“They go back and forth about what words should be on the label – that’s what’s happening now,” said Dr. Arnold Monto, executive chairman of the FDA’s Vaccines and Related Biological Products Advisory Committee. 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 follow suit. “There are a lot of people with allergies – how do you define it?” Monto said. A source close to the White House Corona virus task force said CNN could be recognized at the end of the day. In an interview on Friday, he noted FDA talks with US Secretary of Health and Human Services Alex Azhar Faizer. “Over the next two days, as we work to negotiate with Pfizer, doctors will need to prescribe it in the right way and we will see the approval of this first vaccine,” Azhar told ABC’s Good Morning USA. “So, next week we can see people getting vaccinated on Tuesday, Monday, Tuesday.” Monto said the allergic reaction issue and more need to be done. “The FDA will move this as quickly as possible, but they need to make sure the label and everything reflect the negotiations with Pfizer,” he said. There is also the question of whether 16- and 17-year-olds should have any special information on the label, assuming that Pfizer’s vaccine was only for minors in clinical trials, Mondo said. “I think they’re going to give recognition by the age of 16 – that’s pretty obvious – but do I know that label has to say that the data for that age is not so comprehensive?” Monto said. “You know what labels are – they’re so long, so you can only imagine what’s going on right now.” This may not be decided before an EUA, but the agency and the company may discuss an issue unrelated to labeling: when should vaccine be given to participants in a clinical trial who have received a placebo? In Pfizer’s clinical trials of more than 40,000 study subjects, half of the participants were vaccinated, and half were given a placebo, or a shot of saliva that did nothing. Neither the study participants nor the doctors conducting the tests knew who received the vaccine and who received the placebo. It is not clear when they should be told, and when should vaccines be given to participants who have received placebo. This interferes with Pfizer’s ability to read any differences between the two groups in the future if placebo – vaccinated participants are vaccinated. Monto said the company wants to address this issue before approving the vaccine. “They want to go as fast as they can, but they have to determine all of these things before the vaccine is approved,” he said. .
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