With US pharmaceutical giant Pfizerand its German partner BioNTech applying for an emergency use authorizationin the United States for their coronavirus vaccine and US biotech companyModerna expected to do so soon, here are the next steps in the approval and distribution process, reports AFP.
– Evaluation begins right away –
The US Food and Drug Administration (FDA) will immediately beginevaluating the results of the Covid-19 vaccine clinical trials conducted byPfizer/BioNTech.
They will concentrate on the safety of the vaccine and its effectiveness,which has been billed at 95 percent by Pfizer/BioNTech. FDA commissionerStephen Hahn said the approval process will include a public meeting of theFDA’s vaccine advisory committee, which includes experts in infectiousdiseases, pediatrics, biostatistics and industry representatives.
The committee’s recommendations are not binding, however, and a finaldecision 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 twoweeks of December, according to MoncefSlaoui, the chief scientist for“Operation Warp Speed,” the US government initiative to develop a Covid-19vaccine.
It would be a conditional approval in the context of the global healthcrisis and would restrict distribution of the vaccine to certain members ofthe population.
Children, for example, would not be included because Pfizer has not yetconducted widespread testing of the vaccine among those under the age of 18.
Another US government agency, the Centers for Disease Control andPrevention (CDC), would determine the order of priority for distribution ofthe vaccine.
Front-line medical workers and elderly residents of nursing homes wouldprobably be among the first to be inoculated.
In Europe, Britain, Canada, Japan and Australia, the process is slightlydifferent and regulators there have been constantly reviewing the data fromclinical trials being conducted by several manufacturers.
The European Union could give a green light to a vaccine as early as thesecond half of December, according to European Commission president Ursulavon der Leyen.
– Distribution late December –
PfizerBioNTech said doses of the vaccine would be ready for distribution“within hours” after US authorization, which could mean shipments beginningin 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 degreesCelsius (-94 degrees Fahrenheit), temperatures much colder than those of astandard freezer.
Pfizer would distribute the doses to vaccination centers in containersfilled with dry ice which should keep the vaccine at the required temperaturefor 15 days.
– Next vaccines early 2021 –
The Moderna Covid-19 vaccine could be ready for distribution soon afterthat of PfizerBioNTech and could be followed by February by that of Johnson& Johnson, according to Slaoui, with AstraZenecaOxford also expected in thenext few months.
While high-risk groups will be the first vaccinated, the US governmenthopes that there will be enough vaccines by April 2021 to offer it to thebroader population and provide high coverage by the summer.
