Children have rarely suffered a serious blow from COVID-19 but a jab for school going children would be a huge step towards normalcy, cutting down on severe cases of illness and ensuring a regular academic year. And in a highly anticipated announcement, data from BioNTech clinical trials published on Monday shows that a lower dose of the COVID-19 vaccine – roughly one-third the amount given to adults and teens — is safe and effective in cutting down COVID-19 infection in children as young as five.
The positive news from Pfizer-BioNtech research coincides with clinical trials being simultaneously conducted by Sinopharm’s Beijing Institute of Biological Products which found that its two-dose shot, BBIBP-CorV, widely used in China’s immunization program, triggers a “robust immune response” in children as little as three to 17.
The news comes at a time when the highly contagious Delta variant of COVID-19 has spread to three coastal cities in China – Putian, Xiamen, Quanzhou – putting nearly 50 school going children in isolation, a safe and effective vaccine for the younger age group was the need of the hour. Scroll below for all the details:
Clinical trials – BioNTech Vaccine
BioNtech conducted the research on 2,268 participants aged five to 11 and gave them two doses of the vaccine, three weeks apart. A 10-microgram dose was selected for children – that’s one-third of the 30-microgram dose given to teens and adults.
The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age – Pfixer-BioNTech in a press statement.
A high level of antibodies after the vaccination determines the efficacy of the jab. Blood work post the trial revealed a “strong immune response in this cohort of children one month after the second dose”, according to the pharma company spokesperson. Complete data of the clinical trial will need to be submitted to the US Food and Drug Administration for peer review and scrutinized by regulators for approvals, the process is expected to be completed by the end of September and if everything is on track, vaccines for this age group might be available for use by Halloween.
The vaccine will have to meet the highest standards of safety before it gets the final clearance from the US FDA and World Health Organisation. A Pfizer-BioNTech spokesperson said that there were no instances of myocarditis, a type of heart inflammation linked with mRNA vaccines, in the trial but clinically 1 in 5,000 teenage boys run the risk of critical side effects of heart muscle inflammation after the shot. The company will now start clinical trials on children as young as 6 months “as soon as the fourth quarter of this year.”