The Novavax vaccine, backed by Operation Warp Speed, has won its first authorization — in Indonesia.

The New York Times, November 1, 2021

Novavax, a Maryland-based company that received $1.75 billion from the United States government to develop a protein-based Covid-19 vaccine, announced Monday it had won emergency authorization for its vaccine in Indonesia.

After months of production delays, this is the first authorization for Novavax and its manufacturing partner, the Serum Institute of India. They have also applied for clearance in India and the Philippines, and Novavax has applied on its own to other countries, including Britain and Canada.

In its Monday announcement, Novavax said it would be submitting an application to the U.S. Food and Drug Administration by the end of the year.

In a statement, Stanley C. Erck, Novavax’s president and chief executive, said that the green light from Indonesia “is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally.”

Novavax’s vaccine is fundamentally different from the Covid-19 vaccines now authorized in the United States from Johnson & Johnson, Moderna and Pfizer-BioNTech. It consists of microscopic particles studded with viral proteins, mixed with an immune-boosting compound called an adjuvant.

In clinical trials in the United States and elsewhere, Novavax’s vaccine proved highly effective. But the company has struggled to ramp up its manufacturing and demonstrate the purity of its vaccines to regulators.

As a result, Novavax fell behind other vaccine developers supported by Operation Warp Speed, the Trump administration’s program to expedite Covid vaccines, missing the first wave of vaccinations in the United States. If authorized in the United States, Novavax might potentially serve as a booster for people who have gotten other vaccines as their primary doses.

Since last year, Novavax was also expected to make up a large portion of the vaccines that would be distributed globally. In February, it announced an agreement to supply 1.1 billion doses to Covax, an initiative to deliver vaccines to low and middle-income countries. In September, Covax had to cut its projected delivery of doses in 2021 by a quarter, in part because Novavax had yet to win authorization for its vaccine.

Indonesia initially began vaccinating its citizens with vaccines from China, but a bout of breakthrough infections among health care workers raised concerns that their immunity had waned quickly. The country subsequently made deals to secure doses from Novavax, as well as Pfizer-BioNTech, AstraZeneca and Moderna.

Indonesia has secured 320 million total doses through these deals, including 50 million from Novavax. Once those vaccines are delivered, they will be enough for 160 million people in a country of 237 million.

So far, only 43 percent of people in Indonesia have received at least one dose, while almost 27 percent are fully vaccinated.

Winning authorization in Indonesia will not on its own enable Novavax to live up to its promises to Covax. Covax accepts vaccines that have won authorization from the World Health Organization or a country that it recognizes as having stringent regulations. Indonesia is not on that list.