Washington | After the request filed Friday by the Pfizer / BioNTech alliance for a marketing authorization to the American authorities, here are the next steps in the calendar, which also concern the company Moderna, very advanced in its clinical trials.
The US Medicines Agency, the Food and Drugs Administration (FDA), will assess the results of the clinical trial supporting Pfizer / BioNTech’s claim, focusing on two central issues: the efficacy of the vaccine, announced as of 95%, and its safety, confirmed by two months of follow-up after the second dose for half of the participants.
A public meeting of the FDA’s advisory committee on vaccines will be called, said Stephen Hahn, director of the agency. This committee is made up of experts in infectious and pediatric diseases, biostatisticians and representatives of consumers and industry.
Its opinion will not be binding, the decision to authorize or not the vaccine will be up to the scientists of the FDA.
Green light: December
The FDA should issue what it calls an “emergency use authorization” from the first half of December, according to Moncef Slaoui, scientific manager of the government operation “Warp Speed”.
It is a conditional authorization, within the framework of the health emergency, and which will undoubtedly restrict the use of the vaccine to certain groups of the population. Children will not be one of them, as Pfizer has not yet extensively tested the vaccine on those under the age of 18.
Another body, the Centers for Disease Prevention and Control (CDC), will need to clarify the prioritization of vaccinations, medical staff, and nursing home residents likely to be targeted initially.
In Europe, the United Kingdom, Canada, Japan and Australia, the procedure is slightly different: regulators have been examining continuously for several months the data transmitted during tests by several manufacturers.
If all goes well, the European Medicines Agency (EMA) could issue a formal opinion “from the second half of December”, according to Commission President Ursula von der Leyen.
Distribution: end of December
Doses of the Pfizer / BioNTech vaccine will be ready to ship “within hours” of authorization, the companies said, expecting the second half of December. They will start from the American plant in Kalamazoo (Michigan) and the Belgian plant in Puurs.
The vaccine should be transported at -70 ° C, an extreme temperature below that of standard freezers. Pfizer will ship its doses to vaccination centers in boxes filled with dry ice that will maintain this temperature for 15 days.
Upcoming vaccines: early 2021
After Pfizer / BioNTech, Moderna’s vaccine could be licensed and distributed on a near schedule.
Then, regulators will await the results of the Johnson & Johnson tests, probably in January according to Moncef Slaoui, and AstraZeneca / Oxford.
The first vaccinations in December will primarily concern Americans most at risk, but with several vaccines authorized, the government hopes to have enough doses by April 2021 to offer the entire population to be vaccinated, with high vaccine coverage expected. by summer.