Article authors:
Reuters
Michael Erman and Manas Mishra
Thursday's U.S. Food and Drug Administration said the COVID-19 vaccine maker changed the design of booster shots from this fall, and the coronavirus's current predominant Omicron Fight BA.4 and BA.5 subvariants.
If approved, the changes indicate the first major modification of the COVID vaccine, but are deployed because the FDA recommends a slightly different design than the one already tested and put into production. It may also delay.
The FDA does not require completion of a new study testing human BA.4 / BA.5 shots for approval, government officials told Reuters. .. Influenza vaccine is handled.
"In a sense, we're chasing the virus like the flu. We have to wait to see how close we can get to the variants that stood out at the time." Infection at Vanderbilt University Medical Center Disease expert Dr. William Schaffner added that the redesigned vaccine can provide better protection than the current one.
The FDA said companies do not need to change vaccines in their primary vaccination series, saying that next year will be "a transitional period in which this modified booster vaccine may be introduced." rice field.
The new booster shot will be a bivalent vaccine that targets both the original virus and the Omicron variant. The
decision follows the recommendation of the agency's external advisor to change the vaccine design this fall to combat the more common version of the coronavirus.
BA.4 and BA.5 are estimated to account for more than 50% of infectious diseases in the United States, according to the Centers for Disease Control and Prevention, and are predominant in other regions.
The FDA said Thursday that it hopes the modified vaccine will be available from early to mid-autumn.
Scientists say that redesigned boosters could spur a broader immune response that could protect against possible future mutations. Suggests.
"COVID has tricked us many times, so it's dangerous to predict the future, especially with COVID-19," Schaffner said.
Different strategies for different countries
Regulators in other countries have launched a new booster based on the BA.1 Omicron variant that caused a massive surge last winter. I am seriously considering its use. Peter Markes said in an interview.
"Some people want a vaccine sooner. It will be available sooner," Marks said after a meeting of international regulators on Thursday.
World Health Organization advisers prefer BA.1-based boosters, arguing that variants are more pronounced and may generate a broader response than the recently circulating subvariants. did.
Pfizer Inc and its partners BioNTech SE and Moderna Inc are testing modified vaccine versions to combat the BA.1 Omicron variant.
They state that these vaccines produce a good immune response against BA.1 and recently circulating mutants, but against BA.4 and BA.5. A lower response was seen.
Both companies have already manufactured the BA.1 vaccine and said switching to the BA.4 / BA.5 design on Tuesday could delay adoption.
Pfizer / BioNTech announced a $ 3.2 billion contract on Wednesday to supply more COVID vaccines to the United States, with a significant amount of BA.4 / BA.5 vaccines in October. First week.
Moderna said it would be late October or early November before the improved vaccine is ready.
The FDA has instructed manufacturers to begin clinical trials to study the BA.4 / 5 vaccine, but the previous BA to support approval of modified shots. He said he would evaluate data for .1-based vaccines.
Marks stated that data from the new trials are important for assessing the continued efficacy of boosters against new mutations that may occur.
(Report by Michael Armand of New Jersey and Manas Mishra of Bangalore, Additional Report by Leroy Leo of Bangalore, edited by Jonathan Oatis and Bill Burke)
