Trump pushes for preelection fast-tracked approval of AstraZeneca COVID-19 vaccine: report

President Donald Trump is considering fast-tracking the authorization of AstraZeneca’s COVID-19 vaccine to ensure a jab is available in time for the November election, according to the Financial Times. The mooted plan is to allow AstraZeneca to gain emergency use authorization (EUA) on the basis of a 10,000-subject U.K. clinical trial. 

AstraZeneca, like many other COVID-19 vaccine developers, is enrolling 30,000 subjects to assess the safety and efficacy of its candidate, AZD1222. The scale of the late-phase clinical trials reflects the FDA’s position that sponsors “will likely need to enroll many thousands of participants, including many with medical comorbidities for trials seeking to assess protection against severe COVID-19.”

However, members of the Trump administration including White House chief of staff Mark Meadows and Treasury Secretary Steven Mnuchin have reportedly discussed the prospect of AstraZeneca filing for an EUA once it has results from its 10,000-subject U.K. study. Granting AstraZeneca an EUA on the basis of the U.K. study, rather than making it wait for the larger data set, could enable the U.S. to get a vaccine to some people before the country goes to the polls in November. 

The FDA’s guidance on the development of COVID-19 vaccines leaves the door open for jabs to come to market via EUAs, albeit with caveats that may prevent it from bringing an authorization forward to before the election. 

In the guidance, the FDA warns that granting an EUA to a COVID-19 vaccine “prior to the completion of large randomized clinical efficacy trials could reduce the ability to demonstrate effectiveness of the investigational vaccine in a clinical disease endpoint efficacy trial to support licensure.” However, the FDA said “issuance of an EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or FDA has completed its formal review of the biologics license application.”

FDA Commissioner Stephen Hahn, M.D., expanded on that position in a JAMA publication co-authored with two of his colleagues at the agency. The co-authors reiterated the guidance, adding that the FDA is keen for companies to seek “review for traditional market authorization considering that any vaccine would be intended for widespread use.”

The guidance and JAMA piece predate the ratcheting up of pressure on the FDA. Over the weekend, Trump took to Twitter to claim that “the deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.” As Trump sees it, those elements of the FDA are “obviously” hoping to delay pharmacological interventions until after the election. Trump cited no evidence to support his argument. Developers of COVID-19 vaccines are enrolling subjects and advancing assets at record rates.

One day after slamming the FDA, Trump held a press conference with Hahn to discuss the EUA for convalescent plasma, which had been held up over concerns about the weakness of the evidence of efficacy. Such concerns were absent from the press conference, where Hahn claimed plasma could save the lives of 35 out of every 100 COVID-19 patients on the basis of a post hoc subgroup analysis of data from an observational study.