USFDA denies political pressure to approve Pfizer COVID vaccine quickly
Pfizer vaccine
US Food and Drug Administration (USFDA) on Saturday denied that the emergency approval to Pfizer-BioNTech COVID vaccine was not given under political pressure. The regulator granted the approval on Saturday paving the way for mass vaccination in USA, the worst affected country in the global coronavirus pandemic.
"The representations in the press that I was threatened to be fired if we didn't get it done by a certain date is inaccurate," said Stephen Hahn, USFDA Commissioner refuting claims of political pressure.
He added that the decision, which had been expected a few days later, was "based on the strongest scientific integrity."
The agency also released new information for health care providers and for patients as the US shipped millions of doses of the vaccine across the country.
The United States has the highest pandemic death toll of any in the world, with fatalities now approaching 300,000 and nearly 16 million cases of infection.
FDA is now warning people who have a history of severe allergic reaction to ingredients in the vaccine, which are included on a patient fact sheet, not to take it.
If they receive the first dose and have a severe allergic reaction, they are advised to not take the second dose.
The FDA has made no definitive ruling regarding whether pregnant women or the immunocompromised should be given the shots, instead punting that call to people to make for themselves in consultation with their doctors.
"There were not enough pregnant women in the trials, or women who became pregnant in the trials to actually know, and make any statement about that," 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 placebo.
Under this proposal, if they received the placebo, they can request the vaccine when their demographic group's turn comes up.