Concerns in US over AstraZeneca vaccine data – With insights from The Wall Street Journal

The AstraZeneca Covid-19 vaccine has had its fair share of hiccups since being introduced. Here in South Africa, the vaccine wasn’t even put to use. Studies have shown that the vaccine – despite being the most widely used inoculation – had very little efficacy against the 501y.v2 variant that is so common locally. Last week, concerns around the vaccine causing blood clots caused numerous European countries to suspend usage until further investigation had been undertaken. The EU’s health agency has said the AstraZeneca vaccine is ‘safe and effective’ to use once again. Now, there are concerns in the United States. According to The Wall Street Journal, US officials said they were told that AstraZeneca may have ‘released outdated information in its disclosure results for its Covid-19 vaccine’. – Jarryd Neves

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U.S. Health Officials Raise Concerns Over AstraZeneca Vaccine Data

Independent monitoring board working with AstraZeneca in U.S. trials said company may have relied on out of date information

U.S. officials said early Tuesday they had been told AstraZeneca AZN 4.04% PLC may have released outdated information in its disclosure of trial results for its Covid-19 vaccine, which could have “provided an incomplete view of the efficacy data.”

The short statement came just hours after AstraZeneca released interim data from large-scale U.S. trials that it said found its Covid-19 vaccine to be 79% effective in preventing symptomatic disease. The release was seen as a vote of confidence in the shot, which has been clouded by uncertainty over its efficacy in earlier trials conducted in the U.K. last year and large-scale production problems. More recently, reported cases of unusual blood clotting in Europe raised concerns about the vaccine’s safety, though European regulators say it is safe.

In an unusual statement early Tuesday morning, the National Institute of Allergy and Infectious Diseases said an independent data monitoring board working with AstraZeneca in conducting its trials had raised concerns with the company’s data disclosure and urged it to work with it to ensure that the most accurate, up-to-date efficacy data would be made public.

The NIAID said the monitoring board, an independent body that works alongside a drug company to conduct trials, “expressed concern that AstraZeneca may have included outdated information from that trial.” The agency said it was urging AstraZeneca “to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”

AstraZeneca wasn’t immediately available to comment early Tuesday.

The company said Monday it is intending to submit its vaccine for emergency use authorization with the Food and Drug Administration and hoped to have its vaccine available in the U.S. by May.

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