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

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

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

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

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

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Global vaccine race

Earlier this month, Russian President Vlimir Putin anunced world’s first clinically approved COVID-19 vaccine which has been manufactured by Gamaleya Research Institute in collaboration with Russian Health Ministry. Amid a global vaccine race, Russia became first country to register a coronavirus vaccine, however, questions were raised over 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 race. Russian Health Minister Mikhail Murashko said that foreign colleagues are sensing specific competitive vants of Russian drug and are trying to express “groundless” doubts.

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