Oxford vaccine update: India is likely to approve Oxford/AstraZeneca’s coronavirus vaccine for emergency use by next week after Serum Institute of India (SII) submitted additional data sought by authorities, two sources with knowledge of the matter told Reuters on Tuesday.
The current development pertains to the fact that AstraZeneca-Oxford’s partner Serum Institute of India has submitted additional data sought by the Drugs Controller General of India (DCGI).
Oxford-AstraZeneca’s Covid-19 vaccine may get emergency use approval by next week, reported Reuters. If the DCGI gives a green signal to SII, India will be the first nation to approve the Oxford vaccine under emergency use authorization.
This could be the first country to give the regulatory green light for the British drugmaker’s vaccine as the British medicine regulator continues to examine data from the trials.
Notably, the British health regulator Medicines and Healthcare products Regulatory Agency (MHRA) is still evaluating the data presented by Oxford-AstraZeneca for their vaccine candidate.
Pfizer India and Bharat Biotech have also applied for an emergency approval from the DCGI, and could also receive clearance as India plans the mass inoculation drive from January.
The Subject Expert Committee (SEC), a government panel tasked with vetting coronavirus vaccines, had earlier asked Bharat Biotech and SII to submit updated country-specific trial data of their vaccine candidates Covaxin and Covishield.
Serum Institute conducted clinical trials on two full doses of the Oxford vaccine, named Covishield. The company is presently conducting phase-3 trials of its experimental vaccine on 1,600 participants in India.
After the clearance, SII may sign a supply contract with the Centre, under which the price of the COVID-19 vaccine may be fixed at Rs 250 per dose, suggest reports.
Although there is not much clarity on the number of doses that would be secured from the Serum Institute, reports say around 60 million could be made available soon. The company is likely to have around 100 million doses for the government by January-February (2021) if the Centre chooses to procure them from it.
Mean-while, A day after recording the lowest number of daily Covid-19 infections, India on Wednesday reported 23,950 new cases, taking the total tally to 10,099066. On Tuesday, the 24-hour tally reached the lowest with only 19,556 cases recorded on Monday. This was the lowest after 173 days.
The number of active cases has dropped below 2 lakh and is now at 1,89,240
The health ministry on Tuesday issued a new SOP in the context of the new variant of SARS-CoV-2 detected in the United Kingdom, making it mandatory for all states to test passengers traveling from or transiting through airports in the UK. Passengers testing positive shall be isolated in an institutional isolation facility in a separate (isolation) unit coordinated by the respective State Health Authorities. Those who are found negative on testing with RT-PCR at the airport would be advised quarantine at home and followed up.
