US-based Novavax expects filing for COVID-19 vaccine approval in December: Report

An American vaccine development company Novavax Inc expects to file for approval of its COVID-19 vaccine candidate in the United States in December 2020. Novavax chief executive Stanley Erck told Czech daily Hospodarske Noviny that the firm plans to produce part of the vaccine at its Czech plant which will give the European nation access to it once it receives approval.

The biotechnology company said on August 24 that it has started enrolling first volunteers for the second phase of its ongoing clinical trial. The Phase 2 clinical trial of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, expands on age group by including older people of 60-84 years of age and the company expects interim data from this trial in the fourth quarter.

“We expect this Phase 2 portion of the trial to expand on the encouraging Phase 1 safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults,” Gregory M. Glenn, M.D. at Novavax, said in a statement.

Novavax said that the second phase of the ongoing clinical trial is a randomised, placebo-controlled, observer-blinded study to evaluate the safety and efficacy of the vaccine candidate. The company has planned to enrol up to 1,500 healthy volunteers, with approximately 50 per cent of participants over the age of 60.

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Read: Russia Announces Advanced Trials For Its COVID-19 Vaccine, Invites Volunteers

Global vaccine race

Earlier this month, Russian President Vladimir Putin announced the world’s first clinically approved COVID-19 vaccine which has been manufactured by the Gamaleya Research Institute in collaboration with the Russian Health Ministry. Amid a global vaccine race, Russia became the first country to register a coronavirus vaccine, however, questions were raised over the decision to approve a vaccine before Phase 3 trials.

US Health Secretary Alex Azar told a news conference that it is more essential to have a safe and effective COVID-19 vaccine than acing the race. Russian Health Minister Mikhail Murashko said that foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express “groundless” doubts.

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