Novavax issues in the West cast a shadow over planned launch in India

Unless one of the Western regulators or the World Health Organization (WHO) approves the Novavax vaccine, the Serum Institute cannot obtain emergency use authorization in India either, the said. manager cited above on condition of anonymity.

Last week, Novavax said it applied for Emergency Use Authorization (EUA) in India, the Philippines and Indonesia through its partner Serum Institute. However, it has delayed filing with the United States Food and Drug Administration and the UK Medicines and Health Products Regulatory Agency (MHRA) for the third time this year, even though six months have passed. since the end of clinical trials. Novavax had planned to file an EUA application in the US and UK by the end of August, but now the timeline has moved to the fourth quarter of this year.

“This timeline is based on several factors,” Novavax chief executive Stan Erck said on an investor call last week. the finalization of our authorization file which is in progress with multiple third parties. “

According to the New York Times which viewed documents filed by Novavax with the Securities Exchange Commission, the company also lost its funding from the US government for the development of the vaccine.

The clinical trial protocol in India filed by the Serum Institute uses the lead candidate Novavax, which has not yet been approved worldwide, as a comparator to verify the safety and immunogenicity of the vaccine.

Unless the main Novavax receives approval, the Serum Institute cannot receive approval in India according to its clinical trial protocol.

In documents filed with the Clinical Trials Registry in India, the Serum Institute said it was conducting a phase 2/3 randomized controlled study in adults over 18 years of age to assess the safety of Covovax (name of Serum brand for the vaccine in India) compared to Novavax -SARS-CoV-2 rS with Matrix-M1 adjuvant and placebo; and for comparison of the immunogenicity of Covovax, it will be compared to the control vaccine of Novavax. The study recruited a total of 1,600 adults.

Serum Institute did not respond to an email asking how it filed for Covovax approval when Novavax had yet to be approved anywhere.

Novavax entered trials late last year, with hopes of adding a more effective covid-19 vaccine to the current pipeline of new platforms such as the mRNA vaccine.

Despite the company’s encouraging Phase 3 trial studies that showed its vaccine to be 92% effective against the Delta variant, the company has faced delays due to manufacturing inconsistencies. “So there has to be negotiations with the US government and do the validation activities meet their standards,” Erck said last week.

He said the company’s delivery of doses to the United States may not officially begin until the first or second quarter of next year.

The company now hopes to use this vaccine as a booster vaccine or as a combination of influenza and covid vaccine.

Serum Institute had planned to manufacture more than a billion doses of Novavax for the Covax facility supported by GAVI; however, this too depends on WHO approval.

In India, where the government aims to deliver more than a billion doses by the end of this year, approval of Novavax is critical.

The Novavax vaccine uses recombinant protein technology to generate an immune response against the SARS Cov2 virus.

The vaccine artificially creates the spike protein, as seen in the coronavirus, and combines it with a bacterial foam with its antigen that evokes an immune response without giving rise to disease. Making the adjuvant is a difficult process to scale up, analysts say.