While the Indian government has given the green signal to use Bharat Biotech's Covaxin for children between 2-18 years, experts feel vaccines for children should undergo extensive clinical trials before commercial use. Most established Covid-19 vaccines in the global market are still undergoing trials among children in various age groups, they cite.
The Pfizer-BionTech and Moderna mRNA vaccines, proven to be the most effective and safe, have not been approved for use in the U.S. for children under 12 years. While the Pfizer vaccine is allowed for 12 years and above, Moderna is allowed to use it for 18 years and above in the US. But Moderna has been sanctioned to use the vaccine among 12-17 year age group in Europe. The US Food and Drug Administration (USFDA) has asked companies to expand the size and scope of their paediatric studies, as these are inadequate to detect rare side effects such as inflammation of heart muscles, which was detected in many people under 30 years who took the m-RNA vaccines.
Extensive trial data needs to be analysed for Covid-19 vaccines before giving approval for use in children, Soumya Swaminathan, chief scientist of the World Health Organization (WHO) told Fortune India a week ago. "Some adenoviral vector platform vaccines (like Sputnik and Covishield) have seen the issue of clotting in some of the vaccinated, especially younger people. Therefore, before we use vaccines in kids, we require large studies and data," she said.
Similarly, Johnson and Johnson's single-dose vaccine has not been given clearance for use among kids in the U.S., though it has sought permission for trials in many countries including India. Russia's Sputnik V is also yet to be used among children, as trials are progressing in the 12-17 age group. Chinese vaccines from Sinopharm and Sionovac are also yet to be used commercially on a large scale even in China, they cite.
Dr. Bipin Singh, assistant professor, School of Engineering & Technology, BML Munjal University (BMU), said it was very interesting to observe that DCGI has given the nod for emergency use of Covaxin for children between 2-18 years based on very small clinical trial data, compared to much larger clinical trials done on adults. "It would have been better if it was first approved for children between 10-18 years and based on a larger and diverse pool of clinical trials data and long-term evaluations it should have been recommended for use in kids less than 10 years", he said.
Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years in September and trial data results are yet to be published. In one of the first approvals worldwide for Covid-19 vaccines, the Subject Expert Committee (SEC) on Covid-19 formed by the government on Tuesday recommended the Drug Controller General of India (DCGI) grant emergency use approval for the 2-18 age group. Zydus Cadila's Zycov-D was earlier approved for emergency use among kids in 12-18 age group. Serum Institute-Novax's Covovax and Biological E's Corbovax are undergoing trials among kids in different age groups.