AstraZeneca still eyes US vaccine filing despite another delay

 

• AstraZeneca confirmed on Thursday plans to seek a standard approval of its coronavirus vaccine Vaxzevria in the U.S., and not an emergency use authorization — a speedier path to market — as originally intended. 
• AstraZeneca reported positive results from a Phase 3 trial in the U.S. in March and executives later said the company would seek an emergency clearance "in the coming weeks." But the timing for that application has slipped due to requests from U.S. regulators for more real-world data. The company now plans to file for full approval before the end of 2021, according to an earnings release. 
• Despite its problems getting to market in the U.S., Vaxzevria is approved in more than 50 countries and is a key contributor to the international vaccine alliance COVAX, which is helping to secure shots for nations that can't afford them. The vaccine generated $894 million in sales for AstraZeneca in the second quarter, more than tripling its total from the first three months of the year. 

The latest delay for AstraZeneca's vaccine in the U.S. doesn't necessarily come as a surprise. A report in April suggested the company might bypass an emergency clearance since the Food and Drug Administration was closely scrutinizing data from multiple large trials as well as real-world use. 

Nonetheless, the company's admission is the latest chapter in what's become a long-running saga. Once a frontrunner in the U.S. and a recipient of one of the largest supply contracts for the Operation Warp Speed coronavirus vaccine initiative, AstraZeneca's progress has slowed due to a lengthy trial halt and multiple setbacks abroad, among them a link between its vaccine and a very rare side effect that temporarily stymied the shot's rollout in several European countries. 

The company also got into an unusual public spat with a trial monitoring board in the U.S. over the results from its Phase 3 trial. 

U.S. regulators, in the meantime, authorized vaccines from Pfizer, Moderna and Johnson & Johnson. The federal government has since stockpiled enough doses of each of them to cover the population, rendering AstraZeneca's shot an afterthought in the nation's immunization campaign.  

And yet, through it all AstraZeneca's shot has still proven strongly protective against severe disease from COVID-19, a benefit that's held up both in clinical testing and beyond. Most recently, a preprint of a U.K. study showed the shot offered 92% protection against the worst outcomes from the fast-spreading delta variant.  

The company still intends to push forward in the U.S., both with its original shot as well as a new shot tailored to a particularly evasive variant known as beta. That shot is currently in Phase 2/3 testing, with results expected by the end of the year, the company disclosed Wednesday.   

But AstraZeneca's plans as a vaccine developer beyond that are unclear. In an interview with Reuters on Wednesday, Ruud Dobber, the executive vice president of AstraZeneca's biopharmaceuticals business division, said the company is "exploring different options" for the vaccine business and could come to a decision on its future by the end of the year. Prior to the pandemic, AstraZeneca had never developed or sold a vaccine, and Vaxzevria was licensed from the University of Oxford, not created in-house. 

Pressed about the report on an earnings call, AstraZeneca CEO Pascal Soriot argued Dobber "may have been misquoted." 

"We of course are going to look forward, but we haven't got any specific timeline for this," Soriot said. "We've been so busy working on delivering the orders we've got and working on the new variant options ... that our priority hasn't been to look at what we're going to do going forward."

Vaxzevria has been one of AstraZeneca's top-selling products in 2021, so far generating about $1.2 billion in sales. That figure is still well behind the likes of Pfizer and Moderna, which have projected more than $33 billion and $19 billion, respectively, in full-year sales of their vaccines. 

AstraZeneca, however, is the only one of the three to vow not to profit from vaccine sales during the pandemic. 

https://www.biopharmadive.com/news/astrazeneca-coronavirus-vaccine-us-filing-plans/604139/