FDA could reject AstraZeneca’s COVID vaccine on efficacy and manufacturing shortfalls: analyst

It was bad enough when a study released last week concluded that AstraZeneca’s COVID-19 vaccine was largely ineffective against the aggressive B.1.351 variant that recently emerged in South Africa. Now, analysts are wondering whether inconsistent manufacturing of the vaccine for the clinical trials may have muddied the results—concerns that could give the FDA pause when considering the vaccine for emergency use. That was the conclusion of a note SVB Leerink analysts sent to clients Wednesday, in which they laid out both the bear and bull cases for FDA authorization of AstraZeneca’s COVID vaccine. The bottom line? The bear case is worrisome, they said. One major concern SVB Leerink cited is that AstraZeneca is manufacturing its vaccine on a “distributed” basis, meaning it’s not centralized, but spread over multiple sites and contract partners. The material used to make the vaccine for the South Africa trial came from a company in India, and it’s not clear where it was manufactured or whether the results from that trial truly reflect the properties of the vaccine that’s being developed for the U.S.