AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments

After missing the boat for emergency use of COVID-19 vaccines, AstraZeneca has finally pulled the plug on efforts to sell its shot in the U.S. 

AstraZeneca has decided to withdraw its application for COVID vaccine Vaxzevria with the FDA, CEO Pascal Soriot told reporters during a press briefing Thursday. The U.S. market is already well supplied, and the demand for vaccines is declining, Soriot said.

Because the FDA has already fully approved mRNA vaccines from Pfizer/BioNTech and Moderna, the agency’s emergency use authorization pathway for other vaccines is closed. Given the two mRNA shots have already become entrenched players in the U.S., there’s little room left for Vaxzevria in the market.

In the third quarter, Vaxzevria booked no U.S. sales, and its global revenue decreased sharply—by 83%—to just $173 million. Meanwhile, Moderna recorded $3.12 billion revenue for its COVID shot Spikevax, down 35% year over year. And the mRNA specialist cut its full-year sales guidance from $21 billion to a range of $18 billion to $19 billion.

By comparison, Pfizer’s Comirnaty brought in $4.4 billion revenue during the same period, also down 66% year over year. While Pfizer dialed up its 2022 Comirnaty revenue projection by $2 billion to $34 billion, analysts argued that the strong performance won’t last long because of a lack of interest in boosters. 

After AZ’s vaccine decision in the U.S., the company’s anti-COVID efforts are shifting to its long-acting antibody combo drug Evusheld, Soriot said. Evusheld is currently authorized to prevent COVID in immunocompromised people in the U.S. and is cleared in Europe both as a preexposure prophylactic and as a treatment. In the third quarter, Evusheld reeled in $536 million in revenue, bringing its total so far this year to $1.45 billion.

But Evusheld shares the same problem as other COVID antibodies—it has started to lose power against some coronavirus variants. Last month, the FDA warned the public of increased risk for developing COVID in those exposed to certain variants not neutralized by Evusheld. These include the emerging omicron subvariant BA.4.6, which has shown greater than 1,000-fold reduction in susceptibility to Evusheld in lab studies.

AZ is working to update Evusheld, Soriot said. Based on a “good, productive relationship” with the FDA, the company hopes to introduce Evusheld 2.0 by the second half of 2023, the CEO said.

All told, AZ’s third-quarter revenue jumped 19% at constant currencies to $11 billion, fueled by growth from all disease areas.

Like many Big Pharma companies that report in U.S. dollars, AZ’s numbers are negatively affected by foreign exchange rates. On a reported basis, AZ’s revenue growth was 11%. If the U.S. dollar remains as strong as it was at the end of October, AZ projects its full-year revenue would take a mid-single-digit percentage point hit.