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Another new Covid-19 vaccine may be available this fall.
US Food and Drug Administration Committee of independent consultants The agency voted unanimously Wednesday to tell vaccine manufacturers to update their Covid-19 vaccines. More effective against JN.1 corona virus lineage.
For the 2024-2025 formulation of covid-19 vaccines in the US, will the committee recommend a monovalent JN.1-lineage vaccine composition? The 16 councilors voted “yes”.
The decision now goes to the full FDA. If the agency agrees with the advisory committee, the new vaccine will be a single vaccine that protects against a single strain of the coronavirus. Some early vaccines are bivalent, meaning they are designed to protect against two variants.
Currently, there are a few types of viruses in circulation, but they are relatively similar.
JN.1 and its progeny KP.2 and KP.3 are the most common versions of the virus in the US. On the basis of now US Centers for Disease Control and Prevention.
The FDA told an advisory committee Wednesday that studies show it is currently available. Covid-19 vaccines are currently less effective against the differences in transmission.
When manufacturers updated their vaccines last year to better match the differences in distribution, it seemed to offer better protection. “Match will make a difference, if at all,” said Dr. Jerry Weir, director of the Division of Viral Products in the Office of Vaccine Research and Evaluation at the FDA's Center for Biologics Evaluation and Research.
“JN.1 continues to evolve, and it makes it somewhat difficult to choose the different strain that will be used this year,” he told the committee. Because of production schedules, experts must now forecast if a new vaccine will fall. That's what an FDA committee has done for the past two years., And “I think it's very well done,” Weir said.
Currently, the number of Covid-19 cases is relatively low. Only 3% to 4% of people who are tested are infected, said Dr. Natalie Thornburgh, acting director of the Division of Immunization and Respiratory Diseases and Other Respiratory Viruses at the CDC's National Laboratory for Immunization and Respiratory Diseases. . By comparison, at Omicron's peak in late 2021, test positive rates were 30 percent.
Hospitalization rates are the lowest since March 2020. Thornburg said.
Most people have some protection from the disease because they are vaccinated or have had Covid before.
People who receive the current Covid-19 vaccine — which was updated last fall — are protected against serious illness and death in all age groups, but as with previous formulations, that protection wanes over time, Dr. Ruth Link-Gales, director of the Vaccine Effectiveness Program told the committee. They are headed by the National Center for Immunization and Respiratory Diseases, he said.
The consultants agreed that more people should get up-to-date vaccinations. About 25% of adults have received the most recent vaccination, according to a presentation to the committee.
Last season only in autumn and winter months, According to data presented at the meeting, Covid has sent more than half a million people to the hospital in the US and killed 40,000.
Those at greatest risk of becoming seriously ill or dying were those who were unvaccinated, Link-Gales said, and among them Half of the hospitalized children had no prior medical conditions.
“This, I think, emphasizes the importance of vaccination, regardless of condition, condition or age,” she said.
The manufacturers of the Covid-19 vaccine told the committee that they have done some work to prepare for the FDA's decision on the composition of the vaccine. Animal and laboratory studies show that vaccines made by Pfizer/BioNTech, Moderna and Novavax that target the JN.1 variant work well and appear to be safe, the companies said.
Novavax says the modified shot must be the JN.1 version because the protein vaccine takes about six months to work, and that's the version it has. He was working on it. The company said it could bring the shot to US warehouses in August.
Pfizer and Moderna's mRNA vaccines could be developed more quickly, and those companies said either the JN.1 shot or the KP.2 shot could be ready for fall. Moderna said it could hit the U.S. market by mid-August, and Pfizer said it could be ready as soon as the shot is approved.
The committee discussed but did not vote on whether the shot should match the JN.1 or the KP.2. Most members choose JN.1 so Americans have the option of getting an mRNA vaccine or a more traditional protein-based vaccine.
Dr. Peter Marks, Director The FDA's Center for Biologics Evaluation and Research told the committee that the FDA will consider these recommendations when making its final selection.