Serum Institute of India (SII) and Bharat Biotech’s Covid-19 vaccines were "not considered" for emergency use authorization on Wednesday over lack of data, sources told News18 on Wednesday, adding that the Central Drugs Standard Control Organization (CDSCO) has sought more data from the vaccine developers.
The health ministry, however, issued a denial after certain media reports said the drugs regulator had “rejected” emergency use authorization to the two vaccines. A Reuters report quoted sources as saying that a decision on the vaccines would be taken "in toto" and it was too early to say whether they would be rejected or accepted. A PTI report, too, quoted sources as saying that the applications of both Bharat Biotech and the Serum Institute of India are still under consideration.
Bharat Biotech had on Monday applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for its Covid-19 vaccine Covaxin, which is being indigenously developed by the Hyderabad-based pharmaceutical firm in collaboration with the Indian Council of Medical Research (ICMR). The SEC recommended that Bharat Biotech should present the safety and efficacy data from the ongoing phase-3 clinical trial in the country for further consideration.
The Pune-based SII had applied to the central drug regulator for emergency use authorisation of AstraZeneca-Oxford’s coronavirus vaccine. While considering its application, the subject expert committee (SEC) of the CDSCO is learnt to have asked for updated safety data of phase-2 and phase-3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Apart from Bharat Biotech and Serum Institute of India, US pharma giant Pfizer Inc, whose vaccine has already been rolled out to the public in the UK, had also applied for early approval for emergency use in India. The application was not taken up for deliberation on Wednesday as the firm sought more time for making presentation before the committee.
Serum Institute of India, the world’s largest vaccine manufacturer, applied for an emergency use license for the Oxford University-AstraZeneca vaccine based on phase-three trials in India and other countries. Bharat Biotech applied for a license for its experimental inactivated virus vaccine without completing phase-three trials, Associated Press quoted health officials as saying.
According to Indian rules for accelerated approval of vaccines, a company can be granted a license if regulators are “satisfied with the risk-benefit ratio,” said Balram Bharagava, head of the Indian Council of Medical Research.
A peer-reviewed data published in The Lancet showed that AstraZeneca and Oxford University have more work to do to confirm whether their Covid-19 vaccine can be 90% effective and questions remain about how well it may help protect those over 55.
Researchers claim the vaccine protected against disease in 62% of those given two full doses and in 90% of those initially given the half dose. However, independent experts have said the second group was too small — 2,741 people — to judge the possible value of that approach and that more testing is needed.
The half-dose group also didn’t include anyone over 55, and among others in the study, only about 12% were in that age group. Older people also were enrolled later, so there hasn't been enough time to see whether they develop infections at a lower rate than those not given the vaccine.