Washington: Results from a US trial of AstraZeneca’s COVID-19 vaccine may have used ‘outdated information’, US federal health officials said early Tuesday. The Data and Safety Monitoring Board said in a statement that it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated US study. It is a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the US.
In the study of 30,000 people, the vaccine was 79 per cent effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalisations among vaccinated volunteers, compared with five such cases in participants who received dummy shots.
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots. It was a scare that led numerous countries to briefly suspend vaccinations last week.
However, the highly unusual rebuke from federal health officials comes just one day after interim data from the drugmaker showed better-than-expected results from the US trial.
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Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the US National Institute of Allergy and Infectious Diseases (NIAID) said in a statement
Also read: AstraZeneca vaccine leads to blood clots: Reports
“We urge the company to work with the Data Safety Monitoring Board (DSMB) to review the efficacy data. AstraZeneca must ensure the most accurate, up-to-date efficacy data is made public as quickly as possible. It will help in clearing doubts,” the US National Institute of Allergy and Infectious Diseases (NIAID) said. It added that the DSMB had informed AstraZeneca of its concerns.
NIAID is headed by US infectious diseases expert Anthony Fauci and is part of the National Institutes of Health. The DSMB is organised by NIAID, according to a document outlining the trial design. The board’s role is to provide study oversight and evaluate clinical data to ensure safe and ethical conduct of the study.
AstraZeneca was hailed as a milestone in the fight against the COVID-19 pandemic when it emerged as a vaccine contender last year. However since then the AstraZeneca shot has seen a steady stream of questions raised about its efficacy and possible side effects. More than a dozen European countries halted use of the vaccine earlier this month. It came after reports linked it to a rare blood clotting disorder in a very small number of people.
Germany and France resumed inoculations after the EU’s drug regulator said last week it was safe. However, an opinion poll Monday showed Europeans remained sceptical about its safety.