The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.

Late-stage trial data suggest that a new COVID-flu vaccine offers good protection against both infections, but experts expect the shot's approval may be delayed.

WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.

The rising coronavirus cases once again in many parts of the world, especially in Asian countries (such as Hong Kong and Singapore), have raised concerns for health experts. Recent reports show that there has been a sharp increase in coronavirus cases here for the last few weeks.

The pharma company secured FDA clearance to manufacture and distribute its COVID-19 vaccine Nuvaxovid for adults and at-risk groups, with no advisory committee hurdles.

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.

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad said based on data from tests that measure immune response in patients, they anticipate that the FDA will be able to approve the boosters for adults over the age of 65 years.