India experts approve AstraZeneca’s COVID-19 vaccine

Experts at India’s drug regulatory agency have recommended the coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, along with a second immunization developed by a state-run institute. 

According to Reuters, the Indian government announced Saturday that a panel at the Central Drugs Standards Control Organisation recommended the AstraZeneca vaccine on Friday, with the agency’s chief expected to issue a final decision at a news conference Sunday. 

The second vaccine, known as Covaxin, was developed by Bharat Biotech and the government-run Indian Council of Medical Research. Reuters reported that sources believed this vaccine would also be quickly approved and distributed, though little information on the findings of the candidate’s clinical trial have been released to the public. 

The government, citing the experts’ backing of Covaxin, said that “grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains,” referring to the new, more transmissible strain of COVID-19 first found in the U.K.

According to Reuters, the government added that the AstraZeneca vaccine’s approval was “subject to multiple regulatory conditionalities,” though officials did not provide any further details. 

Information and Broadcasting Minister Prakash Javadekar told reporters that two additional vaccine candidates are also awaiting approval in India: Zydus Cadila’s ZyCoV-D and Russia’s Sputnik V. 

“India is perhaps the only country where four vaccines are getting ready,” he said, according to Reuters. 

The approval of multiple vaccines clears the way for a mass vaccination campaign in a country with the second-highest number of total coronavirus infections. 

As of Saturday, India has had an estimated 10.3 million COVID-19 cases as well as more than 149,000 deaths due to the virus, according to data compiled by Johns Hopkins University. 

The U.K. this week also cleared the AstraZeneca vaccine for emergency use after previously beginning distribution of the Pfizer-BioNTech vaccine, which has also been approved in the U.S. 

However, Moncef Slaoui, the Trump administration’s chief science adviser for Operation Warp Speed, said Wednesday that the AstraZeneca vaccine likely won’t be approved in the U.S. until April. 

The shot has a 62 percent efficacy rate if given in two full doses 28 days apart like it was for most participants, though the company found the drug to be 90 percent effective when a small group in the trial was mistakenly given half a dose initially followed by a full dose.

Slaoui expressed some concern with the data but indicated the ultimate decision would be up to the Food and Drug Administration.

Slaoui also told reporters that he questioned the true efficacy of the drug, with AstraZeneca previously saying that the combined “pooled” numbers from its trial amounted to an average of 70 percent efficacy. 

“We need a clear and concrete number, more than a number that is, you know, accumulated by putting together different trials with different schedules and different materials,” Slaoui explained.