AstraZeneca pauses Covid-19 vaccine trial just after 9 drug makers take safety pledge
The move comes amid a growing perception that despite his claims to the contrary, US President Donald Trump is rushing the search for a vaccine breakthrough before November 3, the election day, to help him win a second term.Updated: Sep 09, 2020, 22:10 IST
AstraZeneca has announced a pause on clinical trials of a candidate vaccine for Covid-19 developed by University of Oxford to review an “unexplained illness” in one of the participants in the UK, just hours after it joined eight other drug makers to make an unusual safety pledge.
Phase 3 clinical trials of its vaccine had started in the US last week and first doses were expected to be delivered as early as October.
There was no word on how long the review will last, or if the illness was caused by the in-trial vaccine.
The British-Swedish company is a front-runner in the race for a vaccine for Covid-19 that has killed nearly 900,000 people globally and infected more than 27 million. Its vaccine candidate has been undergoing late-stage trials around the world, with the India leg expected to start soon.
The company said in a statement the pause in the global trials was a “routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials”.
“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully,” it added.
The announcement came just hours after AstraZeneca joined eight other pharmaceutical giants to release a joint pledge to not apply for regulatory approval or authorisation of their candidate vaccines till their safety and efficacy had been established, a move that they said was “historic”.
Signed by the chief executive officers of AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Sanofi, BioNTech and Pfizer, it said the companies would seek regulatory approval or authorisation for vaccines only if their safety and efficacy had been established in Phase 3 clinical trials.
“The safety and well-being of vaccinated individuals (is) our top priority,” the companies said in the pledge on Tuesday, titled ‘Biopharma Leaders Unite to Stand with Science.’
The companies have between themselves developed 70 novel vaccines in the past.
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved,” they added.
AstraZeneca began Phase 3 clinical trials in the US on August 31 on 30,000 volunteers. Called D8110C00001, it is funded by the US department of health and human services and the National Institute of Allergy and Infectious Diseases (NIAID), which is led by Dr Anthony Fauci, the foremost US epidemiologist.
According to an agreement AstraZeneca had signed with the US government, it was expected to make available at least 300 million doses of the vaccine to the country, with the first lots delivered as early as October 2020, subject to approval by the Food and Drug Administration, the US drug regulator, or its European counterpart.
The US has invested billions of dollars in other vaccine projects as well, under a multi-agency programme called ‘Operation Warp Speed’.
The safety pledge by the vaccine companies came amid growing perception that despite him claims to the contrary, President Donald Trump is rushing the search for a vaccine breakthrough before November 3, the election day, to help his re-election chances.
Many Americans are sceptical of the vaccine search and will not be queueing up for a shot when one becomes available, according to polls. A CBS/YouGov poll released on Sunday found that 65% respondents would think the vaccine is “rushed through”, if they were told it had been found. The rest said they would call it a “scientific achievement”.
Only 21% of them will try to get a shot “as soon as possible”, down from 32% in July; and 58% will “wait to see what happens”, up from 51% in July. It’s a trend that has been reflected in many recent polls, showing growing scepticism about a coronavirus vaccine.
Lately, the president has clashed with his Democratic challenger Joe Biden and his running mate Kamala Harris for their scepticism about his claims. He has demanded an apology from Harris for saying she “would not trust” the president on a vaccine.
The Biden-Harris campaign doubled down on their criticism of the president on Tuesday, asking for the criteria that would be used to determine the vaccine is safe and works, who will make that determination and if the vaccine will be distributed “free, safely, equitably, and without politics”.