No emergency use authorization has been granted to the Serum Institute of India (SII) or Bharat Biotech’s COVID-19
vaccines for lack of data, sources told News18 on Wednesday.
Bharat Biotech had on Monday applied to the Controller General of Drugs of India (DCGI) for an emergency use authorization for COVID-19 the Covaxin vaccine, which is being developed by the Hyderabad-based pharmaceutical company in collaboration with the Indian Council for Medical Research (ICMR). The Pune-based SII had applied to the central medicines regulator for the emergency use authorization of AstraZeneca-Oxford coronavirus vaccine.
In addition to Bharat Biotech and the Serum Institute of India, the US pharmaceutical giant Pfizer Inc, whose vaccine has already been released to the public in the UK, has also applied for advance approval for emergency use in India. The Health Ministry had said Tuesday that some COVID-19 The vaccines are likely to be licensed in the coming weeks.
The Serum Institute of India, the world’s largest vaccine manufacturer, applied for an emergency use license for the AstraZeneca vaccine from the University of Oxford 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 they quoted health officials as saying.
Under Indian rules for accelerated vaccine approval, a company can get a license if regulators are “satisfied with the risk-benefit ratio,” said Balram Bharagava, head of the Indian Council for Medical Research.
Peer-reviewed data published in The lancet showed that AstraZeneca and the University of Oxford have more work to do to confirm whether their COVID-19 The vaccine may be 90% effective, and questions remain about how well it can help protect people 55 and older.
The researchers say that the vaccine protects against the disease in 62% of those who received two full doses and in 90% of those who initially received half the dose. However, independent experts have said that the second group was too small (2,741 people) to judge the possible value of that approach and that more evidence is needed.
The half-dose group also did not include anyone older than 55 years, and among others in the study, only about 12% were in that age group. Older people also signed up later, so there hasn’t been enough time to see if they develop infections at a lower rate than those who didn’t get the vaccine.
.
