Moneycontrol Pro Panorama | Oops!...AstraZeneca does it again

Vaccine hesitancy has been a problem in countries across the world, and such episodes make it worse.

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AstraZeneca is in the news for the wrong reasons again. On March 22, the company said its US phase III trials for its vaccine against COVID-19 had shown, based on interim safety and efficacy analysis, a 79percent efficacy against preventing symptomatic disease and a 100percent efficacy against severe disease and hospitalisation.

A 79percent efficacy was a solid number even if not as high as some of the other vaccines developed in the US and Europe. The safety board concluded that no safety concerns were identified and they did a specific study that showed no risks of clots. This was the reason a few European countries had halted using the AZ vaccine to examine why some patients developed clots that appeared after vaccination. AZ also said it will ask the US Food and Drug Administration to grant it emergency use authorisation for the vaccine in the coming weeks.

This was good news not just for AZ but also for countries using the vaccine. But the warm feeling has evaporated just a day later. The Data and Safety Monitoring Board said it was concerned that the interim data was based on outdated information. The board wanted AZ to include the most up-to-date data from the trial to give a more complete picture. This pushback saw AZ issue a short press release a day later that the numbers were presented with a data cut-off of February 17. It has assured that it will do a primary analysis using the full data set and issue these results within 48 hours.

This episode does more damage to the reputation of AZ’s vaccine and the company itself. This article in the Washington Post says that adding data for a month more saw the efficacy range between 69 to 75percent. It appears that the safety board wanted this data to be included in the interim release. The company’s decision to take an earlier cut-off that showed results in a more favourable light appears to have prompted this rare rebuke. It was an avoidable error of judgement.

Earlier too, AZ did a poor job of communicating results from its first global trial omitting to mention that a dosing error was why some recipients had got only a half dose in the first instance. Instead, it presented these as two separate trials. Later, it emerged that the half-dose trial, which had shown a 90percent efficacy, was not conducted on volunteers over 55 years (the most vulnerable group).

That eroded trust in the company and raised questions over its vaccines too. The US trials were an opportunity to end doubts over the efficacy of the vaccine. But, unfortunately that opportunity has been squandered. As an unnamed health official told FT: “How does AstraZeneca manage to screw up every time?”

Vaccine hesitancy has been a problem in countries across the world, and such episodes make it worse. The AZ vaccine is the same one that’s licensed to the Serum Institute of India and being sold as Covishield in India. It also accounts for the bulk of doses given in India. Since vaccine hesitancy is a problem in India too, the AZ US trials could have convinced some fence-sitters to take the vaccine. Now, one awaits AZ’s revised data and hope the efficacy numbers are not way off from the earlier one so that the damage done is limited.

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Ravi Ananthanarayanan
Moneycontrol Pro