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.
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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.
