Nod for proposal to study mixing of Covid-19 vaccine doses


Panel of India’s central drug authority has recommended Christian Medical College in Vellore for conducting a clinical trial of mixing of two Covid-19 vaccines — Covaxin and Covishield, reports Asian Lite News

An expert panel of India’s central drug authority has recommended granting permission to the Christian Medical College (CMC) in Vellore for conducting a clinical trial of mixing of two Covid-19 vaccines — Covaxin and Covishield — official sources said.

The panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word “interchangeability” from the study title and submit a revised protocol for approval.

“The SEC (subject expert committee) after detailed deliberations recommended granting permission to CMC, Vellore for conducting the phase-4 clinical trial covering 300 healthy volunteers for mixing of Covid-19 vaccines Covaxin and Covishield,” a source said.

“The aim of the study is to assess whether a person can be given two different vaccine shots — one each of Covishield and Covaxin — to complete the inoculation course,” the source said.

The expert group also discussed the application by Biological E for conducting Phase 2/3 clinical trial of its Covud-19 vaccine in the paediatric population aged 5 to 17 years, along with the safety and immunogenicity data (after dose 1) from the ongoing phase 2/3 clinical trial on adults.

“After deliberation, the committee recommended that the safety and immunogenicity data from phase 2 part of the phase 2/3 clinical trial on adults should be submitted to the CDSCO (Central Drugs Standard Control Organisation),” the source said.

It also suggested that the firm should submit the clinical trial protocol along with data for further review by the committee, the source said.

The application of Johnson and Johnson (J&J) seeking permission to conduct phase-3 clinical trial of its single-dose Covid-19 vaccine was on the agenda, but “the firm informed that they are withdrawing their proposal,” another official source said.

The US-based pharmaceutical company J&J had sought approval for conducting phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups — those aged between 18 and 59 years and those aged 60 and above — to evaluate the safety, reactogenicity, and immunogenicity of the jab in healthy Indian adults.

The firm has conducted clinical trials in the USA, Brazil and South Africa.

J&J’s single dose vaccine first received the emergency use authorisation (EUA) in Bahrain on 25 February 2021. As of April 16, 2021, the vaccine has been approved in several countries/markets around the world, including the US and the EU.

Kerala’s daily Covid TPR jumps to 15.91%

Meanwhile, hovering over the 13 per cent mark for a while, the daily Covid test positivity rate in Kerala on Tuesday jumped to 15.91 per cent, Chief Minister Pinarayi Vijayan said.

In a statement issued here, he said that 21,119 people turned Covid positive after 1,32,769 samples were tested in the past 24 hours.

This is the first time in a few weeks that the daily TPR has crossed 15 per cent, while Kerala continues to have more than 50 per cent of the daily new cases in the country.

Vijayan also said that there were 1,71,985 active cases in the state after 18,493 people turned negative.

The day also saw 152 Covid deaths, taking the death toll to 18,004.

Malappuram district continues to lead in the number of daily cases, with 3,603, followed by Ernakulam with 2,539 cases.

With Kerala now heading for Onam festival season, it remains to be seen on what would be its impact as most of the restrictions have been relaxed till August 22, including lifting of triple lockdown on Sundays.

Hitherto since April, all Sundays saw triple lockdown across the state but on account of Independence Day and Third Onam falling on Sundays, there will be no lockdown.

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