COVID-19 vaccines and treatments, regulatory status at a glance (3 of 3)

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.

Company(ies)/
Organisation
ProductIssuing regulatory agency/OrganisationRegulatory staus updateDate
Sky BioscienceMultidose COVID-19 vaccine SKYCovione Multi Inj. (recombinant protein-based vaccine) MFDS/South KoreaMarketing authorisation granted for use with conditions, to prevent COVID-19 in individuals 18 years of age and older.29 Jun 2022
Pfizer Australia Pty LtdComirnaty COVID-19 vaccineTGA/AustraliaProvisional determinationgranted.
Currently, the vaccine provisionally approved for use in individuals 5 years of age and older.
28 Jun 2022
AstraZeneca UK LimitedVaxzevria COVID-19 vaccineMHRA/UK1) 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
PfizerAnvisa/BrazilAnvisa 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 old24 Jun 2022
Moderna Switzerland GmbHSpikevaxSwissmedicApplication submitted with review on a rolling basis, to extend the authorisation of the vaccine to a bivalent 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. 24 Jun 2022
Valneva Austria GmbHCOVID-19 Vaccine (inactivated, adjuvanted) Valneva EMA/EUMarketing 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.NuvaxovidEMA/EUThe 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
Moderna Biotech Spain, S.L.Spikevax COVID-19 vaccineEMA/EURolling 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 VaccineFDA/USEUA 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 VaccineFDA/USEUA 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.LSpikevaxMHRA/UKProduct 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/BioNTechComirnaty vaccineEMA/EURolling 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 AGPaxlovid (nirmatrelvir [PF-07321332] and ritonavir)SwissmedicTemporary 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 vaccineSAHPRARegistered 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.NuvaxovidTGA/AustraliaExtension 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.

10 June 2022
Dr Reddy’s Laboratories (Pty) Ltd, IndiaMolnupiravir 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, IndiaMolcovir 
(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 vaccineSwissmedicApplication submitted and under review, for a booster for children aged 5 to 11 years.31 May 2022
SinopharmSinopharm BIBP COVID-19 vaccineSAHPRA/ South AfricaRegistered with conditions under Section 15(6a) of the Medicines and Related Substance Act 101 of 1965.24 May 2022
BioNTech Manufacturing GmbHComirnaty 10 micrograms/dose concentrate for dispersion for injection (orange cap product) MHRA/UKShelf-life information updated, resulting in an update to the SmPC and PIL.24 May 2022
Gilead Sciences Farmacêutica do Brasil LtdaVeklury (remdesivir) Anvisa/BrazilNew 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
AstraZeneca ABVaxzevria COVID-19 vaccineEMA/EUThe 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 vaccineSwissmedicAn application to extend the indication for the vaccine to children aged 6 months to 5 years has been submitted.18 May 2022
Valneva Austria GmbHValneva COVID-19 vaccineEMA/EUThe CHMP has started evaluating an application for a conditional marketing authorisation for the vaccine18 May 2022
Janssen-Cilag International NVJcovden (previously COVID-19 Vaccine Janssen)EMU/EUThe (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 vaccineMHRA/UKThe 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 202217 May 2022
Pfizer-BioNTechComirnaty ( Pfizer-BioNTech COVID-19 Vaccine)FDA/USEUA 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 LPEVUSHELD™ (tixagevimab co-packaged with cilgavimab)FDA/USEUA 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 BiologicalsConvidecia COVID-19 vaccineAnvisa/BrazilApplication received and assessment commenced for the registration of the vaccine13 May 2022
Moderna inc.Spikevax COVID-19 vaccineSwissmedicExtension of the indication authorised to children aged 6 to 11 years.13 May 2022
Moderna Australia Pty Ltd.Spikevax COVID-19 vaccineTGA/AustraliaEvaluation 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., UKCOVID-19 Vaccine Janssen MHRA/UKSPC 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, LLCOlumiant (baricitinib)FDA/USNew 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 LtdNuvaxovid (NVX-CoV2373) COVID-19 VaccineMedsafe/New ZealandVariation 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 VaccineTGA/AustraliaVariation 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/AustraliaBased 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 LtdVeklury (remdesivir)TGA/AustraliaProvisional 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, IncJanssen COVID-19 VaccineFDA/USThe 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
Novavax Nuvaxovid (NVX-CoV2373) COVID-19 VaccineMHRA/UKApplication 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)MolnupiravirAnvisa/BrazilEmergency 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 Ltdbivalent 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/BrazilRegistration 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 GmbHComirnaty COVID-19 vaccineMHRA UKThe 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 vaccinePMDA/JapanRevision 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/BioNTechComirnaty COVID-19 vaccinePMDA/JapanRevision 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/IndiaApproved for Restricted Use in Emergency Situation in the country, in patients ≥ 12 years of age.26 Apr 2022
Gilead Sciences Inc.Veklury (remdesivir)FDA/USApproval 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 AGComirnaty COVID-19 vaccineSwissmedicCOMIRNATY® 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
MSDLagevrio (Molnupiravir)HSA/SingaporeInterim 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 IncEvusheld (Cilgavimab and tixagevimab)Health CanadaAuthorized 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 vaccineMHRA/UKThe 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 GmbHCOVID-19 vaccine Valneva (inactivated, adjuvanted, adsorbed).MHRA/UKConditional 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