US health agency questions AstraZeneca COVID-19 vaccine efficacy

An US health agency has raised concerns that AstraZeneca might have provided an incomplete view of efficacy data for its coronavirus vaccine. The apprehensions come a day after interim trial data for the jab showed better-than-expected efficacy levels at 79 per cent and posed no risk of blood clots.

The development has cast dark clouds over emergency use authorisation for the AstraZeneca COVID-19 vaccine. The British-Swedish drugmaker had conducted a large trial of the shot in the US, Chile and Peru. It was expected to file for US emergency use authorisation in the coming weeks.

The Data Safety Monitoring Board (DSMB) expressed concern that AstraZeneca may have included outdated information from that trial, leading to an incomplete view of the efficacy data, Reuters quoted a statement from the US National Institute of Allergy and Infectious Diseases (NIAID).

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"We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible," it said.

NIAID is headed by US' topmost infectious diseases expert Dr Anthony Fauci and is part of the National Institutes of Health.

The US will issue authorisation and guidelines for the AstraZeneca COVID-19 vaccine after thorough review of the trial data by independent advisory committees, it further stated.

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One of the earliest vaccines against SARS-CoV-2, AstraZeneca had developed the shot in collaboration with Oxford University. A substantial quantity of the jab is being produced by Pune-based vaccine manufacturing major Serum Institute of India, and is one of the two jabs being used in India's own vaccination drive.

However, the vaccine has been faced with doubts and suspension in more than a dozen European countries. The action came after reports of a rare blood clotting disorder in a small group of people out of those who have been inoculated with the shot.

While AstraZeneca is yet to respond to the concerns raised by the US, an analysis of its trial data for its COVID-19 vaccine by independent advisory panels might reinforce the faith in it even across the Atlantic Ocean.

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(With Reuters input)