Johnson and Johnson’s single-dose vaccine is poised for approval after U.S. regulators find it protects against COVID-19 and is safe. Get the latest.
Even while the Senate is busy with Donald Trump’s impeachment trial, the House has gotten down to work on a covid relief bill using the budget reconciliation process. Meanwhile, the watchword for covid this week among the public is confusion — over masks, vaccines and just about everything else science-related. Joanne Kenen of Politico, Paige Winfield Cunningham of The Washington Post and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these issues and more. Also this week, the panelists recommend their favorite “health policy valentines” along with their favorite health policy stories they think you should read, too.
The FDA is making rapid COVID tests more accessible.The government is providing $550 million in funding to community-based testing programs na…
"These little distilleries are very small businesses, and some of them can't afford the $14,000 facility fee, especially this year," said Nels Forde, general manager for Yahara Bay Distillers.
The FDA has authorized a second COVID-19 vaccine as the U.S. broke another daily record for new infections.The emergency use authorization of …
The U.S. gave the final go-ahead Friday to Pfizer's COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.
After becoming hotbeds for coronavirus across the country, many universities were forced to shut down in-person classes and turn to online lea…
Regeneron's antibody drug, given to President Trump after he contracted the coronavirus, got an emergency use authorization from the FDA.
It’s pretty easy when you have vaccines that are 95% effective. Can’t get much better than that. I think what people need to appreciate — and that’s why I have said it like maybe 100 times in the last week or two — is the process by which a decision is made. The company looks at the data. I look at the data. Then the company puts the data to the FDA. The FDA will make the decision to do an emergency use authorization or a license application approval. And they have career scientists who are really independent. They’re not beholden to anybody. Then there’s another independent group, the Vaccines and Related Biological Products Advisory Committee. The FDA commissioner has vowed publicly that he will go according to the opinion of the career scientists and the advisory board.
UW Health said it plans to contact participants to provide updates and set up appointments to continue the trial.
The EUA program, established in 2004, gives the U.S. Food and Drug Administration the power to grant temporary, accelerated approval to a medical drug or device needed in a public health emergency. The EUA review process is less rigorous than a regular approval.
A COVID-19 vaccine would need to prevent or decrease the severity of the disease by 50% or more, according to FDA guidelines. FDA Commissioner Stephen Hahn has repeatedly stressed that the agency won’t cut corners.
TRUMP: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” — tweet Saturday.
The FDA is advising consumers not to use hand sanitizer products manufactured by Eskbiochem SA due to the potential presence of a toxic chemical.
The FDA has been working on more stringent guidelines on sunscreen testing and safety for decades. In 2019 the agency proposed what was to be a set of final rules that placed safety testing requirements on manufacturers, a stipulation that had not been in place before.
With many people turning to hand sanitizer to avoid germs when on-the-go during the pandemic, there are some downsides to relying on it too mu…