U.S. gives final clearance to COVID-19 shots for children 5-11
The decision marks the first opportunity for Americans under 12 to get the protection of any COVID-19 vaccine.
The decision marks the first opportunity for Americans under 12 to get the protection of any COVID-19 vaccine.
The purchase will amount to 614,000 doses of two drugs, bamlanivimab and etesevimab, that make up the drug-cocktail infusion, Lilly said.
The compromise would allow Medicare to negotiate some prescription drug prices but significantly scale back Democrats’ earlier ambitions.
Anticipating a green light from vaccine advisers, the Biden administration is assembling and shipping millions of COVID-19 shots for children ages 5-11, the White House said Monday. The first could go into arms by midweek.
The ruling from Senior Judge Sarah Evans Barker also hinted that Congress needs to address the problems with the 340B Drug Pricing Program.
Indiana officials said Wednesday that the state should be able to immediately inoculate a third of children ages 5 to 11 if the federal government gives approval to vaccines for that age group.
Researchers tested the pill used for depression and obsessive-compulsive disorder because it was known to reduce inflammation and looked promising in smaller studies.
The U.S. moved a step closer to expanding COVID-19 vaccinations for millions more children as government advisers on Tuesday endorsed youth-size doses of Pfizer’s shots for 5- to 11-year-olds.
Indianapolis-based Eli Lilly and Co. saw revenue in the third quarter increase 18 percent over the same period of 2020, to $6.77 billion.
The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month.
Preliminary results of a U.S. government-sponsored trial found that mixing coronavirus vaccines produces as much or more antibodies as using the same shot as a booster.
U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing growing worry that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.
The panel of outside advisers to the FDA voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19.
FDA scientists didn’t reach a firm conclusion about whether there’s enough evidence for J&J boosters, citing shortcomings with the company’s data and little information on protection against the extra-contagious delta variant.
On Thursday, advisers are expected to consider data supporting a third shot of Moderna, which would be the equivalent of a half-dose of the original shot. The booster would be administered at least six months after initial vaccination.
On Thursday and Friday, the FDA convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when.
“A cut [in drug prices] like is being proposed would have about a 40% reduction in our U.S. revenues,” Lilly CEO David Ricks said in a television interview this week with Gerry Dick on Inside Indiana Business, a division of IBJ Media.
The company said Tuesday that the treatment, known as AZD7442, would be the first long-acting antibody combination to receive an emergency authorization for COVID-19 prevention.
Catalent plans to expand production at its Bloomington operations by year’s end amid rising demand for its products, including COVID-19 vaccines.
If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major step forward in global efforts to control the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.