Covid-19 Vaccine: Formulations to be examined today by Pfizer, Bharat Biotech and Serum Institute.

Key sentence:

1.  The three pharmaceutical firms that have requested emergency use authorization for their Covid-19 vaccine candidates.
2. On December 4, the Indian arm of US pharmaceutical giant Pfizer obtained permission from the central drug regulator for its vaccine.
3. This will be very detailed scrutiny, said ICMR Director-General Balram Bhargava.
4. Most vaccines consist of two to three doses, and in doses, there will be a delay of a few weeks.

The applications of Pfizer, the Serum Institute of India including Bharat Biotech, the three pharmaceutical firms that have requested emergency use authorization for their Covid-19 vaccine candidates, will be reviewed by the Central Drug Quality Control Organisation (CDSCO), which would be the National Regulatory Authority of India.

On December 4, the Indian arm of pharmaceutical giant Pfizer obtained permission from the central drug regulator for its vaccine, after the company received such clearance in the UK as well as Bahrain. 

Pune’s Serum Institute of India was seeking a nod for its Oxford Covid-19 vaccine on December 6. Bharat Biotech subsequently demanded the same on December 7.

What does the legislative system of India say about emergency authorization? 

No legislation exists to issue licenses to vaccine manufacturers in India under the name of the emergency use authorization law.

 But the provisions for the reason are there. Union health secretary Rajesh Bhushan stated that the exact term is not being used, but the Latest Medicines and Clinical Trials Rules are used.

2019 specifically states that relaxation, abbreviation, omission, as well as deferment of data, including local clinical trial data, can be considered for approval in particular special circumstances.

How will the applications be reviewed by India? 

This will be very detailed scrutiny, said ICMR Director-General Balram Bhargava. “This requires looking at voluminous material. We hope that the decision will be expeditious, but it will never hesitate on scientific rigour as well as the processes involved,” he said.”

 The authorization can only be given by the experts if they are satisfied with the cost-benefit ratio, which is if the benefit is greater than the risk.

In addressing a press conference in which the specifics of India’s planned vaccination campaign were announced, the Health Secretary said that some vaccine manufacturers would receive licenses in the next few weeks.

“But it’s hard to say which one is going to get or when. Most vaccines consist of two to three doses, and in doses, there will be a delay of a few weeks. “Precautions must be taken even after vaccination,” Bhushan stated.