ABN Amro venter, at de amerikanske sundhedsmyndigheder, FDA, i denne uge vil godkende Pfizer/BioNTch- covid 19 vaccinen i USA, efter at vaccinationer er begyndt i Storbritannien. Det sker i henhold til bestemmelserne for en nødsituation, EUA. Der vil fortsat blive foretaget kliniske tests. Der er endnu ikke en klar vurdering af, hvor lang tid en vaccination vil vare. Det bliver afgørende for, hvornår verden bliver “normal”.
Pfizer vaccine on the brink of emergency use authorisation in US
Global Macro: FDA report suggests Pfizer vaccine approval on Thursday or shortly after – The U.S. Food and Drug Administration (FDA) has made available the briefing document on the Pfizer/BioNTech COVID-19 vaccine ahead of Thursday’s public hearing and external review.
In the report, the FDA basically concludes that the efficacy, safety and immunogenicity data in Pfizer’s/BioNTech’s emergency use authorisation (EUA) application supports a positive assessment of risk and benefit for the COVID-19 vaccine.
The Pfizer/BioNTech COVID-19 vaccine clinical trial will continue as long as possible to monitor participants and obtain additional data to support a Biologics License Application (BLA) filing in the “near future”, or in other words a full licensing of a vaccine. Pfizer/BioNTech plans to also have an extensive post-authorisation plan to monitor long-term safety on vaccine recipients under an EUA.
There is still not verdict on the durability of the vaccine-induced immune response beyond two months or whether vaccination prevents transmission of SARS-CoV-2. Especially the latter is a critical unknown about all vaccine candidates because while they may be highly effective at preventing COVID-19, it remains uncertain whether they are able to stem the spread of the coronavirus.
That is of course important because it is a key factor in determining how quick the world is able to return to ‘normal’.
Today’s communication implies that the FDA already feels that the Pfizer/BioNTech vaccine is worthy of an EUA. The external review will take place as aforementioned this Thursday where we expect the vaccine to be authorized. The Vaccines and Related Biological Products Advisory Committee—a committee made up of external experts—will provide feedback on the Pfizer/BioNTech data.
We expect the committee to be in favour of granting an EUA given the overwhelming evidence regarding the safety and efficacy of the Pfizer/BioNTech product. The risk here is that the committee recommends waiting for additional data to monitor longer-term safety and immunogenicity to get a better idea of the duration of the immune response.
However, our base case scenario remains that a vaccine is approved under an EUA this week either on Thursday or in the days that follow. This should provide a boost to risk assets, albeit the move is mostly priced in at this stage. Cyclical assets and battered names could benefit as institutional money continues rebalancing amid the confirmation that a recovery is on the horizon.
