AstraZeneca May Skip EUA Process and Seek Full Vaccine Approval
AstraZeneca (AZ) may forgo seeking Emergency Use Authorization (EUA) from the FDA and instead go for full approval for its COVID-19 vaccine off the bat.
In March, AZ said that it was gearing up to file for FDA emergency authorization “in the coming weeks,” but April has come and gone without a submission. While an EUA filing is not yet off the table, the drugmaker is reportedly now leaning toward filing a Biologics License Application (BLA).
AZ’s two-dose adenovirus-based vaccine was once seen as a contender to receive the FDA’s first authorization for a coronavirus vaccine and to become a key weapon in the U.S. pandemic response. But a number of setbacks have delayed progress in gathering the two-month follow-up data needed to file for emergency clearance, including a lengthy clinical hold over safety concerns (DID, Oct. 26, 2020).
Because of the delays, the company has yet to file an application for an EUA. But the U.S. has stockpiled millions of doses of the vaccine, and the Biden administration has begun sharing them with other countries as the AZ vaccine is not yet authorized for U.S. distribution (DID, April 27).
The British-Swedish company’s vaccine has been authorized elsewhere, including in the EU and the UK, where it has seen heavy use.
The company did not immediately respond to a request for comment on a potential filing for a full approval.
Partners Pfizer and BioNTech on Friday became the first to file an application with the FDA for full approval after accruing the six months of follow-up data required, and Moderna expects to soon follow suit for its vaccine (DID, May 10). Vaccines that are fully approved by the FDA may be marketed directly to consumers. A full agency approval may also help persuade some vaccine-hesitant Americans to get vaccinated, as the approvals are based on longer-term data.
With the outstanding success of the Pfizer/BioNTech and Moderna vaccines, the White House has said it’s not sure how much use the AZ vaccine will see upon an eventual clearance, whether that comes in the form of an EUA or BLA.
Novavax is also experiencing delays in filing for an EUA and will not make its submission until June at the earliest. Reportedly, the company does not expect to have results from its U.S. phase 3 trial until the end of this month.
In other vaccine news, the World Health Organization (WHO) approved the first nonWestern shot for use under COVAX, a program that helps low- and middle-income nations gain access to vaccines, granting an emergency-use listing for a vaccine from China’s Sinopharm. The Beijing-based, state-owned company aims to expand its production capacity to 3 billion doses annually. — James Miessler