The Food and Drug Administration (FDA) yesterday approved Pfizer-BioNTech’s vaccine against COVID.
Until today the vaccine had only Emergency Use Authorization since it did not yet pass normal scientific rigor to approve the new vaccine. To some this approval gives the experimental vaccine greater legitimacy, for others the approval process was a big missed opportunity.
An article published last week in the British Medical Journal (BMJ) called attention to some of the flaws in the approval process, for example, last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.” But in a more recent statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.
Drug safety advocate Kim Witczak elaborated, saying, “These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization.” She continued: “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 scrutinized in advance of an approval.”
“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,” she warned.
Witczak, along with over 30 medical professionals known as the Coalition Advocating for Adequately Licensed Medicines (CAALM), filed a Citizens’ Petition to the FDA to help improve the process.
The petition starts by describing reasons that should not be a factor in giving approval to the new vaccines, among them, to further enable vaccine mandates. Stating that “consideration of vaccine mandates is outside of FDA’s purview. Furthermore, a mandate should only be considered once the evidentiary conditions are met for a BLA (demonstrating that benefits outweigh harms).”
Another reason, mentioned in the petition, that should not be a factor in granting approval is “To bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview. Approving, before substantial evidence that population-based evidence of clinical effectiveness is superior to harms may contribute to public wariness and hesitancy, not only about COVID-19 vaccines but other vaccines and public health authorities more broadly. An approval may bolster public confidence, but it is not a valid reason to approve.”
The petition went on to list several actions that the FDA should do prior to granting approval, among them are waiting a minimum of two years for follow-ups on the participants in the studies. “This would be consistent with the June 2020 FDA guidance on COVID-19 vaccines which stated participants should be followed for COVID-19 outcomes for “as long as feasible, ideally at least one to two years.” The petition explains that the “two year follow-up from trials allows the detection of commonly experienced longer-term adverse effects that may not manifest until many months following vaccination.” in addition the “two year follow-up from trials would also allow for more detailed assessment of infection, re-infection, infectiousness, and the monitoring of immune response over time, among all vaccinated participants”
Unfortunately, the FDA did not wait the two years, against its own guidance.
Another issue that was not being addressed, according to the petition, was clarification of the vaccine’s effectiveness vs possible harm across various populations. “The question is not simply whether there is efficacy, but how much efficacy exists in these populations, what kind of efficacy (e.g. reduction in risk of symptomatic COVID-19 vs. reduction in risk of hospitalization or death), and do efficacy advantages outweigh potential harms in these populations.” Pointing out that, the ongoing phase 3 trials of COVID-19 vaccines excluded important populations in which there is reason to believe the effects of the product may differ such as those who are immunosuppressed, have a history of or currently have cancer, are pregnant or nursing, frail older adults, etc.
Objections to the FDA approval process also came from Congress. Yesterday, the Washington Times reported on a letter from Senator Ron Johnson to the heads of the NIH, CDC, and FDA. In that letter, Senator Johnson highlighted several issues including the alarming number of adverse events after vaccination.
“It should also be noted that the 12,791 deaths related to COVID-19 vaccines reported on VAERS over the period of 8 months, compares to 8,966 deaths related to all other vaccines reported on VAERS since the inception of VAERS – a period of 31 years.” The Senator challenged the approval process by concluding “And this does not raise alarm bells within your agencies, or cause you to reconsider assembling an independent safety panel of outside experts?”
Senator Johnson also raised the issue of natural immunity, which according to other research is superior to vaccination immunity, by writing; “Your agencies’ dismissive attitude toward natural immunity has also been puzzling to say the least, and may increase the chances of vaccine injury in previously infected individuals. In its May 19, 2021 advisory, the FDA specifically discouraged Americans and their physicians from determining the status of their antibody immunity to SARS-CoV-2. It would seem to me that more medical information, not less, is the key to improving health outcomes related to any disease, including COVID-19.”
The FDA declined to hold an open public forum for the vaccine’s approval and didn’t heed the advice of the petition brought by experts in the field, what’s even more concerning is that this flawed approval will be used as a basis for legitimizing vaccination coercion. Just yesterday, the U.S. Surgeon General Vivek Murthy said on Fox News Sunday, “I think this announcement from the FDA would likely encourage them [educational institutions and workplaces] and make them feel more comfortable in putting some requirements in place.” This echoes statements from several weeks ago by Dr. Anthony Fauci, Joe Biden’s chief medical adviser, who also argued that approval would lead to “a flood” of vaccine mandates, “They can say: ‘If you want to come to this college or this university, you’ve got to get vaccinated. If you want to work in this plant, you have to get vaccinated. If you want to work in this enterprise, you’ve got to get vaccinated. If you want to work in this hospital, you’ve got to get vaccinated.”
The approval of the first vaccine against COVID marks a milestone, but also a missed opportunity to clarify some of the scientific controversies, to provide more precise direction to physicians, and to help build back some of the diminished trust the public had in the governments’ handling of COVID. But instead, this milestone will ultimately be used by governments and institutions to further justify vaccination mandates and coercion.