The U.S. Food and Drug Administration approved Novavax's COVIDd-19 vaccine with age restrictions after a six-week delay.

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump administration has introduced uncertainty into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.

The House Judiciary Committee revealed Thursday that Pfizer’s former Global Head of Vaccines Research and Development, Dr. Philip Dormitzer, may have “conspired to withhold public

Another Breakthrough Summit West in the books, and what an excellent event! We kicked off the day with former FDA head Robert Califf, who stopped by to tell attendees how health secretary Robert F. Kennedy’s hesitance to endorse vaccines is harming the American public.

A new report says Health and Human Services Secretary Robert F. Kennedy Jr. will roll back current CDC guidance on COVID vaccinations for pregnant women and children.

HHS Secretary Robert F. Kennedy Jr. plans to remove CDC recommendations for COVID-19 vaccination in pregnant women and children. Come the fall, it may just be older adults and people with comorbidities who are urged to get a COVID shot. ( Wall Street Journal via MSN, New York Times)

The World Health Organization (WHO) Technical Advisory Group on COVID-19 vaccine composition, after meeting earlier this month, today released its recommendations for updated vaccines, which say the current monovalent JN.1 or KP.2 strains are still appropriate, but monovalent LP.8.1 is a suitable alternative.

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for vaccines.