U.S. regulators approved updated COVID-19 shots Wednesday but limited their use for many Americans — and removed one of the two vaccines available for young children. The new shots from Pfizer, Moderna and Novavax are approved for all seniors. But the Food and Drug Administration narrowed their use for younger adults and children to those with at least one high-risk health condition, such as asthma or obesity. That presents new barriers to access for millions of Americans who would have to prove their risk — and millions more who may want to get vaccinated and suddenly no longer qualify. Additionally, Pfizer’s vaccine will no longer be available for any child under 5, because the FDA said it was revoking the shot’s emergency authorization for that age group. Parents will still be able to seek out shots from rival drugmaker Moderna, the other maker of mRNA vaccines, which has full FDA approval for children as young as 6 months. But the company’s Spikevax vaccine is only approved for children with at least one serious health problem. The revamped vaccines target a newer version of the continuously evolving virus and are set to begin shipping immediately. But it could be days or weeks before many Americans know if they’ll be able to get one, with access dependent on decisions by federal health advisers, private health insurers, pharmacies and state authorities. The new restrictions — previewed by FDA officials in May — are a break from the previous U.S. policy, which recommended an annual COVID-19 shot for all Americans 6 months and up. The approach reflects heightened skepticism about the ongoing risks of COVID-19 and the need for yearly booster shots from Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, both outspoken critics of wide-scale vaccinations. “The American people demanded science, safety, and common sense. This framework delivers all three,” Kennedy wrote on social media. Novavax’s shot is only open to people 12 or older, not younger children, and under the same risk-based restrictions as are now in place for the Moderna and Pfizer options. It’s the nation’s only traditional, protein-based COVID-19 vaccine. Coverage questions and access issues are unresolved The limits “can’t help but create barriers to vaccinations” and cause confusion for patients, doctors and pharmacists, said Dr. William Schaffner, a Vanderbilt University vaccines expert. Some medical groups, including the American Academy of Pediatrics, have objected to the new limits, saying they may block vaccine access for families who want to protect their children. Last week, the group offered its own recommendations for kids, saying annual shots are strongly recommended for children ages 6 months to 2 years and advised for older children. In his post Wednesday, Kennedy said the shots will be “available for all patients who choose them after consulting with their doctors.” But Americans are likely to confront a number of logistical hurdles. Insurers typically base their vaccine coverage decisions on the recommendations of a panel of advisers to Centers for Disease Control and Prevention, but some say they will also look to medical professional groups, including the American Medical Association. Earlier this year, Kennedy replaced the entire CDC panel, naming several doctors and researchers who have repeatedly questioned the safety of commonly used vaccines and ingredients. The panel is expected to meet in September, but no agenda has been released. Depending on the panel’s advice, Americans under age 65 could be expected to […]  | Read More The Yeshiva World