Annika Kim Constantino@annikakimc<\/p>\n\n\n\n
Key Points<\/p>\n\n\n\n
Pfizer\u2019s Covid vaccine Comirnaty, seen at a CVS Pharmacy in Eagle Rock, California, Sept. 14, 2023.<\/p>\n\n\n\n
Irfan Khan | Los Angeles Times | Getty Images<\/p>\n\n\n\n
The Food and Drug Administration on Wednesday approved the latest round of Covid vaccines in the U.S., but set new limits<\/a> on who can get them.<\/p>\n\n\n\n The agency ended its broader authorization of the shots, only clearing them for people at higher risk of severe illness. That includes those 65 and up and younger adults with at least one underlying condition that puts them at higher risk.<\/p>\n\n\n\n The move could complicate access to the shots for millions of Americans, and raises questions about whether insurance plans will still cover them for healthy adults.<\/p>\n\n\n\n \u201cThe emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,\u201d Health and Human Services Secretary Robert F. Kennedy Jr. said in a post<\/a> on X.<\/p>\n\n\n\n \u201cThe American people demanded science, safety, and common sense,\u201d he said. \u201cThis framework delivers all three.\u201d<\/p>\n\n\n\n It follows several efforts by Kennedy, a prominent vaccine skeptic, to change immunizations in the U.S. The new limited authorizations are a break from U.S. vaccine policy in previous years, which recommended an annual Covid shot for all Americans 6 months and up.<\/p>\n\n\n\n A key panel of vaccine advisors<\/a> to the Centers for Disease Control and Prevention must vote to recommend the Covid shots. But Kennedy earlier this year gutted that panel<\/a> and named new members, some of whom are widely known vaccine critics.<\/p>\n\n\n\n In the post, Kennedy said the shots are available for all patients who choose them after consulting with their doctors. But it\u2019s unclear how easily patients without high-risk factors will be able to get a Covid vaccine.<\/p>\n\n\n\n Kennedy said the FDA has authorized Moderna<\/a>\u2019s shot for those 6 months and up, Pfizer<\/a>\u2019s vaccine for people ages 5 and up, and Novavax<\/a>\u2019s jab for those ages 12 and up, but only for those specifically at higher risk of getting severely sick from the virus.<\/p>\n\n\n\n Adults ages 65 and up are at higher risk of severe Covid, and so are younger adults who are immunocompromised or have underlying medical conditions such as cancer, obesity, diabetes, chronic kidney disease and heart diseases, according to the CDC<\/a>\u2019s website.<\/p>\n\n\n\n The end of the so-called emergency use authorizations means that Pfizer\u2019s shot is no longer cleared for children ages 6 months to 4 years. It comes after Pfizer in August said it has requested that the FDA keep that authorization in place for the upcoming fall and winter season.<\/p>\n\n\n\n In a release, Pfizer confirmed that the FDA had cleared its updated Covid shot<\/a> for use in adults 65 and above and those ages five through 64 with at least one underlying condition that puts them at high risk for severe illness. The company will begin shipping the shot immediately, and it will be available in pharmacies, hospitals and clinics nationwide \u201cin the coming days.\u201d<\/p>\n\n\n\n In a separate release, Moderna also confirmed that its updated Covid shot is approved for those 65 and up and people 6 months through 64 years of age who are at higher risk of severe illness. The company added that its new, next-generation Covid vaccine is approved for older adults and high-risk patients ages 12 through 64. Moderna said it expects the shots to be available in the coming days.<\/p>\n\n\n\n Shares of Pfizer and Moderna were trading slightly higher Wednesday afternoon, while Novavax shares dipped.<\/p>\n\n\n\n In May, the CDC dropped the recommendation<\/a> that pregnant women and healthy children receive Covid shots. But the American Academy of Pediatrics diverged<\/a> from the agency earlier this month, recommending Covid shots for children between 6 months and 2 years old.<\/p>\n\n\n\n In a statement on Wednesday, Dr. Susan Kressly, president of the American Academy of Pediatrics, called the FDA\u2019s more limited approval \u201cdeeply troubling.\u201d She said respiratory illnesses like Covid can be \u201cespecially risky for infants and toddlers, whose airways and lungs are small and still developing.\u201d<\/p>\n\n\n\n \u201cAny parent who wants their child vaccinated should have access to this vaccine,\u201d she said. \u201cToday\u2019s unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children.\u201d<\/p>\n\n\n\n She said the AAP urges the administration to \u201callow these choices to remain with medical experts and families.\u201d<\/p>\n\n\n\n