been submitted to extend the authorisation for its vaccine. The bivalent vaccine contains (mRNA) both for the spike protein of the Wuhan strain and for that of the Omicron variant. The modified composition promises to be more effective against the Omicron variant of the SARS-CoV-2 coronavirus. | 2 Aug 2022 |
| Gilead Sciences Canada Inc | Veklury (Remdesivir) | Health Canada | Pediatric dose (older than 28 days-11 years) – Under review | 2 Aug 2022 |
| Pfizer/BioNtech | Comirnaty COVID-19 vaccine | Anvisa/Brazil | Request received by the agency to extend the use of the vaccine to the age group from 6 months to 4 years of age . | 1 Aug 2022 |
| AstraZeneca | Evusheld | HSA/ Singapore | Interim authorisation granted under the Pandemic Special Access Route for used for the prevention of COVID-19 in adults who have not had a known recent exposure to an individual with COVID-19 infection (pre-exposure prophylaxis) and: · are unlikely to mount an adequate immune response to COVID-19 due to their moderate to severe immunocompromised state from a medical condition or receipt of immunosuppressive medications or treatments[ · for whom COVID-19 vaccination is not recommended. | 1 Aug 2022 |
| Pfizer | Comirnaty COVID-19 vaccine | Anvisa/Brazil | Anvisa has received a request from the company to include the age group from 6 months to 4 years of age in the indication. Currently, the vaccine package insert provides for the indication for the age group from 5 years of age. | 29 Jul 2022 |
| GlaxoSmithKline LLC | Sotrovimab | FDA/US | FDA and ASPR authorized an additional extension to the shelf life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. Due to the prevalence of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the Emergency Use Authorization (EUA). | 29 Jul 2022 |
| Valneva Austria GmbH | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | EMA/EU | Section 6.3 of the SmPC and section 6 of the Patient Leaflet have been updated to reflect the extension of the shelf-life of the finished product from 12 months to 15 months when stored at 5°C ± 3°C. Additionally, the PI has been updated to implement the official abbreviation “AgU” for Antigen Units. | 28 Jul 2022 |
| Veru | Sabizabulin | EMA/EU | EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19, the first to be triggered triggered under Article 18 of the new EU Regulation 2022/123 Although the developer, Veru, has not yet applied to EMA for a marketing authorisation or a rolling review, the review (based on data from the company) will assist EU Member States which may consider allowing use of the medicine before a possible authorisation. The ETF will conduct this review and send recommendations to the CHMP, which will issue the Agency’s opinion. | 27 Jul 2022 |
| Pfizer Canada ULC/BioNTech SE | Comirnaty | Health Canada | Bivalent booster (ages 12 years and over) – Under review | 25 Jul 2022 |
| Biocelect Pty Ltd (on behalf of Novavax Inc.) | COVID-19 vaccine, NUVAXOVID | TGA/Australia | Provisionally approved granted for use in individuals aged 12-17 years. The decision follows provisional approvals on 19 Jan 2022 for use of vaccine in adults and on 9 Jun 2022, a booster dose for use in adults. | 25 Jul 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | EMA/EU | EMA’s CHMP started evaluating an application for the authorisation of an adapted version of Comirnaty | 22 Jul 2022 |
| Novavax Inc. | Nuvaxovid® COVID-19 vaccine | Haalth Canada | First booster dose – Under review | 22 Jul 2022 |
| Celltrion Healthcare Hungary Kft. | Regikrona (Regdanvimab) | EMA/EU | To update the product information as follows: To update Section 6.3 of the SmPC to extend the shelf-life of the finished product from 18 months to 21 months. To introduce editorial changes including deletion of the QR code from Annex III (Labelling, section 18 and Package Leaflet, section 6) and to implement linguistic review | 21 Jul 2022 |
| Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine | EMA/EU | Section 6.3 of the SmPC updated to state that stability has been demonstrated for 12 months when Spikevax is stored under certain conditions. | 20 Jul 2022 |
| Moderna | Spikevax COVID-19 vaccine | TGA/Australia | Provisional approval granted for a paediatric dose of the vaccine, for use in individuals aged 6 months to less than 6 years (6 months to 5 years). | 19 Jul 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | EMA/EU | EMA has started evaluating the use of the vaccine in children aged 6 months to 4 years | 18 Jul 2022 |
| Butantan Institute | Coronavac vaccine | Anvisa/Brazil | Expansion of authorisation for emergency use of the vaccine for the age group from 3 to 5 years of age. | 13 Jul 2022 |
| Novavax, Inc. | Novavax COVID-19 Vaccine | FDA/US | Emergency use authorisation granted. Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. | 13 Jul 2022 |
| Novavax + Takeda | Nuvaxovid COVID-19 vaccine | PMDA/Japan | Important precautions added on myocarditis and pericarditis. | 8 Jul 2022 |
| Butantan Institute | CoronaVac vaccine | Anvisa/Brazil | Application submitted for registration. The vaccine has been in emergency use in Brazil since January 17, 2021. | 8 Jul 2022 |
| Pfizer Inc. | Paxlovid (nirmatrelvir and ritonavir) | FDA/US | EUA revised to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. | 6 Jul 2022 |
| Pfizer Australia Pty Ltd | COMIRNATY OMICRON (a monovalent COVID-19 vaccine, riltozinameran) A vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. | TGA/Australia | Provisional determination granted | 6 Jul 2022 |
| Pfizer Australia Pty Ltd | COMIRNATY BIVALENT (a bivalent COVID-19 vaccine, tozinameran & riltozinameran) Amixture of mRNAs of the original (ancestral) and Omicron BA.1 coronavirus strains. | TGA/Australia | Provisional determination granted | 6 Jul 2022 |
| Pfizer Europe MA EEIG | Paxlovid | EMA/EU | Sections 4.3 and 4.5 of the SmPC updated in order to remove piroxicam as a contraindicated medicinal product and to indicate that piroxicam exposure may be decreased due to interaction with Paxlovid, based on scientific literature. The package leaflet is updated accordingly. | 1 Jul 2022 |
| ModernaTX, Inc | Spiikevax COVID-19 vaccine | Health Canada | Bivalent booster (ages 12 years and over) – Under review | 30 Jun 2022 |
| AstraZeneca Pharmaceuticals LP | Evusheld (tixagevimab co-packaged with cilgavimab) | FDA/US | FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval. More information in this letter. | 29 Jun 2022 |
| Sky Bioscience | Multidose COVID-19 vaccine SKYCovione Multi Inj. (recombinant protein-based vaccine) | MFDS/South Korea | Marketing authorisation granted for use with conditions, to prevent COVID-19 in individuals 18 years of age and older. | 29 Jun 2022 |
| AstraZeneca Pharmaceuticals LP | cilgavimab) | FDA/US | Extension to the shelf-life from 18 months to 24 months for specific lots of the monoclonal antibody therapy, | 28 Jun 2022 |
| M/s Gennova Biopharmaceuticals Limited | Lyophilized mRNA Vaccine for Injection (COVID-19) [HGCO-19 | CDSCO/India | Approved for Restricted Use in Emergency Situation in the country for those aged 18 years and over. | 28 Jun 2022 |
| Pfizer Australia Pty Ltd | Comirnaty COVID-19 vaccine | TGA/Australia | Provisional determinationgranted. Currently, the vaccine provisionally approved for use in individuals 5 years of age and older. | 28 Jun 2022 |
| Regeneron Pharmaceuticals, Inc | Casirivimab and REGEN-COV | FDA/US | FDA authorized an extension to the shelf-life from 24 months to 30 months for specific lots. Due to the high frequency of the Omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. | 27 Jun 2022 |
| AstraZeneca UK Limited | Vaxzevria COVID-19 vaccine | MHRA/UK | 1) Updated efficacy and immunogenicity data (SPC section 5.1) 2) Updated preclinical data (SPC sections 4.6 and 5.3 and package leaflet information) 3) Updated frequency of thrombocytopenia (SPC section 4.8 and package leaflet information) | 27 Jun 2022 |
| Pfizer | Comirnaty COVID-19 vaccine | Anvisa/Brazil | Anvisa received a request from the company for the inclusion in the package insert of the booster dose of its vaccine against Covid-19 (Comirnaty) for adolescents aged 12 to 15 and aged 16 to 17. years old | 24 Jun 2022 |
| Valneva Austria GmbH | COVID-19 Vaccine (inactivated, adjuvanted) Valneva | EMA/EU | Marketing authorisation granted for use. It is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. | 24 Jun 2022 |
| Novavax CZ a.s. | Nuvaxovid | EMA/EU | The CHMP has recommended granting an extension of indication to include use in adolescents aged 12 to 17 years. The vaccine is already approved for use in adults aged 18 and above. | 23 Jun 2022 |
| Pfizer Canada ULC/BioNTech SE | Comirnaty | Health Canada | Pediatric dose (ages 6 months-5 years) – Under review | 23 Jun 2022 |
| AstraZeneca Canada Inc | Evusheld | Health Canada | Expanded indication – Under review | 22 Jun 2022 |
| Novavax Inc. | Nuvaxovid COVID-19 vaccine | Health Canada | Adolescent dose (ages 12-17 years) – Under review | 21 Jun 2022 |
| Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine | EMA/EU | Rolling review started for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that causes COVID-19. The review concerns a bivalent vaccine. This means it will target two strains of SARS-CoV-2, in this case the original strain and the Omicron variant of concern. | 17 Jun 2022 |
| Moderna TX Inc. | Moderna COVID-19 Vaccine | FDA/US | EUA amended to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had already been authorised for use in adults 18 years of age and older. | 17 Jun 2022 |
| Pfizer Inc. | Pfizer-BioNTech COVID-19 Vaccine | FDA/US | EUA amended to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had already been authorised for use in individuals 5 years of age and older. | 17 June 2022 |
| Moderna Biotech Spain, S.L | Spikevax | MHRA/UK | Product Information updated (section 4.4 of SmPC and section 2 of PIL) to include a warning concerning the risk of flare-ups of capillary leak syndrome (CLS) in individuals who already have CLS. | 17 Jun 2022 |
| Pfizer/BioNTech | Comirnaty vaccine | EMA/EU | Rolling review has started for a version of Comirnaty adapted to provide better protection against a specific variant or variants of SARS-CoV-2. The review will initially focus on chemistry, manufacturing and controls (CMC), which relate to the manufacturing of the vaccine. | 15 Jun 2022 |
| Pfizer AG | Paxlovid (nirmatrelvir [PF-07321332] and ritonavir) | Swissmedic | Temporary authorisation granted for two years, for use in adults who do not require supplemental oxygen or hospitalisation due to COVID-19 and are at increased risk of developing a severe form of COVID-19. | 15 Jun 2022 |
| Curanto Pharma (Pty) Ltd. | Coronavac, COVDI-19 vaccine | SAHPRA | Registered under Section 15(6a) of the Medicines and Related Substance Act 101 of 1965 and subject to conditions. The Coronavac is an inactivated SARS-CoV-2 virus (CZo2 strain) indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18-59 years of age. | 14 Jun 2022 |
| Biocelect Pty. Ltd. | Nuvaxovid | TGA/Australia | Extension of indication of provisionally registered product, to include booster dose. A booster dose of Nuvaxovid (0.5 mL) may be administered intramuscular y approximately 6 months after completion of a primary series in individuals 18 years of age and older. Nuvaxovid is administered intramuscularly as a single booster dose (0.5 mL) at least 10 weeks after completing a primary series. | 9 June 2022 |
| Dr Reddy’s Laboratories (Pty) Ltd, India | Molnupiravir 200 DRL (molnupiravir) | SAHPRA/ South Africa | Emergency use authorisation granted. for the treatment of adults with mild to moderate COVID-19, who do not require supplemental oxygen and who are at risk of progression to severe COVID-19. These adults must be within 5 days of symptom onset. | 3 Jun 2022 |
| Bliss Pharmaceuticals (Pty) Ltd, India | Molcovir (molnupiravir) | SAHPRA/ South Africa | Emergency use authorisation granted. for the treatment of adults with mild to moderate COVID-19, who do not require supplemental oxygen and who are at risk of progression to severe COVID-19. These adults must be within 5 days of symptom onset. | 31 May 2022 |
| Pfizer Schweiz AG | Comirnaty® paediatric vaccine | Swissmedic | Application submitted and under review, for a booster for children aged 5 to 11 years. | 31 May 2022 |
| Janssen Pharmaceutical K.K. | Jcovden Intramuscular Injection | PMDA/Japan | Approved for the indication, Prevention of disease caused by SARS-CoV-2 infection (COVID-19) for persons aged 18 years and older. | 30 May 2022 |
| Pfizer Canada ULC/BioNTech SE | Comirnaty | Health Canada | First booster dose (ages 5-11 years) – Under review | |
| Sinopharm | Sinopharm BIBP COVID-19 vaccine | SAHPRA/ South Africa | Registered with conditions under Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. | 24 May 2022 |
| BioNTech Manufacturing GmbH | Comirnaty 10 micrograms/dose concentrate for dispersion for injection (orange cap product) | MHRA/UK | Shelf-life information updated, resulting in an update to the SmPC and PIL. | 24 May 2022 |
| Gilead Sciences Farmacêutica do Brasil Ltda | Veklury (remdesivir) | Anvisa/Brazil | New indication approved for the treatment of Covid-19 for adult patients who do not require supplemental oxygen administration and who are at increased risk of progressing to a severe case of Covid 19. | 23 May 2022 |
| Eli Lilly and Company | Bebtelovimab | FDA/US | Authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody | 20 May 2022 |
| AstraZeneca AB | Vaxzevria COVID-19 vaccine | EMA/EU | The CHMP recommended authorising a booster dose (third dose) of the vaccinefor adults who completed the primary vaccination course with this vaccine or an approved mRNA COVID-19 vaccine. Sections 4.2, 4.4, 4.8 and 5.1 of the SmPC haveeen updated, as has the PIL. | 20 May 2022 |
| Moderna Switzerland GmbH | Spikevax COVID-19 vaccine | Swissmedic | An application to extend the indication for the vaccine to children aged 6 months to 5 years has been submitted. | 18 May 2022 |
| Valneva Austria GmbH | Valneva COVID-19 vaccine | EMA/EU | The CHMP has started evaluating an application for a conditional marketing authorisation for the vaccine | 18 May 2022 |
| Janssen-Cilag International NV | Jcovden (previously COVID-19 Vaccine Janssen) | EMU/EU | The (invented) name of the medicinal product was changed from from COVID-19 Vaccine Janssen to Jcovden. | 17 May 2022 |
| Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine | MHRA/UK | The SmPC has been updated to allow for a third dose via heterologous boosting (i.e. someone having a different vaccine to their primary course as a booster) and to shorten the interval between the primary course and booster dose from ‘at least 6 months’ to ‘at least 3 months’. The patient information leaflet remains unchanged. PIL updated on 10 June 2022 | 17 May 2022 |
| Pfizer-BioNTech | Comirnaty ( Pfizer-BioNTech COVID-19 Vaccine) | FDA/US | EUA amended authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the vaccine. More information available on this page. | 17 May 2022 |
| AstraZeneca Pharmaceuticals LP | EVUSHELD™ (tixagevimab co-packaged with cilgavimab) | FDA/US | EUA revised to include new information on hypersensitiv ty reactions and the risk of cross-hypersensitivity with COVID-19 vaccines and related clinical recommendations. For all individuals, Evusheld should be administered under the supervision of a health care provider with appropriate medical support to manage severe allergic reactions. | 17 May 2022 |
| Biomm SA on behalf of CanSino Biologicals | Convidecia COVID-19 vaccine | Anvisa/Brazil | Application received and assessment commenced for the registration of the vaccine | 13 May 2022 |
| Moderna inc. | Spikevax COVID-19 vaccine | Swissmedic | Extension of the indication authorised to children aged 6 to 11 years. | 13 May 2022 |
| Moderna Australia Pty Ltd. | Spikevax COVID-19 vaccine | TGA/Australia | Evaluation of an application to extend the use of the vaccine to children aged 6 months to 5 years old has commenced. A lower dose of the vaccine (25 micrograms in 0.25 mL) is being assessed for 6 months to 5 year old children compared to that used for children, adolescents and adults. | 13 May 2022 |
| Janssen-Cilag Ltd., UK | COVID-19 Vaccine Janssen | MHRA/UK | SPC section 4.4 Special warnings and precautions for use – “Guillain-Barré syndrome” section updated to include transverse myelitis. PIL updated as follows: 1) Section 2 What you need to know before being given the vaccine – info added on Neurological disorders – Inflamation of the spinal corrd (transverse myelitis) 2) PIL section 4 Possible side effects Inflamation of the spinal cord added under “unknown” heading. | 12 May 2022 |
| Lilly USA, LLC | Olumiant (baricitinib) | FDA/US | New indication approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). | 10 May 2022 |
| Biocelect New Zealand Ltd | Nuvaxovid (NVX-CoV2373) COVID-19 Vaccine | Medsafe/New Zealand | Variation submitted to extend the provisional approval of the vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years. | 6 May 2022 |
| Biocelect Pty. Ltd. | Nuvaxovid (NVX-CoV2373) COVID-19 Vaccine | TGA/Australia | Variation submitted to extend the provisional approval of the vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years. | 6 May 2022 |
| GlaxoSmithKline (GSK) Australia Pty Ltd. | Xevudy (sotrovimab) | TGA/Australia | Based on advice from the Advisory Committee on Medicines, which met on 26 April 2022, the Product Information has been updated to advise that it is uncertain if the approved dose (500 mg) of Xevudy will be effective against the Omicron BA.2 sublineage. In the meantime, the TGA is waiting on further data from the sponsor to support the efficacy of the higher (1000 mg) dose of XEVUDY against the Omicron BA.2 sublineage. | 6 May 2022 |
| Gilead Sciences Pty Ltd | Veklury (remdesivir) | TGA/Australia | Provisional approval granted to extend the use of the treatment to include the following · adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, who require supplemental oxygen, and · adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. | 6 May 2022 |
| Janssen Biotech, Inc | Janssen COVID-19 Vaccine | FDA/US | The FDA has limited the authorized use of the vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the vaccine because they would otherwise not receive a COVID-19 vaccine. | 5 May 2022 |
| Eli Lilly and Company | bamlanivimab and etesevimab | FDA/US | FDA authorized an extension to the shelf-life from 18 months to 24 months for specific lots. Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. | 4 May 2022 |
| Novavax | Nuvaxovid (NVX-CoV2373) COVID-19 Vaccine | MHRA/UK | Application submitted to etend the conditional marketing authorisation for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years. | 4 May 2022 |
| Merck Sharp & Dohme (MSD) | Molnupiravir | Anvisa/Brazil | Emergency use approved for the treatment of Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of disease progression to severe cases and whose alternative Covid-19 treatment options approved or authorized by Anvisa are not accessible or clinically suitable. | 4 May 2022 |
| Moderna Australia Pty Ltd | bivalent COVID-19 vaccine, elasomeran/elasomeran 0-omicron (SPIKEVAX Bivalent Zero/Omicron). | TGA/Australia | Provisional determination granted. This mRNA vaccine (mRNA-1273) is based on the original (“wild type”) SARS-CoV-2 spike glycoprotein. With the emergence of COVID-19 variants of concern, Moderna has developed a bivalent vaccine that includes the mRNA sequence encoding the spike protein of the Omicron variant of concern and the same mRNA-1273 backbone as in the original SPIKEVAX vaccine. | 27 Apr 2022 |
| Zalika Farmacêutica Ltda, representing Serum Institute of India. | Covid-19 vaccine (recombinant) Covovax The vaccine uses recombinant protein technology | Anvisa/Brazil | Registration request was submitted within the scope of RDC 415/2020 which brings extraordinary criteria and procedures for registration requests arising from the new coronavirus. The proposed indication is for adults over 18 years of age. | 27 Apr 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | MHRA UK | The MHRA website states “Updated information to SPCs and and PILs (Purple Cap and Orange Cap)”. No other information is provided. | 27 Apr 2022 |
| Takeda Pharmaceutical Company Limited | Spikevax COVID-19 vaccine | PMDA/Japan | Revision of precautions. Information added on 2nd booster dose as follows: For the fourth dose, the vaccination may be considered in elderly people, etc. based on the benefit/risk balance at least 5 months after the third dose. | 26 Apr 2022 |
| Pfizer/BioNTech | Comirnaty COVID-19 vaccine | PMDA/Japan | Revision of precautions. Information added on 2nd booster dose as follows: For the fourth dose, the vaccination may be considered in elderly people, etc. based on the benefit/risk balance at least 5 months after the third dose. | 26 Apr 2022 |
| M/s Cadila Healthcare Limited | Novel Corona Virus-2019-nCov vaccine (rDNA) (ZyCoV-D) | CDSCO/India | Approved for Restricted Use in Emergency Situation in the country, in patients ≥ 12 years of age. | 26 Apr 2022 |
| Gilead Sciences Inc. | Veklury (remdesivir) | FDA/US | Approval expanded to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: – Hospitalized, or – Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. | 25 Apr 2022 |
| Pfizer AG | Comirnaty COVID-19 vaccine | Swissmedic | COMIRNATY® 30 micrograms/dose concentrate for dispersion for injection for persons 12 years and older (PURPLE cap) – updated new shelf life for the frozen vials, extended from 9 months to 12 months. COMIRNATY® 10 micrograms/dose concentrate for dispersion for injection for children aged 5 to less than 12 years (ORANGE cap) -updated with the =shelf life for the frozen vials, extended from 9 months to 12 months. | 20 Apr 2022 |
| MSD | Lagevrio (Molnupiravir) | HSA/Singapore | Interim authorisation granted under the Pandemic Special Access Route for the treatment of mild to moderate COVID-19 in individuals aged 18 years and above, who are at risk of progressing to severe COVID-19 and/or hospitalisation, and in whom alternative COVID-19 treatment options are not clinically appropriate. | 19 Apr 2022 |
| AstraZeneca Canada Inc | Evusheld (Cilgavimab and tixagevimab) | Health Canada | Authorized in adults and adolescents (12 years of age and older weighing at least 40 kg) for the pre-exposure prophylaxis of COVID-19 in individuals who are immune compromised and unlikely to mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended. | 14 Apr 2022 |
| Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine | MHRA/UK | The MHRA has approved an update to the current UK approval of the vaccine thereby allowing its use in Great Britain (GB) in 6 to 11 year-olds. This approval takes into account the extension to use in children aged 6 to 11 years already approved by the EMA on 2 March 2022, as the original GB licence for Spikevax in adults was approved by relying on the EU decision. Spikevax is authorised for use in children aged 6 to 11 in 6 in NI under the update granted by the European Medicines Agency on 2 March 2022. | 14 Apr 2022 |
| Valneva Austrial GmbH | COVID-19 vaccine Valneva (inactivated, adjuvanted, adsorbed). | MHRA/UK | Conditional Marketing Authorisation granted valid in GB and NI. It is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in adults from 18 to 50 years of age. | 14 Apr 2022 |