KEY POINTS

  • AstraZeneca COVID-19 vaccine is not yet approved for use in the U.S.
  • Millions of doses are now stuck at U.S. manufacturing facilities 
  • European and British regulators are not linking to vaccine to the blood clots reported  

The suspension of the AstraZeneca COVID-19 vaccine by a few European nations, citing blood clots in some who received the jabs, has cast a cloud over its usage even as the world is struggling to get vaccines to everyone. So how will this impact the pace of the U.S. vaccination program?

First the most important fact: The reports on the suspension of the vaccine's use are not something that Americans need to lose sleep over, at least for now. The AstraZeneca vaccine is yet to get Food and Drug Administration (FDA) greenlight. In fact, of the seven vaccines that have completed clinical trials, the U.S. has only approved for use just three: Moderna, Pfizer-BioNTech and J&J vaccines. AstraZeneca is yet to apply for FDA approval though it said last week that it plans to seek FDA approval for the vaccine in the next few weeks.

The late-stage clinical trials in the U.S. for the vaccine were suspended last September. That has led to tens of millions of doses of the vaccine produced in the U.S. sitting unused, while scores of countries where it is approved for use still don't have enough doses to go around, the NYT said in a report. The company has said it plans “to deliver roughly 50 million doses instantly to Americans” upon approval.

What are the facts on the reports linking the vaccine to blood clots? Around 5 million Europeans have already received the AstraZeneca vaccine, developed by Oxford University. And its link to the blood clots is yet to be proved. In Britain, where more than 11 million doses of the vaccine have so far been administered, the Medicines and Healthcare products Regulatory Agency (MHRA) said people should still go and get vaccinated.

AstraZeneca's Covid-19 vaccine
AstraZeneca's Covid-19 vaccine AFP / Tiziana FABI

The European Medicines Agency too insisted there is so far no indication that AstraZeneca jabs are linked to blood clots. "The vaccine's benefits continue to outweigh its risks and the vaccine can continue to be administered while the investigation of cases of thromboembolic events is ongoing," it said.

There were reports that a 50-year-old man had died in Italy after developing deep vein thrombosis after administering the vaccine. But Danish Health Minister Magnus Heunicke made clear that the suspension was a "precautionary measure." Iceland too maintained that they were waiting for advice from the European Medicines Agency.

The company has also defended its vaccine. "The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirms the vaccine is generally well-tolerated," AstraZeneca said in a statement.

That said, like Pfizer and Moderna, AstraZeneca has mild side effects, which include a mild cold or flu-like symptoms besides pain at the injection site and fatigue.

The AstraZeneca vaccine remains one of the cheapest now available in the world, in part because the company has pledged not to profit from the vaccine during the pandemic. It also doesn't have to be stored and transported at ultra-low temperatures, which simplifies the logistics of vaccine distribution a lot, especially for developing countries.

Last May, the U.S. agreed to buy 300 million doses of AstraZeneca’s vaccine and had pledged $1 billion to advance the development of antibody-based COVID-19 treatments. And those millions of doses can definitely help in speeding up the U.S. vaccination program. Especially after President Joe Biden said Thursday that he has directed all American adults eligible to receive COVID-19 vaccines should get it no later than May 1. "July 4th with your loved ones is the goal," Biden said.

"If we all do our part, this country will be vaccinated soon, our economy will be on the mend, our kids will be back in school, and we’ll have proven once again that this country can do anything,” he said.

The U.S. has the capability to produce almost 4.7 billion COVID-19 vaccine doses up until the end of 2021, said a Statista report.