30 Million AstraZeneca COVID Vaccine Doses Sitting in Ohio as Company Awaits FDA Approval

About 30 million doses of the AstraZeneca coronavirus vaccine are sitting idly at its West Chester, Ohio, facility as the British-Swedish pharmaceutical company awaits approval from the U.S. Food and Drug Administration.

According to a report from The New York Times, the batch in Ohio is in its final phase of the process during which the vaccine is placed into vials, and is part of the tens of millions of AstraZeneca doses waiting for a green light from federal health officials.

The company is still waiting for results from its U.S. clinical trials before it applies for an emergency use authorization from the FDA.

In the meantime, the vaccine has been authorized in more than 70 countries, some of which are begging for the White House to ship these doses to places like the European Union or Brazil, where more vaccines are desperately needed—a request the Biden administration has declined thus far.

On Friday, press secretary Jen Psaki confirmed that administration is holding onto as many shots as possible for "maximal flexibility," despite AstraZeneca's pending approval.

This comes a day after President Joe Biden promised that there would be enough vaccine doses for every adult in the U.S. before the end of May. Although Biden is coming close to his goal of 100 million doses months before his first 100 days is up, the administration still has a long road ahead to ensure that the American population will all be vaccinated before the summer.

In a statement sent to Newsweek, an AstraZeneca spokesperson Abigail Bozarth said the doses located in the U.S. are owned by the federal government, which means it would be up to the White House to redistribute the 30 million doses that would be available by the end of March.

"We understand other governments may have reached out to the U.S. Government about donation of AstraZeneca doses and we've asked the U.S. government to give thoughtful consideration to these requests. If those donation actions were to proceed, we would seek guidance from the U.S. Government on replacement of doses for use in the US," Bozarth said.

Bozarth added that the company expects the results of the Phase 3 trial to be available in the coming weeks, which would allow AstraZeneca to quickly file for emergency use authorization with the FDA shortly thereafter.

By the end of April, the pharmaceutical giant expects a total of 50 million vaccine doses to be available in the U.S.

AstraZeneca
A picture taken on March 12 at the Universite Bretagne Occidentale in Brest, France, shows syringes filled with the AstraZeneca COVID-19 vaccine. About 30 million doses of the AstraZeneca vaccine are sitting in an Ohio facility as the company awaits approval from the Food and Drug Administration. Fred Tanneau/AFP

Last May, the former Trump administration pledged up to $1.2 billion to the AstraZeneca to help finance the development and manufacture of its vaccine, striking a deal of 300 million doses for the U.S. if the vaccine proved effective.

However, due to a series of communication mishaps with the pharmaceutical giant, American regulators have been slow to grant approval. The company hesitated to provide the FDA with data last fall after two volunteers suffered serious neurological side effects.

Those who have received the AstraZeneca vaccine in Europe are also now beginning to report severe blood clots after being immunized—a scare that caused authorities in Denmark, Norway and Iceland to suspend the authorization of the vaccine.

Speaking about the nation's total vaccine supply on Wednesday, Biden told supporters, "If we have a surplus, we're going to share it with the rest of the world. We're going to start off making sure Americans are taken care of first."

Approximately 18 percent of the U.S. population has now received at least one dose of a COVID-19 vaccine. So far, three vaccines have been granted an FDA approval: Pfizer, Moderna and Johnson & Johnson, the last which is a one-dose vaccine.

Update 03/12/21 at 5:55 p.m. ET, with comments from Bozarth.