Pfizer and BioNTech have filed an application for emergency use approval for a coronavirus vaccine
Since the US pharmaceutical company Pfizer and its German partner BioNTech are applying for emergency approval for their coronavirus vaccine in the US and the US biotech company Moderna is expected to do so soon, here are the next steps in the approval process Sales process:
The evaluation begins immediately
The US Food and Drug Administration (FDA) will begin evaluating the results of the clinical trials conducted by Pfizer / BioNTech with COVID-19 vaccines immediately.
You will focus on the safety of the vaccine and its effectiveness, which was 95 percent billed by Pfizer / BioNTech.
FDA Commissioner Stephen Hahn said the approval process will include a public meeting of the FDA’s Vaccine Advisory Board, attended by experts in infectious diseases, pediatrics, biostatistics and industry representatives.
However, the committee’s recommendations are not binding and a final decision on whether or not to approve the vaccine rests with the FDA scientists.
Green light: December
According to Moncef Slaoui, the chief scientist of Operation Warp Speed, the US government’s initiative to develop a COVID-19 vaccine, the FDA could issue an emergency clearance as early as the first two weeks of December.
This would be conditional approval in the context of the global health crisis and would restrict the distribution of the vaccine to specific populations.
Children, for example, would not be considered because Pfizer has not yet conducted extensive testing of the vaccine in anyone under the age of 18.
Another U.S. government agency, the Centers for Disease Control and Prevention (CDC), would set the order of priority for distributing the vaccine.
Frontline medical workers and elderly nursing home residents are likely to be among the first to be vaccinated.
The process is slightly different in Europe, the UK, Canada, Japan and Australia, and regulators there have been constantly reviewing data from clinical trials conducted by multiple manufacturers.
According to the President of the European Commission, Ursula von der Leyen, the European Union could give the green light for a vaccine as early as the second half of December.
Distribution: late December
Pfizer / BioNTech said doses of the vaccine would be ready for distribution “within hours” of US approval, which could mean shipments begin in the second half of December.
They would initially be supplied by a US factory in Kalamazoo, Michigan, and a Belgian factory in Puurs.
The vaccine must be stored at -70 degrees Celsius, temperatures that are much colder than a standard freezer.
Pfizer would distribute the doses to vaccination centers in dry ice-filled containers that would keep the vaccine at the required temperature for 15 days.
Next vaccines: early 2021
Moderna’s COVID-19 vaccine could be ready for distribution soon after Pfizer / BioNTech’s, and Johnson & Johnson’s could follow in February, with AstraZeneca / Oxford also expected in the next few months, according to Slaoui.
While high-risk groups will be the first to be vaccinated, the U.S. government hopes there will be enough vaccines by April 2021 to offer them to the wider population and provide high coverage by the summer.
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© 2020 AFP
Quote: Covid-19 Vaccine: The next steps (2020, November 20) were accessed on November 21, 2020 from https://medicalxpress.com/news/2020-11-covid-vaccine-1.html
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