COVID-19 vaccine trials for kids 6 months and up, what we know so far

VACCINES FOR CHILDREN: There UAE has organised vaccinations among school-going children against COVID-19 ahead of the academic year. The new school year started on August 29, 2021. Sinopharm was the first vaccine authorised for children in the 3-11 years age group. On Monday (November 1, 2021) the UAE has given an emergency-use authorisation for the Pfizer COVID-19 vaccine for 5 to 11-year-olds.

900 CHILDREN TOOK PART IN UAE VACCINE TRIAL: Clinical trials hold the key in proving vaccine safety and efficacy with scientific data. In June 2021, the UAE launched a clinical trial of the Sinopharm COVID-19 vaccine on children, with 900 children aged between 3 and 17-years-old enrolled. Following rigorous trials, the UAE approved the Sinopharm COVID vaccine for children for that age group.

VACCINE BRIDGE STUDY IN THE UAE: On August 1, 2021 (Sunday), Abu Dhabi’s health regulator, the Department of Health (DoH) announced the successful completion of the Sinopharm “bridge study”. The clinical trial was carried out under the supervision of the Ministry of Health and Prevention (MoHAP), in collaboration with the Abu Dabi Health Services Company (Seha), the emirate’s public health provider.

IMMUNE RESPONSE: It was the first project in the MENA region designed to study young children’s immune response to being inoculated against COVID-19. Other vaccine-making countries — China, US, UK and India — have also begun clinical trials for this group over the past few months.

VACCINE FOR CHILDREN APPROVED: On August 2, 2021, the UAE approved the use of Sinopharm vaccine for children aged between 3 and 17 years, following the results of clinical studies. The move came following a strict assessment that led to emergency-use approval of the vaccine for the young ones and the local evaluation that complies with the country’s health regulations. Children have signed up with full parental consent.

YOUNG HEROES: Children of different nationalities were enrolled, and administered Sinopharm vaccine doses. The children were also closely monitored over the following weeks. The participating children and their families had been hailed as “heroes” in the UAE’s fight against the COVID-19 pandemic. The children’s shots came with full parental consent.

CHANGING THE COURSE OF THE PANDEMIC: Every drug or jab must first undergo rigorous tests. Vaccine trials on children ages 6 months to 2 years old, then 2 to 5 and 5 to 11 had been conducted and reviewed. In the US, an advisory committee reviewed data from a clinical trial testing a low-dose version of the Pfizer-BioNTech vaccine on children in that age group — and voted nearly unanimously to recommend that the FDA grant emergency approval. Billions of COVID-19 vaccines had been administered on adults, and are proven to work. Now, with more countries approving COVID-19 shots for youngsters, inoculating the world's 1.9 billion children could change the course of the pandemic, the journal 'Nature' reported on October 27, 2021. Photo shows Yassin Rashwan getting vaccinated against COVID-19 at Al Barsha Health Centre, Dubai.

PREVENTIVE: A Kuwaiti teenager holds her phone showing off her COVID-19 coronavirus vaccination certificate after receiving her shot of the Pfizer-BioNTech vaccine, at a vaccination centre in Kuwait City. On July 18, 2021, Kuwait kicked off offering vaccinations to children aged 12-15 ahead of the start of the school year in September.

MOVING FORWARD: Evaluation of COVID vaccines for infants and toddlers is now moving forward. Inci Yildirim, MD, PhD, associate professor of paediatrics (infectious diseases) at Yale School of Medicine, is leading Yale’s component of Moderna’s clinical trial of a vaccine for children 6 months to 12 years of age. Yildirim said vaccinating young children could protect their own health more than people assumed when the pandemic began.

DATA BY SEPTEMBER: With the highly-contagious Delta variant taking hold in communities across the world, and a new school year approaching, parents are eager for kids of all ages to have the protection of a COVID-19 vaccine. The Pfizer vaccine has been available for children aged 12 years or older. Both Pfizer and Moderna are running trials in children as young as 6 months old. Pfizer has said it expects data on 2 to 11 year olds in September.

VACCINE FOR CHILDREN AGES 3 AND UP APPROVED IN CHINA: On June 5, 2021, China approved a COVID-19 vaccine for children as young as three. The vaccine maker Sinovac told state broadcaster CCTV that it has been carrying out trials on minors and found no differences with adults. While other countries have authorised vaccinations for under-18s but nowhere else has given the green light for their use on such a young age group.

CLINICAL TRIAL: Currently, there are no approved COVID-19 vaccines for infants. Before vaccines can be approved, the shots need to be studied well, in terms of the right dosage for specific age groups (“age-ranging” study). In a "dose ranging” trial, different doses of the vaccine are tested in order to learn which dose is safe, and if it can produce the desired immune response.

RAPID TRIAL: The COVID-19 vaccine threshold is getting younger. On April 9, Pfizer and BioNTech submitted data based on completed clinical trials for ages 12 to 15. On May 10, 2021, the FDA authorised this age group to be vaccinated before the school year begins in late summer. In the past, vaccine trials took time. This is due mostly to the logistics involved in enrolling volunteers. With online databases today, the process is much faster.

4,600 PARTICIPANTS IN PFIZER TRIAL FOR INFANTS AND TODDLERS: There are least two trials on vaccines for children 6 months to 11 years old. One is the Pfizer/BioNTech trial, which seeks to enrol over 4,600 participants in 3 age groups 5 to 11-year-old age group; 2 to 5-year-old age group; and 6-month to 2-year-old age group. Participation in the study will last approximately 2 years. The clinicaltrials.gov ID for the Pfizer trial is NCT04816643. Dose finding is being initiated in this study in participants ≥5 to <12 years of age based on the acceptable blinded safety assessment of the 30-μg (microgram) dose in 12- to 15-year-olds in the previous (study code: C4591001).

90 SITES: Today, clinical trials had been hugely accelerated. With the internet, sign-up (a requirement for getting “informed consent”) is massive and rapid, which is not possible in the telegram age. For example, Pfizer announced on June 8, 2021 vaccine trials in healthy from 6 months to 11 years of age would involves 4,500 participants at more than 90 sites in the US, Finland, Poland and Spain. An interim data analysis is expected as early as next month (September).

OBSERVER-BLIND, PLACEBO CONTROLLED: In the case of Pfizer/BioNTech and Moderna trials, the Phase 2/3 are divided into two parts. Part 1 is an open label, dose-escalation, age de-escalation trials. Part 2 is randomised, observer-blind, placebo-controlled" expansion" study. Both will evaluate the safety, tolerability, “reactogenicity” and effectiveness of two doses. File photo shows kindergarten kids at play in Yongzhou in China's Hunan province.

MODERNA VACCINE TRIAL FOR INFANTS: On March 15, 2021 Moderna announced that the first participants had been dosed in the Phase 2/3 study, called the “KidCOVE” study. It involves the use of mRNA-1273 in children ages 6 months to <12 years. The study is being conducted with the US National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA).

6,795 PARTICIPANTS. Moderna is seeks approximately 6,795 paediatric participants in the US and Canada ages 6 months to less than 12 years. In Part 1, each participant ages 2 years to <12 years may receive one of two dose levels 50 pr 100 micrograms (50 μg or 100 μg). Also in Part 1, each participant ages 6 months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg).

PAEDIATRIC VACCINE TRIALS: The paediatric COVID vaccine studies will help vaccine akers and regulators assess the potential safety and “immunogenicity” of the candidate vaccines. If approved for infants and toddlers, the COVID vaccines will come full circle, as younger-age population form an important part of society.

INTERIM ANALYSIS: An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination. The initial results may come as early as September or October 2021.