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.
Over several hours of discussion on Friday, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on the safety of extra doses.
Pfizer said that data from the United States and Israel suggest that the efficacy of its COVID-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants.
Booster confusion appears to have reached epidemic proportions amid a flood of new scientific studies that are not always consistent with one another. “Fully vaccinated” is suddenly a squishy concept.
President Joe Biden’s plans to start delivery of booster shots by Sept. 20 for most Americans who received the COVID-19 vaccines are facing new complications that could delay the availability of third doses for those who received the Moderna vaccine, administration officials said Friday.
Two former job applicants, aged 55 and 49, filed a proposed class-action lawsuit in U.S. District Court in Indianapolis on Wednesday, accusing the Indianapolis-based drug maker of age discrimination.
If it withstands appeals, the deal will resolve a mountain of 3,000 lawsuits from state and local governments, Native American tribes, unions and others that accuse the company of helping to spark the overdose epidemic.
Last week, U.S. health officials announced plans to give COVID-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the coronavirus.
