In A Setback To Global Vaccine Drive, Novavax Reports Further Delays In Approval And Production Of Covid-19 Vaccine

Novavax on Monday (May 10) announced that it does not expect to seek regulatory authorisation for its vaccine in the United States, Britain and Europe until the third quarter of 2021 and will not be able to scale peak production until the end of the year.

Novavax is expected to play a critical role in ramping up global vaccination efforts especially in countries such as India. Novavax has a deal with Gavi, a public-private global vaccine partnership, to supply 1.1 billion doses of its shot to low- and middle-income countries.

The biotechnology company said that it intends to file for authorization with the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) in Europe in the third quarter of 2021. The company had previously targeted the second quarter for regulatory filings.

The Maryland-based company, which received grants up to $1.6 billion under Operation Warp Speed and whose vaccine demonstrated robust results in clinical trials, has struggled to access raw materials and equipment needed to make its vaccine.

In January, Novavax reported that its vaccine NVX-COV2373,was about 90% effective in a phase 3 study involving 15,000 patients in the U.K.

The company's production ambitions has been hit by shortages of raw materials, such as 2,000-liter plastic bags used to grow cells for vaccine production. This has cut the company’s expected production numbers by about half.

Novavax said it does not expect to hit its production target of 150 million shots per month until the fourth quarter of 2021, later than its previous forecast of sometime in the third quarter.

“We know that we are delayed from where we thought we would be at this point. Now we’re giving guidance that nearly all of the major challenges have been overcome,” said Novavax CEO Stanley Erck Monday afternoon during the company’s first-quarter earnings call.

“Although demand in the US has clearly been met by the mRNA vaccines, demand outside the U.S. remains very high and the company remains in communications with governments that want vaccine now and for 2022,” wrote Jefferies analyst Kelechi Chikere in a note to investors Monday night.

Novavax has a commercial arrangement with Serum Institute of India to manufacture and distribute 750 million doses to low- and middle-income countries.

In March , SII had announced that the launch of the Covid-19 vaccine Covovax developed jointly by the company and Novavax is likely to be delayed to September in the country.

The ICMR and SII are jointly performing a phase-2/3 observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covovax in Indian adults.