AstraZeneca’s US entry in doubt as panel accuses it of including outdated info

An independent US vaccine trial monitoring committee has cast aspersions on AstraZeneca’s COVID vaccine shot, thus raising doubts about the Cambridge-based vaccine maker’s rollout in the United States.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) issued a statement on Tuesday (March 23) saying, “The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”

Surprisingly, a day before, i.e. on Monday (March 22), AstraZeneca released interim data that shows better-than-expected results from the U.S. trial.

AstraZeneca has partnered with Oxford University to develop the vaccine, which has proved 79% effective in preventing symptomatic illness — way less than its US-based mRNA vaccine competitors like Pfizer and Moderna. The vaccine was also found completely effective against severe or critical forms of the disease and hospitalisation, and posed no increased risk of blood clots, as against claims made by some European countries last week.

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NIAID requested AstraZeneca to work with the DSMB and review the efficacy data and come up with most accurate, up-to-date data on efficacy of the vaccine at the earliest.

AstraZeneca was one of the earliest vaccines to be launched after the COVID-19 pandemic broke out last year and was hailed as one of the most efficient means to check the spread of coronavirus. However, of late, the efficacy of the jab has come under question, especially in Europe where several countries halted use of the vaccine in the first week of March after reports linked it to a rare blood clotting disorder in some people.

The European Union’s (EU) drug regulatory body recently gave a green signal to the vaccine, after which Germany and France resumed vaccinations. Despite safety assurances, a public opinion poll conducted in several European countries on Monday (March 21) found that a majority of common citizens are wary of the vaccine’s safety.

Also watch: Are vaccine shots and blood clots linked?

The European Medicines Agency (EMA) stated last week that AstraZeneca vaccine is “safe and effective” and “its benefits… outweigh the possible risks,” though it did not rule out a link between the vaccine and a very rare clotting disorder.

The AstraZeneca vaccine is awaiting entry in the US market, though it has already received emergency use authorisation in more than 70 countries.

Experts say the AstraZeneca vaccine, which is manufactured in India by Serum Institute of India, is very crucial for the globe’s fight against COVID pandemic because it is very convenient and cheaper to transport than others.