US will probably difficulty allergy warning over Pfizer vaccine: official
Moncef Slaoui, the chief advisor to the U.S. program to develop Covid vaccines and treatments, expects the Food and Drug Administration to issue an allergy warning to the Pfizer vaccine
If the U.S. Food and Drug Administration (FDA) decides to approve the Pfizer-BioNTech COVID vaccine, it will likely tell people with a known history of severe allergic reactions not to take it, a senior government scientist said Wednesday.
The news follows a similar warning in the UK after two health care workers suffered allergic reactions and needed treatment.
Both the UK and Canada have already approved the two-dose vaccination regimen in an emergency, and the US is expected to follow suit within days after an FDA advisory panel met on Thursday on the matter.
Moncef Slaoui, who is the lead advisor to the US program for COVID vaccine and treatment development, told reporters, “Looking at the data, patients or subjects with a history of severe allergic reaction were excluded from the clinical trial.
“I anticipate the FDA will make these decisions, that this will be part of the consideration tomorrow and, like the UK, it is expected that people with known severe reactions will not (will) take the vaccine – until we understand exactly what happened here. “
The FDA is also likely to ask providers to consider whether people develop a rare but transient and not very severe form of facial paralysis called Bell’s palsy after data showed that four out of approximately 19,000 people in the study’s vaccine arm would develop the disease are.
Overall, Slaoui was impressed with the vaccine data published in the information documents submitted to the FDA, including the fact that strong protection set in after the first dose – although the recommendation remains that both injections be given 21 days apart.
It is unknown when exactly the regulator might be able to issue its emergency clearance, but Health Minister Alex Azar said officials will be keeping an eye on early next week.
General Gus Perna, who oversees logistics across the country, said he placed an order on Wednesday to begin distributing syringes, needles, alcohol swabs and diluents for the Pfizer vaccine. This process should be completed by Friday.
The US is hoping to vaccinate 20 million people this month, with long-term care residents and health workers at the forefront.
The goal is to reach 100 million by the end of February and the entire population by June.
The next vaccines to get approved could be those made by Moderna, Johnson & Johnson, and AstraZeneca, most likely in that order.
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© 2020 AFP
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