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 24 September 2021 – 13 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 3 of 3 for regulatory status from 14 April 2022
Other news including on vaccines, treatments, trials and side effects, here.
| Company(ies)/ Organisation/ Others | Product | Issuing Regulatory Agency/Organisation | Regulatory status update | Date |
|---|---|---|---|---|
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | MHRA/UK | Updated shelf-life from 9-months to 12-months for Comirnaty 30 microgram COVID-19 mRNA Vaccine (purple cap) | 13 Apr 2022 |
| Future Health Pharma GmbH on behalf of Novavax | Nuvaxovid COVID-19 vaccine (a protein based vaccine) | Swissmedic | Temporary authorisation granted for use in people aged 18 and over. | 13 Apr 2022 |
| Pfizer/BioNTech | Comirnaty COVID-19 vaccine | Swissmedic | Extension of shelf-life from 9 months to 12 months approved. | 12 Apr 2022 |
| Pfizer Australia Pty Ltd | COVID-19 vaccine, Comirnaty | TGA/Australia | Provisional approval granted for use as a booster in individuals aged 12 to 15 years old. | 8 April 2022 |
| GlaxoSmithKline (GSK) Australia Pty Ltd | Sotrovimab (Xevudy) | TGA/Australia | TGA has received an application for a higher (1000 mg) dose of GSK’s COVID 19 treatment, sotrovimab (Xevudy). This higher dose will be considered for treatment of patients suspected to have infection caused by the Omicron BA.2 sublineage. | 7 Apr 2022 |
| Janssen-Cilag | Covid-19 vaccine (recombinant) | Anvisa/Brazil | Full registration approved. In addition to contemplating primary immunization, the registry includes the approval of the booster dose. The vaccine was approved for emergency use on March 31, 2021. It is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in persons 18 years of age and older. | 5 Apr 2022 |
| GlaxoSmithKline LLC | Sotrovimab | FDA/US | Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant | 5 Apr 2022 |
| Sanofi Pasteur | Vidprevtyn | EMA/EU | EMA has started evaluating a MAA authorisation | 30 Mar 2022 |
| Wyeth Indústria Farmacêutica Ltda./Pfizer | Paxlovid (nirmatrelvir + ritonavir) | Anvisa/Brazil | Temporary authorisation for emergency use approved for the treatment of Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of progression to severe Covid-19. | 30 Mar 2022 |
| Moderna US Inc. | Spikevax COVID-19 vaccine | FDA/US | FDA authorised a second booster dose of the vaccine. The agency amended the EUA as follows: A second booster dose of the vaccine may be administered: – to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine – at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise. | 29 Mar 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | FDA/US | FDA authorised a second booster dose of the vaccine. The agency amended the EUA as follows: A second booster dose of the vaccine may be administered: – to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine – to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise. | 29 Mar 2022 |
| HIPRA Human Health S.L.U. | COVID-19 Vaccine HIPRA (also known as PHH-1V). | EMA/EU | The CHMP has started a rolling review of this vaccine. This protein-based vaccine is being developed by HIPRA Human Health S.L.U. as a booster vaccine for adults who have already been fully vaccinated with a different COVID-19 vaccine. According to the data presented by the company, the drugs Regn-Cov-2 and Regkirona showed a significant drop in activity against the Ômicron variant of the new coronavirus. | 29 Mar 2022 |
| Celltrion Healthcare Distribuição d e Produtos Farmacêuticos do Brasil Ltda | Regkirona (regdanvimab) | ANVISA/Brazil | Emergency Use Authorisation temporarily suspended until data are presented. that prove its effectiveness against the Omicron variant of Sars-CoV-2 or another variant of concern that will become predominant in the country. | 28 Mar 2022 |
| Regn-Cov-2 (casirivimab and imdevimab) | ANVISA/Brazil | Emergency Use Authorisation temporarily suspended until data are presented. that prove its effectiveness against the Omicron variant of Sars-CoV-2 or another variant of concern that will become predominant in the country. | 28 Mar 2022 | |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | MHRA/UK | Updated 30mg and 10mg PIL and SPC. No further information provided by the MHRA. | 25 Mar 2022 |
| Moderna Biotech Spain S.L. | Spikevax COVID-19 vaccine | MHRA/UK | Updated SmPC and PIL. No further information provided by the MHRA. Moderna has confirmed the following updates: Sections 4.6 and 4.8 of the SmPC (Paraesthesia added to the ADR table in section 4.8) have been updated. Sections 2 and 4 of the PIL have been updated. | 24 Mar 2022 |
| AstraZeneca AB | Evusheld (tixagevimab/cilgavimab) | EMA/EU | The CHMP has recommended granting a marketing authorisation for the prevention of COVID-19 in adults and adolescents from 12 years of age weighing at least 40 kg before potential exposure to the SARS-CoV-2 virus. | 24 Mar 2022 |
| Serum Institute of India Pvt. Ltd. (SII) | Covovax™ (NVX-CoV2373) | CDSCO/India | Emergency use authorisation (EUA) granted for adolescents aged ≥12 to <18 years. | 22 Mar 2022 |
| Moderna Inc. | Spikevax COVID-19 vaccine | FDA/US | Application submitted to ask for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of vaccine in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. | 17 Mar 2022 |
| ModernaTX, Inc. | Spikevax COVID-19 vaccine | Health Canada | Extension of the indication of Spikevax to include active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 6 years to 11 years of age approved. | 17 Mar 2022 |
| AstraZeneca UK Limited | Evusheld (tixagevimab/cilgavimab) | MHRA/UK | Conditional Marketing Authorisation for Evusheld in Great Britain granted. Evusheld is indicated for the pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and: -Who are unlikely to mount an adequate immune response to COVID-19 vaccination or -For whom COVID-19 vaccination is not recommended. | 17 Mar 2022 |
| M/s Hetero Biopharma Ltd | SPUTNIK Light (Recombinant adenoviral vector vaccine containing particles of serotype 26 containing the protein S gene of the SARS-CoV-2 virus) | CDSCO/India | For ≥ 18 years age For Restricted Use in Emergency Situation | 16 Mar 2022 |
| Pfizer/BionNTech | Comirnaty COVID-19 vaccine | FDA/US | Application submitted for U.S. Emergency Use Authorization of an additional booster dose of the vaccine for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines, | 15 Mar 2022 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | MHRA/UK | • SmPC and PIL Comirnaty 30mg/dose concentrate, title updated to include reference to purple cap. • Section 4.2 of the SmPC Includes new reference to the fact there is now paediatric formulation available for children 5 to 11 years of age. • In section 4.8 the SmPC and section 4 of the PIL, and Myo/pericarditis changed from a potential side effect of unknown frequency to “very rare”. • In section 4.8 the SmPC and section 4 of the PIL, Erythema multiforme added as a potential side effect with unknown frequency. • In section 6.3 of the SmPC and section 5 of the PIL, shelf life updated from 6 months to 9 months. | 14 Mar 2022 |
Moderna Biotech Spain, S.L. | Spikevax (elasomeran) | EMA/EU | EMAs PRAC has recommended that a warning for flare-ups of capillary leak syndrome (CLS) should be added to the product information for the vaccine. | 11 Mar 2022 |
| Janssen-Cilag International NV | COVID-19 Vaccine Janssen | EMA/EU | EMAs PRAC has recommended that small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skin’s surface and bruising) should be added to the product information of the vaccine as a possible side effect of unknown frequency. | 11 Mar 2022 |
| Biocelect Pty Ltd (on behalf of Novavax Inc.) | Nuvaxovid | TGA/Australia | Second provisional determination granted. This means that the company is now able to apply for provisional registration for the vaccine for use in adolescents and children as data becomes available. Biocelect Pty Ltd has indicated that they intend to apply for provisional registration of the vaccine for use in individuals 12 years and older in April 2022 and anticipate that an application for use in children 5-11 years old will be submitted to the TGA later in the year. Currently, Nuvaxovid is provisionally approved for the active immunisation of adults aged 18 years and older for the prevention of disease caused by SARS-CoV-2. | 10 Mar 2022 |
| Janssen Biotech Inc | Janssen COVID-19 Vaccine | FDA/US | EUA updated. FDA authorized an extension for the shelf life of the refrigerated vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. | 4 Mar 2022 |
| Astrazeneca do Brasil Ltda | Evusheld®️(cilgavimab + tixagevimab + tixagevimab ). | ANVISA/ Brazil | Temporary authorisation for emergency use approved for the indication for prophylaxis before exposure to Covid-19, in adult and pediatric individuals (12 years of age and older, weighing at least 40 kg), who have not had a known recent exposure to an individual infected with SARS-CoV-2 and who have moderate to severe immune compromise due to a medical condition and/or receiving immunosuppressive drugs or treatments and who may not have an adequate immune response to vaccination against Covid-19. The drug will also be indicated for whom vaccination with any available Covid-19 vaccine is not recommended, due to a history of serious adverse reaction (e.g. severe allergic reaction) or allergy to any component of the Covid-19 vaccine. | 24 Feb 2022 |
| AstraZeneca Pharmaceuticals LP | EVUSHELD™ (tixagevimab co-packaged with cilgavimab) | FDA/US | EUA revised to change the initial dose for the authorised use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients. Based on the most recent information and data available, Evusheld may be less active against certain Omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorised Evusheld dose. | 24 Feb 2022 |
| AstraZeneca Pty Ltd | tixagevimab and cilgavimab (Evusheld) | TGA/Australia | Granted provisional approval for the pre-exposure* prophylaxis (prevention) of COVID-19 in people aged 12 years and older weighing at least 40 kg: -who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination; or -for whom vaccination is not recommended due to a history of severe adverse reaction to a COVID‐19 vaccine or COVID‐19 vaccine component. *people who are at risk of infection but have not been exposed to the virus, known as pre-exposure prevention of COVID-19. | 24 Feb 2022 |
| Medicago Inc. | COVIFENZ, COVID-19 Vaccine (plant-based virus-like particles [VLP], recombinant, adjuvanted) | Health Canada | Recommended for authorisation under Division 8 of the Food and Drug Regulations, for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 64 years of age. | 24 Feb 2022 |
BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | EMA/EU | The CHMP has recommended that a booster dose of Comirnaty may be given where appropriate to adolescents from 12 years of age. The vaccine is already authorised in the EU as a 2-dose primary course in adolescents (as well as adults and children from 5 years of age) and a booster dose is currently authorised from 18 years of age. | 24 Feb 2022 |
| Moderna Biotech Spain S.L. | Spikevax COVID-19 vaccine | EMA/EU | The CHMP has recommended granting an extension of indication to include use in children aged 6 to 11 years. The vaccine is already approved for use in adults and children aged 12 and above. | 24 Feb 2022 |
| Medicago Inc. | Covifenz COVID-19 vaccine (uses plant based protein technology) | Health Canada | Authorised with terms and conditions, for the prevention of COVID-19 in adults 18 to 64 years of age | 24 Feb 2022 |
| Novavax Inc. | Nuvaxovid COVID-19 vaccine | Health Canada | Authorised for use in active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. | 17 Feb 2022 |
| Pfizer(Pty) Ltd. | Paxlovid (nirmatrelvir and ritonavir) | SAHPRA/South Africa | An application has been submitted for use in adults diagnosed with mild-to-moderate COVID-19 and is under consideration. | 17 Feb 2022 |
| MSD (Pty) Ltd | Molnupiravir (Lagevrio) | SAHPRA/South Africa | Authorised, with conditions, the importation of a limited quantity molnupiravir in terms of section 21 of the Medicines and Related Substances Act, 1965 , initially for a period of 6 months. Application for the registration of “LAGEVRIO”, for which a rolling review has commenced. | 17 Feb 2022 |
| Moderna Australia Pty Ltd. | Spikevax Covid-19 vaccine | TGA/Australia | Provisional approval granted for use in individuals aged 6 years and older. The decision follows the provisional approvals granted for the use of Spikevax in individuals aged 12 years and older on 3 September 2021, and on 7 December 2021 the Spikevax booster dose for use in adults 18 years and older. | 17 Feb 2022 |
| Janssen-Cilag Ltd. | Covid-19 vaccine Janssen | MHRA/UK | The MHRA confirms an update to the product information but no further information has been provided. Janssen have confiremde the following updates: On 11 February: SmPC i) Section 6.3 Shelf Life updated to reflect extended shelf life of the product from 3 months to 4.5 months when stored at 2 to 8°C ii) Section 6.4 Special precautions – Updated to reflect extend shelf-life in section 6.3. On 14 February SmPC Sections 4.4 Special Warnings and Precuartions for use and 4.8 Undesirable Effects updated to include Venous Thromboembolism (VTE) as an ADR; to add a new warning on Immune Thrombocytopenia (ITP) and to add dizziness and ITP to the table of ADRs with frequencies uncommon and not known respectively. the PIL has been updated to reflect the above changes. | 14 Feb 2022 |
| Future Health Pharma GmbH (representing Novavax) | Nuvaxovid vaccine | Swissmedic | Authorisation application submitted under the procedure according to Art. 13 of the Therapeutic Products Act (TPA). This enables Swissmedic to take the review by the EMA into consideration. | 14 Feb 2022 |
| Eli Lilly and Company | bebtelovimab, monoclonal antibody) | FDA/US | Emergency Use Authorisation granted for the treatment of mild/moderate COVID-19 in adults and pediatric patients (aged 12 years and over, and weighing at least 40kg) with a +ve COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. | 11 Feb 2022 |
| Pfizer Japan Inc. | Paxlovid (Nirmatrelvir + Ritonavir) | PMDA/Japan | Special Approval for Emergency under Article 14-3 granted for use in the treatment of disease caused by SARS-CoV-2 infection (COVID-19) for adults and children aged ≥12 years. | 10 Feb 2022 |
| AstraZeneca Pty Ltd | COVID-19 vaccine, Vaxzevria | TGA/Australia | Provisional approval of a booster dose for individuals aged 18 years and older. | 8 Feb 2022 |
| BioNTech Manufacturing GmbH | Comirnaty vaccine | EMA/ EU | Evaluation of an application for the use of a booster dose of the vaccine in adolescents aged 12 to 15 years has started. | 8 Feb 2022 |
| M/s Dr. Reddy’s Lab. Ltd. (Importer) | Recombinant adenoviral vector vaccine containing particles of serotype 26 containing the protein S gene of the SARS-CoV-2 virus (SPUTNIK Light) | CDSCO/India | Approved for Restricted Use in Emergency Situation for those ≥ 18 years age. | 5 Feb 2022 |
| Gilead Sciences Pty Ltd | Veklury (remdesivir) | TGA/Australia | Second Provisional determination granted allowing Gilead Sciences to vary the provisional approval (see below), for use in children and adults who have not yet progressed to severe COVID-19 (those not in hospital). Currently, VEKLURY is provisionally approved for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised and require oxygen. | 5 Feb 2022 |
| Novavax | Nuvaxovid COVID-19 vaccine | Medsafe/New Zealand | Provisional approval granted. | 4 Feb 2022 |
| Novavax | Nuvaxovid COVID-19 vaccine | HSA/Singapore | Interim authorisation granted under the Pandemic Special Access Route (PSAR) for the prevention of COVID-19 in individuals aged 18 years and above. | 3 Feb 2022 |
| Novavax | Nuvaxovid COVID-19 vaccine ((recombinant, adjuvanted)) | MHRA/UK | Conditional Marketing Authorisation (CMA) granted in Great Britain only. It is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine is authorised in Northern Ireland under an Emergency Use Authorisation granted by the European Medicines Agency on 20 December 2021. | 3 Feb 2022 |
| MC Pharma | COVID-19 Vaccine MC pharma (inactivated Vero Cell vaccine) Initially developed by the Beijing Institute of Biological Products Co., Ltd, this product has also been referred to as the Sinopharm/BBIBP vaccine. | SAHPRA/South Africa | Registered under section 15 of the Medicines and Related Substance Act (Act 101 of 1965 as Amended), with conditions, indicated for immunisation against SARS-CoV-2 in those aged 18 years and older. | 31 Jan 2022 |
| Pfizer | Paxlovid | HSA/Singapore | Interim authorisation granted under the Pandemic Special Access Route (PSAR) | 31 Jan 2022 |
| ModernaTx, Inc | Spikevax (also known as Moderna COVID-19 vaccine for EUA use) | FDA/US | Approved for use for the active immunization against coronavirus disease 2019 (COVID-19) caused by the SARS‑CoV-2 virus in persons 18 years of age and older. Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine. Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. | 31 Jan 2022 |
| Pfizer Australia Pty Ltd. | Comirnaty COVID-19 vaccine | TGA/Australia | Provisionally approved for use as a booster in individuals aged 16 and 17 years old. | 28 Jan 2022 |
| Pfizer Europe MA EEIG | Paxlovid (PF-07321332 / ritonavir) | EMA/EU | Conditional Marketing Authorisation granted to treat COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. | 28 Jan 2022 |
| AstraZeneca UK Limited | Vaxzevria COVID-19 vaccine | MHRA/UK | SmPC section 4.4 Special warnings and precautions for use, sub-section ‘Neurological events’ updated to add extremely rare cases of transverse myelitis. Table 1 in the Section 4.8 Undesirable effects, sub section ‘Nervous system disorders’ updated to add Frequency (Not known): transverse myelitis. The PIL has been updated according in the respective sections. | 26 Jan 2022 |
| Pfizer | Comirnaty vaccine | SAHPRA/South Africa | Registered under section 15 of the Medicines and Related Substance Act (Act 101 of 1965 as Amended), with conditions, with the indication for active immunisation to prevent COVID-19 in individuals 12 years of age and older. | 25 Jan 2022 |
| Eli Lilly and Company | Bamlanivimab and etesevimab administered together | FDA/US | FDA revised the authorisation to limit its use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Revised fact sheet for healthcare providers. | 24 Jan 2022 |
| Regeneron Pharmaceuticals Inc. | REGEN-COV (casirivimab and imdevimab) | FDA/US | FDA revised the authorisation to limit its use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Revised fact sheet for healthcare providers. | 24 Jan 2022 |
| AstraZeneca AB | Vaxzevria COVID-19 vaccine | EMA/EU | The EMA has approved a scale up of manufacturing of Vaxzevria. An existing manufacturing site operated by Universal Farma in Guadalajara, Spain, will add a second filling line for the finished product | 24 Jan 2022 |
| Pfizer/BioNTech | Comirnaty COVID-19 vaccine | Special Approval for Emergency Use granted for the prevention of disease caused by SARS-CoV-2 infection (COVID-19) in children 5 to 11 years of age. | 22 Jan 2022 | |
| Chugai Pharmaceutical Co., Ltd | Actemra for Intravenous Infusion (tocilizumab) | PMDA/Jaoan | Approved with conditions for use in pneumonia caused by SARS-CoV-2 infection (COVID-19) (limited to patients requiring supplemental oxygen) | 21 Jan 2022 |
| Gilead Sciences Inc. | Veklury (remdesivir) | FDA/US | The FDA has expanded the approved indication for Veklury to include its use in adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. The agency also revised the Emergency Use Authorization (EUA) for Veklury to additionally authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization of death. | 21 Jan 2022 |
| Butantan on behalf os SInovac, China | Butantan Coronavac | ANVISA/Brazil | Emergency use authorisation granted for the inclusion of use in children and adolescents between 6 and 17 years old, who are not immunocompromised, | 20 Jan 2022 |
| Merck Sharp & Dohme (Australia) Pty Ltd. | Lagevrio (molnupiravir) | TGA/Australia | Provisional approval granted for the treatment of adults with COVID-19 who do not require initiation of oxygen and who are at increased risk of progression to hospitalisation or death. | 20 Jan 2022 |
| Pfizer Australia Pty Ltd. | Paxlovid (nirmatrelvir + ritonavir) | TGA/Australia | Provisional approval granted for the treatment of adults with COVID-19 who do not require initiation of oxygen and who are at increased risk of progression to hospitalisation or death. | 20 Jan 2022 |
| Biocelect Pty Ltd. (on behalf of Novavax) | COVID-19 vaccine, Nuvaxovid | TGA/Australia | Provisional approval granted for active immunisation to prevent COVID-19 in individuals 18 years of age and older. | 19 Jan 2022 |
| Moderna Switzerland GmbH | Spikevax | Swissmedic | Shelf-life extended from 7 to 9 months for storage between -25 °C and -15 °C for Spikevax, dispersion for injection. | 19 Jan 2022 |
| Pfizer | Paxlovid (has two synthetic active substances (nirmatrelvir/ritonavir) in separate tablets | Swissmedic | An authorisation application has been submitted (under a rolling review process) for the treatment of COVID-19. | 18 Jan 2022 |
| Pfizer Canada ULC | Paxlovid (nirmatrelvir and ritonavir) | Health Canada | Notice of COmpliance Issued for New Drug Submission. Authorised with terms and conditions for for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death | 17 Jan 2022 |
| Pfizer | Paxlovid | Cofepris/Mexico | Authorised for controlled emergency use to treat adult patients with mild or moderate COVID-19 and at risk of complications | 14 Jan 2022 |
| GlaxoSmithKline | Xevudy (sotrovimab) antibody | Swissmedic | Temporary authorisation granted for treatment of COVID-19 in adults and adolescents aged 12 years and over and with a body weight of at least 40 kg if oxygen therapy or hospitalisation is not required due to the disease and there is a high risk of developing a severe form of COVID-19. | 14 Jan 2022 |
| iQone Healthcare Switzerland | Regkirona (regdanvimab) antibody | Swissmedic | Temporary authorisation granted for treatment of COVID-19 in adults if oxygen therapy or hospitalisation is not required due to the disease and there is a high risk of developing a severe form of COVID-19. | 13 Jan 2022 |
| Janssen Biotech Inc. | Janssen (Johnson and Johnson) COVID-19 Vaccine | FDA/US | EUA reissued with the following changes: 1) Section 5 Warnings and Precautions of the EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (Full Prescribing Information) is revised to include new information on an increased risk of immune thrombocytopenia (ITP) during the 42 days following vaccination. ii) Related changes were also made to the EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (short version) for consistency. More information here. | 11 Jan 2022 |
| Pfizer Limited | Paxlovid (Paxlovid is PF-07321332 tablets co-packaged with ritonavir tablets.) | MHRA/UK | The MHRA website states, Updated the SPC and PIL for Paxlovid. Drug Interactions stated in the SmPC and PIL have been harmonised following an MHRA request. Section 4.5 of the SmPC and Section 2 the PIL have been updated to achieve the harmonisation. | 11 Jan 2022 |
| MSD | Molnupiravir | Cofepris/Mexico | Authorised for emergency use to treat patients with mild or moderate COVID-19, and with high risk of complications | 7 Jan 2022 |
| ModernaTX, Inc | Moderna COVID-19 Vaccine | FDA/US | EUA amended to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. | 7 Jan 2022 |
| AstraZeneca UK Limited | Vaxzevria vaccine | MHRA/UK | MHRA website states -‘Updated summary of product characteristics and package leaflet information’. -Updated the Reg 174 information for Healthcare professionals and UK recipients. No other information is provided but it seems from this safety update (Volume 15 issue 6 Jan 2022) that the product information for was updated to allow for the use of the vaccine as a booster or third dose and to include safety information on immune thrombocytopenia (ITP), cerebral venous sinus thrombosis (CVST) without thrombocytopenia, and facial paralysis. | 5 Jan 2022 |
| AstraZeneca Pty Ltd. | tixagevimab and cilgavimab (Evusheld) | TGA/Australia | Further provisional determination granted, for prevention and treatment of COVID-19 in individuals aged 12 years and older. | 4 Jan 2022 |
| Pfizer-BioNTech | Comirnaty, Pfizer-BioNTech COVID-19 Vaccine | FDA/US | EUA amended to: -Expand the use of a single booster dose to include use in individuals 12 through 15 years of age. -Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months. – Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age. | 3 Jan 2022 |
| Pfizer Limited | Paxlovid (Paxlovid is PF-07321332 tablets co-packaged with ritonavir tablets.) | MHRA/UK | Conditional Marketing Authorisation issued for Great Britain and a temporary Regulation 174 authorisation for Northern Ireland to ensure supply across all of the UK. More information here. Paxlovid is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19. | 31 Dec 2021 |
| M/s Serum Institute of India Pvt. Ltd | SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine [COVOVAX] | CDSCO/India | Approved for restricted emergency use for the prevention of COVID-19 | 28 Dec 2021 |
| M/s Biological E Limited | SARS-CoV-2 vaccine containing Receptor Binding Domain (RBD) of SARS-CoV-2 gene (CORBEVAX) | CDSCO/India | Approved for restricted emergency use for the prevention of COVID-19 | 28 Dec 2021 |
| Center for Genetic Engineering and Biotechnology (CIGB) in Havana | Recombinant protein of the receptor-binding domain of the SARS-CoV-2 virus (Abdala COVID-19 vaccine) | Cofepris/Mexico | Authorised for emergency use. This is a three dose vaccine. More about the vaccien here. | 28 Dec 2021 |
| Janssen-Cilag AG | COVID-19 Vaccine Janssen | Swissmedic | Approval granted for booster dose so that persons aged 18 years and older can now receive a booster dose after a first vaccination. The booster dose of the vaccine can be administered, at the earliest, two months after the first dose. | 27 Dec 2021 |
| Bharat Biotech | Covaxin COVID-19 vaccine | CDSCO/India | Approval granted for emergency use in children aged 12 to 18. | 25 Dec 2021 |
| MSD KK | Lagevrio (Molnupiravir) | PMDA/Japan | Special Approval for Emergency Use granted for the Treatment of disease caused by SARS-CoV-2 infection (COVID-19) for patients aged ≥18 years. | 24 Dec 2021 |
| Moderna, Biotech Spain, S.L. | Spikevax vaccine | MHRA/UK | The MHRA update states ‘Frozen storage instructions’. It seems that the following text has been deleted from section 6.4 of the SmPC ‘Do not store on dry ice or below -50ºC’. The leaflet will have been updated accordingly. Note that the date of the updated SmPC is 22 Dec 2021. | 24 Dec 2021 |
| Roche | Ronapreve (a combination of antiboides casirivimab and imdevimab) | Swissmedic | Swissmedic has approved the product which was already authorised for prescription use, for use under COVID-19 Ordinance 3. Ronapreve is indicated in adults and adolescents aged 12 years or older with a bodyweight of at least 40 kg: – for treatment of COVID-19 if oxygen therapy or hospitalisation is not required and there is a high risk of developing a severe form of COVID-19. – for prevention of COVID-19 when an adequate immune response to COVID-19 vaccination is not possible. | 23 Dec 2021 |
| Janssen | COVID-19 Vaccine Janssen | SAHPRA/South Africa | Booster dose granted approval for use with conditions, under section 15 Medicines and Related Substance Act (Act 101 of 1965), for 2nd dose at least 2 months after primary vaccination. | 23 Dec 2021 |
| Merck Sharp & Dohme Corp | molnupiravir | FDA/US | Emergency Use Authorisation (EUA) issued for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. | 23 Dec 2021 |
| Moderna, Biotech Spain, S.L. | Spikevax vaccine | MHRA/UK | The MHRA update states ‘SmPC & PIL updated’. No further infromation is provided. It seems that the section 6.4 of the SmPC has been updated to change the storage time period for the unopened vial from 7 months to 9 months. The leaflet will have been updated accordingly. | 22 Dec 2021 |
| ? | Turkovac COVID-19 vaccine | TITCK/Turkey | Emergency use approval granted. | 22 Dec 2021 |
| Pfizer Inc. | Oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) | FDA/US | EUA issued for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. | 22 Dec 2021 |
| BioNTech Manufacturing GmbH | Comirnaty vaccine | MHRA/UK | Approval granted for a new age-appropriate formulation of Comirnaty, for use in children aged 5 to 11 years old. This new authorisation to the Conditional Marketing Authorisation (CMA) granted by the MHRA is valid in Great Britain only. | 22 Dec 2021 |
| Pharmac? | Ronapreve monoclonal antibody | Medsafe/New Zealand | Ronapreve is approved for: -the treatment of COVID-19 for people who are affected by COVID-19 and are at increased risk of progressing to severe COVID-19 disease. -for preventing COVID-19 for people who have been exposed to the virus and have a medical condition that makes them unlikely to be protected by vaccination. | 21 Dec 2021 |
| Novavax CZ, a.s. | Nuvaxovid (also known as NVX-CoV2373) | EMA/EU | Conditional Marketing Authorisation granted, to prevent COVID-19 in people from 18 years of age | 20 Dec 2021 |
| Vaxine Pty Ltd | COVID-19 vaccine: Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2 | TGA/Australia | Provisional determination granted. | 20 Dec 2021 |
| Gilead Sciences Ireland UC | Veklury (remdesivir) | EMA/EU | The CHMP adopted a change to the existing indication to add that Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in: adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. | 16 Dec 2021 |
| BioNTech Manufacturing GmbH | Comirnaty COVID-19 vaccine | FDA/US | Approval to include a new 30 mcg dose formulation (Tris/Sucrose) manufactured at the Pfizer Manufacturing Belgium NV, Puurs, Belgium (Pfizer, Puurs) facility. This new formulation: -is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers. -does not need to be diluted before use, thus, vaccination providers can more readily prepare and deliver appropriate doses. -contains Tris buffer, a commonly used buffer in other FDA-approved vaccines and biologics. | 16 Dec 2021 |
| Janssen-Cilag International NV. | COVID-19 Vaccine Janssen | EMA/EU | CHMP approves an additional manufacturing site for the production of the vaccine. The site, located in Marcy-l’Étoile, France, and operated by Sanofi Pasteur, will manufacture finished product | 16 Dec 2021 |
| BioNTech Manufacturing GmbH | Comirnaty Vaccine | EMA/EU | CHMP approves an increase in production of the active substance of the vaccine at manufacturing site operated by Wyeth BioPharma Division of Wyeth Pharmaceuticals, located in Andover, MA, USA. | 16 Dec 2021 |
| Moderna Biotech Spain, S.L. | COVID-19 vaccine Spikevax | EMA/EU | CHMP has given a positivie opinion for an increase in production of Spikevax, at the manufacturing site operated by ROVI Contract Manufacturing, located in Madrid, Spain. The increase in production includes a 50% scale-up of the batch size of the finished product and a second fill-and-finish line | 16 Dec 2021 |
| Pfizer | Paxlovid (PF-07321332/ritonavir) an oral treatment for COVID-19. | EMA/EU | The CHMP has issued advice on the use of Paxlovid and ritonavir for the treatment of COVID-19. The medicine, which is not yet authorised in the EU (butreview has started) , can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. Paxlovid should be administered ASAP after diagnosis of COVID-19 and within 5 days of the start of symptoms. The separate tablets, should be taken together twice a day for 5 days. | 16 Dec 2021 |
| Swedish Orphan Biovitrum AB (publ) | Immunosuppressive, Kineret (anakinra) | EMA/EU | The CHMP has recommended extending the indication of the product, to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml. | 16 Dec 2021 |
| GlaxoSmithKline Trading Services Limited | monoclonal antibody Xevudy (sotrovimab) | EMA/EU | The CHMP has recommended authorising Xevudy for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. | 16 Dec 2021 |
| Moderna | Spikevax COVID-19 vaccine | PMDA/Japan | Booster dose approved. Special approval for emergency use. Further information in this list. | 16 Dec 2021 |
| Janssen-Cilag International NV | COVID-19 Vaccine Janssen | EMA/EU | The CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at least two months after the first dose in people aged 18 years and above. CHMP has also concluded that that a booster dose with COVID-19 Vaccine Janssen may be given after two doses of one of the mRNA vaccines authorised in the EU, i.e. Comirnaty or Spikevax. | 15 Dec 2021 |
| Janssen Biotech Inc. | Janssen (Johnson and Johnson) COVID-19 Vaccine | FDA/US | EUA amended with the following changes: EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (Full Prescribing Information) is revised to include new informatin in the following sections: 4 CONTRAINDICATIONS 4.2 Thrombosis with Thrombocytopenia 5 WARNINGS AND PRECAUTIONS 5.2 Thrombosis with Thrombocytopenia Syndrome (TTS) 6 OVERALL SAFETY SUMMARY 6.1 Clinical Trial Experience Related changes were also made to the EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (short version) for consistency More information here. | 14 Dec 2021 |
| Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics | oral antiviral medicine Lagevrio (molnupiravir) | EMA/EU | Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio (molnupiravir) prior to marketing authorisation, the Agency will review more data from the main study of Lagevrio (MK-4482-002) EMA has started evaluating a marketing authorisation application under a reduced timeline. | 14 Dec 2021 |
| Pfizer/BioNTech | Comirnaty vaccine | Swissmedic | Approval granted for use in children aged 5 to 11 years. | 10 Dec 2021 |
| Pfizer-BioNTech | Comirnaty Vaccine | HSA Singapore | HSA extends the PSAR authorisation for use in children of ages 5 to 11 years for the prevention of COVID-19, at a lower dose of 10mcg. | 10 Dec 2021 |
| BioNTech Manufacturing GmbH | Pfizer-BioNTech COVID-19 Vaccine. | FDA/US | Emergency use authorisation (EUA) amended, authorising the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. | 9 Dec 2021 |
| AstraZeneca Pharmaceuticals LP | Evusheld (tixagevimab co-packaged with cilgavimab and administered together) | FDA/US | Emergency Use Authorisation granted for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg [about 88 lbs). The product is only authorised for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. | 8 Dec 2021 |
| Pfizer | Comirnaty vaccine | SAHPRA/ South Africa | Booster dose granted approved for use under section 21 of the Medicines and Related Substance Act (Act 101 of 1965) as follows: A third dose of the Comirnaty® COVID-19 vaccine: – in individuals aged 18 years and older, to be administered at least 6 months after the second dose. – in individuals aged 12 years and older who are severely immunocompromised, to be administered at least 28 days after the second dose. | 8 Dec 2021 |
| Moderna Australia Pty Ltd | COVID-19 vaccine Spikevax | TGA/Australia | Provisional approved granted for a booster dose of the vaccine, for individuals 18 years and older. In addition, the TGA Product Information (PI) also now includes a statement in relation to a 3rd primary dose of COVID-19 vaccine for severely immunocompromised people aged 12 years and over at least 28 days after the second dose. A 3rd primary dose is intended to address the risk of suboptimal or non-response to the standard 2 dose schedule | 7 Dec 2021 |
| MODERNA BIOTECH SPAIN, S.L. | Spikevax vaccine | MHRA/UK | THe MHRA website states Product Information Updated. Sections 2, 4.2, 4.4, 4.8, 5.1, 6.5 and 6.6 of the SmPC updated. It seems from the MHRA safety update (Volume 15 issue 6 Jan 2022) that the SmPCc and PIL were upated to to allow for use of the vaccine as a booster or third dose in individuals 18 years of age and older and for immunocompromised patients, and safety updates (to include diarrhoea and skin reaction as adverse reactions, further information on delayed injection site reactions, minor amendments to the hypersensitivity text, updates to myocarditis and pericarditis. The above information has been obtained from the MHRA safety update (Volume 15 issue 6 Jan 2022) | 6 Dec 2021 |
| Roche Registration GmbH | RoActemra (tocilizumab) | EMA/EU | CHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic treatment with corticosteroids and require supplemental oxygen or mechanical ventilation. | 6 Dec 2021 |
| Celltrion Healthcare Australia Pty Ltd | monoclonal antibody, regdanvimab (REGKIRONA) | TGA/Australia | Provisional approval granted for the for the treatment of adults with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19. | 6 Dec 2021 |
| Pfizer Australia Pty Ltd. | COVID-19 vaccine, Comirnaty | TGA/ Australia | Provisional approval granted for use in children 5-11 years of age. | 5 Dec 2021 |
| Eli Lilly and company | monoclonal antibodies bamlanivimab and etesevimab | FDA/US | The EUA (previously authorised for pediatric patients 12 years of age and older weighing at least 40kg, or about 88 lbs), revised to additionally be used for: i) the treatment of mild/moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalisation or death. ii) post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalisation or death | 3 Dec 2021 |
| Valneva | VLA2001, COVID-19 vaccine | EMA/EU | Rolling review commenced. | 2 Dec 2021 |
| GlaxoSmithKline UK Limited | Monoclonal antibody, Xevudy (sotrovimab) | MHRA/UK | Conditional Marketing Authorisation granted (valid in GB only) and an emergency use authorisation granted in Northern Ireland, for the treatment of symptomatic adults and adolescents (aged 12 years and over and weighing at least 40 kg) with acute covid-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe covid infection. | 2 Dec 2021 |
| bamlanivimab and etesevimab combination | Cofepris/Mexico | Authorised for emergency use, for the treatment of mild to moderate coronavirus disease in adults and pediatric patients (12 years and older weighing at least 40 kilograms), with positive direct diagnostic test results for the SARS-CoV-2 virus. , and who present very high-risk comorbidities that are not controlled | 1 Dec 2021 | |
| AstraZeneca AB | Vaxzevria COVID-19 Vaccine | EMA/EU | The CHMP has approved a new site (operated by WuXi Biologics, in Leverkusen, Germany) to manufacture Vaxzevria finished product. CHMP has also given a positive opinion to scale up manufacturing to triple the batch size of finished product at a site operated by Amylin Ohio in West Chester Township, Ohio, US. | 1 Dec 2021 |
| Roche Products Pty Ltd COVID-19 | monoclonal antibody, tocilizumab (Actemra) | TGA/Australia | Provisional approval granted for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation | 1 Dec 2021 |
| Moderna | Spikevax vaccine | Swissmedic | Booster dose approved. A booster dose (half-dose) can now be administered to anyone aged 18 or over with immediate effect. High-risk individuals can still obtain the booster from age 12. In both cases, however, the second dose must have been administered at least six months previously. | 26 Nov 2021 |
| BioNTech and Pfizer | Comirnaty COVID-19 vaccine | EMA/EU | The CHMP has recommended granting an extension of indication to include use in children aged 5 to 11 years. | 25 Nov 2021 |
| Novavax Inc. | COVID-19 vaccine NVX-CoV2373 | HSA/Singapore | Application submitted for interim authorisation under the Pandemic Special Access Route (PSAR). | 24 Nov 2021 |
| Janssen Inc | Ad26.COV2.S (recombinant) | Health Canada | Authroised with terms and conditions. To transition the regulatory status of the from being authorised under the Interim Order (IO), to being authorised under Division 8 of the Food and Drug Regulations. | 23 Nov 2021 |
| Pfizer/BioNTech | Comirnaty vaccine | Swissmedic | Individuals aged 16 years and over can now be administered a booster dose. As stipulated in the Swissmedic decision of 26 Oct 2021, high-risk individuals can still obtain the booster from age 12. In both cases, however, the second dose must have been administered at least six months previously. | 23 Nov 2021 |
| Janssen-Cilag International NV | COVID-19 Vaccine Janssen | EMA/EU | Evaluation started of an application for the use of a booster dose of the vaccine to be given at least two months after the first dose to people aged 18 years and older. | 22 Nov 2021 |
| Grand Pacific CRO (the Australian sponsor acting on behalf of Medigen Vaccine Biologics Corp,Taiwan) | COVID-19 vaccine: MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine). | TGA/Australia | Provisional determination granted. The vaccine will be considered for for the active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals aged 18 years of age and older | 22 Nov 2021 |
| Pfizer | Paxlovid (PF-07321332/ritonavir) an oral treatment for COVID-19. | EMA/EU | Review started to support national authorities who may decide on its early use for COVID-19 e.g. in emergency use settings, prior to marketing authorisation. | 19 Nov 2021 |
| BioNTech Manufacturing GmbH | Comirnaty (tozinameran) COVID-19 vaccine | Health Canada | Authorised for use with terms and conditions for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in children 5 to less than 12 years. Authorised under Food and Drug Regulations for drugs for use in relation to COVID-19 | 19 Nov 2021 |
| Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics | molnupiravir (also known as MK 4482 or Lagevrio) | EMA/EU | CHMP has issued adivce on use while the rolling review is in progress. The medicine, currently not authorised in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19. | 19 Nov 2021 |
| Pfizer-BioNTech | Comirnaty vaccine | FDA/US | Emergency use authorisation (EUA) amended, authorising use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorised or approved COVID-19 vaccine. | 19 Nov 2021 |
| Janssen Biotech Inc. | Janssen (Johnson and Johnson) COVID-19 Vaccine | FDA/US | Letter of authorisation of EUA reissued. Revisions incorporated to amend the EUA to authorize the vaccine as a single booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine More information here. | 19 Nov 2021 |
| ModernaTX, Inc | Moderna COVID-19 vaccine | FDA/US | Emergency use authorisation (EUA) amended, authorising use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorised or approved COVID-19 vaccine. | 19 Nov 2021 |
| Pfizer Schweiz AG | Comirnaty vaccine | Swissmedic | Application submitted to request extension of the use of the vaccine in children aged 5 to 11 years. | 19 Nov 2021 |
| BioNTech Manufacturing GmbH | Comirnaty vaccine | MHRA/UK | Sections of the SmPC and PIL updated to include information about receiving a 3rd/booster dose and two new reagents, sodium hydroxide and hydrochloric acid, which are used in small quantities during the preparation of one of the solutions used in the manufacturing process. The official International non-proprietary name ‘tozinameran’ has also been added. | 15 Nov 2021 |
| ModernaTX, Inc. | SPikevax (Elasomeran mRNA Vaccine) | Health Canada | Authorised with terms and conditions, a booster dose that may be administered at least 6 months after completion of the primary series in individuals 18 years of age or older. | 12 Nov 2021 |
| Roche Registration GmbH | Ronapreve (casirivimab/imdevimab), monoclonal antibodies | EMA/EU | Ronapreve is authorised in the EU for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms. | 12 Nov 2021 |
| Celltrion Healthcare Hungary Kft | Regkirona (regdanvimab) monoclonal antibody | EMA/EU | Regikrona is authorised in the EU for the treatment of adults with COVID 19 who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. | 12 Nov 2021 |
| Pfizer Japan Inc. | Comirnaty Intramuscular Injection (tozinameran) | PMDA/Japan | New dosage indicated for the prevention of disease caused by SARS-CoV-2 infection (COVID-19). Special Approval for Emergency] | 11 Nov 2021 |
| Moderna Biotech Spain, S.L. | COVID-19 vaccine, Spikevax | EMA/EU | Evaluation of an application to extend the use of the vaccine in children aged 6 to 11 has commenced. | 10 Nov 2021 |
| Chugai Pharmaceutical Co Ltd. | Ronapreve Casirivimab and Imdevimab) | PMDA/Japan | Special approval for emergency use granted for treatment and suppression of development of disease caused by SARS-CoV-2 infection (COVID-19) Original special approval for emergency use granted on 19 July 2021 for treatment of disease caused by SARS-CoV-2 infection (COVID-19) | 5 Nov 2021 |
| AstraZeneca Pty Ltd. | COVID-19 monoclonal antibody treatment tixagevimab and cilgavimab (Evusheld) | TGA/Australia | Provisional determination granted. To be considered for the prevention of COVID-19 in adults aged 18 years and older. | 4 Nov 2021 |
| Merck Sharp & Dohme (UK) Limited | Lagevrio (molnupiravir) oral antiviral | MHRA (UK) | Conditional Marketing Authorisation granted (valid in GB only) and an emergency use authorisation granted for Northern Ireland, for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease. SmPC and PIL | 4 Nov 2021 |
| AstraZeneca AG | COVID-19 Vaccine AstraZeneca | Swissmedic | AstraZeneca withdraws authorisation application. | 4 Nov 2021 |
| Bharat Biotech, India | BBV152 COVAXIN vaccine | WHO | Emergency Use Listing (EUL) . | 3 Nov 2021 |
| Novavax Inc. | COVID-19 vaccine, NVX-CoV2373 | Medsafe/ New Zealand | Submission completed. | 3 Nov 2021 |
| Janssen-Cilag Ltd. | COVID-19 Vaccine Janssen suspension for injection | MHRA/UK | Updated SmPC and PIL. SmPC Sections updated were: 4.3 (addition of Capillary Leak syndrome (CLS)), 4.4 (addition of CLS and Guillain -Barre Syndrome), 4.8, 5.0 and 6.4. PIL sections updated were: 2 and 4, including information on CLS and Guillain-Barre Syndrome. | 3 Nov 2021 |
| AstraZeneca Canada | AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) | Health Canada | Rolling review New Drug Submission initiated with Health Canada for the prevention of symptomatic COVID-19. | 3 Nov 2021 |
| Bharat Biotech | Covaxin vaccine | World Health Organsiation (WHO) | Emergency Use Listing (EUL) | 3 Nov 2021 |
| Elli Lilly Netherlands BV | antibodies bamlanivimab and etesevimab | EMA/EU | Rolling review ended upon company withdrawing from the process. | 2 Nov 2021 |
| Novavax Inc. | COVID-19 vaccine candidate, NVX-CoV2373 | Health Canada | Rolling submission completed, for authirisation. | 1 Nov 2021 |
| Novavax Inc. | COVID-19 vaccine candidate, NVX-CoV2373 | TGA/Australia | Rolling submission completed, for provisional approval. | 29 Oct 2021 |
| Pfizer-BioNTech | Comirnaty COVID-19 Vaccine | FDA/US | EUA authorised for the prevention of COVID-19 to include children from 5 to 11 years of age. FDA also authorised a manufacturing change for the vaccine to include a formulation that uses a different buffer. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers | 29 Oct 2021 |
| BioNTech Manufacturing GmbH | Comirnaty vaccine | MHRA/UK | Updated figures in HCP information Table 5: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2 – participants without evidence of infection and with or without evidence of infection prior to 7 days after Dose 2 – adolescents 12 to 15 years of age evaluable efficacy (7 days) population. The above information appears in section 5.1 Pharmacodynamic Properties in the document Information for Healthcare Professionals on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174). | 28 Oct 2021 |
| Novavax Inc | COVID-19 vaccine, NVX-CoV2373 | MHRA/UK | Rolling submission completed, for authorisation. | 27 Oct 2021 |
| BioNTech Manufacturing GmbH | Comirnaty vaccine | MHRA/UK | Update to the SmPC sections 4.8 Undesirable effects and section 5.1 Pharmacodynamic Properties and patient information leaflet section 4 Possible side effects. | 27 Oct 2021 |
| Pfizer Australia Pty Ltd. | COVID-19 vaccine, Comirnaty. | TGA/Australia | Provisional approval of a booster dose of for individuals 18 years and older. | 27 Oct 2021 |
| Moderna | Spikevax vaccine | Swissmedic | Booster half dose approved for people at especially high risk e.g. older people or at-risk patients approved for use at least 6 months after the second dose. Three-dose schedule for patients with a weakened immune system approved i.e. for immunocompromised individuals or patients with a suppressed immune response for use at least 28 days after the second dose | 26 Oct 2021 |
| Pfizer/BioNTech | Comirnaty vaccine | Swissmedic | Booster dose approved for people at especially high risk e.g. older people or at-risk patients approved for use at least 6 months after the second dose. Three-dose schedule for patients with a weakened immune system approved i.e. for immunocompromised individuals or patients with a suppressed immune response for use at least 28 days after the second dose | 26 Oct 2021 |
| Moderna Biotech Spain, S.L. | Spikevax COVID-19 vaccine | EMA/EU | EMA has concluded that a booster dose may be considered in in people aged 18 years and above. | 25 Oct 2021 |
| Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics | molnupiravir (also known as MK 4482 or Lagevrio) | EMA/EU | Rolling review commenced, for the treatment of COVID-19 in adults. | 25 Oct 2021 |
| Sinovac Biotech | Sinovac-CoronaVac Vaccine an inactivated SARS-CoV-2 vaccine | HSA/Singapore | Interim authorisation granted under the Pandemic Special Access Route, for the prevention of COVID-19 in individuals aged 18 years and above. | 23 Oct 2021 |
| AstraZeneca UK Limited | Vaxzevria vaccine | MHRA/UK | Guillain-Barré syndrome [GBS] added as a very rare side effect. | 21 Oct 2021 |
| Moderna TX Inc. | Moderna COVID-19 Vaccine | FDA/US | EUA amended to allow for the use of a single booster dose as follows: i) to allow for the use of a single booster dose at least 6 months after completion of the primary series as detailed. ii) The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. | 20 Oct 2021 |
| Janssen Biotech Inc. | Janssen (Johnson and Johnson) COVID-19 Vaccine | FDA/US | EUA amended to allow for the use of a single booster dose as follows: i) to allow for the use of a single booster dose at least 2 months after completion of the single-dose primary regimen ii) The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. | 20 Oct 2021 |
| Pfizer/BioNTech | Pfizer-BioNTech COVID-19 Vaccine | FDA/US | EUA amended to allow for the use of a single booster dose as follows: i) The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. ii) To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. | 20 Oct 2021 |
| AstraZeneca UK Limited. | Vaxzevria vaccine | MHRA/UK | MHRA website states ‘Updated information for healthcare professionals and for patients’. No other information provided. | 19 Oct 2021 |
| CureVac Swiss AG | CVnCoV vaccine | Swissmedic | Application withdrawn. CureVac will no longer be developing its first-generation COVID-19 vaccine to market readiness, and will instead be focusing on a second-generation COVID-19 vaccine. | 19 Oct 2021 |
| ? | Sputnik V vaccine | SAHPRA/South Africa | Rolling review ongoing since Feb 2021. Vaccine will remain unapproved at this time until concerns are addressed. | 18 Oct 2021 |
| BioNTech and Pfizer | Comirnaty, COVID-19 vaccine | EMA/EU | Two additional manufacturing sites approved One site, located in Monza, Italy, is operated by Patheon Italia S.p.A. The other in Anagni, Italy, is operated by Catalent Anagni S.R.L. Both sites will manufacture finished product. New ready-to-use-formulation approved. It does not require dilution prior to administration, will be available in a 10-vial (60 dose) pack size and can be stored at 2-8°C for up to 10 weeks. | 18 Oct 2021 |
| Roche Products Pty Ltd. | combination therapy, casirivimab + imdevimab (Ronapreve) | TGA/Australia | Provisional approval granted for the treatment and prevention of COVID-19 in specific target populations | 18 Oct 2021 |
| Pfizer | Comirnaty Injection | PMDA/Japan | Other precautions revised to include myocarditis and pericarditis | 15 Oct 2021 |
| AstraZeneca AB | Evusheld (also known as AZD7442), a combination of two monoclonal antibodies (tixagevimab and cilgavimab) | EMA/EU | Rolling review started, for the prevention of COVID-19 in adults. | 14 Oct 2021 |
| CureVac AG | CVnCoV COVID-19 vaccine | EMA/EU | EMA has ended the rolling review of the vaccine, after the company informed the Agency that it was withdrawing from the process. | 12 Oct 2021 |
| Chugai Pharmaceutical Co Ltd | Monoclonal antibody Ronapreve (casirivimab /imdevimab) | PMDA/Japan | Application filed for additional indications for prophylaxis of COVID-19 and treatment of asymptomatic COVID-19 infected patients. This application also contains subcutaneous administration in addition to the drug’s current intravenous administration and seeks the Special Approval for Emergency. | 11 Oct 2021 |
| Merck | oral molnupiravir | FDA/US | EUA application submitted to the U.S. FDA for for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalisation. | 11 Oct 2021 |
| Roche Registration GmbH | Ronapreve, a monoclonal antibody combination (casirivimab / imdevimab) | EMA/EU | Evaluating of an an application for marketing authorisation has commenced, for the treatment of COVID-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19, and for the prevention of COVID-19 in adults and adolescents aged 12 years and older. | 11 Oct 2021 |
| M/s Hetero Biopharma Ltd | Gam COVID Vac (component I & II) (SPUTNIK-V) | CDSCO/India | Approved for restricted emergency use for the prevention of COVID-19. | 7 Oct 2021 |
| Janssen-Cilag International N.V. | COVID-19 Vaccine Janssen Ad26.COV2.S viral vector vaccine | EMA/EU | An additional manufacturing site been approved. It is located in West Point, Pennsylvania, US and operated by MSD Corp. It will manufacture finished product. | 7 Oct 2021 |
| AstraZeneca | AZD7442, long-acting antibody (LAAB) combination consisting of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061). | FDA/US | Request submitted to the US FDA for an EUA for AZD7442 for prophylaxis of symptomatic COVID-19. | 5 Oct 2021 |
| Celltrion Healthcare Hungary Kft | monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) | EMA/EU | Evaluation of an application for a marketing authorisation commenced, to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19. Will be assessed under a reduced timeline with opinion potentially in two months. | 4 Oct 2021 |
| Pfizer Australia | Combination medicine containing PF-07321332 (oral antiviral) and ritonavir | TGA/Australia | Provisional determination granted for the treatment of adult patients with symptomatic, confirmed coronavirus infection. | 1 Oct 2021 |
| AstraZeneca AB | Vaxzevria – COVID-19 Vaccine (ChAdOx1-S [recombinant]) | EMA/EU | Immune thrombocytopenia (ITP) The committee assessed all the available data and recommended updating the PI to include ITP as an adverse reaction with an unknown frequency. | 1 Oct 2021 |
Janssen-Cilag International N.V. | COVID-19 Vaccine Janssen Ad26.COV2.S viral vector vaccine | EMA/EU | VTE The PRAC has concluded that there is a possible link to rare cases of venous thromboembolism (VTE) with this vaccine. and is therefore recommending listing VTE as a rare side effect in the PI, plus a warning to raise awareness among HCPs and vaccine recipients, especially those who may have an increased risk of VTE. Immune thrombocytopenia (ITP) The committee assessed all the available data and recommended updating the PI to include ITP as an adverse reaction with an unknown frequency. | 1 Oct 2021 |
| Special Approval for Emergency under Article 14-3 | Xevudy (sotrovimab) | PMDA/Japan | Special approval for emergency use under Article 14-3 granted for disease caused by SARS-CoV-2 infection (COVID-19) in adults and pediatric patients (≥12 years of age weighing ≥40 kg). | 27 Sep 2021 |
| Pfizer/BioNTech | Comirnaty COVID-19 mRNA Vaccine | MHRA/UK | Vaccine shelf-life extended from 6 months to 9 months | 27 Sep 2021 |
| Moderna Biotech Spain, S.L. | COVID-19 Vaccine Moderna (now known as Spikevax) mRNA-1273 vaccine | EMA/EU | EMA has started evaluating an application (via accelerated assessment) for the use of a booster dose of Spikevax to be given at least 6 months after the second dose in people aged 12 years and older. | 27 Sep 2021 |
Image by Miroslava Chrienova from Pixabay