While the SII will need to apply for emergency use, the firm is expected to do so in December. The Centre is finalising a contract with vaccine manufacturers for procurement of doses. The government, which will make bulk purchases, has also negotiated a better price — almost half that of the likely MRP of Rs 500-600 for the two-shot vaccine, an official source said.
Bharat Biotech’s Covaxin can be considered for emergency approval after it submits data from phase I and II trials. Regulatory sources told TOI that Bharat Biotech is in the process of publishing data for the vaccine which is now in phase 3 trials in India. So, two vaccines could be available by February.
“If everything goes as per plan and the company (SII) manages to secure emergency authorisation in December, we are expecting the first lot of vaccines by January-February and the first set of beneficiaries has been identified,” the official said.
While an estimated 50-60 crore doses will be required to inoculate 25-30 crore priority population categorised into four different groups, initially limited stocks are expected by January-end that will be administered mainly to some of the estimated 70 lakh healthcare professionals and over 2 crore frontline workers including police, municipal workers and armed forces.
The SII has almost completed its phase 3 trials in India and a follow-up of the data is likely to start soon.
“If Serum Institute submits its efficacy data from UK and applies for emergency authorisation here, it can easily be granted. But even in case of Bharat Biotech, if the company applies for emergency use approval after its data from phase 1 and 2 are published, the regulator can consider the same,” the official said, indicating that by February-March, more than one vaccine is likely to get at least emergency use authorisation provided the regulator finds data generated from clinical trials satisfactory.
Meanwhile, government is framing terms of references for two major bodies dealing with vaccine introduction — the National Technical Advisory Group on Immunisation and the Central Drug Standards and Control Organisation — to look into grant of emergency authorisation.