Friday, October 15, 2021

With demand uncertain and its U.S. manufacturing in limbo, AstraZeneca still aims to seek FDA nod for COVID-19 vaccine


Its COVID-19 vaccine has been vilified and its manufacturing network has been questioned, but AstraZeneca is still planning to apply for emergency use authorization of its shot in the U.S., a company spokesman confirmed.

A month ago, after AZ said its vaccine succeeded in phase 3 testing, an AstraZeneca executive said the company would apply for an emergency nod in America in the first half of April.

“Assuming that the approval will take place in a fast way, we hope to deliver 30 million doses instantly,” Ruud Dobber, vice president of AstraZeneca’s biopharmaceuticals business unit, told CNBC. 

The company’s early April timeline has passed, but a spokesman on Wednesday said the company is still “progressing submission to the FDA.”

The shot has been plagued by safety concerns in Europe, where more than 100 cases of rare and severe blood clots have been reported with at least 37 fatalities. After an investigation, drug regulators there endorsed the shot with a safety warning about rare, serious blood clots.

The vaccine’s reputation took another hit in the U.S. last month, when federal officials took the unusual step of publicly questioning the company’s data. At first, AZ said the shot was 79% effective in a phase 3 trial. Days later, the company reduced the figure to 76%. While the numbers aren’t far apart, the episode placed yet another spotlight on the company’s handling of its vaccine program.

With COVID-19 vaccines from Pfizer-BioNTech and Moderna suffering no safety concerns and rapidly supplying demand in the U.S., medical experts in America have expressed doubt that the AZ shot will ever be used here. In recent days, officials have noticed that supply is starting to outstrip demand in some parts of the country.

“We already have contracted for enough vaccines,” Centers for Disease Control and Prevention chief Anthony Fauci, M.D., told CNN on April 9. “There is no plan to immediately start utilizing the AstraZeneca (vaccine), even if it gets approved through the EUA, which it very well might.”

RELATED: AstraZeneca scrambles to update COVID-19 vaccine data after NIH flags ‘concerns’ 

Other U.S. experts expressed hope that AZ would not apply for authorization.

“This vaccine has a checkered past,” a medical adviser told CNN. “There’s baggage. Why go down that road if we don’t have to?”

But if going down that road yields an endorsement from the U.S., it could help boost the damaged reputation of the shot. Much of the world, especially poorer nations, are in dire need of vaccines and global demand is expected to extend into the next few years at least.

In addition, the shot has a key advantage over its mRNA rivals––its lower price, which makes it particularly attractive to developing nations.

RELATED: AstraZeneca COVID-19 shot tagged with new warning in EU, highlighting rare blood clot risk

Meanwhile, AstraZeneca’s U.S. drug substance production remains an uncertainty. After AZ’s production partner Emergent BioSolutions ruined up to 15 million doses of a rival vaccine from Johnson & Johnson in a plant mix-up, the feds put J&J in charge of the site. The site is now set to exclusively produce J&J vaccine material, forcing AstraZeneca to search for another partner. AstraZeneca said in early April that it would work with the government to locate new capacity, but the company so far has not provided an update on that front.



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