The following article, FDA Shocks Nation, Will Forego Public Discussion in Vaccine Approval Process, was first published on Flag And Cross.
The talk of the American electorate over the last several months has largely revolved around a singular, pointed issue, (no pun intended): Vaccinations.
Specifically, inoculations against COVID-19 that have been approved for “emergency use authorization”.
Not only are many Americans already concerned about vaccinations in general, but there are new concerns about the speed at which these jabs were developed. This has created enough doubt to leave about 30% of the population unvaccinated still, which, in turn, means that herd immunity could be difficult to reach.
What the Biden administration needs now is to shore up confidence in these shots, but the FDA’s latest decision seems to be heading in the wrong direction.
Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.
Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.
The statement had a very “boilerplate” vibe about it.
“The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 20202 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.
“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.”
The news will almost certainly stir up more criticism of the FDA and the vaccine in general, and is sure to stir up a number of new debates over the reason for the organization’s clandestine work.
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