Novavax’s Covid-19 Vaccine Approved by EU
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, dubbed Nuvaxovid, was safe and effective. The European Commission almost immediately granted conditional marketing authorization in the European Union. The approval applies to adults only.
Novavax shares jumped more than 10% after the EMA made its recommendation, but ended the day down 7%.
The endorsement broadens the EU’s Covid-19 vaccine menu to include a technology that is widely used against other diseases, including in some routine childhood immunizations, for example against hepatitis B. The use of a long-established vaccine technology may help overcome concerns among people who have been hesitant to take up shots so far.
Novavax Chief Executive Stanley Erck said the authorization came “during a critical time when we believe having choice among vaccines will lead to increased immunization.”
The shots also can be stored at normal refrigerator temperatures, averting the need for the freezers required for some other Covid-19 vaccines.
The shot’s efficacy against symptomatic Covid-19 in clinical trials was around 90%, said the EMA. It based its recommendation on two large trials that together included more than 45,000 people across the U.S., U.K. and Mexico. The trials were conducted when either the Alpha or Beta variants were dominant, so didn’t measure the shot’s effectiveness against newer strains such as Delta and Omicron.
The recommendation comes within weeks of its endorsement by authorities in Indonesia and the Philippines. It is the fifth vaccine to win the endorsement of the EMA, and the first to use a traditional approach to vaccination.
Other approved shots use genetic material to instruct body cells to manufacture harmless versions of the coronavirus’s spike protein, the part of the virus that enters cells. In contrast, Novavax’s shot comprises of particles that resemble the spike protein itself. It also contains an adjuvant that is designed to enhance the immune response, which is derived from the bark of an evergreen tree native to Chile.
Novavax, based in Gaithersburg, Md., and supported with $1.6 billion from the U.S. government, has yet to seek approval from the Food and Drug Administration because of manufacturing issues that have held up its application. It plans to file for FDA approval by the end of the year. It is already seeking approval in several other countries, including the U.K, Canada and Australia.
The European Commission in August struck a deal with Novavax for 200 million doses of its shot. The company said initial doses would come from the Serum Institute of India, a manufacturing partner, with further doses coming from elsewhere as other sites ramp up.
Separately on Monday, the European Commission said it had agreed to buy a further 200 million doses of the vaccine made by Pfizer Inc. and
bringing the total number of doses slated for delivery next year to 650 million. The 27-nation bloc during 2021 purchased 600 million doses of the Pfizer shot.
Write to Denise Roland at [email protected]
Copyright ©2021 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Appeared in the December 21, 2021, print edition as ‘Novavax’s Shot Gets EU Clearance.’