Novavax’s COVID-19 vaccine approved by the European Union

Novavax Inc’s COVID-19 vaccine was recommended for use by the European Medicines Agency, marking the first endorsement by a major regulator of a shot that uses an established technology.

A scientific committee said the Novavax shot, called Novoxovid, was safe and effective. The European Commission almost immediately granted a conditional marketing authorization in the European Union. Approval applies to adults only.

Novavax shares jumped more than 10% following the EMA’s recommendation before falling. They were down more than 2% as of late morning in New York.

The approval seeks to broaden the EU’s COVID-19 vaccine menu to include a technology that is widely used against other diseases, including some routine childhood vaccinations, for example hepatitis. against B. This can help allay concerns among people who are hesitant to take shots. So far.

Novavax chief executive Stanley Erck said the authorization “came during a critical time when we believe that having the choice between vaccines will lead to increased vaccination.”

Shots can also be stored at normal refrigerator temperature, leaving the freezer required for some other COVID-19 vaccines.

The EMA said the efficacy of the shot against symptomatic COVID-19 in clinical trials was around 90%. It based its recommendation on two large trials that together involved more than 45,000 people in the US, UK and Mexico. The tests were done when either the alpha or beta variants were dominant, so did not measure the shot’s effectiveness against newer strains such as Delta and Omicron.

The recommendation comes within weeks of its endorsement by officials in Indonesia and the Philippines. It is the fifth vaccine to win the EMA’s endorsement, and the first to use a conventional approach to vaccination.

Other approved shots use genetic material to instruct the body’s cells to manufacture harmless versions of the coronavirus’s spike protein, the part of the virus that enters cells. In contrast, Novavax’s shot contains particles that resemble spike proteins. It also contains an adjuvant designed to enhance the immune response, derived from the bark of an evergreen tree native to Chile.

Novavax, based in Gaithersburg, MD, and backed with $1.6 billion from the US government, has yet to receive approval from the Food and Drug Administration due to manufacturing issues, which halted its application. Is. It plans to file for FDA approval by the end of the year. It is already seeking approval in several other countries, including the UK, Canada and Australia.

In August the European Commission struck a deal with Novavax for 200 million doses of its shot. The company said the initial doses would come from Serum Institute of India, which is a manufacturing partner, and the doses would be coming from elsewhere as other sites ramp up.

Separately on Monday, the European Commission said it has agreed to buy another 200 million doses of the vaccine made by Pfizer Inc. and BioNTech SE, bringing the total number of doses for delivery next year to 650 million. The 27-nation bloc purchased 600 million doses of the Pfizer shot during 2021.

This story has been published without modification in text from a wire agency feed