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

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.

Certificates for clinical trial candidates
 
The government would soon issue vaccination certificates through the CoWIN portal for those who were part of the vaccine trials. The health ministry has directed the Indian Council of Medical Research to collate information of such persons in a specified format.

 
Only those candidates who were part of the trial of vaccines that have already been given Emergency Use Authorisation will be granted such certificates. These include Covishield, Covaxin and Sputnik. People who received the placebo would not get the certification. Participants of these studies will be able to download the certificate through their mobile number or CoWIN account.


Cases rising in 22 districts
 
Over 10% positivity in 54. Even as India registered the lowest daily cases in 132 days at less than 30,000, there is an upward trend in Covid cases in 22 districts in the last four weeks. The number of districts showing over 10 per cent positivity rate has also increased to 54 in the last week compared to 46 the week before.

 
“It may be an aberration but it is a cause of concern that the second wave is not over. We may be tired but the virus is not,” said V K Paul, member-health, Niti Aayog during a press briefing on the Covid situation in India.
 
The states where districts have shown an increase in daily cases in the last month include Kerala, Manipur, Meghalaya, Arunachal Pradesh, Maharashtra, Assam and Tripura.
 
Ten districts in Kerala had over 10 per cent positivity rate in the last week; and seven are seeing an increasing trend in cases including Alappuzha, Kottayam, Malappuram, Thrissur, Wayanad, Ernakulam and Pathanamthitta.

 
The health ministry said it was in constant touch with states for early detection of cases. “Reproduction number in Kerala is 1.2,” said Paul, adding. “Mortality in the state is not high but when there is so much virus replication, variants can emerge and other areas can get the infection.”