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.
The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said he hoped the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”
President Joe Biden stepped up his battle over drug costs on Thursday, calling on Congress to pass legislation that would let Medicare negotiate directly with pharmaceutical manufacturers and penalize drugmakers that increase prices faster than inflation.
Shares of the Greenfield-based maker of animal feeds and vaccines dove after the firm warned that it’s facing inflationary pressures, increased logistics costs and other headwinds.
Eli Lilly and Co. turned in a profitable second quarter, but the results were shy of Wall Street analyst predictions. The drugmaker, however, saw revenue growth that topped Wall Street expectations.
Eli Lilly and Co. passed up the chance to develop a vaccine and instead focused on making antibody treatments for patients who were already infected with the coronavirus. That turned out to be a financial whiff. Now all eyes will be on Lilly’s second-quarter earnings, which the company will release early Tuesday.
A federal official predicted that authorization of a coronavirus vaccine for children 5 through 11 might come by late October or early November.
Local governments currently litigating, such as Indianapolis, were provided the ability to opt out of the state’s opioid plan. Those local governments have the opportunity to opt back in within 60 days of opting out, according to the attorney general’s office.
The national settlement is expected to be the biggest single settlement in the complicated universe of litigation over the opioid epidemic in the United States. It won’t end the cases, but it would change them.
Even as some drugmakers, including Indianapolis-based Eli Lilly and Co., are pushing to get experimental drugs approved, federal regulators are still dealing with a huge blowback over the controversial way they reviewed a new Alzheimer’s drug by rival Biogen.
A new report submitted to the Indiana Legislative Council calls for the regulation of “white bagging,” a practice that requires hospitals to buy drugs from an outside pharmacy, which delivers them premixed ahead of time of the patient’s visit. It is a growing practice, aimed at lowering the cost of care, but many providers say it can compromise care.
The company said it was scheduled to have the meeting with the Food and Drug Administration and other officials Monday, days after Pfizer asserted that booster shots would be needed within 12 months.
The narrower label means the drug might be offered to 1 million or 2 million Alzheimer’s patients, rather than the more than 6 million people with Alzheimer’s in the United States.
The collaboration could be worth as much as $694 million and potential royalties to Verge Genomics if the two companies hit development milestones.
