51ÊÓƵ

The Food and Drug Administration announced Monday that it had greenlit two updated Covid-19 booster shots in people as young as 6 months old, triggering a process that could see the Moderna and Pfizer-BioNTech vaccines become available in doctors’ offices, clinics, and pharmacies later this week. The updated approvals relate only to the two messenger RNA vaccines on the U.S. market. An application for an updated vaccine from Novavax is still pending. (Branswell and Herper, 9/11)

Unlike the bivalent shots from last fall, the latest mRNA vaccines developed by Pfizer and Moderna are monovalent, meaning they are designed to protect against just one variant: XBB.1.5, a recent descendant of Omicron that emerged earlier this year. (Sheikh, 9/11)

If the Centers for Disease Control and Prevention signs off Tuesday, injections could be available in pharmacies, clinics and doctor’s offices by the end of the week. ... The CDC is leaning toward a broad recommendation that covers almost all ages, mirroring the FDA approach, according to federal officials who spoke on the condition of anonymity because they were not authorized to discuss the matter publicly. But it is possible that some on the agency’s panel of outside experts, the Advisory Committee on Immunization Practices, will push for a targeted recommendation focused on those at greatest risk — older Americans or people with weakened immune systems or other illnesses. The committee is scheduled to meet Tuesday on the matter and CDC Director Mandy Cohen is expected to weigh in shortly afterward, the final step in allowing the new shot to be administered. (McGinley and Sun, 9/11)

The FDA fully approved Pfizer and Moderna vaccines as a single shot for individuals 12 years and older. The agency granted emergency authorizations for use in children between 6 months and 11 years old. Children aged 5 years and older are eligible for one shot, while children aged 6 months to 4 years are eligible for one or two shots depending on which vaccine they received previously. Unvaccinated children between the ages of 6 months and 4 years are eligible for either two doses of the new Moderna shot or three doses of the new Pfizer shot.(Clason, 9/11)

The boosters will be the first that their manufacturers sell commercially, rather than to the federal government.  ... Moderna said it would price its vaccine at $130 a dose. Pfizer hasn’t specified a price to date, though it has said it was considering up to that sum. The expected prices are significantly more than the U.S. government paid, but the vaccine makers will probably offer discounts to health plans. Many people with health insurance will be able to get boosted without having to pay anything out of pocket. People without insurance should be able to get the shots—at a retail pharmacy and certain government sites—at no cost under a federal program. (Whyte, 9/11)

Also of concern in the handoff to the private market: the nation’s 23 million adults with no health insurance. The Biden administration has made plans to cover costs and offer the Covid vaccine through local clinics and major pharmacies, but some experts are worried about whether people who lack insurance will be aware of the new shots — or where to get them. ... Vaccine manufacturers are expected to donate doses for the uninsured. Kelly Cunningham, a spokeswoman for Moderna, said the company had no cap on the number. (Jewett and Weiland, 9/11)

A third shot, made by Novavax, is still under review by the FDA. Novavax said it did not expect its shot to be authorized in the United States before a meeting of a Centers for Disease Control and Prevention (CDC) advisory panel on Tuesday to recommend who should receive the updated vaccines. (Erman and Roy, 9/11)

In a statement, Novavax said doses of its vaccine arrived in the United States today and will be ready for release as soon as the FDA grants approval. The company added that it will present the latest data on the vaccine at tomorrow's meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). (Schnirring, 9/11)