FDA panel recommends Novavax approval

The US Food and Drug Administration's advisory committee has voted to recommend the emergency use of a coronavirus vaccine developed by Novavax.

The panel of independent experts concluded on Tuesday that the benefits of using the American pharmaceutical company's two-dose vaccine outweigh the risks.

The FDA is expected to approve the vaccine soon, which would make it the fourth COVID-19 shot to win clearance for adults aged 18 or older in the United States.

The Novavax shot is what is known as a recombinant protein-based vaccine. It is already authorized in dozens of countries, including Japan.

The advisory panel reported in a meeting on Tuesday that six cases of inflammation of the heart muscle or of the membrane enclosing the heart were identified in participants of clinical trials.

Novavax officials said the rates of the cardiac conditions in people who had been given the vaccine were about the same as those who had received a placebo. They said that a causal relationship could not be established between the vaccine and the conditions, and that the vaccine poses no serious safety concerns.

Some experts noted that studies on the vaccine should continue. But the panel overwhelmingly voted to recommend emergency use authorization for adults.