AstraZeneca may have given outdated COVID-19 vaccine data ─Regulator

*The United States Data and Safety Monitoring Board, charged with ensuring the safety and accuracy of AstraZeneca’s vaccine trial, has expressed concerns that the information released about the testing results included outdated information

Alexander Davis | ConsumerConnect

Raising concerns over the information released about the testing results, the United States leading agency on infectious diseases has said that AstraZeneca Plc may have released outdated information about its COVID-19 vaccine trial, giving an “incomplete” view of the efficacy of the shot.

The Data and Safety Monitoring Board (DSMB), which is charged with ensuring the safety and accuracy of AstraZeneca’s vaccine trial in the country, expressed concerns to the National Institute for Allergy and Infectious Diseases, that the information released about the testing results included outdated information.

The regulator stated this “may have provided an incomplete view of the efficacy data.”

The Institute, headed by Dr. Anthony Fauci, a foremost US scientist and infectious disease expert, in a statement in a statement Tuesday, March 22 said: “We urge the company (AstraZeneca Plc) 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.”

AstraZeneca did not immediately respond to a request for comment made outside of office hours, agency report noted.

The company’s shares traded 1.3% lower early Tuesday in London.

The DSMB, an independent panel, also raised its concerns to the British drugmaker and to the Biomedical Advanced Research and Development Authority, a US agency that partially funded the shot’s development.

It was gathered that the latest disclosure is another setback for AstraZeneca, which earlier Monday said its vaccine was found 79% effective in preventing COVID-19 in a US clinical trial of more than 30,000 volunteers.

After being cleared for use in the United Kingdom (UK) and many other countries across the world, the company is preparing to seek approval from the US Food and Drug Administration (FDA).

Incidentally, the expected greenlight is now likely to be delayed after the monitoring board’s concerns, report stated.

The efficacy rate in the US trial was also reported to be much stronger than the 70% figure AstraZeneca had reported from an earlier study.

But those data were an average of different readings — 62% and 90% — from two arms of the trial.

Because of a manufacturing error, a group of participants had received a lower first dose, which produced the higher reading, compared with those getting two standard doses.

Further analysis suggested it was the greater dosing gap rather than amount that had created the difference.

It is noted that AstraZeneca’s vaccine, developed with Oxford University, which hitherto was regarded as a frontrunner to protect the world against COVID-19, has been beset by a series of complications in recent times.

It is now at the centre of a supply showdown with the European Union (EU) just days after concerns about blood clots prompted a dozen member states to suspend immunisations.

Paul Griffin, an Associate Professor of Medicine at the University of Queensland in Brisbane, who is conducting clinical studies in Australia on four COVID-19 vaccine candidates, said: “The last thing this vaccine needs is more concern when we kind of thought we were at that point now where we’d put to bed all the other concerns, and then a new one pops up the same day.”

Griffin, who is an infectious-disease physician and microbiologist, added: “It was referring to outdated information, and it’s kind of hard to imagine how outdated information could be included when these vaccines are all fairly new.

“The impression I got was that it seemed to be something very significant they were alluding to.”