Health Ministry Refutes Media Reports Of Serum, Bharat Biotech EUA Rejected

The subject expert committee at the national regulator has asked the two vaccine manufacturers to reappear with more data

The Ministry of Health and Family Welfare took to Twitter to call out a graphic by NDTV that said the Emergency Use Authorization (EUA) requests filed by Serum Institute of India and Bharat Biotech for their COVID-19 vaccines have been rejected.

Both the vaccine makers presented before the Subject Expert Committee (SEC) meeting held on Wednesday at the Central Drugs Standard Control Organization (CDSCO), The SEC updated its minutes of its meetings stating that both the manufacturers need to return with more data.

Emergency Use Authorisation is wherein the process of approval of a vaccine/drug is expediated during a health emergency. Unapproved medical products are permitted to be used for prevention and treatment under EUA.

The Ministry did not give any information other than what is in the tweet. BOOM sought a clarification from the Ministry spokesperson but did not receive a response.

BOOM contacted both Serum Institute and Bharat Biotech who declined to comment on the latest developments.

Other news organizations such as CNBC TV 18 and India Today reported citing sources that the SEC found that the data provided by both the companies was inadequate to grant approval. Both the vaccine manufacturers have been requested to reappear with more data, trial information and documents to seek further approval.

CNN News 18 also reported citing sources that the Emergency Use Authorisation was 'rejected' by DGCI.

BOOM looked at NDTV's coverage to understand what was being reported at the time when the news of the proposals being rejected was shared. The graphic on the screen as well as the anchor said that the proposal was rejected.

The reporter, however, is heard saying, "The committee has recommended that they (Serum Institute of India and Bharat Biotech) need to give in more data. But what we would want to really highlights to our viewers at this point of time is that this decision is not to be seen as a finality sort of way because the job of the expert committee is to give recommendations to the regulators. The decision of approving a vaccine is not taken in one meeting alone."

Normally, the CDSCO uploads the minutes of the meetings that are held for drug and vaccine approval on its website. The members of the SEC deliberate and analyse the data presented to them in the meetings and ask for more data if they feel that it is insufficient. Before they began their clinical trials, both Serum and Bharat Biotech were even then asked to reappear before the committee with adequate data.

The SEC has asked both the vaccine manufacturers to return with more data on the safety and immunogenicity of the vaccines.

Currently, Pfizer, Serum Institute, and Bharat Biotech applied for EUA to the CDSCO. While the other two are undergoing Phase 3 trials, Pfizer has not conducted any trials in the country.

(Note: This story has been updated with the minutes of the SEC meeting)

Updated On: 2020-12-25T19:13:06+05:30
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