Which COVID Vaccine Is Made by AstraZeneca, and Is It Approved in the U.S.?

Multiple COVID vaccines are now rolling out across the U.S., but one brand has been absent despite approvals by other countries.

That vaccine, by British-Swedish pharmaceutical company AstraZeneca and the U.K.'s University of Oxford, is now known simply as COVID-19 Vaccine AstraZeneca, however was formally called AZD1222. Before that, it was titled ChAdOx1 nCov-19.

Like vaccines from Pfizer-BioNTech and Moderna, it stimulates the immune system and causes the body to produce protection against the disease.

The vaccine works by pushing the genetic code of the virus that causes COVID into body cells. A spike protein is then produced. After that, an immune response kickstarts, giving the body a way to recognise—and fight—a future coronavirus infection.

The AstraZeneca vaccine is given via an injection into the upper arm in two doses, with the second dose coming between four and 12 weeks after the first. Like other COVID vaccines it does not contain the virus itself, and won't give people the disease.

According to the University of Oxford's Vaccine Knowledge Project, the AstraZeneca vaccine was tested in over 23,000 people in the U.K., Brazil and South Africa. It is also running a trial with 40,000 people in the U.S., Argentina, Chile, Columbia and Peru.

In a press release on February 3, 2021, AstraZeneca said primary analysis of a Phase III clinical trial from the U.K., Brazil and South Africa confirmed the vaccine was "safe and effective at preventing COVID, with no severe cases and no hospitalizations more than 22 days after the first dose." That trial ultimately had 17,177 participants.

AstraZeneca has said its vaccine can be "transported at normal refrigerated conditions for at least six months, and administered within existing healthcare settings."

Like all vaccines, there are several possible side effects. Uncommon side effects include dizziness, decreased appetite and abdominal pain. Very common side effects include bruising at the injection site, fatigue, nausea, headache or feeling feverish.

The company said it had been granted "marketing authorization or emergency use" in close to 50 countries, including in the EU, India, Morocco and the UK. It was approved for use by the World Health Organization (WHO) and the European Union (EU).

Currently, the U.S is not on that list, despite collaborating to make at least 300 million doses available under the Trump administration's Operation Warp Speed project.

A U.S. clinical trial remains ongoing, although millions of doses are already sitting in the country. Due to the slower confirmation, AstraZeneca has not yet applied for emergency use authorization (EUA) from the U.S. Food and Drug Administration.

The Biden administration has, for now, denied a request to send unused doses to other countries, The New York Times reported, citing a government official.

An AstraZeneca spokesperson told the NYT: "We understand other governments may have reached out to the U.S.... about donation of AstraZeneca doses, and we've asked the U.S. government to give thoughtful consideration to these requests."

On Thursday, the European Medicines Agency (EMA) said it was aware that the Danish Health Authority paused use of AstraZeneca's vaccine as a precaution after reports about blood clots in people who received the vaccine, including one fatal case.

"There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine," it said in a media release.

The FDA has approved three vaccines: Pfizer-BioNTech (December 11, 2020), Moderna (December 18, 2020) and Johnson & Johnson/Janssen (February 27, 2021).

While supplies are still limited, President Biden on Thursday directed all states to make all American adults eligible for COVID vaccines by May 1. That doesn't mean all adults would be vaccinated by that date, but that all would at least be in the waiting line.

The Centers for Disease Control and Prevention (CDC) has said 131,131,470 vaccines were delivered to states as of March 11, with 98,203,893 total doses administered.

AstraZeneca
AstraZeneca vaccine bottles on March 09, 2021 in Bari, Italy. Multiple COVID vaccines are now rolling out across the U.S., but one brand has so far been absent despite approvals by other countries. Getty Images/Donato Fasano