US FDA Should Take Its Time With COVID Vaccine BLAs
Agency is pledging to act well ahead of the six-month review deadline in reviewing full applications for COVID 19 vaccines that are already authorized for emergency use. Going too fast may be counterproductive, in more ways than one.
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There is an old adage that FDA only has two speeds: too fast and too slow. Recent pushback on neurology reviews and Covid vaccines show that paradox – but also the flaw of treating contradictory criticism as a sign that everything is actually fine.
A study indicates that the Delta variant of SARS-CoV-2 and its sub-lineage Delta Plus can be neutralized by Bharat Biotech’s COVID-19 vaccine, but a federal investigation in Brazil and a class action suit against its US partner have hurt the firm’s global ambitions. Experts weigh in on what the future could possibly hold.
Dosing is capped under emergency use authorizations, but studies show reduced antibody response following primary vaccination series in individuals with compromised immune systems; although BLA approval could allow for off-label prescribing, government officials are exploring other regulatory options for earlier access, including through a study.