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.

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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 UK Limited.Vaxzevria vaccineMHRA/UKMHRA website states ‘Updated information for healthcare professionals and for patients’. No other information provided. It is quite plausible that the update applied is the same as that applied by the EU concerning Guillain-Barre syndrome as shown in this document (decision of 14/09/21).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CureVac Swiss AG CVnCoV vaccineSwissmedicApplication withdrawn.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.

Evaluation of an application to extend the use of the vaccine, to children aged 5 to 11 has commenced.
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
Roche Products Pty Ltd COVID-19tocilizumab (ACTEMRA)TGA/AustraliaProvisional determination granted.28 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