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Opinion

Pfizer, Serum Institute, and Bharat Biotech Apply for USA in India – Here’s What Could Happen Next

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Hopes for an early vaccine for the coronavirus disease (Covid-19) in India have been rekindled after three companies, within days of each other, applied for emergency use authorization (USA) of their respective candidate vaccines in the country. While Pfizer Inc of the United States was the first to apply on December 4, the Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech International Limited applied on December 6 and 7 respectively.

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While IBS will manufacture the candidate vaccine at Oxford-AstraZeneca University, Covishield in India, Bharat Biotech’s candidate Covaxin is the first candidate vaccine developed in the country, and so far the only one in the country. The US applications from the three companies will reportedly be reviewed on Wednesday.

This is what will likely happen next:

1. The US Food and Drug Administration (FDA) describes the US as a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current Covid-19 pandemic. “. To approve full-time use, a company must submit, among other information, data on the efficacy of the candidate vaccine.

Read also | Explanation of the emergency use authorization for Covid-19 vaccines

2. In India, the power to grant USA rests with the Central Drug Standards Control Organization (CDSCO). However, there are no provisions for the USA under the Indian drug regulations. In such a scenario, the processes to obtain US here are not clearly defined. However, CDSCO had granted permission for the use of drugs such as remdesivir and favipiravir in June and itolizumab in July.

3. Since there are no fixed rules for the granting of USA in India, the minimum efficiency that a candidate needs to be allowed to use in an emergency is not yet known. In the case of the FDA, the agency says it would consider a US application only if the candidate vaccine has shown at least 50% efficacy in phase 3 trials. Additionally, the data should have been generated from more than 3,000 participants. .

4. In terms of how long it could take for a vaccine candidate to obtain EUA in India, NITI Aayog member Dr. VK Paul told NDTV that it could take 90 days for a US application to be reviewed and granted. the permission. The Comptroller General of Drugs of India (DCGI) is the department within CDSCO that grants such approvals.

5. Globally, Pfizer has applied for the US in the United States and the application is likely to be reviewed this week. The UK on Tuesday started using Pfizer’s candidate vaccine in emergencies. Bahrain has also granted USA for the vaccine from the US company.

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