Novavax again delays US approval request for COVID-19 vaccine

Aug. 5 (Reuters) – Novavax Inc on Thursday again delayed its schedule for applying for US authorization for its two-dose COVID-19 vaccine, but hopes to become a major distributor in low- and middle-income countries this year .

He had previously said he would apply for an Emergency Use Authorization (EUA) from the United States Food and Drug Administration in the third quarter of 2021, but now plans to file in the fourth quarter.

Novavax shares fell about 7% in after-hours trading.

“This is about having validation work done” to demonstrate the consistency of the vaccine manufacturing process at the FDA, CEO Stanley Erck said in an interview with Reuters.

He added that regulators in other countries have been more aggressive in getting Novavax’s vaccine through the authorization process.

The company said it has filed for regulatory clearance for its filming in India, Indonesia and the Philippines.

“Initially, our doses may be prioritized for low-income countries, where we will be able to meet critical unmet demand for primary vaccinations,” Erck said during Novavax’s quarterly investor appeal.

Despite promising clinical data, the Maryland-based company lags behind rival vaccine makers such as Pfizer Inc (PFE.N) and Johnson & Johnson (JNJ.N). It repeatedly delayed regulatory filings and the production ramp-up schedule as it struggled to access the raw materials and equipment needed to produce the vaccine. Read more

Erck said Novavax remains on track to produce 100 million doses per month in the current quarter and 150 million doses by the fourth quarter.

Erck told Reuters the company was on track to submit a regulatory dossier to the UK in September, followed in a few weeks by submissions in Australia and Canada.

Separately, Novavax said that a single booster of its vaccine, given six months after an initial two-dose regimen, caused a 4.6-fold increase in antibodies.

According to Erck, the company will file a separate application for the booster injections with the FDA once its emergency use authorization application is processed.

“We appear to have overcome (some) supply issues and are now able to produce on a large scale,” Erck told Reuters.

Novavax has already manufactured tens of millions of vaccines and is not worried about their expiration before they are approved because the vaccine material is kept frozen, Erck said on the call to investors.

The drugmaker said it had expanded its late-stage US trial to include pediatric patients and recruited more than 2,000 volunteers aged 12 to 17. The two rivals Moderna (MRNA.O) and Pfizer have already launched trials of their vaccines in children under 12.

In May, the FDA cleared the vaccine developed by Pfizer and its German partner BioNTech (22UAy.DE) for use in children aged 12 to 15 while Moderna applied for the use of its vaccine in adolescents is under review.

Novavax reported a net loss of $ 352 million, or $ 4.75 per share, for the second quarter of 2021, well above its net loss of $ 18 million for the same period in 2020. Its revenue from second quarter was $ 298 million.

Reporting by Mrinalika Roy in Bengaluru and Carl O’Donnell in New York; Editing by Lisa Shumaker and Bill Berkrot

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