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CDSCO expert committee seeks India-specific trial data of Covaxin and Covishield vaccines

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While reviewing the application of Serum Institute, the SEC recommended that the firm submit updated safety data of the Phase II/III clinical trials in the country along with immunogenicity data from the clinical trial in UK and India.

CDSCO expert committee seeks India-specific trial data of Covaxin and Covishield vaccines
In its first review of the applications for emergency use approval of COVID-19 vaccine candidates Covaxin and Covishield, the Indian Drug Regulator's subject expert committee has sought country-specific trial data on both vaccines.
While reviewing the application of Serum Institute, the SEC recommended that the firm submit updated safety data of the Phase II/III clinical trials in the country along with immunogenicity data from the clinical trial in UK and India. SII is currently conducting bridge Phase III trials of Covishield on 1600 participants in India and a senior company official told CNBC-TV18 that the Phase III immunogenicity data is expected by the third week of December.
On December 9, the SEC noted that since Oxford-Astrazeneca's proposal for grant of emergency use authorisation (EUA) is currently under evaluation with the UK drug regulator MHRA, Serum Institute must also submit the outcome of the assessment of UK-MHRA for grant of EUA. "As per the condition of the permission to conduct phase II/III clinical trial in the country, the clinical data generated in the trial shall be considered along with the data from the OXFORD clinical trial outcome," according to the minutes of the SEC meeting.
SII had submitted interim safety data from Phase II/III clinical trials carried out in India and interim safety and efficacy results of Phase II/III and Phase III clinical trials carried out in UK, other countries and India before the committee.
While reviewing data submitted by Bharat Biotech for approval of its vaccine Covaxin, the expert committee recommended "the firm should present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration".
Bharat Biotech had submitted interim safety and immunogenicity data of Phase I and II clinical trial carried out in the country before the committee. Company had commenced Phase III trials on November 17 for its Whole Virion, Inactivated Corona Virus Vaccine (BBV152) and efficacy data from Phase III trials has yet not been generated.
Covaxin is a two-dose vaccine to be given 28 days apart and the company has earlier stated that it is "designed for efficacy 14 days after the second dose."
Pfizer Inc which was the first to apply to DCGI for the emergency authorisation of its mRNA vaccine sought more time before making its presentation before the expert committee.
Pfizer's vaccine is up for a review by the US FDA for a US emergency authorisation on December 10th. Pfizer which has submitted global clinical trial data has sought for a waiver of bridge clinical trials in India. Pfizer's vaccines has already been approved by UK, Bahrain and Canada.
Meanwhile, Prime Minister Narendra Modi said last week that experts believe that the wait for a COVID-19 vaccine will not be long and it may be ready in a few weeks, asserting the vaccination drive in India will begin as soon as scientists give the nod. In his remarks here at an all-party meeting held virtually, Modi said healthcare workers involved in treating COVID-19 patients, frontline workers, who include police personnel and municipal staff, and old people suffering from serious conditions would be inoculated on priority. Noting that there have been questions about the price of the COVID-19 vaccine, the prime minister said it is natural to have such queries and asserted that public health will be accorded top priority in the matter and states will be fully involved.

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