42% of COVID Infections in RI Are in the Vaccinated – Ten Deaths Reported in Past 3 Days
Friday, October 22, 2021
In the past week, both the FDA (Food and Drug Administration) and the CDC (Centers for Disease Control and Prevention) Advisory Committee approved the use of third, ‘booster’ doses of the Moderna and J&J COVID vaccines. This follows the approval last month of a booster dose of the Pfizer COVID vaccine.
It’s a tremendous relief that total COVID infections in the country over the past few weeks are declining, including a small decrease in Rhode Island. However, the pandemic is far from over. Every state is still at a High, Very High, or Extreme Risk of infection. More than 1,500 people are dying every day from COVID - the equivalent of 15 fully loaded airliners crashing daily. Every day more than 75,000 new infections are reported (with the actual number certainly much higher) – the equivalent of everyone in Rhode Island becoming infected every two weeks. Rhode Island is reporting 247 new cases a day – 10 people every hour – with the actual numbers again likely much higher. New hospital admissions for COVID are up to 97 this week from 78 last week.
Vaccination alone is not a magic shield. Last week 42% of COVID infections in Rhode Island were in vaccinated individuals, up from 39% the prior week.
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTEven more concerning may be COVID deaths. Two weeks ago 50% of COVID deaths in Rhode Island (5/10) were in vaccinated individuals. Last week all 5/5 COVID deaths in the state were in the vaccinated.
In the past three days, Rhode Island has suffered 10 deaths, according to the RI Department of Health. It is unknown if any of those individuals who died were vaccinated.
What are we doing wrong?
Conflicting roles of FDA vs. CDC vs. others
The process of a vaccine receiving approval in the U.S. goes through a seemingly complex and bureaucratic series of steps:
1. Review by an Advisory Committee to the FDA
2. Action by the FDA itself
3. Review by an Advisory Committee to the CDC
4. Final action by the CDC
The FDA regulates vaccine clinical trials, licenses vaccines, and monitors vaccine safety after the product has been approved and is being used by the public. The FDA approval process includes both internal review by FDA employees, and also reviews and recommendations by advisory committees of outside experts who are not direct FDA employees.
The first step in the process is the review by an Advisory Committee to the FDA. For the Pfizer vaccine, this committee met on September 17. The Advisory Committee met again on October 14 to discuss the Moderna vaccine, and October 15 for the Johnson & Johnson (also known as Janssen) vaccine.
The next step is a review by the FDA itself. On September 22 the FDA issued its approval of booster doses of the Pfizer vaccine, and on October 20 authorized booster doses of the Moderna and Johnson & Johnson vaccines.
Once the FDA approves a vaccine, the CDC's Advisory Committee on Immunization Practices (ACIP) considers not only FDA-approved labeling, but also disease epidemiology, burden of disease, economic analyses and implementation issues in establishing how the vaccine should be used in the civilian population. Similar to the FDA, the CDC both use an outside panel of experts, as well as renders its own decisions internally.
On September 23 the CDC Advisory Committee (ACIP) recommended essentially following the previous guidance of the FDA Advisory Committee in approving booster shots of the Pfizer vaccine and in which specific groups of people.
On October 20 and 21 the CDC Advisory Committee met again to review booster doses for the Moderna and Johnson & Johnson vaccines. Perhaps chastened by last month’s meeting in which they issued detailed restrictions on use of the Pfizer booster that were then overturned by Dr. Rochelle Walensky, this meeting simply endorsed the use of a Moderna booster shot six months after the initial vaccination, and a Johnson & Johnson booster after two months.
The process is designed to provide multiple layers of review and maximize safety for the general public by minimizing the chance that something will be overlooked and people could be exposed to undue risk. However, the downside with all these steps and multiple agencies and committees being involved is that it takes time, and breeds conservatism. Moving slowly and ponderously may not be the best way to go in a fast-moving and dangerous situation.
One of the oldest principles of medicine is the doctrine of “First, do no harm”. There are some well-known examples in the history of drugs being approved that later turned out to be harmful, most notoriously, thalidomide. Thalidomide was introduced in the U.S. in 1960 as a ‘miracle drug’ to prevent morning sickness in pregnant women. Unfortunately, it was then found to cause severe birth defects or deaths in babies (in recent years it has been reintroduced as a treatment for bone cancer and leprosy).
Though this calamity happened over 60 years ago, it left an indelible impression on the FDA to err on the side of caution so that this would never happen again (though it continues to happen often enough to reinforce the extreme caution pervading the regulatory agencies.
However, the rest of the dictum says, “Then try to prevent it”. Being excessively cautious and moving too slowly in a time of an incredibly fast-moving pandemic and the ever-changing viral threat is not the best way to get ahead of it and prevent harm.
Not following the science
There have now been multiple clinical studies showing both the declines in effectiveness over time of all three approved COVID vaccines, as well as the benefit of booster shots.
Receiving a different vaccine from the one used for the primary vaccination can result in a stronger immune response, particularly if a Johnson & Johnson initial vaccination is followed by either a Moderna or Pfizer booster dose. This greatly simplifies distribution of booster doses without having to specifically match them to the primary shots. It also follows the long precedent of flu vaccines – each year people receive a new vaccination without regard to the brand they got the year before.
Additionally, the experiences of Israel are telling. 3.7 million booster doses have been administered to date to 4.9 million initially vaccinated people. Israel has been freely offering booster shots to all those over age 16. The results show that booster doses result in substantial decreases in severe infections, hospitalizations, deaths, and all cases, across all age groups.
In the U.S. we often seem to be mired in politics rather than truly following the science, with well-intentioned but misinformed and misguided arguments about vaccine ‘equity’. Instead of following the lead of Israel where booster shots are offered to all those over 16, or the European Union where they are available to anyone over 18, the FDA and CDC approved a convoluted structure with the following people being eligible for booster doses:
All people 65 and older; people 18 and older in long-term care settings; people 50 to 64 with relevant underlying medical conditions; people 18 to 49 years with certain medical conditions; and people 18 to 64 who have COVID-19 risks related to their work or who live in certain institutional settings. Since clinical trials and the experiences in Israel show that everyone can benefit from a booster dose, wouldn’t it have been so much simpler (and more ‘equitable’) to just say that?
Discussions about who is at ‘high risk’ of infection are also interesting. In the country with the most both COVID infections and deaths in the world, aren’t we all at ‘high risk’?
While these debates drag on, Americans continue to get infected and die.
Low booster vaccination rates
As of October 20, only 6.4% of fully vaccinated Rhode Islanders have received a booster dose (about the same as the 6.1% overall booster rate across the U.S. In comparison, 75% of people in Israel who were initially vaccinated have already received a booster dose. The science shows that everyone can benefit from a booster dose of vaccine – why not just do it?
The battle is not just for a third vaccine dose now, but the likelihood that regular doses will be needed for the foreseeable future. Israel is already preparing to start administering fourth doses, while this country is still arguing over a third dose.
This does not mean the COVID vaccines aren’t working. On the contrary, they work amazingly well. However, just like with flu vaccines, the protection doesn’t last forever. We are accustomed to getting a flu shot every year, both because different strains evolve, and because protection wanes. Why should the COVID vaccines be held to a different standard?
Vaccination is essential – but is not enough. Numerous experts and studies have shown that it will take more than vaccination alone to bring life back to normal. In addition to vaccination and regular booster shots, it will also take other public health precautions including masking, regular and widespread testing, social distancing, and being careful about travel and indoor gatherings.
The CDC Advisory Committee discussed the impact of ‘risk behaviors’ on breakthrough infections - vaccinated individuals disregarding masking and other precautions. The appallingly high COVID infection and death rates in the vaccinated in Rhode Island, combined with casual observations of how few people seem to wear masks in stores or observe other precautions, offers grim evidence that in some ways we are our own worst enemies.
With all the politics, bureaucracy, debates and consternation among regulatory agencies, and our own disregard for common-sense and proven precautions, we continue to play catch-up against the SARS-CoV-2 virus and don’t seem to be able to get ahead of it. This is no way to defeat an unpredictable, fast-moving foe that continues to throw unpleasant surprises at us. In the war of politics and bureaucracy against the SARS-CoV-2 virus, the virus has the upper hand.
Nick Landekic is a retired scientist and biotechnology executive with over 35 years of experience in the pharmaceutical industry.
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