These last ten days have been the most important in coming to an understanding of our Covid-19 vaccination strategy.

You can be forgiven if you don’t follow governmental biomedical machinations closely. What happened was this: Last week, without any input from the Food and Drug Administration (FDA)’s own Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA authorized a second booster dose of the Pfizer-BioNTech and Moderna Covid-19 vaccines for people over 50 and the immunocompromised.

Then, two days ago, the VRBPAC committee convened for a scheduled discussion about the future of Covid-19 vaccines. And for the first time, the public could witness, via its live-streamed meeting, a group of experts honestly addressing what has become the grim reality of our current strategy dealing with the Covid-19 pandemic. In a palpably concerned forum the panel members could be seen calculating the human expense of a continued vaccine strategy where we have reached an untenable every-four-months booster effort. It seemed that the VRBPAC was looking for a vision of pandemic resolution that was no longer possible through vaccine eyes and that another path was needed.

Translation: Vaccines are not the answer; we need to concentrate on therapeutics.

With 35 years of experience analyzing healthcare funding, discovery, development, trialing, and sales, I feel confident saying that we are entering the most critical turn along our tortured Covid-19 pandemic pathway. While turns are a given in such an endeavor, what makes this one critical is our lack of ability to anticipate, much less address, what lies ahead. In the U.S., higher rates of vaccination have not translated into lower death rates. Other countries, such as those in Africa, have lower vaccination levels yet report much lower death rates compared to ours. If vaccines were the answer, we would expect the reverse to be the case.

It seemed almost a pile-on when a debate was attempted as to why we are not developing a bivalent vaccine that stimulates a response to different strains of the virus. Conferring about fourth or fifth shots by this fall was openly looked on askance given the limited benefits of such actions. Consider that the most recent Israeli data suggests that a second booster (fourth injection) protection against infection begins to wane at four weeks and disappears by eight weeks. A cost-benefit analysis of a second booster discussion was further complicated when manufacturing, distribution, access, administration, compliance, and tracking expenses were added to the equation. The third rail that couldn’t even be touched was the political back and forth to provide minimal financial support.

Translation: we do not have the means or the Congressional willpower to pay for such ineffective strategies.

The VRBPAC admission, albeit in couched terms, that our vaccine strategy has failed to produce the desired results is an important first step. Now we need to concentrate our efforts on preventing, mitigating, and treating the damage inflicted by this virus, other pathogens, and other related disease processes.

Even antivirals are not the answer as it is naïve to think that similar viral resistance will not emerge to them as well. Antivirals can, however, buy us time as we work to detect escape pathogens. Such detection requires not only vigilant monitoring, but also constant testing and genetic surveillance. Genetic sequencing is essential for the detection of mutant strains.

What was not discussed was the strategy for dealing with new mutant strains. Will we be required to return to non-pharmaceutical interventions: masking, distancing, isolation of infected persons, and avoidance of large crowds in enclosed spaces to limit spread? If we do find ourselves in that scenario, we must combine such personal actions with a fierce focus on therapeutics.

Considerable evidence suggests that the major damage the SARS-CoV-2 virus causes to our body is brought about by inflammation. Inflation, in turn, causes a wide-ranging microvascular-coagulopathy which showers every organ system with microscopic clots. The clots cut off blood supply and are believed to be responsible for not only acute damage but also the array of sequalae — the aftereffects — which could include long-Covid. The latter includes breathing difficulties, mental dysfunction (brain fog), diabetes, cardiac disorders, and a host of other maladies. One of our only treatments to reduce Covid-19 induced inflammation is the administration of steroids. We need more and better alternatives. Therapeutics that prevent or limit inflammation will be of benefit in preventing and treating not damage caused by Covid-19. In addition, such treatments could potentially address damage caused by other diseases such as immunodeficiency disorders and may also reduce or prevent damage wrought by future, as yet unknown, pathogens.

It is clear Covid-19 is still with us, whether we like it or not. Our defiant gestures such as televising mask-less Oscar and Grammy ceremonies, peeling off floor markings in supermarkets that once kept line holders six feet apart, returning unmasked to sporting and cultural events, and acting blithely as though we can simply move on, are more than acts of viral defiance — they are premature, ill-founded, and dangerous acts of a frustrated and exhausted populace. While understandable to a degree, they are in no way a strategy for dealing with a pandemic.

Omicron subvariant BA.2 is already dominant in this country and will continue to spread. The next mutation, XE, is already in the UK and will soon be here. XE is a recombinant variant made up of elements of BA.1 and BA.2 and is at least 10% more transmissible than the previous versions. There is not enough data to say whether it will evade current vaccines and therapies or whether it will prove to be more virulent. The VRBPAC meeting raised many important questions. Only time will tell if they identified the most important ones. But time is in shorter and shorter supply. Action, not aspiration, is required.

History is watching. We live in the country that spends the most money on health care, yet we have little to show for our investment. It is time to reset our pandemic pathway course. Failure to do so will provide us with not only bad health care, but unsustainable health care.

Translation: we need innovative therapeutics; our very lives depend on their development.

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