FDA
COVID-19 vaccines for kids ages 5 to 11 could be ready as soon as next week
WASHINGTON — The next wave of the massive COVID-19 vaccination campaign could begin as soon as next week, after federal regulators decide if elementary school students across the U.S. should begin rolling up their tiny sleeves. That multistep approval process kicks off Tuesday, when the Food & Drug Administration’s panel of vaccine experts will vote on […]
COVID-19 boosters from Moderna, J&J OK’d along with ‘mix and match’ shots
WASHINGTON — Tens of millions of additional Americans are now eligible to receive a booster dose of one of the COVID-19 vaccines, after federal health officials gave the green light late Thursday to follow-up doses of the shots made by Moderna and Johnson & Johnson. Anyone who received the one-shot J&J vaccine is now eligible for a second […]
Kids age 5 to 11 next in line for COVID-19 vaccines as White House rolls out plans
WASHINGTON — Smaller needles. Redesigned shipments to ease the storage needs in pediatricians’ offices. And enough vials of the COVID-19 vaccine to inoculate the 28 million U.S. children between ages 5 and 11. Those are among the plans announced by the White House on Wednesday as federal and state officials prepare for a regulatory decision to be […]
Feds OK ‘mix-and-match’ approach for COVID-19 booster shots
WASHINGTON — The U.S. Food and Drug Administration has given a green light to Americans who want to receive a booster dose of a COVID-19 vaccine manufactured by a different company than the one that produced the initial shot they received. The announcement Wednesday on allowing “mix-and-match” shots from different manufacturers will give more flexibility to state […]
Booster shot of Johnson & Johnson COVID-19 vaccine recommended by FDA panel
WASHINGTON — A federal vaccine advisory panel on Friday endorsed a second dose of Johnson & Johnson’s one-shot COVID-19 vaccine, meaning millions more Americans are expected to soon join the line for booster shots. Anyone who received a J&J shot at least two months ago will be eligible for an additional dose, under the committee’s […]
FDA panel recommends booster shot of Moderna’s COVID-19 vaccine
WASHINGTON — Millions of Americans who received Moderna’s two-shot COVID-19 vaccine are expected to be eligible soon for booster shots, after a federal advisory panel on Thursday recommended a third dose for older and higher-risk adults as well as certain workers. The unanimous recommendation from the Food and Drug Administration vaccine panel came a few […]
Ohio lawmaker calls on Congress to investigate opioid consultant
Management consulting firm McKinsey and Company has already been forced into nearly $600 million in settlements over its role in fueling the opioid crisis that’s taken the lives of more than 450,000 Americans the last two decades, but an Ohio state representative wants Congress to investigate the firm further. Rep. Brian Stewart, R-Ashville, pointed to […]
McKinsey never told the FDA it was working for opioid makers while also working for the agency
By Ian MacDougall for ProPublica This story was originally published by ProPublica Since 2008, McKinsey & Company has regularly advised the Food and Drug Administration’s drug-regulation division, according to agency records. The consulting giant has had its hand in a range of important FDA projects, from revamping drug-approval processes to implementing new tools for monitoring […]
FDA panel backs COVID-19 booster shots only for elderly and high-risk Americans
WASHINGTON — A federal health advisory panel wrestled Friday with whether to widely authorize a booster dose of Pfizer’s two-shot COVID-19 vaccine for most Americans, ultimately recommending that a third dose be offered only to older or higher-risk individuals. The Biden administration had hoped that states could begin rolling out a wide national booster shot […]
Do people have the “right” to contract and spread a deadly disease?
From the beginning of the spread of COVID-19, we knew a vaccine would be the most effective tool we would have to stymie its spread, reduce infections, and save lives. While so many things were new about COVID-19, we knew, like with any infectious disease, that vaccine technology would be our best bet for prevention […]
FDA grants full approval to Pfizer’s COVID-19 shot
WASHINGTON — The U.S. has its first fully approved vaccine against COVID-19, with federal health officials announcing Monday the approval of Pfizer-BioNTech’s two-dose vaccine. The green light from the U.S. Food and Drug Administration to move Pfizer’s vaccine from emergency use to full approval is a milestone in the national pandemic response, and one that comes as […]
Troubled Maryland plant told to toss part of the J&J vaccine ingredient it manufactured
WASHINGTON — Federal health regulators have instructed Maryland’s Emergent BioSolutions to scrap some batches of the Johnson & Johnson COVID-19 vaccine substance manufactured at the company’s troubled Baltimore plant, while clearing a small portion to be used in the U.S. or sent abroad. Two batches of the J&J vaccine substance made in Baltimore were deemed “suitable […]