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Before the FDA can authorize the shots, it would need to sign off on Novavax’s manufacturing process, which has stumbled again and again over the course of two years. → Read More
In the middle of last year, the World Health Organization began promoting an ambitious goal, one it said was essential for ending the pandemic: fully vaccinate 70 percent of the population in every country against COVID-19 by June 2022. → Read More
With COVID-19 treatments still in short supply in the United States, the Food and Drug Administration on Friday gave emergency authorization to a new monoclonal antibody drug that has been found in the laboratory to be potent against the Omicron variant of the coronavirus. → Read More
At the onset of the coronavirus pandemic in 2020, scarce ventilators and protective equipment faced strict rationing. Today, as the pandemic rages into its third year, another precious category of products is coming under tight controls: treatments to stave off severe COVID-19. → Read More
Expert advisers to the Centers for Disease Control and Prevention will meet Thursday to discuss what federal health officials see as a concerning increase in the rates of a rare but serious blood-clotting disorder linked to Johnson & Johnson’s coronavirus vaccine. → Read More
The Biden administration plans to pay more than $5 billion for a stockpile of Pfizer’s new COVID-19 pill, enough for about 10 million courses of treatment to be delivered in the next 10 months, according to people familiar with the agreement. → Read More
The National Institutes of Health is prepared to aggressively defend its assertion that its scientists helped invent a crucial component of the Moderna coronavirus vaccine — including taking legal action if government lawyers deem it necessary, the agency’s director, Dr. Francis Collins, said. → Read More
Cambridge-based Moderna, whose coronavirus vaccine appears to be the world’s best defense against COVID-19, has been supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting and earning billions in profit. → Read More
Two months before the Food and Drug Administration’s deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked. → Read More
The Food and Drug Administration on Wednesday authorized a monoclonal antibody drug developed by GlaxoSmithKline and Vir as the third treatment of its kind cleared to help keep high-risk COVID patients out of the hospital. → Read More
Sanofi, the French pharmaceutical company, said Monday that it would move the experimental COVID-19 vaccine it is developing with GlaxoSmithKline into a late-stage trial after the shot produced strong immune responses in volunteers in a mid-stage study. → Read More
President Biden and drugmakers are facing demands from liberal activists and global leaders to suspend intellectual property rights on the vaccines as the pandemic surges. → Read More
More than 5 million people, or nearly 8% of those who got a first shot of the Pfizer or Moderna vaccines, have missed their second doses, according to the most recent data from the Centers for Disease Control and Prevention. → Read More
The letter by US officials is an extraordinary blow to the credibility of a company whose product has been seen as critical to the global fight against the pandemic. → Read More
The fate of those doses of AstraZeneca’s vaccine is the subject of an intense debate among White House and federal health officials, with some arguing the administration should let them go abroad where they are desperately needed, while others are not ready to relinquish them, according to senior administration officials. → Read More
South Africa halted use of the AstraZeneca-Oxford coronavirus vaccine Sunday after evidence emerged that the vaccine did not protect clinical trial volunteers from mild or moderate illness caused by the more contagious virus variant that was first seen there. → Read More
As governments around the world rush to vaccinate their citizens against the surging coronavirus, scientists are locked in a heated debate over a surprising question: Is it wisest to hold back the second doses everyone will need, or to give as many people as possible an inoculation now — and push back the second doses until later? → Read More
Logistical problems in clinics across the country have put the campaign to vaccinate the United States against COVID-19 far behind schedule in its third week, raising fears about how quickly the country will be able to tame the epidemic. → Read More
CVS has reached a deal with the federal government to give out a COVID-19 antibody treatment in patients’ homes and long-term care facilities, the pharmacy chain announced Wednesday, providing a new way for certain high-risk patients to get a drug aimed at keeping them out of the hospital. → Read More
This week, we discuss two high-profile pauses to Covid-19 clinical trials and explain why experts say they offer more good news than bad. → Read More