The week
The Oxford-AstraZeneca COVID-19 vaccine looks promising. See why it has not yet been approved in the U.S.
Confidence in the University of Oxford and AstraZeneca’s COVID-19 vaccine appears to be growing. A new analysis released this week suggests that not only does the vaccine protect against symptomatic COVID-19 infections, but it can also significantly reduce transmission, making it a potentially very effective tool for controlling the virus. The vaccine is affordable, easy to produce and store and has been approved by health regulators in the UK, India and Europe, as well as in several other countries. But it has not yet been approved by the Food and Drug Administration in the United States, where it is still in the final testing phase. This led to some severe criticism. Vincent Rajkumar, of the Mayo Clinic, called the delay “a big blunder”, while The Atlantic’s Conor Friedersdorf described it as “the most profound impact I have ever faced on my freedom”. Writer Matthew Yglesias lamented the lack of pressure from US lawmakers and the media for swift approval. To begin with, AstraZeneca has not submitted any paperwork to the FDA, so in short, it cannot grant approval for what has not been requested, notes Sam Baker of Axios: AstraZeneca has not submitted this product for FDA authorization. The FDA cannot authorize products whose manufacturers do not request authorization. Political pressure on the FDA, in addition to being something that everyone was correctly opposed to when Trump did this, cannot change that https://t.co/LnsZPGz4ZG – Sam Baker (@sam_baker) February 3, 2021 But there are reasons more complex behind the assault. In the UK, Business Insider notes, health regulators “rely more on a company’s data to draw conclusions”, while in the United States an independent advisory committee examines data sets from the FDA and pharmaceutical companies before the FDA can make your final decision. In this case, the FDA was concerned about a series of missteps by AstraZeneca, including the company’s failure to alert the agency about the decision to suspend testing after a UK participant fell ill in September, and a strange discrepancy and tests incomplete promises – but wrongly administered – half strength doses. It is speculated that submission and approval will come in April, but until the U.S. obtains clearer data, the vaccine will remain in regulatory limbo. More stories from theweek.com5 scathing caricatures about the Republican Party’s Marjorie Taylor Greene problem. Watch Steny Hoyer ask Republican Party lawmakers to imagine if Greene’s fiery social media messages were about them.