09.18.2021 | Forbes
By Steve Brozak
Friday’s FDA Vaccines and Related Biological Products (VRBPAC) meeting on Pfizer’s Covid-19 vaccine booster was so problematic as to make a reasonable person wonder whether our vaccine strategy was ever about science. To make it clear, vaccines have played the most positive role in the world’s efforts to address the ever-growing Covid-19 pandemic crisis, but the hearing presentation didn’t even meet the basic technical minimums of a PowerPoint presentation. While some might say this might be placing form over substance, but after multiple VRBPAC hearings and you still can’t even manage basic IT hurdles, how can you ensure intelligent deliberation?
Before discussing the glaring weaknesses of Friday’s meeting, consider the administration’s stumbling August announcement that the booster shots would, with the uncomfortable tacit approval of CDC Director, Rochelle Walensky, begin getting into the arms of Americans beginning September 20. For those with a calendar, that’s Monday! For those with a sense of logic, that’s before FDA approval of the Pfizer booster shot and before the Moderna and Johnson & Johnson even submit a request for approval! Using railroad terminology, the booster train left the station without the cars attached and the conductor has not been identified.
Friday’s VRBPAC meeting could have helped save face for the administration and restore confidence in the system, but it didn’t, or maybe, it couldn’t. One must start with the Byzantine process taking place. The FDA, through VRBPAC, renders a decision to the Advisory Committee on Immunization Practices (ACIP). And ACIP at its meeting next week will then make a recommendation to CDC on how to implement the label indication with regards to specific subgroups of the population (with the caveat that there will not be data on every subgroup of interest) in such a manner that will provide maximum impact for overall public health. If you’re confused, Friday’s meeting did little to provide clarification.
The first salvo came with a presentation by Dr. Jonathan Sterne and his methodological analysis of vaccine data efficacy. He questioned whether it was even possible to collect useful information with so many new and growing variables. He described the variables as temporal confounding factors and succinctly put they represent the problems with our continued lack of understanding around the virus in these fast moving times. His presentation continued to have an unnerving effect when you consider what the implications would mean for future vaccine studies. His most telling statement came in a very subtle way and it raised a question that needs to be understood carefully. What happens as more people become Covid-19 infected and recover? One cannot include them in a placebo versus treatment study as the numbers will become skewed very quickly.
This was followed unsurprisingly by multiple studies revealing that Covid-19 vaccine protection wanes over time. Hence the reasonable assumption that a booster injection will restore protection. But the focus on the data began on the risk/benefit profile, for the unvaccinated, when it should have been on the vaccinated for whom the booster was intended and needed.
Much of the data provided at Friday’s meeting came from Israel, but some of it was based on one-month follow-ups where even the definition of severe disease had different standards. These realities combined with how the United States population does not mirror that of Israel made for no definitive answers. Thus, began a, sometimes embarrassing, meeting.
The question before VRBPAC initially came down to whether to approve Pfizer’s request to grant full approval for a vaccine booster for eligible recipients, 16 years of age and older, who were 6+ months post full initial vaccination, based on its clinical trial C4591001 of 306 subjects. The hubris of Pfizer’s proposal was amplified by the revelation that a mere 12 of those 300+ subjects were over the age of 65, no one was under the age of 18, and no information on diabetics/obese individuals (the group most at risk of serious Covid-19) was even given.
Back to the distractions presented by multiple IT audio difficulties made much of the ensuing debate confusing if not unintelligible. After hours of testimony, there was repeated confusion on not only on how to phrase questions, but even when, how, and who was voting. The deciding vote and poll outcome was clear; doubt was the victor. To quote the acting chair of the hearing, Dr Arnold Monto, the use of specific vaccine language, i.e. who would get the vaccine, was “opening a can of worms.” Unfortunately, the result of this haphazard presentation will give more than enough ammunition to any vaccine critic to highlight the lack of solid information and safety.
We are left with more question than answers and here are 5 of the most critical questions left unanswered:
- What constitutes an acceptable level of protection from Covid-19 in terms of neutralizing antibodies (or any other measurable determinant – since breakthrough infections are the real concern with waning immunity)?
- Between the spread of multiple variants (Delta as the current threat) and waning vaccine immunity, is the FDA suggesting that we will need a booster injection every 6 months?
- Ultimately what will be the best long-term strategy since, as one speaker suggested, herd immunity is unachievable?
- What therapeutic measures are likely to replace (or at least augment) vaccination?
- What ethical studies can be conducted to accumulate useful data to establish a best-practices paradigm?
In the end, VRBPAC denied Pfizer’s request but not before producing a helter-skelter alternative recommending approval of booster vaccination for individuals 65+ years of age or at high risk of severe Covid-19. Yet even then the recommendation had to be revised to allow for booster injections for those at high risk of acquiring Covid-19 when it was realized that, in its original form, it did not cover health care providers and first-line responders.
These are the agencies we look to for guidance and safe passage. Instead, we seem to find ourselves on a train that is beginning to look like the proverbial slow motion wreck. Let’s hope at the very least it doesn’t speed up.
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