International Pfizer, Serum Institute and Bharat Biotech apply for EUA in India: Here’s...

Pfizer, Serum Institute and Bharat Biotech apply for EUA in India: Here’s what might happen next




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India, Dec. 8 — Hopes for an early vaccine for the coronavirus disease (Covid-19) in India have been rekindled after three firms, within days of each other, applied for emergency use authorisation (EUA) of their respective vaccine candidates in the country. While America’s Pfizer Inc was the first to apply on December 4, 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 SII will manufacture in India the Oxford University-AstraZeneca vaccine candidate, Covishield, Bharat Biotech’s candidate, Covaxin, is the country’s first, and thus far only, indigenously developed vaccine candidate. According to reports, the EUA applications of all three companies will be reviewed on Wednesday.

Here’s what is likely to happen next:

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

Also Read | Emergency use authorisation for Covid-19 vaccines explained

2. In India, the power to grant EUA lies with the Central Drugs Standard Control Organisation (CDSCO). However, there are no provisions for EUA under India’s drug regulations. In such a scenario, processes to obtain EUA here are not clearly defined. However, CDSCO had granted permission for the use of drugs like remdesivir and favipiravir in June, and itolizumab in July.

3. Since there are no fixed rules for granting EUA in India, the minimum efficacy that a candidate needs to have to be granted permission for use in emergency cases is not yet known. In FDA’s case, the agency says it would consider a EUA application only if the vaccine candidate 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 might take for a vaccine candidate to be granted EUA in India, Dr VK Paul, NITI Aayog member, told NDTV it might take 90 days for an EUA application to be reviewed and permission to be granted. The Drugs Controller General of India (DCGI) is the department within CDSCO which grants such approvals.

5. Globally, Pfizer has filed for EUA in the United States and the application is likely to be reviewed this week. The United Kingdom on Tuesday initiated the use of Pfizer’s vaccine candidate in emergency cases. Bahrain, too, has granted EUA for the US firm’s vaccine.

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