United States: The U.S. Food and Drug Administration said on Thursday that COVID vaccine manufacturers will be encouraged to modify their doses to target the KP.2 variation. This phenotype emerged from the JN.1 variant and spread rapidly last winter.
Shift in Strategy:
There has been a change in the agency: The revised suggestion comes after a unanimous decision by an FDA advisory group last week that said COVID vaccinations for autumn should target the older JN.1 strain.
Panel members and the agency’s chief vaccine regulator, Dr. Peter Marks, disagreed on which variety the agency ought to focus on after that vote. Most panelists selected JN.1, but Marks wanted to go with a more recent strain, such as KP.2.
“We are paying an incredibly high premium for mRNA vaccines to have the freshest vaccines,” Marks stated at the time.
Manufacturer Notification
The FDA stated that while it first recommended vaccine manufacturers to target JN.1, the most recent findings, in conjunction with a recent increase in COVID cases, indicate that the KP.2 strain is now the ideal variety to target for the updated immunizations.
The FDA also stated, “The manufacturers of the licensed and authorized COVID-19 vaccines have been informed of this change.” “The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines for the United States.”
Current Strain Data:
The U.S. Centers for Disease Control and Prevention state that JN.1 is no longer widely distributed in the country. Currently, KP.2 is responsible for 22.5% of newly diagnosed COVID cases in this nation, whereas KP.3, a sister variation, is the cause of 25% of new cases.
Vaccine Production Plans:
The three manufacturers of COVID vaccines are Novavax, Moderna, and Pfizer. The vaccines from Moderna and Pfizer are mRNA-based, whereas the one from Novavax is protein-based. Protein-based vaccines need a far lengthier manufacturing process. Hence, Novavax has said it will not be able to produce a KP.2 vaccine in time for the fall , as reported by NBC News. Instead, it also plans to distribute a JN.1 Vaccine, which it has already been producing.
Comparison with Flu Vaccine Process:
The next round of COVID vaccine selection follows a schedule similar to the annual flu shot update process.
In contrast to the existing vaccination, which targets the now-extinct XBB.1.5 variation, a JN.1 vaccine should produce more robust levels of antibodies against circulating strains of the virus, according to data provided by vaccine manufacturers during the FDA advisory committee meeting.
CDC’s Role:
The FDA advisory group did not recommend who should receive the new vaccinations. The CDC will address that matter when it meets later this month with its own advisory council on vaccinations.