The AP reported, "But the FDA framework,
published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. It’s a stark break from the previous federal policy recommending an annual COVID shot for all Americans six months and older. In the paper and a subsequent online webcast, the FDA’s top vaccine official said more than 100 million Americans still should qualify for what he termed a booster under the new guidance...“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”...[Vinay] Prasad said the FDA will ask all manufacturers to do new clinical trials in healthy people ages 50 to 64, randomly assigning them to get a vaccine or a placebo and tracking outcomes with special attention to severe disease, hospitalization or death." A placebo? I eagerly await the response of those wiser in the area of medical ethics than I am.
NPR
reported, ""Secretary Kennedy had made it clear that he would never take vaccines away from anyone,"
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview with NPR, referring to Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA. "This violates that in every way possible" because if insurance companies won't pay for the vaccine many people simply won't be able to afford it.""
Lucky Tran of Columbia University
wrote on BlueSky, "Under its new leadership — who spread misinformation throughout the pandemic — the FDA announced it will limit all Covid vaccines to adults over 65 and those with certain medical conditions. Covid continues to spread and cause harm. This [is] an anti-science move that will kill more Americans."
ARS Technica
reported, "These trials can easily cost hundreds of millions of dollars, and they can take many months to complete. The requirement for such trials will make it difficult, if not impossible, for drug makers to conduct them each year and within a timeframe that will allow for seasonal shots to complete the trial, get regulatory approval, and be produced at scale in time for the start of the respiratory virus season."
