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FDA Advisor to Consider Whether Omicron-Specific Coronavirus Vaccine is Needed

(CNN)The United States is preparing for the need to renew the Covid-19 vaccine.

The U.S. Food and Drug Administration's independent vaccine and related biological product advisory board met on Tuesdayto change the composition of the Covid-19 vaccine for specific coronavirus strains, And in that case, which stock should be selected.

In other words, the Covid-19 vaccination that people will receive in the future may have a slightly or completely different prescription than what is currently being administered. The current vaccine is based on the corona virus that emerged in late 2019, but experts will discuss on Tuesday whether the vaccine should also target the Omicron variant.

At their meeting, VRBPAC members will votequestions:"The Commission recommends that the US COVID-19 booster vaccine contain the SARS-CoV-2 omicron component. Do you? ""

This is the moment of transition of the approach to coronavirus vaccine. There is growing expectation that vaccination may be required each year. This is the same as seasonal influenza injections being given annually.

"It is expected that a fall booster will be needed, what will the framework be, and will vaccines be needed for different variants," said the National Association's Chief Executive Officer. One Lori Tremmel Freeman said. I told CNN, the health authorities of the counties and cities.

"This can be difficult, because if you don't have the same prescription, you're really a booster. Should we discuss that, or is it just a new vaccination?" Freeman added. I did. "I won't talk about receiving a booster of influenza shots over the years. It's only part of getting your influenza shots each year. So this transition is important.

In May, a trio of FDA executives wrote in themedical journal JAMAthat the United States needs to renew the Covid-19 vaccine each year, and the "new normal" is: It writes that it may contain something like. Annual Covid-19 vaccine with seasonal influenza shots.

"By the summer, who will be eligible for additional booster vaccinations, we need to make a decision on the composition of the vaccine for the 2022-2023 season," the FDA said. Dr. Peter Marks, director of the center, writes. Biological assessment and research; Chief Deputy Secretary Janet Woodcock. Dr. Robert Calif, FDA Commissioner.

"Administration of additional COVID-19 vaccine doses to appropriate individuals this fall during the normal influenza vaccine campaign may protect sensitive individuals from hospitalization and death. Therefore, it is a consideration of the FDA. "They wrote.

'This will be. Transitional'

FDA's Vaccine Advisors met earlier in April to discuss how to change the composition of the Covid-19 vaccine to target new coronavirus variants. .. The Commission agreed that a framework for when and how such changes would be made is needed.

The FDA's mark calls this year "transitional" in terms of how it looks at the evolving Covid-19 vaccine schedule.

"Currently, it is hypothesized that this looks like influenza. In this 2022-23 season, not only will you be vaccinated against influenza, but you will also get a Covid-19 booster. Let's see what happens, "Marks told Bloomberg earlier this month in aopinion article.

"If the people who get that boost go well and avoid another big wave from October to March to April next year, people will get used to it." He said.

People over 5 years old are already eligible for booster administration, and certain people with weakened immunity and adults over 50 years old are eligible for additional administration ofCovid-19 vaccine. There are

"We need to start thinking about vaccines that can be adjusted annually to get closer to the influenza model. Every 5 or 4 months. I'm not saying you'll get another booster, "Marks told Bloomberg. "The idea here is that next year we have one campaign and we don't have to follow up with another booster campaign. Ultimately, the next generation of vaccines is ideal for maintaining that year.

Currently, the original version of Pfizer / BioNTech, Moderna, Johnson & Johnson Corona Virus Vaccine is used in the United States, but vaccine makers are working on an updated version of the vaccine. ..

Moderna has developed a divalent Covid-19 vaccine booster named mRNA-1273.214. It isannounced this month thathas been shown to elicit a "strong" immune response against the Omicron subvariant BA. 4 and BA.5. This bivalent booster vaccine candidate includes components of both Moderna's original Covid-19 vaccine and vaccines that target the Omicron variant. T
On Saturday, Pfizer and BioNTech announced that two Covid-19 vaccine boosterstargeting Omicronare significantly more than the current Covid-19 vaccine. He said he showed a high immune response. Preliminary laboratory studies suggest that the vaccine may neutralize Omicron BA.4 and BA.5.
Another vaccine maker, Novavax, has receivedVRBPAC emergency license supportin the United States, but has not yet received FDA approval. Novavax scientists are also developing variant-specific updated versions of the Covid-19 vaccine, as well as a combination vaccine of Covid-19 and influenza.

'Booster uptake so far is not very large'

Public health experts say that uptake of the modified Covid-19 vaccine will be delayed in the future I am concerned about the possibility.

"Because the booster uptake so far isn't that big, another booster doesn't always have a shortage of people to get a booster that you've already missed," Freeman said. I am.

About two-thirds (67%) of the US population are completely vaccinated against Covid-19 with at least the first series of vaccines, but less than one-third (32). %) Is a booster as of Friday, according to data from the CDC.

Children's vaccination rates are far behind other age groups. Only 30% of children aged 5-11 and 60% of aged 12-17 are fully vaccinated, compared to nearly 77% of adults. National data on vaccination rates for children under the age of 5 who qualify forthis month may not be available for several weeks. The
CDC considers a single dose of Pfizer / BioNTech or Moderna vaccine or a single dose of Johnson&Johnson vaccine to be fully vaccinated. Additional doses are called "boosters" and completing booster immunizations for all recommended vaccines is considered "latest"

, but additional doses That word and message about the completion-and considering them, Dr. Peter Hotes, a vaccine scientist and dean of the National Tropical Medicine Department of Baylor Medical University, told CNN. This is evident from the slow uptake of additional doses.

"Since the beginning of January 2021, I've always said this is a three-dose vaccine," he said.

Currently, people who have not yet completed booster administration are more vulnerable to Covid-19 infection, hospitalization, and death.

"Because we are beginning to see not only breakthrough hospitalizations, but even breakthrough deaths for people who received only two vaccines and no boosters, especially those over the age of 65. It has a big impact.-So this is more than a theoretical argument. The message is killing me. "

At this time, vaccine protection against Covid-19 does not seem to be as persistent as vaccine experts desire, but the reason is not so clear. The decline in protection may be due to the vaccine itself or the emergence of coronavirus variants that evade the vaccine.

Hotez said he believes the White House needs to convene a panel of vaccine experts at a special meeting to determine if there are any weaknesses in Covid-19 vaccine technology in terms of durability. I did. And what does that mean for future vaccine strategies?

"Two things are happening at the same time. It's possible that your immunity is weak," Hotes said, but at the same time variants like Delta and Omicron appeared.

"If Delta was the only thing we had to worry about, would we have a problem?" That's why we want to convene experts. . "