COVID-19 vaccines and treatments, regulatory status at a glance (2 of 2)

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 27 September 2021 is covered.

On mobile, the table is best viewed by scrolling sideways.

For regulatory status prior to 27 September 2021, please visit this page.

Other news including on vaccines, treatments, trials and side effects, here.

Company(ies)/ Organisation/
Others
ProductIssuing Regulatory Agency/OrganisationRegulatory status updateDate
AstraZeneca ABVaxzevria COVID-19 Vaccine EMA/EUThe 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/AustraliaProvisional approval granted.1 Dec 2021
ModernaSpikevax vaccineSwissmedicBooster 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 vaccineEMA/EUThe 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-CoV2373HSA/SingaporeApplication submitted for interim authorisation under the Pandemic Special Access Route (PSAR).24 Nov 2021
Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics oral antiviral medicine Lagevrio (molnupiravir) EMA/EUEMA has started evaluating a marketing authorisation 
application under a reduced timeline.
23 Nov 2021
Pfizer/BioNTech Comirnaty vaccineSwissmedicIndividuals 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 NVCOVID-19 Vaccine JanssenEMA/EUEvaluation 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/AustraliaProvisional 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 older22 Nov 2021
PfizerPaxlovid (PF-07321332/ritonavir) an oral treatment for COVID-19. EMA/EUReview 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 GmbHComirnaty (tozinameran) COVID-19 vaccine Health Canada

Authorised for use (with terms and conditions) in children 5 to 11 years of age.

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/EUCHMP 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-BioNTechComirnaty vaccineFDA/USEmergency 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
ModernaTX, IncModerna COVID-19 vaccineFDA/USEmergency 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 AGComirnaty vaccineSwissmedicApplication submitted to request extension of the use of the vaccine in children aged 5 to 11 years.19 Nov 2021
GlaxoSmithKline Trading Services Limitedmonoclonal antibody Xevudy (sotrovimab)EMA/EUEvaluation has commenced on an application for marketing authorisation and will be assessedd under a reduced timeline.
Xevudy is intended for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.  
18 Nov 2021
ModernaCOVID-19 vaccine, Spikevax®SwissmedicApplication to submitted to extend the indication of vaccine to children aged 6 years and older.18 Nov 21
NovavaxCOVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373)EMA/EUEvaluation of application for conditional marketing authorisation under an accelerated timeline has begun.17 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
Roche Registration GmbHRonapreve (casirivimab/imdevimab), monoclonal antibodiesEMA/EURonapreve 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 KftRegkirona (regdanvimab) monoclonal antibodyEMA/EURegikrona 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
Moderna Biotech Spain, S.L.COVID-19 vaccine, SpikevaxEMA/EU Evaluation of an application to extend the use of the vaccine in children aged 6 to 11 has commenced.10 Nov 2021
Moderna Australia Pty LtdCOVID-19 vaccine, Spikevax.TGA/AustraliaProvisional determination granted.10 Nov 2021
AstraZeneca Pty Ltd.COVID-19 monoclonal antibody treatment tixagevimab and cilgavimab (Evusheld)TGA/AustraliaProvisional 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)Authorised 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 AGCOVID-19 Vaccine AstraZenecaSwissmedicAstraZeneca withdraws authorisation application.4 Nov 2021
Novavax Inc.COVID-19 vaccine, NVX-CoV2373Medsafe/ New ZealandSubmission completed.3 Nov 2021
Janssen-Cilag Ltd.COVID-19 Vaccine Janssen suspension for injectionMHRA/UKUpdated 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 CanadaAZD7442  is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) Health CanadaRolling review New Drug Submission initiated with Health Canada for the prevention of symptomatic COVID-19.3 Nov 2021
Bharat BiotechCovaxin vaccineWorld Health Organsiation (WHO)Emergency Use Listing (EUL)3 Nov 2021
Elli Lilly Netherlands BVantibodies bamlanivimab and etesevimabEMA/EURolling review ended upon company withdrawing from the process.2 Nov 2021
Novavax Inc.COVID-19 vaccine candidate, NVX-CoV2373 Health CanadaRolling submission completed, for authirisation.1 Nov 2021
Novavax Inc.COVID-19 vaccine candidate, NVX-CoV2373TGA/AustraliaRolling submission completed, for provisional approval.29 Oct 2021
Pfizer-BioNTech Comirnaty COVID-19 VaccineFDA/USEUA 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 IncCOVID-19 vaccine, NVX-CoV2373MHRA/UKRolling submission completed, for authorisation.27 Oct 2021
BioNTech Manufacturing GmbHComirnaty vaccineMHRA/UKUpdate 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/AustraliaProvisional approval of a booster dose of for individuals 18 years and older.27 Oct 2021
ModernaSpikevax vaccineSwissmedicBooster 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/BioNTechComirnaty vaccineSwissmedicBooster 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 vaccineEMA/EUEMA 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 Biotherapeuticsmolnupiravir (also known as MK 4482 or Lagevrio)EMA/EURolling review commenced, for the treatment of COVID-19 in adults.25 Oct 2021
Sinovac BiotechSinovac-CoronaVac Vaccine an inactivated SARS-CoV-2 vaccineHSA/SingaporeInterim 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 LimitedVaxzevria vaccine MHRA/UKGuillain-Barré syndrome [GBS] added as a very rare side effect.21 Oct 2021
Moderna TX Inc.Moderna COVID-19 VaccineFDA/USEUA amended to allow for the use of a single booster dose at least 6 months after completion of the primary series, as detailed here.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 at least 2 months after completion of the single-dose primary regimen, as detailed here. 20 Oct 2021
Pfizer/BioNTech Pfizer-BioNTech COVID-19 VaccineFDA/US EUA amended to allow for the use of a single booster dose at least 6 months after completion of the primary series, as detailed here. 20 Oct 2021
AstraZeneca UK Limited.Vaxzevria vaccineMHRA/UKMHRA website states ‘Updated information for healthcare professionals and for patients’. No other information provided.19 Oct 2021
CureVac Swiss AG CVnCoV vaccineSwissmedicApplication 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 vaccineSAHPRA/South AfricaRolling review ongoing since Feb 2021. Vaccine will remain unapproved at this time until concerns are addressed.18 Oct 2021
BioNTech and PfizerComirnaty, COVID-19 vaccineEMA/EUTwo 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/AustraliaProvisional approval granted for the treatment and prevention of COVID-19 in specific target populations18 Oct 2021
PfizerComirnaty InjectionPMDA/JapanOther precautions revised to include myocarditis and pericarditis15 Oct 2021
AstraZeneca ABEvusheld (also known as AZD7442), a combination of two monoclonal antibodies (tixagevimab and cilgavimab)EMA/EURolling review started, for the prevention of COVID-19 in adults.14 Oct 2021
Pfizer Australia Pty LtdCOVID-19 Vaccine, ComirnatyTGA/AustraliaProvisional determination granted – proposed for use in children 5-11 years of age13 Oct 2021
CureVac AGCVnCoV COVID-19 vaccineEMA/EUEMA 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 LtdMonoclonal antibody Ronapreve (casirivimab /imdevimab)PMDA/JapanApplication 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
Merckoral molnupiravirFDA/USEUA 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 GmbHRonapreve, a monoclonal antibody combination (casirivimab / imdevimab)EMA/EUEvaluating 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
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
AstraZenecaAZD7442, long-acting antibody (LAAB) combination consisting of  two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061).FDA/USRequest submitted to the US FDA for an EUA for AZD7442 for prophylaxis of symptomatic COVID-19.5 Oct 2021
Celltrion Healthcare Hungary Kftmonoclonal antibody Regkirona (regdanvimab, also known as CT-P59)EMA/EUEvaluation 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 AustraliaCombination medicine containing PF-07321332 (oral antiviral) and ritonavirTGA/AustraliaProvisional determination granted for the treatment of adult patients with symptomatic, confirmed coronavirus infection.1 Oct 2021
AstraZeneca ABVaxzevria –
COVID-19 Vaccine (ChAdOx1-S [recombinant])
EMA/EUImmune 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/EUVTE
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 14-3Xevudy (sotrovimab)PMDA/JapanSpecial Approval for Emergency under Article 14-3 granted.27 Sep 2021
Pfizer/BioNTech Comirnaty
COVID-19 mRNA Vaccine
MHRA/UKVaccine shelf-life extended from 6 months to 9 months27 Sep 2021
Moderna Biotech Spain, S.L. COVID-19 Vaccine Moderna (now known as Spikevax)

mRNA-1273 vaccine
EMA/EUEMA 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