Rural pharmacies, independent or chain, can be a
A vial of Moderna COVID-19 vaccine rests on a table at an inoculation station in Jackson, Miss., on July 19, 2022. (AP Photo/Rogelio V. Solis, File)Pfizer and Moderna, makers of the most commonly used COVID shots, each said they would continue to work with the agency.
For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots so long as they show as much immune protection as the previous year’s version.But FDA’s new guidance appears to be the end of that approach, according to Prasad and, who co-authored the journal paper and joined the FDA webcast.
Prasad and Makary criticized the U.S.’s “one-size-fits-all,” contrasting it with some European countries that recommend boosters based on age, risk and other factors.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. Companies might need to repeat that requirement for future vaccine approvals if there’s a large virus mutation rather than the past year’s incremental evolution. Companies are also free to test their vaccines for approval in younger adults and children, Prasad said, adding “this is a free country.”
Since becoming the nation’s top health official in February, Kennedy has filled the FDA and other health agencies with outspoken critics of the government’s handling of COVID shots, including Makary and Prasad. Under federal procedures, the FDA releases new guidance in draft form and allows the public to comment before finalizing its plans. The publication of Tuesday’s policy in a medical journal is highly unusual and could run afoul of federal procedures, according to FDA experts.
Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended only for people at increased risk.Pineapple Healthcare, which doesn’t receive initiative money, offers full-scope primary care to mostly Latino males. Hermida gets his HIV medication at no cost there because the clinic is part of a federal drug discount program.
The clinic is in many ways an oasis. The new diagnosis rate for Latinos in Orange County, Florida, which includes Orlando, rose by about a third from 2012 through 2022, while dropping by a third for others. Florida has the third-largest Latino population in the U.S., and had the seventh-highest rate of new overall HIV diagnoses among Latinos in the nation in 2022.Hermida, whose asylum case is pending, never imagined getting medication would be so difficult, he said during the 500-mile drive from North Carolina to Florida. After hotel rooms, jobs lost and family goodbyes, he is hopeful his search for consistent HIV treatment — which has come to define his life the past two years — can finally come to an end.
“Soy un nómada a la fuerza, pero bueno, como me comenta mi prometido y mis familiares, yo tengo que estar donde me den buenos servicios médicos,” he said. I’m forced to be a nomad, but like my family and my fiancé say, I have to be where I can get good medical services.That’s the priority, he said. “Esa es la prioridad ahora.”