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Novavax CEO anticipates filing COVID-19 vaccine for approval in December

Pfizer also announces over 50% enrolment in COVID-19 vaccine trial

Novavax CEO Stanley Erck has said that the company is aiming to file its COVID-19 vaccine for approval by December in the US.

In an interview with Czech daily Hospodarske Noviny newspaper, Erck said the company also plans to produce part of its potential vaccine at its Czech plant.

Novavax has already started enrolment for the phase 2 portion of its ongoing phase 1/2 clinical trial evaluating the immunogenicity and safety of its vaccine candidate NVXCoV2373.

The phase 2 arm of the clinical trial programme expands on the age range included in the phase 1 portion, with older adults aged 60-84 years making up approximately 50% of the trial’s population.

The trial will evaluate Novavax’s vaccine with its Matrix-M adjuvant, with the vaccine due to be tested at two doses (5µg and 25µg) alongside 50µg of Matrix-M respectively.

Pfizer confirms over 50% enrolment in vaccine trial

Meanwhile, Pfizer has confirmed that enrolment in its 30,000 participant US-based clinical trial is over 50% complete.

Nicholas Kitchin, a Pfizer vaccine research and development scientist, revealed the enrolment status of the BioNTech-partnered study at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting yesterday.

Last Friday, Pfizer and BioNTech revealed plans to potentially seek regulatory approval for their lead mRNA-based vaccine candidate, BNT162b2, by October this year. The companies added that 11,000 participants have already been dosed with the vaccine, as of 21 August.

Pfizer/BioNTech plan to enrol 30,000 participants into the phase 2/3 efficacy and safety trial, which is actively enrolling in the US, Argentina and Brazil, with further planned enrolment in Germany, Turkey and South Africa.

If all goes to plan in this study, the companies have said they are on track to file for regulatory review for BNT162b2 as early as October and plan to supply up to 100 million doses globally by the end of the year if approval is obtained.

Article by
Lucy Parsons

27th August 2020

From: Research



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