Eligible patients can now receive a fourth dose of the COVID-19 vaccine, according to an announcement made by the Food and Drug Administration on March 29. “Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns,” said the FDA.
Shortly after the FDA’s swift approval, Director Dr. Rochelle P. Walensky of the Centers for Disease Control and Prevention pushed the recommendation and said, “Boosters are safe, and people over the age of 50 can now get an additional booster four months after their prior dose to increase their protection further. … [The] CDC, in collaboration with FDA and our public health partners, will continue to evaluate the need for additional booster doses for all Americans.”
However, the authorization of an additional booster has been met with even more controversy than previous vaccine approvals.
Dr. Eric Rubin, the editor in chief of The New England Journal of Medicine, sits on the FDA’s Vaccines and Related Biological Products Advisory Committee, a group of experts who advise the FDA on vaccine approvals. He told CNN he had not been provided with enough data on the fourth dose to decide whether healthy adults should receive them.
In September, Marion Gruber, the former director of the Office of Vaccine Research and Review, and Deputy Director Philip Krause left the FDA for the lack of data supporting broad booster authorizations. They subsequently authored a paper about the discrepancy.
“Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects,” they wrote.
In an interview with the Washington Examiner, Dr. Marty Makary said the FDA and the CDC have continuously bypassed experts to authorize vaccinations and failed to investigate later complications.
“The calculus on additional doses is skewed due to the complete lack of interest in monitoring vaccine-associated complications. In fact, the head of the Mayo Vaccine Research Group developed severe ringing of the ear driving home from his second dose,” he said.
Dr. Gregory Poland, the director of Mayo Clinic’s Vaccine Research Group, developed tinnitus, a ringing or buzzing sound in one or both ears, after his second shot. In an interview with MedPage Today, Poland describes experiencing a noise resembling a dog whistle in his ear. Poland said since then, he has suffered “life-altering tinnitus” in both ears but remains committed that his decision to receive the booster was favorable.
“When the CDC looks into vaccine-related complications with a lack of alacrity, they tend to conclude that on an individual case basis, no conclusion can be made stemming from the vaccine versus a random occurrence,” said Makary. “My argument is that such a close temporal relationship, where an otherwise healthy person develops an issue, is causal until proven otherwise in a non-risky group.”
“The understanding of complications is crowded, and we spend essentially no money on research of those complications,” he added. “So, we have a situation now where ‘pharma’ CEOs tell the public, ‘You need an additional dose,’ and the FDA and CDC fall in line. We saw this uncanny enthusiasm at the FDA for boosters in general, which was never shown to reduce hospitalization for young people.”
A recent report from the Maine Policy Institute discovered complaints of inconsistencies regarding the state’s CDC vaccine data. Carolyne Frank, a molecular biologist, authored a letter to the director of Maine’s CDC, Dr. Nirav Shah, asserting that those with a breakthrough case were 56% more likely to be hospitalized and 60% more likely to die than those not fully vaccinated.
“Albeit rare, vaccination complications should be studied. I believe we have been under-capturing complications. I know of a few dozen from patients I have seen and from doctor colleagues who have shared with me those seen at their practices,” said Makary.
According to Makary, another concern is myocarditis, an inflammation of the heart muscle, affecting 1 in 1,800 vaccinated healthy males. On Oct. 6, 2021, the Swedish health agency announced it would pause the Moderna vaccine for people born in 1991 and later due to an uptick in myocarditis and pericarditis diagnoses. Sweden and Denmark now recommend the Comirnaty vaccine instead.
The swift approvals for Pfizer and Moderna also stand in contrast to the FDA’s approval for new COVID-19 vaccines, Novavax and Covaxin, which use traditional vaccine technology compared to the mRNA shots. The FDA has failed to respond to Novavax’s Jan. 31 application for emergency use.
“I don’t believe the vaccination is dangerous,” Makary added, “but when we talk about a strategy that is unsustainable for boosters for a different variant, it is problematic, and when we authorize boosters, they tend to translate into mandates whether that was the intent or not.”
“Colleges already mandated boosters before the CDC authorized them. So, there is an uncanny booster enthusiasm that is very bizarre given that the data has not fully supported the idea and the FDA’s decision to bypass their experts.”
Makary went on to add, “The new norm of bypassing external and internal experts, not bringing important authorizations to a vote, dismissal and downplaying vaccine complications, and lack of compelling data for healthy children is exposing a process that is more discretionary and political than it is medical and based in scientific processes.”
An additional study released by the Seattle Children’s Hospital, just days before the fourth dose’s approval, found that more than 60% of children who dealt with myocarditis after the vaccine had late gadolinium enhancement, an abnormality signifying myocardial fibrosis or scaring, in an MRI three to eight months later.
“When the CDC director emphatically recommends boosters in healthy children but admits they have never been able to tell how many children have died of COVID-19, people see what they perceive as an agenda and have concerns that Big Pharma has a hammerlock on the medical establishment,” he said.
“People are concerned that the White House and Big Pharma believe they own the FDA,” Makary said. “The current administration campaigned that they would listen to scientists, but they have created a new norm to bypass the Scientific Advisory Committee. We have never seen this rate of authorizations bypassing the committee as we have now. It’s almost become a new way of business at the CDC and FDA.”
