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% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose.
The Indian regulator is only considering the two full-dose regimen of the shot despite it showing a lower success rate, the sources said. “Serum is ready,” said one of the sources. “Initially, we may get around 50 million to 60 million doses.” The sources declined to be named as deliberations were ongoing and the timeline could change. CDSCO chief VG Somani did not immediately respond to a request for comment. Bharat Biotech and Pfizer declined to comment, while SII did not immediately respond to an email seeking comment.
India has not yet signed a vaccine supply deal with any company, but SII has already stockpiled more than 50 million doses of the AstraZeneca shot and plans to make a total of 400 million doses by July.
Meanwhile, AstraZeneca Plc has said its Covid-19 vaccine should be effective against the new coronavirus variant, adding that studies were under way to fully probe the impact of the mutation. “AZD1222 (AstraZeneca’s vaccine candidate) contains the genetic material of the SARS-CoV-2 virus spike protein, and the changes to the genetic code seen in this new viral strain do not appear to change the structure of the spike protein,” an AstraZeneca representative said. Drugmakers are scrambling to test their COVID-19 vaccines against the new fast-spreading variant of the virus that is raging in Britain, the latest challenge in the breakneck race to curb the pandemic.
“Through vaccination with AZD1222, the body’s immune system is trained to recognise many different parts of the spike protein, so that it can eliminate the virus if it is later exposed,” the AstraZeneca representative added. The mutation known as the B.1.1.7 lineage may be up to 70% more infectious and more of a concern for children. It has sown chaos in Britain, prompting a wave of travel bans that are disrupting trade with Europe and threatening to further isolate the island country. The AstraZeneca-Oxford shot is considered vital for lower-income countries and those in hot climates because it is cheaper, easier to transport and can be stored for long periods at normal refrigerator temperatures.
Data from AstraZeneca’s late-stage trials in the UK and Brazil released earlier this month showed the vaccine had efficacy of 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose. Reuters reported late on Tuesday that India is likely to approve AstraZeneca’s vaccine for emergency use by next week.