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October 27, 2021

Coronavirus company news summary – FDA panel recommends EUA expansion for Pfizer/BioNTech jab in children aged five to 12 – Vaxart begins world-first Phase II trial of Covid-19 oral tablet vaccine

By Chris Lo

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) has recommended granting Emergency Use Authorization (EUA) to Pfizer and BioNTech’s Covid-19 vaccine in children aged five to 12. The panel reviewed all evidence submitted by the companies, including data from a controlled, randomised Phase II/III clinical trial that saw enrolment of nearly 4,500 children of the same age group. The FDA is expected to make a decision on expanding the vaccine’s EUA in the days to come.

Vaxart has dosed the first patient in a Phase II clinical trial of its oral tablet vaccine for Covid-19. The first part of this trial plans to enrol 96 participants at four centres in the US. The US portion of the trial is an open-label randomised dose and age escalation lead-in segment. It will feature untreated as well as previously vaccinated subjects. On concluding this part, the company will commence a global, placebo-controlled efficacy trial recruiting more subjects. Vaxart plans to report complete results from the US trial in the first quarter of 2022.

The Technical Advisory Group (TAG) of the World Health Organisation (WHO) has sought further clarifications from Indian firm Bharat Biotech for its Covid-19 vaccine, Covaxin, to complete a final risk/benefit analysis for Emergency Use Listing (EUL), PTI reported. The panel will conduct a final analysis on 3 November this year on obtaining the data. On 19 April, Bharat Biotech filed an Expression of Interest to the WHO for the vaccine’s EUL. The vaccine showed a 77.8% efficiency against symptomatic Covid-19.

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