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The FDA issued an emergency use authorization for the two-dose regimen late Friday night after reports that President Donald Trump had threatened to fire the agency’s director if he did not act that day.
In this file photo taken on November 23, 2020, this image taken on November 23, 2020 shows a bottle that says “Vaccine Covid-19” alongside the logos of the US pharmaceutical company Pfizer and the German biotechnology company Biontech. November 23, 2020. Image: AFP
WASHINGTON – The U.S. Food and Drug Administration on Saturday defended itself against allegations of political pressure over the timing of the approval of the Pfizer-BioNTech Covid vaccine and provided new information on the risks for people with allergies.
The FDA issued an emergency use authorization for the two-dose regimen late Friday night after reports that President Donald Trump had threatened to fire the agency’s director if he did not act that day.
Commissioner Stephen Hahn denied that this had happened, telling reporters: “Statements in the press that I was threatened with being fired if we did not do so by a certain date are inaccurate.”
He added that the decision, which was expected a few days later, was based “on the strongest scientific integrity.”
The agency also released new information for healthcare providers and patients, as the US shipped millions of doses of the vaccine nationwide.
The United States has the highest number of pandemic deaths in the world, with deaths approaching 300,000 and nearly 16 million cases of infection.
Over the past two weeks, the US has surpassed 2,000 daily Covid-related deaths multiple times, rivaling the tolls it saw in the early days of the pandemic.
Following reports in Britain that two people who received the injection had a severe allergic reaction, the FDA was expected to dictate that anyone with a history of severe allergies should avoid the vaccine.
THERE ARE NO RULES ON PREGNANT WOMEN
This could have excluded the nearly four million Americans who carry EpiPen (epinephrines).
But the FDA is now warning people who have a history of severe allergic reactions to the vaccine ingredients, which are included in a patient information sheet, not to take it.
If they receive the first dose and have a severe allergic reaction, they are advised not to take the second dose.
The FDA has not issued a definitive ruling as to whether pregnant women or the immunosuppressed should receive the injections, instead asking people to do so themselves in consultation with their doctors.
“There weren’t enough pregnant women in the trials, or women who got pregnant in the trials, to know and make any statements about it,” said FDA scientist Peter Marks.
“It will be something that providers will need to consider on an individual basis for patients.”
Marks also voiced support for Pfizer’s plan to allow people involved in the clinical trial to find out whether they had received the vaccine or the placebo.
Under this proposal, if they received the placebo, they can request the vaccine when it is their demographic turn.
Some scientists have objected to this plan because if trial participants “clear up” and find out what they got, they can change their behavior and this would corrupt the trial data.
But Marks said: “We have to balance the amount of blinded data we receive with the need to protect people from a pandemic that is claiming thousands of lives daily.”
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