August 31, 2022: COVID-19 booster vaccines targeting the newly dominant Omicron BA. 4 and BA. 5 subvariants in the U. S. The U. S. government could be available in the coming days, but its arrival comes with some controversy.
The FDA granted emergency approval to mRNA boosters from Pfizer and Moderna. Upcoming CDC advisory committee meetings on vaccination practices on Thursday and Friday may pave the way for formal vaccine approval through the CDC before the weekend.
The U. S. government The U. S. Department of Homeland Security has purchased more than 170 million doses of the two vaccines that will be in a position to be used once all approvals are in place (with an order for an additional four million doses for children, if approved later).
But the expected arrival of the updated vaccines has sparked debate among infectious disease experts and others.
Some have criticized the fact that the new reinforcements have not been tested on humans and say they will wait to get the updated booster or skip it altogether. public already reluctant to re-vaccinate.
Still, many experts applaud the speed with which the updated vaccines have been developed and say the protection of VACCINES AGAINST COVID-19 is well established. and each year, refine the formula of an established vaccine platform to combat new viruses or variants that are expected to circulate.
The new reinforcements
Earlier this year, vaccine brands provided the FDA with information on an updated vaccine targeting BA. 1, the variant of Omicron that dominated in the past. But then the FDA asked corporations to update their vaccines to load an Omicron BA. 4/5 component, to create a vaccine that is a bivalent booster, meaning it will cover the original strain of the virus that emerged from China and the new subvariants BA. 4 and BA. 5.
This will be the first of the mRNA vaccines since their availability in December 2020.
The FDA’s Vaccine and Repast Biologics Advisory Committee met with vaccine brands in late June to review data on Omicron-specific COVID-19 vaccine candidates.
For the new recalls, the FDA has not scheduled the meeting of its vaccine advisory group, according to FDA Commissioner Robert Califf, MD. She noted on Twitter that “the company feels confident in the in-depth discussion that took place in June. “”
Updated reinforcement test
In late June, Pfizer BioNTech and Moderna submitted human data on the BA. 1 vaccine to the FDA. The companies also submitted laboratory or animal data on vaccine candidates ba. 4 and BA. 5.
Both companies demonstrated that BA. 1 vaccines triggered antibody responses opposite to BA. 4 and BA. 5, but lower than those of BA. 1.
The companies also reported that the side effects of the updated vaccines were similar to those of the original vaccine, such as pain at the site where the vaccine was administered and tiredness.
In studies with mice submitted to the FDA, Pfizer said its new recall of higher antibody responses for all variants of Omicron, BA. 4 and BA. 5.
The effects of human clinical trials are coming, but soon. Moderna has completed registration of its BA. 4 and BA. 5 retirement clinical trial, with expected effects in the fourth quarter of 2022. Pfizer said it plans to start a trial soon.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, told NPR that knowledge from mouse studies recommends that the new vaccines may be about 20 times more protective than the original vaccines compared to Omicron.
Reacting to any consideration of the knowledge of human protection from the new vaccine, CDC Director Rochelle Walensky, MD, recently told CNBC that the new vaccines involve very small adjustments in the mRNA series and that this is not expected to have an effect on protection.
Infectious disease experts give their opinion
The lack of convincing knowledge about neutralizing antibodies opposed to BA. 4 and BA. 5 in humans is a problem, says Paul Offit, MD, an infectious disease expert and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
“At least, what I’d like to see is neutralize the knowledge of antibodies in other people who won this BA. 4 vaccine, BA. five to get the monovalent vaccine and see a dramatic buildup in the neutralizing antibodies, four or five times more,” he says.
Offit also wonders which teams get the updated benefit-based vaccine and believes the most productive technique is to target those who are most at risk for severe COVID-19, such as the elderly, other people with serious medical problems or those with weakened immune systems.
“They are the ones who are hospitalized,” he says. Consider that the purpose of the updated vaccine is to save you from serious diseases.
Offit, who says he was vaccinated and received booster, and who had a mild COVID-19 infection about 3 months ago, plans to skip this booster.
Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape (WebMD’s sister site for healthcare professionals), applauded the FDA’s “aggressive and accelerated” approach, with a BA. 5 vaccine available for review just 2 months after the FDA assembly requested such a vaccine.
He noted that mouse knowledge is used annually to update the quadrivalent flu vaccine program. “But there are considerations that it might not be so simple to extrapolate mice to humans for SARS-CoV-2, a different virus from the flu. “wrote online on his online platform Ground Truths.
According to Topol and others, another possible fear is the so-called fingerprint, also known by the catchy but prospectively misleading term “original antigenic sin,” in which a person’s first exposure to a virus has an effect on an upcoming reaction to similar viruses. The fear is that other people may “train” their immune formula for the reaction to the first infection and be less able to respond to long-term ones when faced with other variants, such as those that are the subject of new recalls.
For now, he says, “it’s an unknown, knowledge is mixed. “
Will the public settle for it?
Topol also expressed fear for public confidence in the vaccine and the option for others to see the new boosters as pressing work. As he also noted, only 32% of the population won one of the original reminders.
Topol’s non-public decision? He is about 8 months away from his fourth injection and said he would wait to see more data. He said it’s just his point of view. ” Many will be eager to receive the new injection. Like I said, okay. “
Infectious disease expert William Schaffner, MD, a professor of preventive medicine at Vanderbilt University in Nashville, is as concerned as others about the lack of data in humans, raising the need to fight the expected winter surge.
“If you want a vaccine to combat what some think is a backlog of [cases] in the winter, you may not have an up-to-date vaccine in time if you wait for a clinical trial,” he says.
He also compares the refinement of the COVID-19 vaccine to what is done year with the flu vaccine.
When it comes to protection, “we know a lot about the protection and efficacy [of the vaccine],” Schaffner says. shows that [updated vaccines] work in the same way as previous vaccines.
As for protective issues, he says the risk of myocarditis (inflammation of the central muscle), which occurred in some adolescents and young adults with the current dose of the vaccine, decreased with the booster dose. He says it is moderate to be waiting for the updated withdrawal to bring also a lower threat of this side effect.
“These changes [with the updated vaccine] are so small that they possibly wouldn’t affect safety,” said Katelyn Jetelina, PhD, an epidemiologist and fitness policy expert who publishes Your Local Epidemiologist, a newsletter that translates science for consumers. .
She acknowledges the fear of footprint, but “we want to respond to the desires of our immune formula right now, amid an [expected] increase,” she said.
Jetelin recognizes unknowns, such as how long the updated vaccine will be effective. Because BA. 5 is so new, there has been no time to test the vaccine in humans. According to her, “demanding an effective vaccine and clinical knowledge is just a fantasy opposed to this evolving virus. “
As for experts who only need to attack other people in the face of the threat of serious illness, he says any breakthrough that helps lessen the threat of infection is important: “We can’t prevent serious illness and death if we don’t prevent transmission. Even if they don’t perfectly prevent transmission, even if it’s 50%, it’s still helping a lot.
She plans to get the reminder updated.
CDC: Immunization Agenda Advisory Committee Meeting; “CDC’s Fall Vaccine Operational Planning Guidance: Information for the Fall Vaccination Campaign, Including Upcoming Booster Doses of the Bivalent COVID-19 Vaccine. “
Eric Topol, MD, Editor-in-Chief, Medscape and Executive Vice President, Scripps Research, La Jolla, CA.
William Schaffner, MD, Professor of Preventive Medicine and Infectious Disease Specialist, Vanderbilt University, Nashville.
Katelyn Jetelina, PhD, MPH, epidemiologist, fitness policy and editor, Your Local Epidemiologist.
Twitter: Dr. Robert M. Califf.
Moderna press release: “Moderna announces that Omicron’s bivalent recall candidate, MRNA-1273. 214, demonstrates an impressive Omicron antibody reaction. “
Pfizer BioNTech Press Release: “Pfizer and BioNTech announce that COVID-19 vaccine applicants tailored to Omicron demonstrate a superior immune reaction opposite to Omicron.
Science: “Omicron booster injections are coming, with a lot of questions. “
NPR: “The FDA will authorize new OMICRON-specific COVID boosters this week. “
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