India Vaccine Maker Reverses Course, Stops Testing Astra Shots
The Serum Institute of India halted its Indian trials after receiving a notice from the Drug Controller General of India.
(Bloomberg) -- The Indian company enlisted to manufacture a billion doses of AstraZeneca Plc’s experimental Covid-19 vaccine is pausing its own clinical trial, after earlier declaring it would push ahead despite safety concerns forcing the British drugmaker to halt its tests.
The Serum Institute of India halted its Indian trials after receiving a notice from the Drug Controller General of India seeking information on the illness of a person participating in Astra’s trials in Britain, the company said in an emailed statement. The regulator asked Serum to demonstrate why its clinical trial license should not be suspended until the safety of the vaccine is established, according to a report from the Press Trust of India.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials,” the company said in its statement. “We are following DCGI’s instructions and will not be able to comment further on trials.”
The DCGI couldn’t be reached for a comment.
AstraZeneca paused its clinical trials worldwide this week as it investigates whether the illness seen in the participant happened by chance or as a result of the treatment. The episode is proving a sobering reminder of the challenges of balancing speed with caution in the race for a vaccine, particularly in hard hit countries like India, whose coronavirus outbreak is likely to surpass the U.S.’s as the world’s biggest.
Serum’s original stance raised questions about pressing ahead before Astra had finished its investigation, especially because many in India are medically illiterate and living in poverty, and so less able to gauge the risks of vaccine trials themselves.
U.S. National Institutes of Health Director Francis Collins told a Senate committee Wednesday that AstraZeneca’s trial had been halted due to a “spinal cord problem.” If AstraZeneca’s review finds the adverse event is related to the vaccine, all the doses already manufactured will be thrown away, Collins said.
AstraZeneca Chief Executive Officer Pascal Soriot said in an online conference Thursday that he can’t evaluate the length of the trial pause.
Serum, the world’s largest vaccine manufacturer, signed on with Astra in June to produce the shot for low- and middle-income countries, and has been proceeding with its own human trials in India running parallel to Astra’s effort. Serum said it could not comment on the pause in Astra’s trials.
The vaccine being developed by AstraZeneca and Oxford University has been considered one of the most likely contenders to reach the market in the near term, along with shots being developed by Moderna Inc. and the tandem of Pfizer Inc. and BioNTech SE. Astra and Oxford are seeking to enroll as many as 50,000 participants for late-stage trials under way in the U.S., the U.K. and other countries.
Serum has not said how many patients it is seeking for its trials in India, where the number of new coronavirus infections discovered each day continues to grow. India’s outbreak this week became the world’s second-biggest behind the U.S.
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