Valneva Seeks Covid Vaccine Approval On AstraZeneca Head-To-Head Data Alone
UK Is Pioneering ‘Correlates Of Protection’ Study
The partnership between Valneva and the UK government could produce the first COVID vaccine approval based on immunogenicity data.
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In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.
Accelerated approval might soon be in the cards for COVID-19 vaccines if an immune correlate of protection can be identified through ongoing work by FDA and NIH. Meanwhile, to speed more vaccines to Americans, FDA is trying to help ramp up manufacturing. Sanofi is set to commence a Phase IIb trial with an active comparator.
Pfizer has unveiled promising results from a study of Xeljanz but needs a bigger trial. Given RECOVERY’s track record, the pharma company may opt to wait for its results.