Novavax’s newest approvals position it as an mRNA ‘alternative’ that health officials say may convince vaccine skeptics

February 4, 2022, 9:27 AM UTC

A string of countries have approved vaccine maker Novavax’s long-awaited COVID-19 jab in recent weeks, giving their citizens a new vaccine that health officials say could win over people who were dissatisfied with past options.

On Friday, New Zealand became the latest country to approve Novavax’s COVID-19 jab, after the U.K. green-lit the vaccine and a German government panel recommended the vaccine’s approval on Thursday. In the past two months, Novavax’s vaccine has earned approval from the World Health Organization, the European Medicines Agency, Indonesia, the Philippines, India, Australia, and South Korea.

Novavax has earned a legion of grassroots followers who are attracted to the vaccine’s protein-based technology that’s also used in widely distributed jabs like the shot for hepatitis B. Unlike mRNA vaccines that trick the body’s cells into inducing an immune response against COVID-19, Novavax’s protein-based jab carries a non-disease-causing portion of the spike protein that helps the body produce antibodies against the virus. Officials in Australia and Germany say they hope that approving the vaccine will boost their vaccination drives.

“We are pleased if some skeptics are now willing to get vaccinated with Novavax,” Clemens Hoch, a health minister in southwestern Germany, recently told German outlet Tagesschau.

In the U.S., Novavax, based in Gaithersburg, Md., finalized its application to the U.S. Food & Drug Administration (FDA) on Sunday.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley Erck, Novavax CEO, said in a statement about Novavax’s FDA application. He told CNBC recently that Novavax expects the FDA to approve its vaccine this month.

Novavax’s stock price has jumped 17% in the past five days, appearing to get a boost from approvals in the U.K. and New Zealand as well as Novavax’s final application to the FDA.

U.S. approval would mark a full-circle moment for Novavax, which relied on U.S. government funding to develop and manufacture its vaccine.

In July 2020, Novavax received $1.6 billion from the U.S.’s COVID-19 vaccine development initiative called Operation Warp Speed, becoming the program’s largest recipient.

“Today’s $1.6 billion investment supports the Novavax candidate…all the way through to manufacturing 100 million doses for the American people,” Alex Azar, former U.S. Health and Human Services secretary, said at the time.

The investment appeared poised to pay dividends quickly. Novavax announced in January 2021 that its vaccine was up to 90% effective in preventing COVID-19 infections. But despite Novavax’s success in clinical trials, the company struggled to make progress through the spring and summer of last year.

Last fall, multiple outlets including Politico and the New York Times reported that Novavax vaccines produced at U.S. plants were not meeting purity standards. COVID-19 vaccine batches must be 90% pure for the FDA to consider them safe for general distribution and to ensure they’re not contaminated. But Politico reported in October that purity levels in Novavax’s vaccine batches were under 70%, far below what would be needed for FDA approval.

Novavax, for its part, appears confident that it has ironed out its manufacturing processes. Novavax said late last year that it expected to have the capacity to produce 150 million vaccine doses per month by the start of this year. Novavax did not immediately respond to Fortune’s request for comment on its current production capacity.

Novavax is producing its COVID-19 vaccine under two brand names, Nuvaxovid and Covavax. Novavax will market its Nuvaxovid vaccine in the U.S., Europe, South Korea, Australia, and other wealthier economies.

Novavax produces the Covovax version of the vaccine with the Serum Institute of India, the world’s largest vaccine maker by volume, which also manufactures a version of AstraZeneca’s COVID-19 vaccine. The Covavax jab will go to lower- and middle-income countries, in line with the equitable distribution pledge Novavax made as part of its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), a global vaccine development foundation. CEPI has provided $399 million to Novavax since March 2020 to ensure Novavax will follow through on its pledge.

The World Health Organization approved the Covavax vaccine on Dec. 17, opening the door for Novavax to supply the vaccine to COVAX, a global facility aimed at sending vaccines to lower- and middle-income countries.

Novavax and the Serum Institute had previously pledged to supply COVAX with 1.1 billion vaccine doses over an unspecified time frame. It is also unclear how Novavax’s 150 million doses per month capacity will be split between the Covavax and Nuvaxovid brands.

Still, Novavax and the Serum Institute appear to be following through with their commitments.

Since December, Novavax and Serum have shipped millions of Covavax doses to Indonesia and the Philippines because the countries’ governments approved the Covavax doses before the World Health Organization.

Starting this month, the Serum Institute will start shipping 250 million Covavax doses to COVAX for global distribution, Indian media reported this week. The reports said that over 10 million Covavax doses have cleared Indian government quality tests, indicating they are safe for delivery to COVAX.

When the WHO approved Covavax in December, the organization said the action gave “a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.”

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