Acting Chairman of the FDA’s Vaccine and Related Biological Products Advisory Committee, Dr. “They’re moving forward with what wording should be on the label,” said Dr. Arnold Monto, who voted Thursday to recommend the authorization, and chair the FDA’s Vaccination and Related Biological Products Advisory Committee. “The vaccine.
In the UK, health officials have warned that people with a “significant history of allergic reactions” should not be vaccinated.
It is unclear whether the FDA will make the claim.
“There are a lot of people with allergies – how can we define it?” Monto said.
Authorization could come by the end of the day, a source close to the White House Coronavirus Task Force told CNN.
In an interview on Friday, U.S. Health and Human Services Secretary Alex Azar referred to FDA negotiations with Pfizer.
“Over the next few days, as we worked with Pfizer to communicate the need for doctors to prescribe it correctly, we should see the authenticity of this first vaccine,” Azar said on ABC’s Good Morning America. . “And so we’ll be watching people get vaccinated on Monday, Tuesday next week.”
Monto said the issue of allergic reactions and others also need to work.
“The FDA will move forward as soon as this happens, but they should be sure that the label and everything else is reflecting their negotiations with Pfizer,” he said.
Monto said there is also a question as to whether the label should contain any special information for people aged 16 to 17, considering that Pfizer’s vaccine clinically included relatively few people aged.
“I think they’ll issue an authorization at age 16 – that’s clear – but I don’t know if they need to label that the data for age people isn’t that comprehensive,” Monto said. “You know what the labels are like – it’s too long, so you can just imagine what they’re going through right now.”
It may not be decided before the EUA, but the agency and company are also discussing an issue that is not related to labeling: when should clinical trial participants who received a placebo be vaccinated?
In Pfizer’s clinical trials of more than 20,000 study subjects, half of the participants were vaccinated, and half were given placebo, or saline shots, which did nothing.
Neither the study participants nor the doctors conducting the tests know who got the vaccine and who got the placebo. It is unclear when they should be told, and when participants should be vaccinated when they received a placebo.
If participants receiving placebo receive the vaccine, it interferes with Pfizer’s ability to study any differences between the two groups in the future.
Monto said the agency would seek to resolve the issue before authorizing the vaccine.
“They want to move forward as quickly as possible, but they will have to make a decision before the vaccine is approved,” he said.
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