FDA Grants Full Approval to Pfizer Injection Without Public Discussion of Data

"It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years”

‘Without a meeting “we have no idea what the data looks like.”’

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 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 spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.”

The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven.

Data scrutiny

Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data.

“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”

Witczak is one of the more than 30 signatories of a citizen petition5 calling on the FDA to refrain from fully approving any covid-19 vaccine this year to gather more data. She warned that without a meeting “we have no idea what the data looks like.”

“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said.

“There is no control group after Pfizer offered the product to placebo participants before the trials were completed.

“Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”

Public discussion

Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings, told The BMJ, “It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know.”

Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said that advisory committee meetings were more than just a way of receiving scientific input from outside experts. “It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” he told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence.

“If there are no advisory committee meetings prior to licensure, the FDA should consider taking extra steps to explain the basis of its decisions to the public.”

On 18 August, before the news that the FDA would not be holding a formal committee meeting, the president of the Infectious Diseases Society of America Barbara Alexander praised the impact of the VRBPAC meetings as “a critical and necessary part” of the process for assessing whether to give booster doses.6

References

Source: The BMJ

13 Comments
  1. Mark says

    Totally unsurprising; Herr Doktor Fauci is on record as pressuring the FDA to grant full approval as this is perceived as the last flimsy defense standing in the way of sweeping mandates, of companies and agencies ordering all employees to undertake a full vaccination program against a supposed virus that only kills a little more than 1% of the people it infects, and kills mostly the elderly and sick, just like the flu.

    Far from meaning all is now lost, and that we must yield to irresistible pressure, the threat of being fired from one’s job because you will not accept vaccination against a ‘disease’ which is about as likely to kill you as lightning, and against which vaccination conveys no benefit – ‘the science’ informed us before that the very great majority of ‘cases’ were asymptomatic or only mildly symptomatic, and this is the best that vaccination promises you – it should be the basis for job actions through unions. It should be the basis for those who do not want to be vaccinated to stop giving blood, and to withdraw their permission as organ donors to gift their usable organs to further use upon their death. The unvaccinated should decline participation in anything for which their cooperation is sought, like voting. They have no rights – how can they have responsibilities? They’re no longer accepted in ‘the community’ – why should they feel any responsibility to it?

    1. osa says

      There is no virus.
      Vaccine – bio-weapon designed to kill slowly in 1-2 years.
      Remember all those dead microbiologists some time ago – now we know why they were killed.

  2. ken says

    If this doesn’t convince people they are up to no good then there is no hope for them.

    What they are doing is criminal There is no way they can approve a drug in a few short months. The Fauci Death Agency (FDA) is corrupted to the core.

  3. yuri says

    CIA approves anything required by emperor gates

  4. GMC says

    According to some data , more than 100,000 people in the world are dead from the mRNA gene therapy jab, and millions have been taken to the hospitals. Do I believe the Data ? Probably more than I believe the WHO and the CDC data.
    And their fake vaxine is feeding the Viruses, which accounts for all the different names of variant viruses, in the photo below. All this in order to keep the Pandemic ongoing , the population dying and the Big Pharma – Rich. It is definitely a depopulation war against the world.

    1. osa says

      They are morons – killing 95 percent of the people, and then what?
      Some kind of elite utopia will suddenly materialize?

      1. GMC says

        They are not vaxing the immigrants , or pushing the minorities to vax, that will take the place of those who get sick and die.

  5. Jerry Hood says

    AllatRA TV International has some good explanation to this global jew Big Pharma genocide: Artificial Intelligence owned by Rat-childs needs billions of goyim to die! Who would feed these useless eaters who will be eternally unemployed and robots replacing them??? Behind everything= Rat-childs and their yiddish managers of this world!!!

    1. Jerry Hood says

      Of course, after the Great Reset by German Schwab= Cockroach in Slovak and Czech!

  6. Tracy says

    not true. read the fdas letters. Pfizer is still under eua. gaslighting to the max. see dr. malone on the war room. also dr. cris marten on peak prosperity.

  7. GMC says

    Pass the mRNA jab or we will spray Sarin around your entire house — O Tay.

  8. chuxtuff says

    And we’re STILL not taking it…

  9. Look deeper says

    Not true, its not approved by the fda, dig deeper

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