The European Medicines Agency announced on Tuesday that it has received applications for conditional marketing authorizations from Pfizer Inc. (NYSE: PFE) –BioNTech SE – ADR (NASDAQ: BNTX) and Moderna Inc. (NASDAQ: MRNA), two pioneers in coronavirus vaccine development.
The decision is unlikely to be made early, thus pushing the timeline for vaccine introduction.
What happened: Pfizer-BioNTech and Moderna began submitting BLAs for their test vaccines on October 6 and November 16, respectively.
As the Agency has already reviewed some data during the ongoing review, when it assessed the quality of the vaccine, the results and efficacy of the laboratory tests, and the initial data from the large late-stage study, it is now a formal application for conditional marketing authorization.
If the data submitted prove to be sufficiently substantiated, the EMA Scientific Committee for Human Medicines will complete its evaluation at special meetings scheduled for Pfizer-BioNTech on 29 December and for Moderna on 12 January.
Related link: Next week in biotechnology: hematology conference begins, Vanda and BioCryst await FDA decisions
What is the next step: If the EMA concludes that the benefits of the vaccine outweigh the risks of protection against COVID 19, it will recommend that the European Commission grant a conditional marketing authorization.
It will be valid in all EU and EEA Member States within days of the permit being granted, the EMA said.
Even if the EMA distributes a positive verdict by day D, distribution can only begin in early January, the Financial Times wrote. It takes three to four to four days for Member States to approve the EMA.
UK regulators are preparing to cancel the Pfizer-BioNTech vaccine as early as this week, FT reported.
The U.S. FDA is well on track to issue emergency licenses to Pfizer-BioNTech and Moderna vaccine candidates by mid- to late-December.
The FDA’s Advisory Committee on Vaccines – the Advisory Committee on Vaccines and Related Biological Products – is scheduled to meet on Dec. 10 to discuss the Pfizer-BioNTech vaccine and make its recommendations on Moderna vaccination on Dec. 17.
Positive recommendations could support the issuance of permits for emergency use by the end of 2020, Morgan Stanley analyst Matthew Harrison said in a note.
Price operation: Finally, Pfizer shares rose 3.18% to $ 39.53. BioNTech shares, which recently paid off optimistically from vaccine expectations, slipped 6.95% to $ 115.60.
Moderna last fell 7.07% to $ 141.95.
Related link: Attention biotechnology investors: Mark your calendar for December PDUFA dates
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