Expert panel seeks more data from SII, Bharat Biotech
NEW DELHI: The expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data from the Serum Institute of India and Bharat Biotech for their coronavirus disease (Covid-19) vaccine, after deliberating upon their applications seeking authorisation for the shots
At a meeting to review the emergency authorisation of vaccine makers, the CDSCO’s subject expert committee (SEC) reviewed the authorisation sought by Serum Institute and Bharat Biotech but did not consider a similar application from Pfizer-BioNTech because their US experts could not attend the meeting.
An official with direct knowledge of the matter told news agency Reuters 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, even as the government has said that some vaccines may be approved in the coming weeks.
Another official said: “The CDSCO just wants more data on efficacy and safety before making a decision. It is part of the process”.
While considering Serum Institute’s application, the CDSCO is learnt to have asked for updated safety data of phase-2 and phase-3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA), news agency PTI quoting government officials said.
As for Bharat Biotech, after detailed deliberations, the SEC recommended that the firm should present the safety and efficacy data from the ongoing phase-3 clinical trial in the country for further consideration, the officials said.
Pune-based Serum Institute of India, the world’s largest vaccine manufacturer, requested approval for the Oxford University-AstraZeneca vaccine, on December 6.
US drugmaker Pfizer sought
Indian approval on December 4 after securing clearances in the UK and Bahrain. On Monday, Hyderabad-based Bharat Biotech became the third vaccine manufacturer to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously-developed vaccine, named Covaxin.
The Oxford-AstraZeneca vaccine has shown an efficacy of 62% when volunteers were given two full doses of the vaccine, but a higher 90% when the first was a half-strength dose, according to interim results from trials in the United Kingdom and Brazil. In India, the vaccine’s trials are being carried out by Serum Institute, which is also producing a billion doses of the shot.
According to top-line data released by Pfizer, its vaccine has 95% efficacy.
The candidate of Bharat Biotech still undergoing large scale Phase 3 clinical trials and the data from the combined Phase 1/2 trials is not public yet.
To be sure, the only locally made vaccine anywhere close to being approved is the SII-manufactured AstraZeneca/Oxford one.