The former officials say the agency's plan to revamp how vaccines for flu, Covid and other respiratory viruses are handled could put "millions of Americans at high risk from serious infections." ...

The Vaccine Adverse Event Reporting System (VAERS) was established to protect public health. Now it's being used against it.

The FDA vaccine approval road map proposes longer trials and stricter evidence to improve vaccine safety and effectiveness oversight.

Six days after a senior FDA official sent a sweeping internal email claiming that COVID vaccines had caused the deaths of "at ...

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...

FDA Commissioner Martin Makary discusses vaccine policy, COVID-era decisions and the erosion of trust in government health ...

The Food and Drug Administration’s abrupt decision on Wednesday to cancel next month’s vaccine advisory committee meeting — where experts recommend the strains for next season’s flu shot — is raising ...

A strict new vaccine approval process in the U.S. could dramatically slow things down for biopharma and the public, experts ...

Food and Drug Administrator Marty Makary says he has a "moral duty" to inform the public of the risks of the COVID-19 vaccine ...

Former FDA Commissioner Dr. Scott Gottlieb spoke with Margaret Brennan on Face the Nation Sunday about the new vaccine ...

Now you can give yourself a flu vaccine at home. Should you try it? If you have a fear of needles and are nervous about getting the flu shot, you’re not alone. It’s estimated that up to 25% of adults ...