ZyCov-D, an indigenously developed vaccine by Zydus Cadila for children above 12 years, will be examined this week by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO), the apex approval authority for new medicines in the country under the Directorate General of Health Services (DGHS).
The SEC of the CDSCO will check the phase 3 trial data for the ZyCov-D vaccine shared by Zydus Cadila, assess the same and then could authorize the vaccine for emergency use, subject to satisfactory results.
The Zydus Cadila teams will soon be called for a presentation for this.
The emergency approval will take a few more days as per the sources, tweeted news agency ANI.
What is ZyCoV-D vaccine?
ZyCoV-D is a plasmid DNA vaccine, which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, says a company statement. These play a vital role in protection from disease as well as viral clearance.
ZyCoV-D is a three-dose, intradermal vaccine, which is applied using the pharmajet needle-free system, Tropis, as per the company.
ZyCoV-D is stored at 2-8°C but has shown good stability at temperatures of 25°C for at least three months.
What’s the status of the vaccine?
Cadila Healthcare said on July 1 that it had filed an application with the Drug Controller General of India (DCGI) seeking emergency use authorization (EUA) of its COVID-19 vaccine for the 12-18 age groups.
Dr Sharvil Patel, Managing Director, Cadila Healthcare, said in an official statement that the vaccine can help adults (a similar tolerability profile was noticed) as well as adolescents in the 12-18 age groups.
The company claims to have conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centres.
This was also the first time, claims the company, that any COVID-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India. Around 1,000 subjects were enrolled in this age group and the vaccine was found to be safe and well-tolerated, the pharma major claimed.
The company claimed that the primary efficacy of 66.6 percent has been attained for symptomatic RT-PCR positive cases in the interim analysis. The company added that no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100 percent efficacy for moderate disease.
No severe cases or deaths due to COVID-19 occurred in the vaccine arm after administering the second dose, it said.
ZyCoV-D had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier, as per the company statement. The Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
The plug-and-play technology on which the plasmid DNA platform is based is ideally suited for dealing with COVID-19 as it can be easily adapted to deal with mutations in the virus.
The company plans to manufacture 10-12 crore doses annually (one crore every month). The supply of ZyCov-D could start from August-September.
ZyCov-D will be the fifth vaccine against Coronavirus (after Covishield, Covaxin, Sputnik V and Moderna) to get EUA in India.
Covid-19 vaccine for children in other countries
Israel lifted the ban on children and Prime Minister Naftali Bennett allowed vaccinating teens in June. Israel launched a national campaign to reach at least 60 percent of adolescent vaccinations before the start of the school year.
Only 2-4 percent of the 12-15-year-olds (out of about 75 percent of Israelis in eligible age groups vaccinated) had received the Pfizer-BioNTech vaccine as of June 22, as per Health Ministry data. However, Israel has left it to the parents to decide about the vaccination of their children, according to a Reuters report.
In the United States, over 2 million kids have been vaccinated without significant problems. In May this year, the US Centers for Disease Control and Prevention (CDC) approved Pfizer-BioNTech COVID-19 Vaccine for children above 12 years and teens.
At present, vaccine manufacturers Pfizer and Moderna are conducting trials in healthy children between the ages of 6 months and 11 years old. These vaccine developers have enrolled thousands of children across the US, Poland, Finland and Spain.
(Edited by : Anshul)
First Published: IST