India Vaccine Maker Is Still Testing AstraZeneca’s Shot After Firm Halts Trials

The Indian company enlisted to manufacture a billion doses ofAstraZeneca Plc’s experimental Covid-19 vaccine is pushing ahead with its own clinical trial even as safety concerns forced the British drugmaker to halt its tests.

TheSerum Institute of India said it received a notice from the Drug Controller General of India seeking information on the illness of a person participating in AstraZeneca’s trials in Britain. 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 areport from the Press Trust of India.

Serum said it was responding to the regulator’s queries, but was proceeding with its own human trials in India in the meantime.

“The Indian trials are continuing and we have faced no issues at all,” Serum said in a statement on its official Twitter account. “We were going by DCGI’s direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols.”

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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. But Serum’s ongoing trial in India, where coronavirus infections are skyrocketing, illustrate how tradeoffs between caution and speed are in no way settled as companies race to bring a vaccine to market.

U.S. National Institutes of Health Director Francis Collinstold 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 told investors on a conference call Wednesday there had been no final diagnosis in the case, according to company spokeswoman Michele Meixell.

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 byModerna Inc. and the tandem ofPfizer Inc. andBioNTech 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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