A woman holds a small bottle labeled with a “Vaccine COVID-19” sticker in this illustration. Photo: Reuters/Dado Ruvic/Illustration.
New Delhi: The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) did not clear the proposals submitted by Bharat Biotech and Serum Institute of India (SII) seeking emergency use approval for their COVID-19 vaccine candidates due to inadequate safety and efficacy data, according to reports.
According to an NDTV report, both the proposals were not cleared by the committee due to “inadequate safety and efficacy data available currently”. The companies have been asked to provide more data at the committee’s next meeting, the date of which has not yet been decided.
The subject expert committee can make recommendations, but the final call on approvals will be made by the Drugs Controller General of India (DCGI).
There was some confusion about the news after reports initially said the approval itself was rejected. Within minutes, the Ministry of Health and Family Welfare called the report ‘fake news’ in a tweet.
— Ministry of Health (@MoHFW_INDIA) December 9, 2020
It later became evident that the proposal was not rejected, but that the subject expert committee had not cleared it.
A report by Reuters said a source with “direct knowledge of the matter” told the news agency that a decision on the vaccines would be taken “in toto” and it was too early to say whether they would be rejected or accepted.
Another source told Reuters: “The CDSCO just wants more data on efficacy and safety before making a decision. It is part of the process”.
SII, Bharat Biotech and Pfizer had submitted their proposals for emergency use of their vaccines. All three were reviewed by the subject expert committee on Wednesday.
Sources within the SII told NDTV that it is “standard practice” for the government to hold several meetings before approving a proposal. “The process is expected to go on for one or two weeks,” the source said.
According to reports, the CDSCO did not consider Pfizer’s application because the committee’s US experts could not attend the Wednesday meeting.
Pfizer’s vaccine candidate was the first in the world to be approved, after it was okayed by the UK government. Mass inoculations began in the UK on Tuesday. The company was also the first to submit a proposal for emergency use in India, on December 6.
The Pune-based SII is developing a vaccine that is based on the AstraZenece-Oxford candidate called Covishield. SII’s proposal was also filed on December 6.
On December 7, the Hyderabad-based Bharat Biotech became the third vaccine-maker to apply for emergency use authorisation for Covaxin, the vaccine candidate that was indigenously developed by the company in collaboration with the Indian Council of Medical Research (ICMR).
At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a vaccine for COVID-19 will be ready in a few weeks.