by Tyler Durden
The Food and Drug Administration (FDA) may give full approval to the Pfizer Covid-19 vaccine As early as September or October, according to The Wall Street Journal, citing FDA advisers and former officials familiar with the process.
Comes rush to get full consent – unlike the current emergency use permission – like many schools and hospitals and employers Full consent was used as a criterion to proceed with mandatory vaccinations.
“We’d like to see it certified as quickly as humanly possible“So we can really go back to the more normal experience,” said Jim Malatras, president of the State University of New York system, which currently cannot enforce a vaccine mandate for the roughly 400,000 students who have served under that system. Nowadays, the school requires either vaccinations or a weekly test.
Three vaccinations – from Pfizer company and partner BioNTech SEAnd Modern company , And Johnson & Johnson Licensed for emergency use in the United States, Pfizer Moderna has submitted preliminary paperwork for full approval. However, Pfizer has only provided all necessary information to the Food and Drug AdministrationAccording to companies and Analysts predict that he will be the first to get the green light. Moderna says it is still completing its renewable data submissions, and Johnson & Johnson says it plans to file for full approval later this year. –The Wall Street Journal
The FDA is taking a “extensive hands-on” approach to reviewing Pfizer’s application for full approval “as quickly as possible consistent with the full, high-quality evaluation the public expects from the FDA.”
like magazine He notes, that full approval would ease restrictions on distribution and advertising, and would allow more states, schools and employers to force people to take a jab, according to attorneys and current/former FDA officials. Once full consent is given, The vaccine will be eligible for prescriptions as a booster dose by doctors.
According to a June Kaiser Family Foundation survey, More than 30% of unvaccinated Americans would likely get it if the Food and Drug Administration granted full approval.
“The vast variation in vaccination rates across the country tells a story about perceptions of risk across the country,” said Harvard Assistant Professor Joseph Allen, chair of the university’s Healthy Buildings Program. “If you’re a company that’s operating in all 50 states and even internationally, it’s hard for them to move forward with a vaccine authorization and getting full approval and authorization from the FDA would make that easier.”
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Pfizer says it began the rolling application process in May, while Moderna did the same in June – allowing them to submit final sections of their applications without having to wait for full completion.
“It’s like saying that not all of the Christmas presents are under the tree, but you can start unwrapping them,” said former FDA chief scientist Dr. Jesse Goodman.
Once the company completes its submission, The FDA has 60 days to decide whether to grant a priority review. Then, under the Drug Users Fee Act of 1992, the FDA must take action on the application within six months of it being filed, compared to 10 months under standard review.
The agency earlier this month gave Pfizer a priority review, and Moderna said it would request a review. AstraZeneca The PLC said it will apply for full approval for its vaccine, which has not yet been authorized for emergency use in the US, by the end of 2021. The US has an oversupply of other vaccines, but The company says its vaccine still plays a role.
However, some public health experts point out that full approval may do little to increase vaccination numbers due to the emergence of a hasty and politicized process.
“This sounds like an easy fix, but I think we need to understand that it isn’t,” said Arnold Montau, professor of epidemiology at the University of Michigan. “If they move more quickly into a complicated situation, I’m afraid some people will say, ‘Why did they do it so fast? Did they really check all the data they were supposed to check?'”