There were three new developments surrounding the AstraZeneca COVID-19 vaccine. This vaccine has had more twists and turns than all the other COVID-19 vaccines combined. There have been problems with its clinical trials, questions concerning its efficacy, and regulatory suspensions in its use because of potential side effects, particularly blood clots.
Today, the European Union’s medicines regulator has concluded its review of the Oxford-AstraZeneca Covid-19 vaccine and concluded it is safe to use. The use of the vaccine was stopped by 14 E.U. countries after reports that it could be linked to blood clots. The European Medicines Agency’s (EMA) executive director Emer Cooke said the agency had “come to a clear scientific conclusion: this is a safe and effective vaccine.”
Cooke said the Agency could not rule out definitively a link to a rare blood clotting disorder, of which seven cases have been reported out of several million doses given. She said the benefits of using the vaccine outweighed the risk.
One of the countries that has not approved the AZ vaccine is the United States. In fact, the data from the AZ vaccine trials in the United States have not even been released. Given this, it may be awhile before this vaccine is approved in the United States.
Since the U.S. is using the three approved vaccines, we have no current need for the AZ vaccine. Today, President Biden announced the United States plans to send millions of doses of the AstraZeneca vaccine to Mexico and Canada; a loan of vaccine that might curry favor with Mexico to help with the migrant crisis.
Jen Psaki, White House press secretary, said the US would share 2.5 million doses of the vaccine with Mexico and 1.5 million doses with Canada. The vaccine is manufactured at several sites around the globe including in the US. Since it is not used here, tens of millions of AZ vaccine doses have been sitting at American manufacturing sites. It is expected that in exchange for this loan the United States will receive doses of AstraZeneca, or other vaccines, in the future.
I think this may also suggest that AZ may never apply for approval of their vaccine in the United States. The US will have adequate doses of the three approved vaccines for all adults, so it might be best if the AZ vaccine goes where the need is the greatest.
Unfortunately, AstraZeneca also received some very bad news from an article in the New England Journal of Medicine that reported it does not protect against the South African variant of the coronavirus. In response, South Africa halted use of the AstraZeneca-Oxford coronavirus vaccine since the vaccine did not protect clinical trial volunteers from even mild or moderate illness caused by the more contagious virus variant.
The findings were a devastating blow to South Africa which had planned to use the vaccine extensively. The B.1.351 variant has spread to at least 32 countries, including the United States.
Fortunately, the other SARS-CoV-2 vaccines currently in use do appear to be effective against this variant virus.