Will the AstraZeneca vaccine eventually come to the U.S.?

mexico approves astrazeneca vaccine
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  • This story is regularly updated for relevance. Last updated: April 27, 2021

The AstraZeneca vaccine has been approved for use in Mexico and for much of Europe to fight the COVID-19 pandemic, opening the door to production and distribution throughout Latin America—even with indications that the U.S. may not approve the AstraZeneca vaccine as the country heads into spring of 2021. 

According to the New York Times, “AstraZeneca said in August it would work with the Mexican and Argentine governments to produce 150 million initial doses for distribution across Latin America, and later produce at least 400 million doses for the region.” 

In February 2021, there was more good news with the AstraZeneca vaccine as studies showed it had 76% efficacy for three months after only one dose (that rate rose to 82.4% when there was at least a 12-week interval before the second dose). The vaccine also noticeably slowed the spread of COVID-19.

But early clinical trials showed the AstraZeneca wasn’t effective in fighting off the South Africa variant of the coronavirus, and vaccine distribution in that country has been paused.

By mid-March, a number of European countries—including Spain, Germany, and France—had halted the AstraZeneca vaccine because of some potentially deadly blood-clotting issues. But the European Medicines Agency ruled on March 18 that the vaccine is “safe and effective” in its use against COVID-19. A few weeks later, though, European officials said it was “plausible” blood clots could be linked to the vaccine.

On March 29, Canada suspended its use of the vaccine for those under the age of 55 because of blood-clotting concerns. Soon after, Dr. Anthony Fauci said that because the other three vaccines in the U.S. have performed so well, AstraZeneca might not even be needed.

A non-peer-reviewed study released by Oxford University in April, though, showed that a person was eight times more likely to suffer a clot in the brain from COVID-19 than they were from getting the vaccine.

By April, the U.S. said it was ready to share its unused doses with the rest of the world as soon as they cleared safety reviews. The government expects to export as many as 60 million doses.

The vaccine, developed in coordination with Oxford University in England, was previously approved for use in the United Kingdom and Argentina, and India announced its approval on Jan. 3. The AstraZeneca vaccine has less efficacy than either the Pfizer/BioNTech and Moderna vaccines, with 79% efficacy compared to 95% for the two vaccines approved for U.S. use. 

But it does have some advantages that position it to be the predominant coronavirus vaccine around the world, especially in developing nations. The vaccine only costs $3-4 a dose, making it less expensive than the Pfizer and Moderna vaccines. And unlike those two, the AstraZeneca vaccine can be stored safely with normal refrigeration for six months, not requiring the ultra-cold temperatures that the Pfizer and Moderna versions require. 

Moncef Slaoui, who heads the Operation Warp Speed effort to get Americans vaccines, noted in late December that the AstraZeneca vaccine wouldn’t likely be approved for use in the U.S. before April. As Politico wrote, there are “lingering questions about its effectiveness in certain groups.” 

The article explained Slaoui’s perspective: “While the AstraZeneca vaccine appears very effective against severe disease, its efficacy among elderly people is ‘effectively unknown’ because few older people were enrolled early in the trial. He said that remains his biggest question about the company’s shot, given the virus’ impact on elderly people.” 

AstraZeneca reported that its vaccine was up to 90% effective in some trials in November 2020, with an initial half-dose followed by a full dose appearing more effective than two full doses. 

AstraZeneca reportedly will file for emergency use with the FDA in April 2021, but as of this update, that hasn’t happened yet.

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Sources: New York Times, Politico

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