10/12/2022
PERSPECTIVE ON THE LATEST COVID BOOSTER
The FDA recently approved the Omicron BA4/5 vaccine for COVID. Every time a new COVID vaccine is approved, I hear questions from my patients. “Should I get it?” “Should get it now or wait?” “Do I really need to get it? I’ve already had COVID.”
These are all valid questions that others may have as well, so here are my thoughts.
The Brief History of COVID Vaccines
The first MRNA vaccines for COVID were approved in December 2020 under an Emergency Use Authorization. Given the number of hospitalizations and deaths at that time due to COVID, issuing an Emergency Use Authorization was not surprising, even though studies were limited and data somewhat inconclusive at the time.
Fast forward almost two years later to this latest version of the COVID vaccine. Unlike two years ago, the COVID virus today is far less deadly and dangerous than the 2020 version. Almost no one these days goes on a ventilator due to COVID without underlying and/or secondary causes.
The Current Conditions Around COVID and Vaccines
While data is incomplete due to low self-reporting of COVID cases, it is currently estimated that at least two-thirds of U.S. residents have contracted COVID, with more of those people having had an Omicron or Omicron variant version of the disease. Contracting COVID provides at least some level of antibodies for at least several months.
Also, vaccines are, inevitably, always “chasing” the currently prevalent variants of the diseases for which they are developed. This is true “in spades” as it applies to COVID. By the time a COVID vaccine has been developed and released, the dominant variant has mutated several versions from the variant(s) for which the latest vaccine has been created.
Where are the Safety and Efficacy Studies?
With all of this medical science being well understood by medical professionals and government health officials, there have been no (as in zero) studies of this latest COVID vaccine in humans. The FDA approval is reported to be based on a study with a few mice mounting an immune response.
What this means is that the early recipients of this COVID vaccine booster will effectively be the participants in a real-time, nationwide experiment.
The Normal Process for Approval of New Drugs by the FDA
Honestly, I expected that the Omicron version of the vaccine would be vetted more thoroughly before being approved, particularly given the protections afforded by the previous COVID vaccines and boosters, the naturally produced antibodies from all of those who have had COVID and the development of antiviral medications like Paxlovid.
The normal way of showing that a new drug works involves 3 phases of trials:
a safety and dosing trial where different doses of the new drug are given to people, and the recipients are monitored for reactions, side effects, and some promise of it working. These trials are usually small, but an important step.
a real dosing trial to see if there is an optimal dose to achieve the desired effect.
a large, placebo-controlled and randomized trial designed to determine if there is a clear benefit to the new drug.
None of the above trials have been performed on humans for the Omicron BA4/5 vaccine. The first COVID vaccine had at least some human data before it was approved. The reality is that we have no clue if this vaccine is safe, if it saves lives, how many people need to be treated to save one life, etc.
I often wait a few years after any new drug has been released before prescribing it, even with all of the studies that have not been applied to this latest COVID vaccine, because post-marketing, real-world, time-tested experience really reveals all the side effects and issues with a new drug/therapy.
Dr. Fink’s Bottom Line
To be clear, this does not mean that the new booster is not safe or effective. It just means that no one really knows yet.
I realize there are people who will still want the updated version of the vaccine, and in all likelihood, it will be roughly as safe as the original version, but it would be nice to know before using the American public as participants in a massive trial to which they don’t even understand they are volunteering.