India likely to approve AstraZeneca vaccine by next week: Report

NEW DELHI, Dec 23, 2020, Reuters. India is likely to approve the vaccine being developed by AstraZeneca and Oxford University for emergency use by next week after its local manufacturer submitted additional data sought by authorities, the Reuters news agency reported citing two sources with knowledge of the matter, Al Jazeera reported.

The approval would make India the first country to give the regulatory green light to the British drugmaker’s vaccine as the British medicine regulator continues to examine data from the vaccine’s late-stage trials.

India, the world’s biggest vaccine manufacturer, wants to start inoculating its citizens next month and is also considering emergency-use authorisation applications for vaccines made by Pfizer and local company Bharat Biotech.

Getting vaccines to the world’s second-most populous country with one of the world’s highest infection rates will also be a big step forward in the battle against the pandemic.

The AstraZeneca-Oxford shot is considered vital for lower-income countries and people living in warmer climates because it is cheaper, easier to transport and can be stored for long periods at normal fridge temperatures.

India’s Central Drugs Standard Control Organization (CDSCO) first reviewed the three applications on December 9 and sought more information from all the companies, including from Serum Institute of India (SII), which is making the AstraZeneca shots.

400 million doses by July

SII, the world’s biggest vaccine manufacturer, has now provided all the data, the two sources said. The authorities were still waiting for more details from Pfizer, a government health adviser told a news briefing on Tuesday, while one of the sources said additional information was expected from Bharat Biotech.

Both sources said Indian health officials were in direct contact with their British counterparts over the AstraZeneca shot and that there were “strong indications” an approval would come by next week.

The expected approval comes after data from AstraZeneca’s late-stage trials in the UK and Brazil released earlier this month showed the vaccine had efficacy of 62 percent for trial participants given two full doses, but 90 percent for a smaller sub-group given a half, then a full dose.