| 19 May 2024, Sunday |

Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says

Novavax Inc expects regulators in India, the Philippines, and other countries to decide on its COVID-19 vaccine within “weeks,” according to its chief executive, after the shot received its first emergency use authorization (EUA) from Indonesia on Monday.

Novavax stock rose about 13% after the company announced that it had applied for emergency use of the vaccine to Canada and the European Medicines Agency.

The shot will be manufactured for Indonesia by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Initial shipments into Indonesia are expected to begin soon, according to Novavax.

The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing, and the company expects that review to be completed in the coming weeks, according to Chief Executive Stanley Erck in a phone interview with Reuters on Monday.

The WHO’s approval would pave the way for Novavax to begin shipping doses to the COVAX program, which provides vaccines to low-income countries. Novavax and SII have pledged to supply more than 1.1 billion doses to COVAX, which is co-led by the WHO.

“I believe we’ll be able to get some doses to COVAX this year,” Erck predicted. “However, I believe (Novavax) will be able to ship large quantities to COVAX in the first quarter” of 2022.

Erck stated that Novavax has resolved all of its manufacturing challenges and does not anticipate any further regulatory concerns about its production processes.

He stated that Novavax is “in dialogue with the United States Food and Drug Administration, and… we anticipate a full submission within the next several weeks.”

Novavax had postponed filing for US approval, and Politico reported last month that the company was experiencing production and quality issues.

SII is authorized to manufacture the Novavax vaccine, and the company said it will apply for regulatory approval for other facilities, such as its Czech Republic plant, in the coming weeks.

  • Reuters