At A Glance:
- FDA approves Pfizer vaccine.
- No long-term data available.
- No public hearing.
- No trials for safety in pregnancy.
- No transparency.
FDA’s Press Release
This morning, the FDA finalized its approval on the Pfizer COVID-19 vaccine for those ages 16 and up. Many, including Dr. Anthony Fauci of the NIH and Joe Biden, hinted that this could be coming by the end of the month. The newly approved drug will be marketed under the brand name, Comirnaty, and the generic, tozinameran. According to the press release by the FDA:
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.1
There remain many questions related to longer-term safety and efficacy of the vaccines. The FDA’s press release does mention some instances:
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.1
It continues to say:
Information is not yet available about potential long-term health outcomes.1
While there haven’t been any trials done on pregnant women, many have already taken the vaccine. According to the governmental trial page, the study dates were set from February 16, 2021 and estimated to finish October 2022.2 To date, there have been no results posted on the trial page.3
The press release does mention a registry:
In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.1
Transparency and Public Comments Laid Aside
October 22, 2020, the FDA held a meeting to discuss the process by which the COVID-19 vaccines would proceed through development, authorization, and finally approval. Slides from that meeting indicate the agency would establish a post for public comment to ensure transparency.4 There have been numerous outreaches to the FDA, however the comments haven’t been made public by the FDA, nor did they hold the planned posting and commenting for the public.
Last year, the FDA made a comment that it backtracked on last week. According to an article on the British Medical Journal’s website, the FDA had stated last year:
“it was ‘committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.’ But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.”5
Many were concerned when the agency announced on August 18, that it had decided to withhold the public comment as they also decided to move forward with EUA for booster shots. This raised flags that the decision was politically motivated. Several experts spoke out in an August 20th article on the bmj.org website in scathing comments regarding the dismissal of public comments.5
Kim Witczak, a drug safety advocate who also serves on the FDA’s Psychopharmacologic Drugs Advisory Committee, shared concern that the move would take away an important factor in scrutinizing data.5 She continued to say:
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinized in advance of an approval.”5
“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed.5
“Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”5
President of the National Center for Health Research, Diana Zuckerman, stated:
“It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know.”5
Safety Insert
When people get a vaccine, they are, by law, required to receive a Fact Sheet stating some of the most common risks. Parents may know them as the pastel-colored sheets they receive in the doctor’s office. Many are simplified to fit on a single sheet of paper. The insert for Pfizer’s Comirnaty vaccine is 21 pages long. Below are a few clips.
In regard to the integrity of the rest of the study:
Upon issuance of the Emergency Use Authorization (December 11, 2020) for COMIRNATY, participants were unblinded to offer placebo participants COMIRNATY. Participants were unblinded in a phased manner over a period of months to offer placebo participants COMIRNATY.6
In regard to breastfeeding mothers:
It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COMIRNATY and any potential adverse effects.6
In regard to other safety as well as fertility:
COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.6
Recalls
According to the FDA website, there have been 372 recalls on approved products since August 30, 20177.
Hold the Phone — Doc’s Thoughts:
That Press Release isn’t exactly a confidence booster in this product. For all the fanfare it received, it’s more like a bucket full of cold water to the face!
- So people who received the vaccine, age 16 and over didn’t have COVID a week after their second dose?! I’m thinking we need to consider the risk/benefit on a greater scale than a week at a time.
- More than half were followed for 4 months and less than half for 6 months for safety outcomes. Hold on…why didn’t you follow all of them?! Why such a short time? Oh yeah…they disbanded their placebo group by vaccinating them and thus rendering their experiment invalid!
- No long-term data is available…that’s why this study was to take over two years! Clearly, it’s not available!
- This one makes my blood boil…read the trial details on their governmental site. First, there isn’t anything showing they are collecting data on the safety of this vaccine on the infant, nor the mother. Second…it is now a registry?! Like the passive system VAERS that only captures 1-10% of adverse reactions?!8 And STILL shows 1,607 miscarriages?! I’ve had numerous nurses confirm for me what was stated in the supplemental appendix to a study the New England Journal of Medicine shares.9 This passive study was done December 14, 2020-February 28, 2021…who was even getting the vaccine at this time?! You had to be in a pretty select area to participate since it wasn’t readily available to most people. Look how many infants died: 49 out of 163. How many had dangerous, life-threatening reactions? 29.9%.10 That’s not normal.
Public comment discarded…they had received numerous outreaches from experts all over the world and been petitioned to withhold full approval by concerned experts. What were they afraid of? What were they trying to hide? Closed doors certainly don’t portray transparency, nor are they trustworthy. They knew their vaccine was neither safe nor effective and couldn’t stand up to real scrutiny. Ask the nurses who are were heroes last year and this year are faced with losing their jobs because of what they are seeing and the choices they are making.
In a recent article, I shared input from Peter Doshi, associate professor at the University of Maryland School of Pharmacy, who focuses his research on the drug approval process. On January 5, 2021, he published an article in the BMJ, in which he’s a senior editor. The article stated:
“According to FDA’s report on Pfizer’s vaccine, there were ‘3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.’”
“With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed, this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19%—far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29%.”11
Did you see that? Read it again: “A rough estimate of vaccine efficacy against developing covid-19 symptoms…risk reduction 19%”! This guy had dedicated his life to researching the drug approval process, he would know where to look if they were trying to hide numbers! Notice that these cases were unconfirmed. If you go back and read the article, it’s because they didn’t submit them to a test…because it would prove the vaccine ineffective!
Why was this full approval so important compared to the EUA approval? Two reasons. Number one: they felt it had more weight and would sway people to overcome vaccine hesitancy. It’s been said on every mainstream media source. They’re hoping it will also push forward the mandates they are trying to push unconstitutionally and illegally. Number two: under EUA, known risks and benefits of the vaccine have to outweigh the known risks of the disease, AND there has to be no other good, viable option for treatment. They were losing ground and the EUA should have been null and void for months, or never have gotten off the ground! There are several good options for treating COVID-19. Depending on the age and health of a person’s immune system, there is good reason to believe the risk doesn’t outweigh the benefit either.
While some may put weight in the FDA approval, it does not change the fact that there are so many cases of myocarditis, blood clots, Guillain-Barre Syndrome, deaths, how much it was harming young people, and other tragic effects. That approval stamp isn’t a magic wand to make those all go away, and it doesn’t make it safe! Taking care of yourself and supporting your immune system is really the only way to help protect yourself not just from COVID-19, but from any other illness as well.
Those mandates that will likely come with a harder push are unconstitutional and illegal. Where there is risk, there must be choice! Health freedoms and informed consent are crucial. We must not only practice them, but we must also protect them. Call and email your local, state, and federally elected. They need to hear from the American people. This is the land of the free because of the brave; don’t be afraid to speak up and remind your elected who they work for. Midterms are coming up and they’re all worried for their cushy, status-filled positions. Let them know you are watching them and how they react.
The FDA has certainly lost some credibility over the years. They approved the Twinkie at one point. And have had over 370 products recalled after approval in the last 4 years. We can hope the same for this one.
1https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
2https://clinicaltrials.gov/ct2/show/study/NCT04754594
3https://clinicaltrials.gov/ct2/show/results/NCT04754594
6https://www.fda.gov/media/151707/download
7https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
9https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117969/#ap1
10https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117969/bin/NEJMoa2104983_appendix.pdf
