First modification: 09/12/2020 – 23:48
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Washington (AFP)
If the U.S. Food and Drug Administration (FDA) decides to approve the Pfizer-BioNTech vaccine against covid-19, it will likely ask people with a known history of severe allergic reactions not to take it, a major said Wednesday. government scientist.
Moncef Slaoui, who is the senior advisor to the US program for the development of treatments and vaccines for covid, told the press: “When examining the data, patients or subjects with a history of severe allergic reactions have been excluded from the clinical trial.” .
“I assume – because the FDA will make those decisions – that tomorrow this will be part of what is taken into account, and as in the UK, the expectation would be that subjects with known severe reactions, (will be asked) not to take the vaccine until we understand exactly what happened here, “he said.
The news follows a similar warning in the UK after two healthcare workers suffered allergic reactions and needed treatment.
Both the United Kingdom and Canada have already approved the two-dose vaccine regimen in emergency mode, and the United States is expected to do the same in a matter of days, after an FDA advisory panel meets Thursday on the issue.
The FDA will also likely ask vaccine providers to be vigilant to determine if people develop a rare but temporary and not very serious form of facial palsy called Bell’s palsy, after data showed that four of the roughly 19,000 people in the trial suffered from the disease.
Overall, Slaoui said he was impressed by the vaccine data that had emerged in the information documents submitted to the FDA, including most notably that strong protection developed after the first dose, although the recommendation remains to take both injections, 21 days apart.
It is not known exactly when the US regulatory agency could issue its emergency use authorization, but Health Secretary Alex Azar said officials have in mind that it be early next week.
The United States expects to vaccinate 20 million people this month and residents of long-term care facilities and healthcare workers are the priority.
© 2020 AFP
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