On May 27, a PIB press release said “Several myths on India’s Covid-19 vaccination program are doing the rounds. These myths are arising due to distorted statements, half-truths and blatant lies”. Dr. Vinod Paul, Member (Health) in NITI Aayog and Chair of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) sought to address seven “myths”. One of them was on vaccination of children.
According to the release, the myth was that the Centre wasn’t taking any step to vaccinate children. Clarifying this, Dr. Paul said: “As of now, no country in the world is giving vaccines to children.”Unfortunately, the “fact” put out by Dr. Paul was completely incorrect. As early as December 11, 2020, when the FDA granted the first emergency use approval to Pfizer’s COVID-19 vaccine, the regulatory body permitted the vaccine to be used on children older than 16 years.
On May 10 this year, the FDA reduced the upper age limit to become eligible for the Pfizer vaccine to 12 years. So far, Canada, the U.S., U.A.E., Singapore, Bahrain and Qatar have approved the use of Pfizer vaccine in children 12–15 years. On May 5, 2021, Canada became the first country to approve its use in children 12–15 years.
The authorisation by Canada’s regulatory agency was based on the phase-3 trial carried out in the U.S. on 2,260 children in the age group 12–15 years.
The trial found that the vaccine was safe and had 100% efficacy. The trial also found that the vaccine produced robust antibody responses in children 12–15 years, exceeding those reported in trials of participants aged 16–25 years, according to a company release.
Approval worldwide
While the U.S., FDA cleared the vaccine for use in children aged 12–15 years on May 10, the U.A.E. approved its use on May 13. On May 18, Singapore became the fourth country to approve the vaccine for children 12–15 years; Bahrain too approved the vaccine for the target group the same day. On May 19, Qatar approved the Pfizer vaccine for children as young as 12 years.
Not only did the U.S. approve the vaccine for children aged 12–15 years weeks before Dr. Paul issued the statement but also vaccinated more than 6,00,000 children in just a week after the CDC on May 12 cleared the vaccine for public distribution. Dr. Rochelle Walensky, Director of CDC also said that in the U.S. as on May 18, in total more than 4.1 million children aged 12–17 years were vaccinated.
Now, on May 28, a day after Dr. Paul’s clarification, the European Commission has approved the use of the Pfizer vaccine in children 12–15 years. The decision comes after European Medicines Agency (EMA) backed the use of the vaccine in the target group earlier in the day. Germany and Italy are already preparing to vaccinate children aged 12–15 years. Japan too approved the vaccine use in children in the same age group on May 28.
Issues clarification
Following the huge storm on social media, Dr. Paul clarified his earlier statement. He said: “It has been found out now that Pfizer [vaccine] can be administered to the younger population. One-two countries will start doing [vaccinating] that now”.
It is surprising that Dr. Paul as the Chair of the National Expert Group on Vaccine Administration for COVID-19 was ignorant about the Pfizer vaccine being approved for use in children 16 years and above in the U.S. and many other countries, and the U.S. has been vaccinating children above 16 years since April 20, 2021 and those above 12 years since May 12. It took this huge uproar on social media for him to know this.
Even then, the clarification from Dr. Paul was not factually correct. He said “one-two countries will start doing [vaccinating] that now” when in reality the U.S. has been vaccinating children above 16 years since April 20. The U.S has already vaccinated 4.1 million children older than 12 years as on May 18. Dubai started vaccinating children above 12 years soon after the FDA approved the vaccine for this age group. As on May 24, 1,800 children aged 12–15 years got their first dose of the Pfizer vaccine.
Lack of accuracy
“From the very beginning of the pandemic, people at the top have not been keen on data accuracy and sharing factual statements. The need for verification of data has not been given sufficient respect by these people. Opinions and facts are mixed up,” says Dr. Jacob John, formerly with CMC Vellore. “It is unacceptable and irresponsible that Dr. Paul, who holds a responsible position, does not respect the truth. People tend to believe what he and others holding responsible positions say as verified facts.”
Dr. John adds: “The need to set a false narrative sets in to suit the ground reality.” In this case, clinical trials in children have not begun in India. So an attempt is being made to show that no country has been vaccinating children.
While, Dr. Paul tried to clarify that the Pfizer vaccine be administered to the younger population and one–two countries will begin vaccination in children, PIB cited a very different reason while issuing a corrected release. The corrected release said: “The release mentions that ‘no country in the world is giving vaccines to children’. It should read ‘no country in the world is giving vaccines to children under 12 years’. The inadvertent typographical omission is regretted.”
Studies on children
Moderna, which was the second vaccine to get an EUA from the FDA, recently said the preliminary results from the Phase 2/3 study in children aged 12–17 year showed 100% efficacy 14 days after the second dose. The company plans to submit data to regulators in early June. While Novavax has just begun a study in children 12–17 years, AstraZeneca is already testing its vaccine among children in Britain aged above six years. Meanwhile, both Pfizer and Moderna have begun studies in children aged six months to 11 years.
