European Drug Regulator Gives 6-Week Time Frame For Opinions On Pfizer-BioNTech, Moderna COVID-19 Vaccines

The European Medicines Agency said Tuesday it has received conditional marketing approval applications from Pfizer Inc. PFE-BioNTech SE – ADR BNTX and Moderna Inc MRNA, the two frontrunners in the development of a coronavirus vaccine. 

The decision isn't likely to come early, thereby pushing out the vaccine launch timeline.

What Happened: Pfizer-BioNTech and Moderna initiated rolling BLA submissions with respect to their investigational vaccines on Oct. 6 and Nov. 16, respectively.

With the agency having already reviewed some data during the rolling review — when it assessed vaccine quality, results from lab studies and effectiveness and initial data from the large-scale late-stage trial — it will now focus on the data submitted as part of the formal application for conditional marketing authorization.

If the data submitted proves robust enough, the EMA's scientific committee for human medicines will conclude its assessment during special meetings scheduled for Dec. 29 for Pfizer-BioNTech and Jan. 12 for Moderna.

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What's Next: If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID 19, it will recommend to the European Commission the granting of conditional marketing authorization.

The authorization, once granted, would be valid in all EU and EEA Member States within days, the EMA statement said. 

Even if the EMA hands out a positive verdict by the D-day, distribution may not start until early January, the Financial Times reported. After the EMA's nod, member state approval would take three to four four days. 

U.K. regulators are gearing up to clear Pfizer-BioNTech's vaccine as early as this week, the FT reported.

The U.S. FDA is on track to issue emergency use authorizations for the vaccine candidates from Pfizer-BioNTech and Moderna by mid- to-late December.

The FDA's vaccines advisory committee — the Vaccines and Related Biological Products Advisory Committee — is scheduled to meet Dec. 10 to discuss Pfizer-BioNTech's vaccine and on Dec. 17 to give its recommendation on Moderna's vaccine.

Positive recommendations could support the issuance of emergency use authorization by late 2020, Morgan Stanley analyst Matthew Harrison said in a note.

Price Action: At last check, Pfizer shares were rising 3.18% to $39.53. BioNTech shares, which have traded up recently on optimistic vaccine expectations, were slipping 6.95% to $115.60.

Moderna was last seen falling 7.07% to $141.95.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

For news coverage in Italian or Spanish, check out Benzinga Italia and Benzinga España.