India approves two coronavirus vaccines

Experts at India s drugs regulator have recommended for emergency use two coronavirus vaccines_ one developed by AstraZeneca and Oxford University and the other backed by a state-run institute_ the government said on Saturday.

A government minister said earlier the AstraZeneca/Oxford vaccine had been given the green light on Friday_ paving the way for a huge immunisation campaign in the world s second most populous country.

The government said the final decision on the two vaccines would be made by the Central Drugs Standards Control Organisation s (CDSCO) chief_ who has called a news conference on Sunday. 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. Citing sources_ Reuters reported on Friday that the shot could be approved_ though little is known about the results of its clinical trials.

 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.

The regulator is likely to approve administering two doses for both vaccines_ each four weeks apart_ two sources with knowledge of the matter told Reuters on Saturday. Calls to CDSCO were unanswered outside regular business hours.

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 CDSCO is expected to announce the dosage and other details about the shot later. SII had applied for a two full-dose regime about 28 days apart. -Reuters