COVID Omicron Booster About To Arrive, But With Some Controversy

August 31, 2022 – A COVID-19 booster vaccine targeting the Omicron BA.4 and BA.5 variants that currently predominate in the United States could be available within the next few days, but its arrival is accompanied by some controversy.

FDA urgently approved To today’s Pfizer and Moderna mRNA boosters. Next comes a meeting of the CDC’s Advisory Board on Immunizations on Thursday and Friday, which could pave the way for the vaccine to be officially approved by the CDC by the end of the week.

US government already purchased After all approvals are obtained, more than 170 million doses of the two vaccines should be available (if approved later, an additional 4 million doses for children will need to be ordered). ).

However, the expected arrival of the latest vaccine has sparked controversy among infectious disease experts and others.

Some have criticized the fact that the new boosters have not been tested on humans and say wait to get updated boosters or skip them altogether. I worry that the already reluctant public will hesitate to get vaccinated again.

FDA’s Advisory Committee on Vaccines and Related Biologics Meets with Vaccine Manufacturers Judging in late June Data on Omicron-specific COVID-19 vaccine candidates.

According to FDA Commissioner Robert Calif, M.D., the FDA did not schedule another meeting of the Vaccine Advisory Committee for the new booster. “The agency is confident in the extensive discussions that took place in June,” he said on Twitter.

Evidence of updated boosters

At the end of June Pfizer Biotech When modernSubmitted to FDA Using human data for the BA.1 vaccine. The companies also announced or animal data on their BA.4 and BA.5 vaccine candidates.

Both companies showed that the BA.1 vaccine elicited antibody responses against BA.4 and BA.5, but to a lesser extent than BA.1.

The companies also presented data showing that the side effects of the updated injection were similar to those of the original vaccine, including pain and fatigue at the injection site.

“At the very least, I would like to see the neutralizing antibody data in people who received this BA.4 and BA.5 vaccine compared to those who received only the monovalent vaccine, and the dramatic effect of neutralizing antibodies. It’s about seeing a dramatic increase, a four-fold or five-fold increase,” he says.

Ofit also questions which groups should get the latest vaccine based on benefits, with the best approach being the elderly, people with serious medical conditions, or people with weakened immune systems. , believes that it is aimed at people who are most at risk of severe COVID-19.

“They are in the hospital,” he says. He believes the goal of modern vaccines is to prevent serious illness.

Offitt, who says he has been vaccinated and boosted and contracted mild COVID-19 about three months ago, plans to skip the booster.

Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape (WebMD’s sister site for medical professionals), praised the FDA’s “proactive and favorable” approach, praising the BA.5 vaccine. was available for review in just two months. After an FDA meeting calling for such a vaccine.

Topol’s personal decision? It’s been about eight months since his fourth injection, and he said he would wait for more data. He said it was just his point of view. “A lot of people will be eager to get their hands on a new shot. You’re right, that’s fine.”

William Schaffner, M.D., an infectious disease expert and professor of preventive medicine at Vanderbilt University in Nashville, cites the need to combat the expected winter surge, citing the lack of human data on others. I’m not so worried.

“If we need a vaccine to counter what some people think, [cases in] In the winter, if we wait for clinical trials, we won’t have the latest vaccine in time,” he says.

He also likens the fine-tuning of the COVID-19 vaccine to what happens every year with the flu vaccine.

Regarding safety, “We [vaccine’s] It’s very safe and effective,” says Schaffner. “I think a large part of the public health and vaccinology communities are very happy that we are doing these immune-bridging studies. [updated vaccines] Works similarly to previous vaccines. “

As for experts who want to focus only on those at risk of serious illness, she says advances that help reduce the risk of infection are important. Even if it doesn’t stop the infection completely, even if she’s 50%, it helps a lot. “

She plans to get the latest booster.