(LifeSiteNews) – The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) decided Tuesday to endorse the use of a second COVID-19 “booster” shot – a fourth jab – in the over-50 population and a record fifth dose for those with compromised immune systems, all while foregoing normal consultation procedures.
A statement from the FDA Tuesday announced the regulatory body’s authorization of both Pfizer and Moderna’s COVID mRNA shots to be injected a fourth time in those over 50 years of age and children over 12 years of age “with certain kinds of immunocompromise.”
In addition, the agency updated its emergency use authorization (EUA) protocol to include a “second booster” for those over 18 who have compromised immune systems on top of the “three-dose primary vaccination series,” amounting to a recommendation of five shots of the mRNA-developed inoculation for supposed protection against the novel coronavirus.
FDA Center for Biologics Evaluation and Research Dr. Peter Marks said that the changes come amid evidence suggesting “some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” recognizing the dwindling efficacy of the shots against that which they were supposedly developed to protect.
In a tone of uncertainty, Marks advised that the extra doses announced Tuesday “could help increase protection levels” instead of confirming that there would be any definite advantage.
In later comments to journalists, Marks said at “some point, we are going to have to realize that this is a virus that’s going to be with us and that we have to come to grips with dealing with it on a regular basis.”
Shortly after the FDA authorization, the CDC issued its own statement updating guidelines on COVID shot doses for the supposedly vulnerable groups in accordance with the new FDA emergency use authorization (EUA) recommendations.
An Israeli study published February discovered that after three doses, booster shots do “not boost immunity,” instead restoring immunity “to its peak levels.” Furthermore, the group found that the fourth jab had an efficacy of between just 11 and 30 percent with most of the healthcare workers (HCW) in the trial who were infected being able to transmit the virus “with relatively high viral loads.”
“Thus, the major objective for vaccinating HCW was not achieved,” the researchers noted.
A CNBC report noted that neither the FDA nor CDC consulted their respective vaccine advisory committees before decreeing that additional shots could be taken, with Marks defending bypassing the advisory board on account of the decision supposedly being “relatively straightforward.”
However, CDC Advisory Committee on Immunization Practices member Dr. Paul Offit criticized the decision to forego the ordinary approval process as “sort of fait accompli.”
“We talk endlessly about how we follow the science — it doesn’t seem to work out that way,” Offit charged.
Dr. Marty Makary of the Johns Hopkins School of Medicine explained that denying the experts the chance to scrutinize the data before authorizing the drug’s usage is “like a judge issuing a verdict and then having lawyers make their arguments.”
Is this following the science?? FDA will authorize 4th doses this week by bypassing the typical voting process of their external experts. FDA will then convene them after the authoriz to “discuss”. It’s like a judge issuing a verdict and then having lawyers make their arguments.
— Marty Makary MD, MPH (@MartyMakary) March 29, 2022
“There is zero clinical data that a 4th dose reduces hospitalization risk. There isn’t even any evidence that a 3rd dose reduces hospitalization risk in young people,” Makary added.
The physician highlighted comments from Dr. Eric Rubin, editor-in-chief of leading medical journal The New England Journal of Medicine and member of the FDA’s vaccine advisory committee, who said that he “”hadn’t yet seen enough data on fourth doses to make a determination about whether they are needed for anyone beyond those who are already recommended to get them – adults who are severely immune deficient.”
The U.K. is set to follow America’s footsteps, with fourth COVID shots being made available to all people over 75 years old and anyone with a compromised immune system who is at least 12 years old from spring. A fifth jab for the same groups will be available by the fall.
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