Biden Needs to Follow the Science, Not Politics, on COVID Vaccine Booster Shots - Nick Landekic

Sunday, September 05, 2021

Nick Landekic, Guest MINDSETTER™

 

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Internal fighting in the Biden administration is creating confusion

The FDA and CDC are now equivocating on their support of COVID vaccine booster shots. It’s completely understandable and necessary to make decisions based on the best available information at hand and to be particularly careful when data are limited. For example, while some initial reports on the potential use of ivermectin to treat COVID infection may have seemed positive, multiple subsequent reviews such as this one, this one, or this one, as well as better-designed and larger clinical trials have found, in the words of one of the clinical investigators, “Ivermectin shows no effect whatsoever on the disease."

However, in the case of vaccine boosters, hubris and bruised egos may also be at play. 

The danger of waiting for ‘conclusive’ data on the need for booster shots is that it may only come after thousands more will have died and millions more have become infected. The light-speed clinical data coming from Israel all point to the declining effectiveness of the Pfizer vaccine against the Delta variant, including showing that vaccine effectiveness declines to 16% in preventing symptomatic infection by 7 months post-vaccination.

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Israel’s clinical experiences with Pfizer booster doses seem clear and compelling, and show corresponding declines in infections after administration of third doses. Among people aged 60 and over, the protection against infection provided from 10 days after a third dose was four times higher than after two doses. The third dose for over 60-year-olds offered five to six times greater protection after 10 days with regard to serious illness and hospitalization.

Supporting clinical work by the Mayo Clinic has corroborated the results from Israel, and also showed that by six months after initial vaccination, the effectiveness of the Pfizer vaccine declined to 42% (compared to 76% for the Moderna vaccine).

The COVID vaccines were developed in record time and rushed into use because of pressing, dire needs. It’s entirely possible (if not likely) that the 3 or 4-week dosing interval may not be not optimal. Dosing regimens for many vaccines call for two or three doses separated by many months. Perhaps a third COVID mRNA vaccine dose at 6 months is not so much a ‘booster’ but simply what might otherwise be considered the normally required dosing regimen (and might have been identified as such if development had proceeded in the typical, longer manner). 

Approval of third COVID vaccine doses in the U.S. is all but a foregone conclusion. It’s hard to imagine that additional delay and perseveration over the decision, and poring through the raw data from Israel, would result in a different decision than has already been reached not only by Israel but a growing number of European countries . The question is how many more infections and deaths will result from the call for ‘more data’. 

Even Pfizer and Moderna are asking for approval of third shots, with their own data showing the potential benefit and have started the process of requesting formal FDA approval for booster doses. As much as some will criticize them as only wanting to ‘boost sales’, the companies are probably more concerned with the risk of their products being seen as failing as a result of increasing illnesses and deaths. 

We should have only the greatest respect for the FDA and CDC, the people who work there and the Herculean efforts they undertake on our behalf. However, these are not normal times. We are in the midst of a catastrophic pandemic, the most serious public health crisis this country, and the world, have faced in a century. There needs to be a sense of urgency. We cannot be using pre-pandemic standards and safety thresholds when thousands of people are dying every day. At a time like this, using pre-pandemic safety levels is negligence. The risk of doing nothing is severe. While we wait for more data, people are dying. There is no coming back from death, or for some people, the health consequences of long COVID.

A combination of an institutional mindset at the FDA of fearing another thalidomide debacle and thus erring on the side of safety, and hubris of not wanting to be seen as following Israel or being told what to do by the Biden administration, is getting in the way of the public good. Yet, at the same time the FDA recently approved a controversial new drug for Alzheimer’s Disease. The FDA’s own Advisory Committee recommended against approving the drug, and several committee members have resigned in protest.

We should be particularly sensitive to the downsides of decisions. The downside of administering third doses is an apparently small risk of adverse events. Out of 373.5 million COVID vaccine doses administered in the U.S. only 532,000 adverse events have been reported to VAERS, the Vaccine Adverse Event Reporting System.

Likewise, Israel has administered 14.1 million Pfizer vaccine doses and has found that adverse effects are substantially greater from COVID infection than vaccination.

The downside of being wrong on the need for third doses and waiting too long could be far more painful. 

5.44 billion total COVID vaccine doses have been given worldwide. In view of the vast real-world experiences with vaccines, it seems the risk of third doses is far less than the consequences of more infections. 

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Rochelle Walensky, Heads the CDC PHOTO: CDC

Drs. Janet Woodcock and Rochelle Walensky may not want to be seen as playing second fiddle to the Israel Ministry of Health. But the hard reality is that Israel is more on top of the pandemic than the U.S. It’s past time to learn from the experiences of others, put egos away and err on the side of protecting health and lives. 

The nature of the scientific process is to learn from the data. Especially in a rapidly changing, fast-moving situation like the COVID pandemic, there will always be new information emerging that will supersede and at times seem to contradict what was previously known. That’s how science works. It’s an iterative process. As you learn more, you know more. It’s frustrating and extremely difficult to try and make sense of chaos, but that’s the hand we’ve been dealt. The SARS-CoV-2 virus doesn’t let us take our time.

However, the FDA and CDC are also not doing themselves any favors in the public opinion department with some of the confusing communications that may have been overly influenced by non-scientific factors. The premature announcement in May that the vaccinated no longer needed to wear masks was not thought through, backfired, and may have contributed to an increase in infections.

This was then was followed by a reversal in July saying that even the vaccinated should wear masks indoors. Now there is an equivocation on whether booster shots should be given after 8 months, or maybe 6 months or possibly even sooner, or maybe not at all.

This is not a way to engender public confidence in their abilities (or at least their communications skills). Being a great scientist does not guarantee also being a great manager or communicator.

It’s overwhelmingly clear that COVID cases are surging in the U.S. At 8.8 million known active cases today (and the actual number is certainly much higher than that), the number of people known to be infected today is about as high as it’s ever been, nearly matching the 8.9 million in January

 

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Source: Worldometer

 

Cases in the U.S. increased 12% over the past two weeks. Deaths are up 59% over that time https://coronavirus.jhu.edu/us-map. Schools are reopening around the country, which will likely result in increased transmission as largely unvaccinated students around the country mix with each other (with added help from travel and socializing around the Labor Day holiday weekend). Is now really the time to be waiting for ‘conclusive’ data? How many breakthrough infections or deaths in vaccinated people will it take to be considered ‘conclusive’?

We have to stay ahead of the virus, not play catch-up. While some at the FDA and CDC may take umbrage at being told what to do, the Biden administration should be commended and applauded for showing proactive, forward-looking leadership and pushing them. When people’s lives are at stake, there is no room for egos or politics as usual. Now is not the time to wait. Science must take precedence over politics and power games. While politicians dither, in the past week alone over 1 million people including 203,000 children in this country got COVID, and almost 8,000 died. When it comes to preventing serious illness and deaths, shouldn’t we learn from Israel and take a more expansive view of who should get booster shots, and make protecting public health the priority? With a proven lethal pandemic, we don’t have the luxury of waiting for all the data we might want.

If we believe that every life is valuable (though the actions of many of our leaders, including Governor McKee, might call that into question), then it would seem wise to follow the lead of Israel and a number of European countries and offer booster shots to everyone, at least for the Pfizer vaccine on which much of the breakthrough infection data are based, and perhaps also the Johnson & Johnson vaccine that some studies have shown to be less effective against the Delta variant. With 25% of COVID infections now occurring in those who are fully vaccinated, how much more evidence is needed?

At a time like this, instead of asking for overwhelming proof that a third doses is needed, maybe we should be asking if there is compelling evidence against booster shots?

15 million vaccine doses have been thrown out in this country. Millions more doses will be expiring in the coming months. Wouldn’t it be better to put those doses in people’s arms, people who are willing and want to get additional shots, rather than into dumpsters? 

Nick Landekic is a retired scientist and biotechnology executive with over 35 years of experience in the pharmaceutical industry.

 

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