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

Since the COVID-19 pandemic, there has been a decline in U.S. vaccine uptake, while widespread misinformation and distrust make it challenging to craft effective public health responses.

President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could spell major changes in what is required to get regulatory approval for immunizations.

Details aren't yet public but the plan is being overseen by the agency's new vaccine chief, Dr. Vinay Prasad, an outspoken critic of FDA's handling of COVID-19 boosters. Makary and other Trump administration officials already have taken unprecedented steps ...

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 GOP-led House Judiciary Committee is requesting records from Pfizer’s CEO and an interview with a former company executive to investigate an allegation that clinical testing related to the development of the company’s Covid-19 vaccine was purposefully delayed until after the 2020 presidential election.

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.