He asked, called the “practical question”, if we want to change the tension, can we assume that the age -related license will not change for any of these [vaccine] Products? “Currently, Covid -19 boosters are accessible to people aged 6 months and older.
Veer reiterated that there was no answer. Another FDA official, David Casil, just said, “Be sure we are engaged with manufacturers on this topic.”
As follows this exchange, Harvard’s VRBPAC member and infectious disease specialist Eric Rubin shot the FDA plan to use random Placebo -controlled trials for licenses for healthy children and adults. Rubin said the abundance of observational data-real-world data-booster shows clear utility. This suggests that despite the availability of effective treatment, people need to kiss the places in a trial.
“There is no equipment in the randomly controlled trial (RCT) at this time, and you cannot do any work,” Rubin said. “I don’t think RCT is possible,” he added.
Choice
When pushbacks and questions were delayed, the committee still had to choose a pressure. For now, Omron still rule, and the variations in the JN.1 lineage are still dominant. This is not a massive change since last year, when vaccinators were advised to target their seasonal shots against JN.1 lineage, or KP.2, which is currently prominent in the JN.1 lineage, especially.
This year, advisers voted unanimously with vaccines targeting the JN.1 lineage, according to the recommendations of the international organization globally. The question of targeting the JN.1 lineage was the only voting question with which the FDA had entrusted them. But there was an open conversation on a specific recommendation. Given the regulatory uncertainty, advisers were divided on whether to stay with JN.1 and KP.2 formulations from last year, or the JN.1 Family, LP.8.1, has been recommended to be transformed into the latest leading variety.
Immediately after the meeting, The FDA announced That it must leave it to the manufacturers. They can live with JN.1 or KP.2, but, if possible, go to LP.8.1.
It states that “the Kovade 19 vaccines used in the United States, which began in 2025, should have a monolon-based JN1-lining-based Covid 19 vaccine (2025-2026 formula), preferably using LP.8.1 stress.”