The Dish on FDA's Booster Shot Vote
From eNewsletter 9/20/2021
DID YOU KNOW that two new studies from European Journal of Nutrition and The American Journal of Clinical Nutrition indict certain carbohydrates as the main drivers of inflammation? Inflammation often equals pain and disease is left unchecked. And the most inflammatory carbohydrates mentioned? Sugar, glutenous carbohydrates, and refined carbohydrates (processed and devoid of fiber).
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Have a happy, healthy day! Steve and Bonnie Minsky
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Well Connect Feature: Gluten and the Brain Part 1
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Understanding Lab Tests: New Non-Invasive Celiac Test
Green Lifestyle: Office Air Quality
Wild Card: Pediatric vs. Adult Celiac Symptoms
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Booster Shot Update
Steve: The FDA Advisory Committee met on Friday to decide if they wanted to give full approval of a third Pfizer mRNA vaccine dose to the general population. Yours truly listened to all nine hours of testimony and discussion. I was pleasantly surprised that they voted not to approve a third dose for the general population. The committee did recommend an Emergency Use Authorization (EUA) for those 65 and older and for those at high risk for severe disease or in occupations at high risk for severe disease. The specific language of the EUA will be released this week after the FDA gives their finalized approval. EUA means there is no mandate, so a third dose is voluntary. Why did the committee, facing an inordinate amount of political pressure to fully approve a third dose for the general population so it could be mandated, vote against the proposal, even after Pfizer admitted that protection against infection wanes six months after the second dose? For many of the reasons we cited weeks ago when boosters first were proposed. We were flattered to hear the committee echo many of our same concerns. Note that the CDC also must convene, but often agrees with FDA decisions. Memory B and T Cell Immunity Is Doing Its Job Dr. Paul Offit, who has drawn the ire of those against the current childhood vaccination schedule, brought up the point that the two dose mRNA vaccine schedule was originally approved to prevent severe illness and death. Pfizer, in their presentation Friday, said that even though the two dose protection against infection wanes after six months, it still does an incredible job preventing hospitalizations and death. Because of this, and the fact that Pfizer could not tell the committee how much better a third dose would improve memory B and T cell immunity, Dr. Offit voted against approving a third dose. 75 Million ELIGIBLE Americans Have Not Been Vaccinated One sensible committee member stated that we could give 10 boosters to the already vaccinated and it won't make a bit of difference if 75 million eligible Americans are still unvaccinated. Paucity of Booster Research for Safety and Efficacy The only data the FDA was using to make their decision upon the safety and efficacy of a third dose was a 300 participant trial from Pfizer that was not peer-reviewed! Let that sink in. For comparison, the approval of the two dose regimen last December used two 40,000 subject trials. This was the dealbreaker for every one of the 18 committee members. Why Not Match the Booster With the Delta Variant? Another shrewd question asked by the committee was why Pfizer wants to use the original mRNA vaccine for the booster? With all the time that passed between approval of the original vaccine and the emergence of the delta variant, why could Pfizer not map the genome of the delta variant and produce boosters that are better suited to fight this strain when they themselves said it only takes a matter of days to map a viral genome? They did not have an answer. There Should Be a Longer Gap Between the First and Second Dose Another brilliant point, because we brought this up months ago ;), was that instead of a booster, why not increase the amount of time between the fist and second dose of either the Pfizer or Moderna vaccine to 8-12 weeks in those who have not been vaccinated. Research has shown that one mRNA dose offers very good protection against severe illness and death and can reduce the likelihood of infection. Stretching out the time between doses will extend effectiveness against preventing infection. Pfizer Is Not in a Rush to Measure Long-Term Immunity or Develop a Titer When asked why Pfizer has not provided data on their original subjects' long-term immunity that could be measured by titer, they said it would be available soon. We know there is copious data showing robust long-term, memory B and T cell immunity. The fact that Pfizer did not provide this irked several committee members. Killed Virus Vaccines Need Boosters. mRNA Vaccines Are Different. Measles, mumps, and other viral pathogens that require vaccinations contain dead viruses. Multiple exposures to the immune system from dead viruses are needed to optimize priming, which is why boosters are necessary. The new mRNA technology is different and should not need boosters for most Americans. Our Recommendation Based Upon the Booster EUA In certain individuals who are severely immunocompromised and have shown no short-term immune response to the two dose mRNA regimen, it may be a good idea to get a booster to see if it will help. In older individuals at high risk for severe disease, which include comorbidities such as obesity and diabetes, a booster may be warranted. For everyone else, we do not recommend a booster.