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Mcclatchy

WASHINGTON — The Food and Drug Administration’s committee of outside experts is not planning to meet to discuss the data on Pfizer’s request for authorization of boosters-for-all, which federal officials are expected to greenlight this week, as they have for other critical decisions on COVID-19 vaccines. The move signals that the Biden administration is willing to forge ahead without the ...

Mcclatchy

Sudeep Taksali thought he’d won his battle to avoid a steep price tag on a medicine for his daughter. He was wrong. In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development — often years earlier than one’s peers. KHN and NPR wrote ...

Mcclatchy

Texas Republican Sen. Ted Cruz appears to think Big Bird is a government plant. The "Sesame Street" staple announced Saturday that he had gotten his COVID-19 vaccine, just days after the FDA approved the Pfizer shot for children ages 5-11. “My wing is feeling a little sore, but it’ll give my body an extra protective boost that keeps me and others healthy,” the supersized bird tweeted. It was ...

Mcclatchy
  • Updated

The benefits of a COVID-19 vaccine for young children made by Pfizer Inc. and BioNTech SE exceed its risks, according to a panel of U.S. experts, putting a shot for the youngest school-age children on track for a likely clearance. The Food and Drug Administration’s vaccines advisory committee voted 17-0, with one abstention, to back the immunization, which is intended for children from 5 to 11 ...

Mcclatchy

Moderna Inc. said that its COVID-19 vaccine showed a strong immune response in younger children in a late-stage clinical trial, paving the way for submission to regulators for clearance in those ages 6 through 11. An interim analysis showed a protective antibody response from children in the study, Cambridge, Massachusetts-based Moderna said Monday in a statement. Participants received two 50 ...

Mcclatchy
  • Updated

The U.S. Food and Drug Administration cleared a broad path for millions more Americans to receive COVID-19 vaccine booster shots, as the nation looks to bolster its defenses and prevent another virus surge. The agency said in a statement Wednesday that Moderna Inc. vaccine recipients 65 and over can receive a third shot, as can adults 18 and up who are at high risk of severe COVID or with ...

Mcclatchy

WASHINGTON — The Biden administration will begin shipping vaccines for kids age 5 to 11 as soon as next week, and shots could start going into arms the week after. President Joe Biden’s COVID-19 response team held a news briefing Wednesday to detail their plan for vaccinating younger children, a long-awaited but logistically complex milestone, the success of which could hinge on efforts to ...

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  • Updated

It’s no secret the U.S. depends on processed, packaged foods; they are convenient and affordable. But these foods are also the source of 70% of sodium in Americans’ diets, the majority of which comes from salt added during the manufacturing and commercial food preparation process. Now, federal health officials have proposed new, and entirely optional, guidelines for the food industry to lower ...

Mcclatchy

WASHINGTON — The U.S. Food and Drug Administration is sending Merck & Co.’s COVID-19 pill to an advisory committee for review, using a public forum to discuss any safety concerns ahead of a potential authorization. The FDA announced the hearing for Nov. 30, saying it would weigh data on the use of the drug, molnupiravir, to treat mild-to-moderate cases in high-risk adults, confirming an ...

Mcclatchy
  • Updated

Booster shots of Moderna Inc.’s COVID-19 vaccine should be given to older people and those at high risk of the disease, advisers to U.S. regulators said. Additional doses of the two-shot messenger RNA vaccine should be offered to people 65 and older, along with adults 18 and older who are at high risk for medical or occupational reasons, the Food and Drug Administration’s vaccine advisory ...