With leading COVID-19 vaccines already in efficacy testing, U.S. authorities are eyeing a possible emergency use authorization for AstraZeneca’s program before the election, the Financial Times reported Monday. But AstraZeneca hasn’t been involved in those talks, and the company says it's too early to speculate about a green light right now.
The British drugmaker “has not discussed emergency use authorization with the U.S. government and it would be premature to speculate on that possibility,” a spokeswoman said by email Tuesday.
AstraZeneca’s vaccine, licensed from the University of Oxford, is in phase 2/3 testing in the U.K., Brazil and South Africa, and the company is also planning a phase 3 trial in the U.S. The company doesn’t “anticipate efficacy results until later this year," she added.
Under AZ’s deal with Operation Warp Speed, unveiled in May, vaccine deliveries were set to begin as early as October. But as of now, AstraZeneca plans to "supply the first doses by the end of 2020 and additional doses in 2021, should it prove effective and tolerated," the company's spokeswoman said.
The developments add to a stream of headlines and speculation about whether a COVID-19 vaccine will be available in the U.S. before the November 3 election. President Donald Trump and allies see a vaccine as key to his re-election prospects, and some experts worry the administration will rush a vaccine to market before adequate safety and efficacy testing. Fears of such an “October surprise” surfaced in June.
The president's own statements haven't helped calm worries about a hasty approval or emergency authorization. On Saturday, he accused the FDA of harboring "deep state" employees who are undermining the administration's fight against the pandemic. The next day, the agency issued an emergency use authorization for convalescent plasma, touching off a separate controversy.
All of the news has startled Democratic leaders of the House Committee on Energy and Commerce. They wrote to FDA Commissioner Stephen Hahn Monday that they're “gravely concerned” about recent statements from Trump and other officials directed at the FDA.
“As FDA Commissioner, it is your responsibility to lead and defend the agency, yet when the President and his Chief of Staff accused the FDA of being part of the 'deep state' you remained silent,” the lawmakers wrote.
They're requesting Hahn answer questions about the agency's plans for COVID-19 vaccine reviews and how the agency will resist political pressure.