India Likely to Approve 2-Dose Regimen for Covid-19 Vaccines to be Administered 28 Days Apart, Says Report

·3-min read

India's drugs regulator is likely to approve administering two doses of the AstraZeneca-Oxford vaccine and another locally developed one by Bharat Biotech, each four weeks apart, a Reuters report said on Sunday, quoting two sources. The Serum Institute of India, which is making the Oxford-AstraZeneca doses, had applied for a two full-dose regime about 28 days apart.

Experts at India's Central Drugs Standards Control Organisation (CDSCO) have already approved the vaccines and a final decision is expected to be announced by the agency's chief at a news conference scheduled on Sunday. Calls to CDSCO were unanswered outside regular business hours, the report said.

The process for the final approval is expected to be a formality given the urgency for a vaccine in the country with the highest number of Covid-19 infections in the world after the United States. The other vaccine, known as COVAXIN, has been developed locally by Bharat Biotech and the government-run Indian Council of Medical Research.

"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," the government cited the experts' recommendation for COVAXIN, referring to the new strain of the virus first detected in Britain. For the AstraZeneca/Oxford vaccine, the approval was "subject to multiple regulatory conditionalities", it said, without giving details.

Information and Broadcasting minister Prakash Javadekar told reporters earlier that two other vaccines were waiting to be approved - Zydus Cadila's ZyCoV-D and Russia's Sputnik V that are both on trial in India. "India is perhaps the only country where four vaccines are getting ready," he said. "One was approved yesterday for emergency use, Serum's COVISHIELD." he said, referring to the fact that the AstraZeneca/Oxford shot is being made locally by the Serum Institute of India (SII).

The AstraZeneca/Oxford vaccine, which was granted its first approval by Britain on Tuesday, is cheaper and easier to use than some rival shots, such as the one from Pfizer Inc - a major advantage in tackling a pandemic that has claimed more than 1.8 million lives worldwide. However, it has been plagued by uncertainty about its most effective dosage ever since data published in November showed a half dose followed by a full dose had a 90% success rate while two full shots were 62% effective.

India's regulator has also received an emergency-use application for the COVID-19 vaccine made by Pfizer with Germany's BioNTech - the first shot to secure regulatory approval in the West. India has reported more than 10.3 million COVID-19 cases and around 150,000 deaths, though its rate of infection has come down significantly from a mid-September peak. The country hopes to inoculate 300 million of its 1.35 billion people in the first six to eight months of this year.

SII, the world's biggest producer of vaccines, has already stockpiled about 50 million doses of the AstraZeneca/Oxford shot, which will be sold to the government at about Rs 250 ($3.42) per dose and Rs 1,000 on the private market.