PUNE, India — India, which faced a severe second wave of Covid-19, is still scrambling to complete the vaccination trials for children.
The pace of trials concerns, especially because some experts suggest that the third wave of Covid might severely impact children. There is no prediction on when the third wave is likely to hit the country.
The Central Drugs Standard Control Organization — India’s apex regulatory body for pharmaceutical and medical devices — announced the beginning of second and third phase trials for children on June 1.
Seven premier medical institutes in India are conducting trials for children aged between 2 and 18 years. The first round of second phase trials began in All India Institute of Medical Sciences (AIIMS)-Patna, in the eastern state of Bihar, on June 3.
“Recruitment of children is underway, and the process will start immediately,” Rajath Rao, senior resident at AIIMS-Patna, told Zenger News.
“Numerous factors affect the trials for children, and it will take six to eight months for the process to complete and the vaccines to roll out.”
India started trials for the Covid vaccine for children only on May 11. By then, a lot of children were impacted during the second wave.
Vaccination program: Comparing nations
Many nations, meanwhile, have already begun vaccinating their children.
The U.S. began vaccinating children above 12 years in May when India was starting with trials for children. US Centers for Disease Control and Prevention notes: “Everyone 12 years and older should get a vaccination to help protect against Covid-19. Children 12 years and older can get the Pfizer-BioNTech Covid-19 vaccine.”
U.S. pharma giant Pfizer has also begun testing its Covid-19 vaccine for those below 12 years.
India’s neighbor China recently approved vaccines manufactured by Sinovac Biotech and Sinopharm for emergency use in people aged three to 17. Singapore, another South Asian country, opened up its vaccination program to adolescents aged 12-18 from June 1.
In Europe, Italy agreed to extend the use of the Pfizer-BioNTech vaccine to 12-15-year-olds on May 31. Germany started to offer the first shot to children aged 12-16 from June 7.
On June 1, Dubai said it began offering the Pfizer-BioNTech vaccine to 12-15-year-olds after the United Arab Emirates approved the shot for emergency use.
Meanwhile, India is looking to collaborate with Pfizer to locally manufacture their Covid-19 vaccines to start vaccinating children above 12 years. India’s negotiations got a boost after the U.K.’s medicines regulator widened the ambit of the Pfizer-BioNTech vaccine to children aged between 12-and-15 years.
Where does India stand
Under the trials, children are being injected with the Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, the national body in India, for the formulation, coordination, and promotion of biomedical research.
The children are divided into three groups — the first group is 2 to 8, the second 8 to 12, and the third 12 to 18.
“We have commenced the trials and have recruited 10 children, with the registration process still on,” Rao said.
For the children’s trial, 525 healthy volunteers will be administered the doses of Covaxin, with 175 in each age group.
“We don’t have a specific target as such because all the selected centers have to study the trials for 525 healthy children,” C.M. Singh, principal investigator of the trial at AIIMS-Patna and the medical superintendent, told Zenger News.
“The aim is to check the safety, reactogenicity, and immunogenicity of the vaccine in children.”
AIIMS-Patna finished the first stage of the second phase trials for the 12-18 years’ category, and children were administered the first dose of the vaccine on June 7.
“Around 74 children in the 12-18 years’ category registered for the trial, of which 27 were eligible. They were administered the first dose of Covaxin and will receive the second dose 28 days later,” Singh said.
The selected volunteers will receive INR 1,000 ($13.73) reimbursement per visit to the institute.
AIIMS-Patna also oversaw Covaxin trials for adults. The trials for Covaxin for adults at AIIMS-Patna started last year and ended on February 3. Forty-six volunteers took part. The second phase of the trials saw 44 volunteers and ended on April 7.
The third phase of the trials, which started in December 2020, for adults is expected to end by September.
The Indian government decided to start the administration of Covaxin for emergency use in January without phase three trial data. The final data is not out even almost six months after emergency use approval was granted. The government has recently said the data from the final analysis would be made public by June 20.
Bharat Biotech published interim analysis for the third phase of their trial, but the results are not peer-reviewed, which is considered to be the final data on vaccinations.
Their findings stated that their vaccine demonstrated an interim efficacy of 81 percent in preventing Covid-19 in those without prior infection after the second dose. Their study included data from 25,800 respondents between the age of 18 to 98. Bharat Biotech plans to start the fourth phase of the trial soon.
“The data was quite good for adults and, hence, the government took the decision [of granting emergency use before final data],” Singh said. “Emergency approval for children can also be done if the data from the initial trials show good results.”
Rollout might not be that soon
While addressing the nation on June 7, Indian Prime Minister Narendra Modi said the vaccine trials for citizens below 18 were underway, and the results will be out soon.
But medical experts believe it will be a long process, somewhere between six and eight months, before the trials throw up significant data for the rollout of vaccines among children to begin.
“The volunteers have to undergo RT-PCR test and antibody test, along with the consent of their legal guardian,” Purushottam, senior resident, AIIMS-Patna, told Zenger News.
The protocol states five visits, and the data system management keeps track of the regularities or irregularities in children.
“We keep a regular check on children enquiring about any signs or symptoms of discomfort and based on the same we calculate the antibodies that are created in the child. Hence, we come up with a set of data proving the efficiency of the vaccine,” Purushottam said.
The third phase is expected to end in September this year.
Other medical institutes like AIIMS-Delhi and Meditrina Institute of Medical Sciences, Nagpur, in the western state of Maharashtra, have also begun trials.
“The follow-up period for the trials is expected to be a minimum of six months,” Anand Rathi, research coordinator, Meditrina Institute of Medical Sciences, Nagpur, told Zenger News.
“We are working towards getting proper data of the vaccine on children that will help at the beginning of circulation of vaccination among them.”
In addition to Covaxin, Ahmedabad-based Zydus Cadila is also testing its vaccine for children aged 12-18. The company is soon expected to apply for a license.
Some experts are predicting the third wave of Covid-19 to impact children severely.
However, Singh believes these are mere speculations, and no adequate research is available to support this hypothesis.
“In almost any Sero survey done by any research institute, it was shown that adults and children had been infected almost at the same rate in the second wave. The third wave might be harmful, but one cannot conclude that children are in grave danger.”
(Edited by Gaurab Dasgupta and Amrita Das)