Fully vaccinated and boosted Americans will likely need to take a second Covid booster or a fourth dose of the shot as soon as this fall, according to the U.S. Food and Drug Administration’s (FDA) top official.
On a conference call Tuesday, Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), the office responsible for vaccine safety, said,
I don’t want to shock anyone, but there may be a need for people to get an additional booster in the fall, along with a more general booster campaign if that takes place, because we may need to shift over to a different variant coverage.
On Tuesday, the FDA, without consulting with its expert panel on vaccine safety and efficacy, granted emergency use authorization (EUA) for a fourth shot for Americans aged 50 and up and a fifth shot for people as young as 12 with weakened immune systems. The Centers for Disease Control and Prevention (CDC) promptly recommended its use — the very same day — similarly skipping a discussion of its vaccine advisory board.
The boosters from Moderna and Pfizer, however, were designed to target the “original” strain of SARS-CoV-2 that was circulating in 2020 and early 2021. Multiple strains have since emerged and become dominant in the United States, with omicron and its subvariant BA.2 being the latest.
Both Moderna and Pfizer announced that they are testing omicron-specific vaccine formulations.
Marks continued by seemingly acknowledging the fact that the vaccines and boosters are outdated:
It may be that a decision is made that rather than what we currently have, the vaccines we currently have—which are called vaccines against the prototype virus—that we will move to a vaccine that is either against one of the variants—whether it’s Omicron, Beta, or Delta, or something else, I can’t say right now, that’s for discussion—or whether it’s some mix of different ones.
It may seem counterintuitive to authorize such products, yet the FDA argued that they were doing so to try to “save lives” and because it will likely take several months to discern whether an omicron-specific booster works, per Marks.
The FDA official cited evidence from Israel that suggested a fourth dose could reduce the risk of hospitalization and death in older and immunocompromised individuals. Marks stressed that vaccines remain the best protective measure against severe disease and death, despite their rapidly waning immune protection.
At one point in the conference call, Marks also noted that Covid is expected to continue circulating in the communities. He noted that “people want to feel comfortable” by accessing “another booster.” He also signaled that the regulators were still uncertain about the potential benefits of the additional doses or about the durability and longevity of the protection that they could provide.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to debate who should get additional Covid booster shots in the coming months and whether the vaccines need to be tailored to specific variants. According to the announcement, the panel won’t discuss a specific application from any company or hold votes during the session.
Announcing the meeting, Marks signaled on March 21 that the Covid booster will likely become a part of Americans’ inoculation routine, similar to seasonal flu shots. He said, “Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others, such as influenza, that we prepare for, protect against, and treat.”
Non-establishment scientists warn against the “arms race” between vaccines and the virus, arguing such competition would turn in favor of the virus.
Dr. Robert Malone, inventor of the messenger RNA technology used in the Pfizer-BioNTech and Moderna vaccines, explicitly stated back in August 2021 that the “strategy to universally vaccinate in the middle of the pandemic is bad science and badly needs a reboot.” He further explained:
The essence of this arms race is this: The more people you vaccinate, the greater the number of vaccine-resistant mutations you are likely to get, the less durable the vaccines will become, ever more powerful vaccines will have to be developed, and individuals will be exposed to more and more risk.
The same message has been sent by the recently deceased Dr. Luc Montagnier, a Nobel Prize laureate, who warned that the coronavirus vaccines facilitate a mutation of the virus. He called a mass-vaccination campaign against Covid an “unacceptable mistake.”
Moreover, many reports, such as this 145-country study, hold that the Covid shots make Covid infections and deaths more likely.
Experts also warn of the safety issues related to repeated dosing.
Among others, Dr. Peter McCullough pointed to the accumulation of vaccine-induced spike protein in the human body. “With repeated doses of the COVID-19 vaccines, the spike protein will progressively accumulate in the brain, heart and other vital organs exceeding the rate of clearance. The spike protein is well known to cause disease, such as myocarditis and neurologic damage as well as injuring blood vessels and promoting blood clotting,” he said.
German pathologist Dr. Sucharit Bhakdi, who, in collaboration with Dr. Arne Burkhardt, found that nearly every Covid vaccine recipient who died within seven days to six months after inoculation likely died because of vaccine-induced autoimmune damage, urged people to refuse the boosters. He argued that just a regular dose of the vaccines is already dangerous enough, and repeated boosters would exponentially amplify the damage.
