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COVID-19 vaccine for 5 to 11 year old kids will be available soon!

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.”

Clinical trials – Sinopharm’s Vaccine 
Sinopharm’s vaccine is the first China-made jab to get approval by the World Health Organisation in May 2021. Unlike the BioNTech vaccine which uses the mRNA technology, Sinopharm’s BBIBP-CorV uses inactivated viruses and carries a 79% efficacy rate in third phase clinical trials. According to the Ministry of Education in China, a billion doses of it have already been administered till date in the adult and teen population, including 91% of the 12 to 17 year olds who have already taken the jab without any known side-effects.
The Sinopharm trial enrolled 288 children in phase one and 720 children in phase two in the Henan province. Phase three research is ongoing in the United Arab Emirates, where children as young as three are enlisted in the study. Till date, critical reactions were not observed except for one in a child with known food allergies, other side-effects have been “mostly mild to moderate”. The vaccine has been approved on an emergency basis for use on children age three to 17 in China, though immunizations have been focused on 12 and above.
In an encouraging development, the Chilean government has independently approved the use of another China-made jab, the Sinovac vaccine, for use on children above the age of six. Previously, only the Pfizer-BioNtech vaccine had obtained approval in Chile for use on 12 to 17 years old. 
Data of Sinopharm’s clinical trials has been published in prestigious medical journal, The Lancet
2021-09-21T17:18:18+00:00 September 21, 2021|Latest, Wellbeing|