FDA Grants Full Approval Of Paxlovid To Treat Covid
Pfizer's covid treatment Paxlovid has been used for the past year under FDA emergency use authorization. The Biden administration also announced Thursday that it will continue to provide the drug for free through its stockpile.
AP:
COVID Pill Paxlovid Gets Full FDA Approval After More Than A Year Of Emergency Use
Pfizer received full approval on Thursday for its COVID-19 pill Paxlovid that’s been the go-to treatment against the coronavirus. More than 11 million prescriptions for Paxlovid have been dispensed since the Food and Drug Administration allowed emergency use in late 2021. The emergency status was based on early studies and was intended to be temporary pending follow-up research. The FDA granted full approval for adults with COVID-19 who face high risks of severe disease, which can lead to hospitalization or death. That group typically includes older adults and those with common medical conditions like diabetes, asthma and obesity. (Perrone, 5/25)
CBS News:
Pfizer's Paxlovid Still Free, For Now, After FDA Grants Full Approval To COVID Drug
The Biden administration will continue to manage the distribution of free courses of Pfizer's Paxlovid treatment for COVID-19 for at least another few months, the drugmaker said, even after the Food and Drug Administration granted Pfizer full approval Thursday to market the pills. "At this time, the U.S. government will continue to oversee the distribution of PAXLOVID, and U.S. residents eligible for PAXLOVID will continue to receive the medicine at no charge," Pfizer said in a release. (Tin, 5/25)
BioNTech gives an update on its next covid vaccine —
Reuters:
BioNTech Is Proceeding With COVID-Shot In Line With WHO Guidance
Germany's BioNTech said it was on track to introduce a COVID-19 shot by the early fall in the northern hemisphere that is adapted to currently dominant virus variants in line with recommendations by the World Health Organization. BioNTech was targeting regulatory approval by the end of the summer to allow for a seasonal vaccination campaign to start in early autumn, CEO and co-founder Ugur Sahin told shareholders at the biotech firm's annual general meeting on Thursday. (5/25)
More on vaccines and the spread of covid —
Bangor Daily News:
Court Revives Lawsuit Challenging Maine’s Health Care Worker Vaccine Mandate
A federal appeals court Thursday overturned a judge’s decision to dismiss a lawsuit challenging Gov. Janet Mills’s COVID-19 vaccine mandate for health care workers, according to the Portland Press Herald. A panel of three judges for the 1st U.S. Circuit Court of Appeals unanimously found U.S. District Judge Jon Levy had not properly weighed the possible public health impact of religious exemptions and ordered the lower court to review that portion of the case, according to the Portland newspaper. (5/25)
KFF Health News:
KFF Health News' 'What the Health?': When An Anti-Vaccine Activist Runs For President
How should journalists cover political candidates who make false claims about the safety and effectiveness of vaccines? That question will need to be answered now that noted anti-vaccine activist Robert F. Kennedy Jr. has officially entered the 2024 presidential race. (5/25)
