The Centers for Disease Control and Prevention (CDC) on June 27 recommended that nearly all Americans receive an updated COVID-19 vaccine this fall, leaving many poised to reject the shot for the tenth time.
The agency is urging everyone ages 6 months and older to receive an updated 2024-2025 vaccine to “protect against the potentially serious outcomes of COVID-19 this fall and winter,” even if they previously received a vaccine or had natural infection.
At this point, most Americans have immunity to SARS-CoV-2, but health officials say the vaccine offers a “boost,” even though nobody is exactly sure what the “vaccine” is boosting outside of an increased risk of experiencing a serious adverse event.
The CDC also recommends receiving an updated flu shot with a COVID-19 booster to increase your odds of neurological damage. The agency claims on its website that it’s safe to receive COVID-19 and flu vaccines at the same visit, but there’s no safety data on this either.
Antibody Levels Aren’t Indicative of Protection
One problem with the current whack-a-mole vaccination strategy is that there is no standard for determining whether a vaccine actually provides protection—and the U.S. Food and Drug Administration (FDA) doesn’t seem concerned that it hasn’t required one.
Neutralizing antibodies against SARS-CoV-2 have been widely used to infer protection against COVID-19, despite the FDA’s acknowledgment early on that antibody levels alone were not indicative of protection.
Both Pfizer and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, have admitted that no specific level of antibodies is needed to confer protection.
When the FDA’s vaccine advisors and Dr. Marks met on June 28, 2022, to discuss reformulating the original vaccines to target the Omicron variant, several panel members raised the issue of using antibodies to measure vaccine effectiveness.
During the meeting, Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, and Dr. Hank Bernstein, professor of pediatrics at Zucker School of Medicine, raised concerns over how effectiveness was being measured.
Likewise, Dr. Ofer Levy, a committee member and an infectious disease physician at Boston Children’s Hospital, voted to change the computation of COVID-19 boosters even though Pfizer admitted there was “no established correlate of protection” during the meeting.
“You have a lot of data now,” Dr. Levy told Pfizer. “What is your relative protection?”
“I would say there is no established correlate of protection,” Kena Swanson, vice president of viral vaccines at Pfizer, told Dr. Levy.
Dr. Levy then asked the FDA what their “overall approach” would be to improve the understanding of correlate protection.
“We spend a good amount of time reviewing antibody data. We have no doubt antibody data is important. We don’t have a level of antibody that anybody is comfortable stating is correlated [with] protection,” he said.
Dr. Levy said antibodies are important, but federal leadership was needed to “encourage, or in fact, require” vaccine sponsors to gather information on T cell responses, which would show whether a vaccine was actually effective.
“This is an effort that’s critical not just now but for future cycles of vaccine revision. If we aren’t able to define a standard for correlate protection, we are fighting with one arm tied behind our back,” Dr. Levy said.
Dr. Marks acknowledged Levy’s question but said it was easier initially to look at antibodies instead of T cell-mediated immunity.
“We have been having conversations with our colleagues at the NIH [National Institutes of Health] and throughout government about how we might move forward here,” Dr. Marks said. “It is something that we don’t have an answer to yet.”
Dr. Marks said as vaccines are developed in the future, it would “become even more important” to define a standard of correlate protection because “we won’t be able to have a large naive population to vaccinate with newer vaccines.”
“We will need to understand the T cell response better,” Dr. Marks said. “I take your point; it’s just that we haven’t solved the problem yet.”
Three years later, the FDA still hasn’t required pharmaceutical companies like Pfizer and Moderna to establish a correlate of protection. Instead, they allow these companies to claim their vaccines are effective if they increase antibodies in a handful of mice and encourage (or coerce) people (children) to get vaccinated, only for studies to come out five minutes later showing the shots do not work, quickly wane, or in some cases, increase one’s susceptibility to getting infected.
Mass Vaccination Creates Escape Variants
Remember in December 2020 when we were told we would only need two doses of an mRNA vaccine or one dose of the Johnson & Johnson shot to prevent COVID-19, and it would protect you and your neighbor?
Then, after everyone got vaccinated (save the minority who signed up for the “winter of severe illness and death”), U.S. health officials pulled the ultimate “psych” and informed everyone that this would be a yearly thing and the vaccine didn’t prevent COVID-19 or transmission. (Pfizer planned on yearly boosters from the start to reinforce its endless revenue stream once the pandemic ended.)
According to the CDC, people need to continuously get vaccinated because the virus is constantly mutating and evading protection.
This fall, the Novavax COVID-19 vaccine will target the JN.1 variant that was dominant last winter and spring. It will not address circulating variants.
Shots by Pfizer and Moderna will target the KP.2 variant, but that variant is quickly being replaced by the KP.3 and LB.1 variants, which now account for more than half of new cases.
Geert Vanden Bossche is a virologist and vaccinologist who has worked with GSK Biologicals, Novartis Vaccines, Solvay Biologicals, the Bill & Melinda Gates Foundation, and GAVI.
In an August 2021 article, Vanden Bossche warned that universal mass vaccination would lead to the widespread emergence of highly infectious variants that evade neutralization and that naturally acquired—or neutralizing antibodies from vaccines—would no longer offer any protection to vaccinated individuals. Additionally, he suggested that the increased infectious pressure would weaken the innate immune defenses of unvaccinated individuals.
As far back as March 2021, Vanden Bossche said:
“There can be no doubt that continued mass vaccination campaigns will enable new, more infectious viral variants to become increasingly dominant and ultimately result in a dramatic incline in new cases despite enhanced vaccine coverage rates. There can be no doubt either that this situation will soon lead to complete resistance of circulating variants to the current vaccines.”
This will trigger vaccine companies to further refine vaccines that will add to the selection pressure, producing ever more transmissible and potentially deadly variants, he said.
Dr. Robert Malone, who invented the mRNA and DNA technology used in these vaccines, subscribes to Vanden Bossche’s belief that continued mass vaccination campaigns enable new, more infectious viral variants.
“Geert Vanden Bossche—I am on board with that now,” Malone said, “that we really shouldn’t be doing universal vaccination because we’re just going to be generating escape mutants.”