Sources said the Indian drug regulator is in touch with its counterpart in the UK, which is reviewing AstraZeneca's application
Serum Institute of India, that has completed phase-3 trial with over 1,600 volunteers in India, is expected to submit the final set of data before the subject expert committee in the next 10 days or so, according to people in the know.
If the data is found satisfactory, an approval for Covishield, Oxford-AstraZeneca’s vaccine candidate, can come in by the first week of January.
Last week, the panel, advising the country’s drug regulator on Covid-19 vaccines, sought additional data from Serum. The firm has completed phase-3 trial in India on November 25. The immunogenicity (whether the vaccine produces the desired immune response) data from the last set of volunteers was not available at the time Serum applied for an accelerated approval.
Immunogenicity is checked after around 15 days of finishing the immunisation module of two doses about a month apart. Serum is now working on this last tranche of data from its trial subjects.
Sources said the Indian drug regulator is in touch with its counterpart in the UK, which is reviewing AstraZeneca's application. "This is the best way to have firsthand information from the UK MHRA and understand the bases on which they take a decision on the vaccine," said a person in the know.
After rolling out the Pfizer-BioNTech vaccine, the UK is hoping that the approval for the Oxford-AstraZeneca’s antidote will be given within a matter of days, David Prior, chair of UK’s National Health Service, has said. “Next three months are going to be difficult. Our hopes are pinned on the vaccine...We are hoping it will be approved within a matter of days,” Prior said.
Serum is in final stages of negotiations with the government on signing a supply contract at Rs 250 or so per dose for Covishield. There is still some time before Serum can start supplying to the low- and medium-income countries through Gavi. Till then, Serum can supply to India and meet the first phase requirement of the government. It has around 50 million doses of the vaccine ready for supply.