By Veronika Kyrylenko
Article Source
“I really believe this is why God gave us two arms — one for the flu shot and the other one for the COVID shot,” said Dr Ashish Jha, White House COVID-19 Response Coordinator, on Tuesday in regard to the prospect of annual Covid boosting.
During the routine press briefing by a White House Covid-19 Response team that included White House Chief Medical Advisor Dr. Anthony Fauci, CDC Director Rochelle Walensky, and HHS Secretary Xavier Becerra, Jha proudly announced the federal government endorsing the first updated boosters for Covid.
On August 31, the Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to new formulations of the Moderna and Pfizer-BioNTech Covid shots for use as a single booster dose at least two months after completing a primary or booster vaccination.
Unlike the previous boosters, the updated formulas are bivalent, meaning they include the ancestral strain of Covid as well as the latest mutations of the omicron strain, BA.4 and BA.5.
The Moderna shot can be offered to Americans age 18 and older who are already vaccinated and boosted; Pfizer will be given to those who are 12 and older.
The EUAs for the previous monovalent mRNA shots have been revoked by the agency.
On September 1, the FDA’s sister agency, the Centers for Disease Control and Prevention (CDC), signed off on the updated booster.
“This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it,” said Dr. Walensky in the official statement.
The “comprehensive scientific evaluation” of the brand-new jab did not include lengthy human studies, and instead relied on testing the level of neutralizing antibodies in mice. Eight mice, to be exact.
The FDA said that “data pertaining to the safety and effectiveness of the current mRNA COVID-19 vaccines, which have been administered to millions of people, including during the omicron waves of COVID-19,” were considered. One may wonder if the FDA looked into the Vaccine Adverse Event Reporting System (VAERS), an official pharmacovigilance database designed to catch safety signals of vaccines. VAERS is run by the Department of Health and Human Services (HHS), the FDA’s parent agency.
When asked about the limited clinical trials, Scott Gottlieb, a Pfizer board member and former FDA commissioner, echoed the arguments of his former employer.
“Obviously, we have tens of thousands of millions of patient data for ancestral strain vaccines. Many people received that, many people received the boosters of that,” he told CNBC, adding that Pfizer has data from the trials for the previous strains, such as delta and the “original” omicron.
The collected “favorable” data now serve as the basis for the “shift in paradigm” in which the government is treating Covid boosters not as a novel and unstudied product, but as a routine seasonal influenza shot, Gottlieb suggested.
While the pharma executive radiated confidence and respectability, left undiscussed was the experimental nature of the updated booster, as indicated by the very definition of the EUA. That status, it is worth remembering, suggests that manufacturers are shielded from legal liability in case anyone gets injured by their product.
And now, the Biden administration is signaling that that updated booster won’t be the last one. Asked about “heading towards that annual booster cadence for your average healthy American,” Jha signaled that such an approach would be very effective and said that Covid waves taught us that “[I]f you’re an average-risk person and if you have stayed up to date on your vaccine, your risk of getting into serious trouble against this virus is really pretty low.”
Jha went on to say that omicron will most likely continue to mutate. Both he and Walensky stated that they expect the updated booster to grant “broad protection” against those new strains, at least for now. Yet nobody ruled out the possibility of the “crazy curveball” — a radically new variant that would completely escape the booster’s protection.
Dr. Fauci was more straightforward:
It is becoming increasingly clear that, looking forward with the COVID-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual, updated COVID-19 shots matched to the currently circulating strains for most of the population.
He added that the groups considered at high risk of Covid may need more frequent boosting.
The scenario of annual Covid vaccinations was “predicted” last year by Pfizer CEO Albert Bourla, and in May of this year, top FDA officials published an article entitled “COVID-19 Vaccination — Becoming Part of the New Normal,” in which they wrote,
It is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal. It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza.
As reported by The New American, the Biden administration placed an order for the updated boosters in early July, long before the FDA evaluated whatever data it had.
Speaking with this author in an upcoming interview for The New American, Dr. Meryl Nass called the repeated boosting “insanity,” arguing that, even setting aside all the possible side effects, the available data clearly show that the more you boost, the more likely you are to get infected with Covid. That is because of the negative efficacy of the Covid shots and the effect they have on people’s immune systems. Dr. Nass stated that while this may be a good business model for Big Pharma, it is devastating for the people.
