An advisory committee of the Food and Drug Administration (FDA) is recommending that the federal government hold off on giving Wuhan coronavirus (COVID-19) booster vaccine doses to the general population.

On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss approving COVID-19 booster vaccines for the general population. Unexpectedly, the committee voted against this proposal. The committee argued that there was a lack of long-term data to justify the use of the booster doses and that the risks outweigh the supposed benefits.

During the meeting’s public comment session, numerous experts came forward explaining that the data did not support the request from big pharmaceutical company Pfizer for its vaccine to be approved for use as a booster.

Kim Witczak, a consumer representative of the FDA, called out big pharma companies for pushing booster doses.

“While boosters may be good for business, mRNA vaccines were never designed to stop transmission or eradicate the virus,” said Witczak.

Witczak added that the government should focus on recognizing natural immunity when it came to vaccine mandates. It should also be wary of the potential of the COVID-19 vaccines to produce resistant variants, she added.

Other health experts pointed out that many people have filed reports regarding adverse effects with the Vaccine Adverse Event Reporting System (VAERS), a program for cataloging reports of vaccine side effects co-managed by the FDA and the Centers for Disease Control and Prevention.

One health expert, Dr. Jessica Rose, a viral immunologist and virologist, pointed out that there are signs in VAERS that strongly suggest the probability of an adverse effect after getting vaccinated is very high.

“Safety and efficacy are the cornerstones of the development and administration of biological products meant for human use,” said Rose.

During the session, Rose pointed out that from 2011 to 2020, VAERS received a total of 392,184 reports regarding vaccine-related adverse effects. In 2021 alone, VAERS received 521,667 reports, and this number is expected to continue rising before the year ends.

“There’s an over 1,000 percent increase in the total number of adverse events for 2021, and we are not done with 2021,” said Rose. “This is highly anomalous on both fronts.”

Dr. Joseph Fraiman, an emergency medicine doctor from New Orleans, revealed that there is no clinical evidence disproving the claims that COVID-19 vaccines are harming more people than they save.

“We, the medical establishment, cannot call out anti-COVID vaccine activists who publicly claim the vaccine harms more than they save, especially in the young and healthy,” said Fraiman. “The fact that we do not have the clinical evidence to say these activists are wrong should terrify us all.”

Fraiman said he wanted to help reduce vaccine hesitancy, but to do that, COVID-19 vaccines needed to go through large clinical trials that will prove that vaccines reduce hospitalizations without causing serious harm.

“I know many think the vaccine-hesitant are dumb or just misinformed, that’s not at all what I’ve seen,” said Fraiman. “In fact, typically, independent of education level, the vaccine-hesitant I’ve met in the ER are more familiar with vaccine studies and more aware of their COVID risks than the vaccinated.”

NIH director expects booster vaccine doses to be available to more people in “next few weeks”

Despite the objections from many health experts, including those in VRBPAC, National Institutes of Health Director Dr. Francis Collins still believes the approval of COVID-19 vaccine boosters will push through. He even said he would be “surprised” if they are not approved for distribution to the general populace within the next few weeks.

In an interview on Fox News, Collins was asked if he thought the booster doses would be necessary for everyone.

“I’m not sure about absolutely everyone. We’ll have to see what they say ultimately about the youngest individuals because of concerns about benefits and risks,” said Collins. “But, I will be surprised if boosters are not recommended for people under 65 going forward in the next few weeks. But we’ll see.” 

The FDA has already recommended giving booster doses of the Pfizer vaccine to Americans over the age of 65 and to those most vulnerable to exposure to COVID-19, such as healthcare workers and teachers.

No comments:

Post a Comment