WASHINGTON, Nov 21, 2020 (BSS/AFP) – With US pharmaceutical giant Pfizer
and its German partner BioNTech applying for an emergency use authorization
in the United States for their coronavirus vaccine and US biotech company
Moderna expected to do so soon, here are the next steps in the approval and
distribution process:
– Evaluation begins right away –
The US Food and Drug Administration (FDA) will immediately begin
evaluating the results of the Covid-19 vaccine clinical trials conducted by
Pfizer/BioNTech.
They will concentrate on the safety of the vaccine and its effectiveness,
which has been billed at 95 percent by Pfizer/BioNTech. FDA commissioner
Stephen Hahn said the approval process will include a public meeting of the
FDA’s vaccine advisory committee, which includes experts in infectious
diseases, pediatrics, biostatistics and industry representatives.
The committee’s recommendations are not binding, however, and a final
decision on whether or not to authorize the vaccine will be up to the
scientists at the FDA.
– Green light: December –
The FDA could provide emergency authorization as soon as the first two
weeks of December, according to Moncef Slaoui, the chief scientist for
“Operation Warp Speed,” the US government initiative to develop a Covid-19
vaccine.
It would be a conditional approval in the context of the global health
crisis and would restrict distribution of the vaccine to certain members of
the population.
Children, for example, would not be included because Pfizer has not yet
conducted widespread testing of the vaccine among those under the age of 18.
Another US government agency, the Centers for Disease Control and
Prevention (CDC), would determine the order of priority for distribution of
the vaccine.
Front-line medical workers and elderly residents of nursing homes would
probably be among the first to be inoculated.
In Europe, Britain, Canada, Japan and Australia, the process is slightly
different and regulators there have been constantly reviewing the data from
clinical trials being conducted by several manufacturers.
The European Union could give a green light to a vaccine as early as the
second half of December, according to European Commission president Ursula
von der Leyen.
– Distribution: late December –
Pfizer/BioNTech said doses of the vaccine would be ready for distribution
“within hours” after US authorization, which could mean shipments beginning
in the second half of December.
They would initially be provided by a US factory in Kalamazoo, Michigan,
and a Belgian plant in Puurs. The vaccine must be stored at -70 degrees
Celsius (-94 degrees Fahrenheit), temperatures much colder than those of a
standard freezer.
Pfizer would distribute the doses to vaccination centers in containers
filled with dry ice which should keep the vaccine at the required temperature
for 15 days.
– Next vaccines: early 2021 –
The Moderna Covid-19 vaccine could be ready for distribution soon after
that of Pfizer/BioNTech and could be followed by February by that of Johnson
& Johnson, according to Slaoui, with AstraZeneca/Oxford also expected in the
next few months.
While high-risk groups will be the first vaccinated, the US government
hopes that there will be enough vaccines by April 2021 to offer it to the
broader population and provide high coverage by the summer.