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The European Medicines Agency said on Tuesday it had received applications for conditional marketing authorization from Pfizer Inc. (NYSE: PFE) –BioNTech SE – ADR (NASDAQ: BNTX) and Moderna Inc (NASDAQ: MRNA), the two pioneers in the development of a vaccine against the coronavirus.
The decision likely won’t come soon, pushing back the vaccine launch schedule.
What happened: Pfizer-BioNTech and Moderna launched ongoing BLA submissions for their investigational vaccines on October 6 and November 16, respectively.
The agency having already looked at some data during the ongoing review – when it assessed the quality of the vaccine, the results of laboratory studies and efficacy, and the 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 is found to be strong enough, the EMA Scientific Committee for Medicines for Human Use will conclude its assessment at special meetings scheduled for December 29 for Pfizer-BioNTech and January 12 for Moderna.
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And after: If the EMA concludes that the benefits of the vaccine outweigh its risks of protection against COVID 19, it will recommend to the European Commission the granting of a conditional marketing authorization.
The authorization, once granted, would be valid in all EU and EEA member states within days, according to the EMA statement.
Even if the EMA delivers a positive verdict by D-Day, distribution may not begin until early January, the Financial Times reported. After the nod from the EMA, approval by member states would take three to four days.
British regulators are preparing to phase out Pfizer-BioNTech’s vaccine as early as this week, the FT reported.
The US FDA is on track to issue emergency use authorizations for Pfizer-BioNTech and Moderna vaccine candidates by mid-late December.
The FDA’s Vaccine Advisory Board – the Advisory Committee for Vaccines and Related Biologics – is scheduled to meet on December 10 to discuss Pfizer-BioNTech’s vaccine and on December 17 to give its recommendation on Moderna’s vaccine.
Positive recommendations could support the issuance of an emergency use authorization by the end of 2020, Morgan Stanley analyst Matthew Harrison said in a note.
Price action: At the last check, Pfizer shares rose 3.18% to $ 39.53. Shares of BioNTech, which recently traded on bullish vaccine expectations, slipped 6.95% to $ 115.60.
Moderna was last seen down 7.07% to $ 141.95.
Related Link: Attention Biotech Investors: Mark Your Calendar for December PDUFA Dates
For news coverage in Italian or Spanish, see Benzinga Italia and Benzinga Spain.
© 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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