Pfizer and BioNTech said in a news release that other people who won their bivalent booster shots had much higher levels of antibodies to fight SARS-CoV-2 than other people who received previous booster shots.
Companies have announced the effects of Phase 2/3 studies, but those effects have not yet been peer-reviewed.
Bivalent COVID-19 boosters that target the original form of the coronavirus and the recently circulating BA. 4 and BA. 5 Omicron variants are now available in the U. S. U. S. for other people up to five years old.
The Food and Drug Administration legalized bivalent COVID-19 recalls on Aug. 31 for others 12 and older, and Oct. 12 for younger age groups.
According to data published by Pfizer and BioNTech, in other people over the age of 55, bivalent memory was linked to a more than 13-fold accumulation in antibody levels compared to pre-memory levels.
Traditional monovalent booster injections resulted in a 2. 9-fold buildup in antibody levels in other people over age 55 compared to pre-booster levels.
The bivalent vaccine was found to result in a 9. 5-fold buildup in antibody levels in older adults aged 18 to 55, compared to pre-booster levels.
“This knowledge demonstrates that our adapted bivalent vaccine BA. 4/BA. 5 works as conceptually intended by offering improved coverage against the Omicron BA. 4 and BA. 5 sublineages,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. said in the statement. ” As a next step and as a component of our clinical approach, we will continue to compare the cross-neutralization of the adapted vaccine against new variants and sublineages. Our purpose is to provide broader immunity to COVID-19 through SARS-CoV-2, adding Omicron and other circulating strains.
The new data from Pfizer and BioNTech comes a day after a study by the U. S. Centers for Disease Control and Prevention of Disease Control and Prevention led to a study by the U. S. Centers for Disease Control and Prevention. The U. S. Food and Drug Administration found that the new bivalent boosters had a protective profile against previous COVID-19 vaccines.
In an effort to stay ahead of the evolution of the coronavirus, the U. S. Food and Drug Administration is in the process of doing so. U. S. He legalized those bivalent recalls before knowledge of human clinical trials became available.
Since the initial approval of bivalent vaccines through the FDA, several new coronavirus subvariants have emerged around the world. Ashish Jha, head of the White House COVID task force, said on Oct. 1. On Jan. 11 at a press conference management “carefully monitors” those strains, adding “those that escape some of our treatments. “
However, since all of those subvariants are derived from existing Omicron strains, the “updated bivalent vaccines will offer a much higher degree of coverage than the original prototype vaccine would have,” Jha said.
The FDA said in August it based its resolution for bivalent vaccines on “all available evidence. “
This animal studies on BA. 4/5 boosters, clinical trials of bivalent ba. 1 boosters, clinical trials of original vaccines and boosters, and continuous monitoring of the protection of existing vaccines.
By allowing bivalent vaccines for younger age groups, the signing of its resolution on the same evidence.
Experts told Healthline that, given this evidence and the fact that BA. 4/5 bivalent boosters are similar to BA. 1 boosters, there is no doubt that newly licensed bivalent vaccines are safe.
However, it may be some time before we know how much the updated vaccines will offer an immune boost compared to the Omicron variants that are circulating recently, and even longer to know how resistant they are to the long-term variants that might emerge. .
Dr. Mohammad Sobhanie, an infectious disease physician at The Ohio State University Wexner Medical Center in Columbus, Ohio, noted that Moderna and Pfizer-BioNTech have used precisely the same generation to expand the bivalent ba. 4/5 boosters they used for their original COVID. -19 vaccines, as bivalent boosters ba. 1.
He likened this to the way seasonal flu vaccines are updated each year to match circulating strains of influenza. Unless vaccine brands use a new generation to produce influenza vaccines, no further clinical trials are needed.
With COVID-19 vaccines, there is already a long history of protection that can be used for the protection of BIVALENT BA. 4/5 vaccines.
In the U. S. alone, more than 640 million doses of COVID-19 mRNA vaccines have been administered, more than 26. 3 million doses of bivalent vaccines, according to the CDC.
Also, “there’s nothing radically new about the [bivalent BA. 4/5] vaccine, other than the fact that they’ve replaced what they attack,” Sobhanie said. “Therefore, the protection profile will be similar to that of the original vaccine. “vaccines. “
The target of this vaccine is the coronavirus spike protein, which the virus uses to infect cells. Omicron’s spike protein and other variants differ from the original form of the virus, on which the first vaccines were based.
According to Dr. David R. Martinez, PhD, a viral immunologist at the UNC Gillings School of Global Public Health in Chapel Hill, North Carolina, the spike proteins of the BA. 1, BA. 4 and BA. 5 variants, all of which are versions of Omicron, are very similar.
As a result, “I think we have enough data to be able to claim that the [bivalent BA. 4/5] vaccine is safe,” he said, because “BA. 4 and BA. 5 have relatively few differences in protein spike compared to BA. 1, which has been tested in humans.
Clinical trials of Moderna and Pfizer-BioNTech’s BA. 1 bivalent boosters have identified new protective concerns, the FDA said in its statement.
The maximum-appearance effects reported were similar to those of the original vaccines and boosters, such as pain, redness and swelling at the injection site, fatigue, headache, muscle aches, chills, joint pain and fever.
These trials also showed that the bivalent ba. 1 vaccine generated a more potent immune reaction than this variant, the original vaccine, the FDA said.
The clinical trial for the BIVALENT BA. 1 booster is smaller than the trials for the original vaccine, so a rare side effect may not occur.
However, “even if you’ve done a large clinical trial, you may not run into all the occasional side effects,” Martinez said. “Therefore, we continue to monitor vaccines in real time after they are licensed. “
This regimen tracking is how the FDA and CDC learned of the increased threat of cardiac inflammation (myocarditis and pericarditis) that went undetected in the original clinical trials.
This side effect occurs within the first week of receiving the instant dose or booster of the original COVID-19 mRNA vaccines.
For the Moderna COVID-19 vaccine, the threat of myocarditis or pericarditis is in men older than 18 to 24 years. For the Pfizer-BioNTech vaccine, the threat is in men ages 12 to 17 and older.
The FDA has included this threat in updated bivalent vaccine fact sheets, the firm said.
Although the FDA authorizes updated vaccines, data shows that the original vaccines continue to provide robust coverage against serious illness, especially when other people have won the number one series and at least one booster.
“The current vaccines are still holding,” Sobhanie said. However, “if those upgraded boosters can save you more hospital admissions and [COVID-19] deaths, it’s definitely an advantage. “
With the bivalent BA. 4/5 recall, the United States has to launch a vaccine that matches the editing of the virus that is recently circulating.
“I hope if you can get vaccinated instead of those [BA. 4 and BA. 5], it will protect you from infection,” Sobhanie said. “This is something that’s quite useful as we approach the fall and winter months, when other people are more likely to gather indoors. “
The inclusion of the original vaccine formulas in the coverage of booster supplies against a variant of the original strain.
However, scientists are confident what coverage the updated boosters will offer.
Understanding this in advance is confusing because of the complex combination of immunity Americans have acquired through vaccination and infection with other variants, adding multiple infections for some people. This past immunity can influence a person’s reaction to vaccination with an updated booster.
“We hope that having a vaccine closer to circulating variants will have an effect on virus transmission,” Martinez said. However, “even if it’s moderate to think that, we literally don’t know if it really will. “
While some experts question the benefits of updated boosters for younger, healthier people, Martinez said other people would actually benefit from bivalent vaccines.
“Where this vaccine could offer the maximum advantages would be in other older people whose immunity decreases,” he said, “and potentially in reducing BA. 5 transmission, assuming it is still circulating in two months. “
Our experts monitor the fitness and wellness area, and we update our articles as new data becomes available.
Current version
November 4, 2022
By means of
Shawn Radcliffe
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Gillian Mohney
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Copy Editors
October 12, 2022
By means of
Shawn Radcliffe
Edited by
Gillian Mohney
Copy edited by
Copy Editors
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