Swiss drug regulator clears use of Novavax's COVID shot in teens & as booster for adults

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Novavax (NASDAQ:NVAX) on Friday said the Swiss drug regulator had expanded its temporary approval of its COVID-19 vaccine for use in teenagers aged 12 through 17 and as a booster dose for adults aged 18 and older.

The clearance came from the Swiss Agency for Therapeutic Products, known as Swissmedic, the Gaithersburg, Md.-based biotech said in a statement.

The approval for the use of the vaccine in teenagers was based on data from an ongoing pediatric expansion of a late-stage trial of more than 2K adolescents in the U.S., NVAX said.

The approval for the use of the vaccine as a booster in adults was based on data from two separate mid-stage trials in Australia and South Africa, and a UK sponsored trial, the company said.

NVAX said its vaccine, called Nuvaxovid, has been granted approval for use in teenagers in the U.S., European Union, UK, Australia, New Zealand, Japan, Thailand, India and South Korea. It has also been authorized as a booster in Japan, Australia and New Zealand.

The European Union and other countries adopted the use of Novavax's (NVAX) vaccine much earlier than the U.S., where regulators cleared the shot only in July.

NVAX stock -4.3% to $30.58 in afternoon trading.