Covid-19 vaccine for children likely in August: Health minister Mandaviya
Zydus Cadila has done trials on 12-plus; Bharat Biotech conducting trials on two-plus
 "coronavirus, covid-19, tests, children, child, kids")
premium
The DCGI and its expert committee are reviewing data submitted by Zydus for its Phase 3 clinical trial, comprising 28,000 people.
The government has indicated that Covid-19 vaccines for children are likely to be available next month. Health Minister Mansukh Mandaviya made the statement during the BJP Parliamentary Party meeting on Tuesday, according to reports.
The health ministry, in response to a query, said clinical trials were on and a decision will be taken based on expert opinion. “If the data is robust, experts will decide whether the vaccines can be given to children,” Lav Agarwal, joint secretary, health ministry, said.
Two vaccine makers — Bharat Biotech, maker of Covaxin, and Zydus Cadila — are developing these vaccines.
Ahmedabad-based pharma major Cadila Healthcare (Zydus Cadila) is awaiting approval from the Drugs Controller General of India (DCGI) for its vaccine, ZyCoV-D. It has sought approval for its use in children above 12 years, and has already submitted safety and tolerability data from the Phase 2 clinical trials. The firm has generated data on 1,000 adolescents (between 12 and 18 years) from its Phase 3 trials, too. This data will be submitted to the regulator soon.
The company plans to soon start clinical trials on children aged five and above for its plasmid DNA technology-based Covid-19 vaccine, its Managing Director, Sharvil Patel, told Business Standard last week.
So far, no vaccine in the world has been approved for children below 12 years. India’s Bharat Biotech is now in the middle of conducting clinical trials on children above two years for its candidate, Covaxin.
The DCGI and its expert committee are reviewing data submitted by Zydus for its Phase 3 clinical trial, comprising 28,000 people.
ZyCoV-D has shown 66.6 per cent efficacy in an interim analysis of the candidate’s Phase 3 trials, and can be stored at 25 degrees Celsius for three months. It is a three-dose vaccine given on day zero, day 28, and day 56.
Zydus has also submitted immunogenicity data from a two-dose regimen (using 3 mg doses) trial to the DCGI, which shows “equivalent immunogenicity” with that of the three-dose regimen.
The government also said that many states are taking decisions to open schools but all protocols have to be followed to ensure the safety of children and staff. “Schools have been closed for a long time and society is concerned about learning loss. It is a tight-rope walk,” said V K Paul, member (health), Niti Aayog.
The health ministry, in response to a query, said clinical trials were on and a decision will be taken based on expert opinion. “If the data is robust, experts will decide whether the vaccines can be given to children,” Lav Agarwal, joint secretary, health ministry, said.
Two vaccine makers — Bharat Biotech, maker of Covaxin, and Zydus Cadila — are developing these vaccines.
Ahmedabad-based pharma major Cadila Healthcare (Zydus Cadila) is awaiting approval from the Drugs Controller General of India (DCGI) for its vaccine, ZyCoV-D. It has sought approval for its use in children above 12 years, and has already submitted safety and tolerability data from the Phase 2 clinical trials. The firm has generated data on 1,000 adolescents (between 12 and 18 years) from its Phase 3 trials, too. This data will be submitted to the regulator soon.
The company plans to soon start clinical trials on children aged five and above for its plasmid DNA technology-based Covid-19 vaccine, its Managing Director, Sharvil Patel, told Business Standard last week.
So far, no vaccine in the world has been approved for children below 12 years. India’s Bharat Biotech is now in the middle of conducting clinical trials on children above two years for its candidate, Covaxin.
The DCGI and its expert committee are reviewing data submitted by Zydus for its Phase 3 clinical trial, comprising 28,000 people.
ZyCoV-D has shown 66.6 per cent efficacy in an interim analysis of the candidate’s Phase 3 trials, and can be stored at 25 degrees Celsius for three months. It is a three-dose vaccine given on day zero, day 28, and day 56.
Zydus has also submitted immunogenicity data from a two-dose regimen (using 3 mg doses) trial to the DCGI, which shows “equivalent immunogenicity” with that of the three-dose regimen.
The government also said that many states are taking decisions to open schools but all protocols have to be followed to ensure the safety of children and staff. “Schools have been closed for a long time and society is concerned about learning loss. It is a tight-rope walk,” said V K Paul, member (health), Niti Aayog.