The Pfizer-BioNTech vaccine is approved but the media second guessing continues.

A Monday the FDA provided final approval to the Pfizer-BioNTech coronavirus vaccine. Dr. Janet Woodcock (acting FDA Director) noted that in the FDA’s “efforts to move as quickly as possible” in approving the Pfizer-BioNTech vaccine did not “sacrifice scientific standards, or the integrity of our process.”

Dr. Peter Marks

Maybe the most noteworthy part of the announcement was that Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, felt compelled to address misinformation being spread about the vaccine. He mentioned theories that the vaccines cause infertility, contain microchips and can cause infections and death. “Let me be clear: these claims are simply not true,” Marks said.

Within hours, news outlets that had been criticizing the FDA for taking “too long” to approve the vaccine started to hypothesize that the approval was “rushed.”

One of the most entertaining exchanges was on Fox News, where Dana Perino interviewed former Trump appointee Brett Giroir, architect of the disastrous COVID testing program in the US.  She first asked him if the approval was rushed and he responded definitively no. He then immediately credited the Pfizer vaccine to the Trump administration’s Operation Warp Speed. In actuality, Pfizer developed its vaccine without any support from the federal government (other than the federal government agreeing to purchase it.) Right after Giroir lauded the vaccine’s approval, Fox’s co-host Bill Hemmer asked, “What took so long?” Remarkably, it did appear that Hemmer and Perino were sitting next to each other!

At the same time new studies show the vaccine still holds up well against the delta variant. Unvaccinated people in Los Angeles County were five times as likely to become infected with the coronavirus and 29 times as likely to be hospitalized as people who were fully immunizednewly released data from California show.

In contrast, the protection against infection dropped as delta became the predominant strain. Where before delta unvaccinated individuals were 8 times more likely to be infected, they now were only 5-6 times more likely. This shows that the vaccines are maintaining their protection against illness and death but are are allowing more infections (although less serious in nature).

Rise in COVID infections and hospitalizations in Los Angeles over the past three months. Note the excess increase in the unvaccinated population.

Only 24 fully vaccinated patients in Los Angeles have died of covid-19. These patients had a median age of 78 and 25% of them were immunocompromised. Booster shots in the elderly may reduce these numbers. In contrast, the median age of the 176 unvaccinated people who died was 63. 

So despite attacks by the press and the delta variant, the COVID vaccines are holding their own!

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

9 thoughts on “The Pfizer-BioNTech vaccine is approved but the media second guessing continues.

  1. It was reported today that 19 of 96 Covid-19 patients at a Henry Ford Hospital were vaccinated. Should this be concerning?

    Sent from my iPhone

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    1. Statements like this are hard to interpret these statements without context or more info. HFH is a transplant center and referral center for cancer patients throughout their system. It is likely they have a large number of immunosuppressed individuals, and much like UM get sent elderly individuals who may be hospitalized for breakthrough observation. So the mix is very different. Nationally, 96% of covid hospitalizations are in unvaccinated individuals.

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  2. Hi Dr. Baker, I found it unusual that in the FDA letter (https://www.fda.gov/media/150386/download) page 2 and footnote 8, the FDA approval is for Pfizer’s “Cominraty” branded vaccine, but the Emergency Use Authorization still remains in effect for the same formulation marketed previously as “Pfizer-BioNTech COVID-19 Vaccine”.

    This seems quite odd to me, given that under the EUA there’s a liability shield to the companies from any side effects (because they’re deemed to be rushed to market under an “emergency”), but also due to EUA, they can’t be mandated.

    People hesitant about the vaccine were waiting to see FDA approval as a sign that Pfizer and others would now have liability from side effects/adverse events. With the FDA doing the approval in such an odd manner, it creates confusion. Why isn’t the product given full approval, with the resultant mandates, but also full liability to the manufacturer for adverse events without these “outs”?

    Not to be too cynical, but one could interpret this as: the FDA is giving an approval to one brand of Pfizer’s vaccine (Cominraty) so that mandates around the country can be justified, but that likely, when people go to get their shots, they’ll continue to receive the same formulation under the old “Pfizer-BioNTech COVID-19 Vaccine” brand covered under the EUA, so the companies can avoid liability.

    I’m so weary of the FDA and CDC’s incompetence (or perhaps, regulatory capture by the pharmaceutical industry), that I can’t help but think this is the likely explanation for such an odd and convoluted approval letter. Would appreciate any thoughts!

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    1. This is a legal technicality. The approved version has a brand name. That means the company is allowed to advertise, market, sell it and do things not possible under EUA. They won’t be able to sell any of the EUA approved material in that manner. So it differentiates pre from post approval vaccine.

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  3. Jim – the antivaxers are touting a study from Israel that is supposed to show superior protection from previous COVID for Delta, over mRNA vaccination group. I haven’t been able to find this study. Several people I had convinced to get vaccinated have cancelled their appointments. Any truth here? – Max

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  4. Reuters reported that 25.3% of LA cases were in fully vaccinated, 3.3% in partially vaccinated…The death rates between vaxed and unvaxed were similar. https://www.reuters.com/business/healthcare-pharmaceuticals/us-data-show-rising-breakthrough-infections-among-fully-vaccinated-2021-08-24/

    Study from Israel show natural immunity from previous infection confers best/longest protection, naturally immunity + one vax better https://www.sciencemag.org/news/2021/08/having-sars-cov-2-once-confers-much-greater-immunity-vaccine-vaccination-remains-vital

    G. Vanden Bossche says mass vaccination in the midst of a pandemic is a disaster and will create viral immune escape (suppress our innate immune systems and cook monstrous new variants). He is begging for debate and a change of direction. Why won’t anyone in charge debate him? https://www.geertvandenbossche.org

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    1. I am doing a post on the Israeli study. LA study shows vaccines are still highly protective against infection and serious illness, but you have to read the MMWR report to get that. Reuters leaves out that most of the vaccinated ill are much older and have significant co-morbidities. Sorry, but cannot bring myself to comment on G. Vanden Bossche ravings. Anyone who’s URL is their name followed by .org needs to get a job.
      JB

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