An expert panel of the country's central drug authority on Wednesday recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trial of COVID-19 vaccine Covovax on children aged two to 17 years, sources said.
The SII applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.
What's the objection?
The expert group responsible for assessing the merits of SII's proposal has noted that the vaccine has not been approved in any country and the trial on adult population in India also began only in March. The government panel has asked Serum Institute to complete trials of Covavax COVID-19 vaccine on adults first, ANI reported citing sources.
"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country," a source said.
"It also recommended that the Pune-based company should submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children," the source said.
The recommendations are learned to have been approved by the DCGI.
In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.
The clinical trials of Covovax began in India in March and the SII hopes to launch it by September for adults.
In January, the SII had rolled out the Covishield vaccine in the country. It had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
Are there any other vaccine candidates for children in India?
Apart from SII, India's indigenously developed COVID-19 vaccine Covaxin, developed by Hyderabad-based Bharat Biotech, started trials for children in the first week of June.
India's drug regulator had granted permission for conducting the Phase 2/3 clinical trial of Covaxin in the age group 2 to 18 years on 12 May.
The trial on children is underway at AIIMS Patna, AIIMS Delhi and Meditrina Institute of Medical Sciences Nagpur to see if the Bharat Biotech jab is suitable for children.
These trials will be conducted on 175 children across the country with every centre carrying out 20 (trials) each, AIIMS Patna Superintendent Dr CM Singh said.
In total, the trials will be conducted on 525 healthy volunteers — 175 of 12-18 years, 175 of 6-12 years and 175 of 2-6 years — to judge the safety, reactogenicity and immunogenicity of the vaccine in children.
Participants would be given the vaccine after their screening report comes.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. "The screening of children for conducting the trial of Covaxin has started. Participants would be given the vaccine after their screening reports come," Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS, told PTI.
Dr Prabhat Kumar Singh, Director, AIIMS, Patna said 54 children registered for the trials of which 16 were in the age group of 12-18. Twenty children of 12-18 years have been vaccinated till now as part of the clinical trial at AIIMS Patna, for which 100 minors have lined up so far, officials told NDTV.
Apart from physical examination, RT-PCR tests were also conducted on these children to check for COVID-19 antibodies or any other pre-existing diseases, he added. "After these trials, the age group will be 6-12 years and then 2-6 years but now we have started trials in the age group of 12-18 years," Singh said.
According to News18, Ahmedabad-based Zydus Cadila is testing its COVID-19 vaccine candidate on children of 12-18 years, apart from adults, and the company is likely to apply for licensure of the vaccine in the next two weeks, a government official said.
Russian news agency TASS in May quoted the director of Gamaleya National Research Center for Epidemiol as saying that trials of the Sputnik V vaccine against the coronavirus infection in children may begin in the next few weeks provided a corresponding permit from the Russian Health Ministry is obtained.
Modenra, the America-made vaccine candidate which is imported in India by Cipla, filed a request with the European Medicines Agency seeking authorisation for use in adolescents in the 12-17 age group. The US Food and Drug Administration (FDA) is also reviewing its medical trial data for emergency use authorisation of its vaccine in kids 12 and up.
Asked if the Pfizer vaccine, if it comes to India, will be considered for children between the age of 12 and 15 years as being approved by the UK, NITI Aayog Member (Health) VK Paul had said that the country has its own vaccines which are being readied for children.
"Child cohort is not a small cohort. My rough guess is that if it is between 12 to 18 years, this itself is about 13 to 14 crore population and for which we will need about 25-26 crore doses,” he said.
He further shared that Zydus Cadila's vaccine is already being tested in children. "So when Zydus comes for licensure, hopefully in the next two weeks, maybe we have enough data to take a view on whether the vaccine can be given to children," he said.
With inputs from agencies