The story so far : Prime Minister Narendra Modi announced that beginning January 3, vaccines would be available for those who are 15 years of age . Boosters would also be available for health-care workers, frontline workers and those over 60 with co-morbidities on a doctor’s prescription.
What is the significance of Prime Minister Modi’s announcement?
Mr. Modi’s announcement came minutes after an approval by the Drugs Controller General of India for Covaxin to be used by those over 12 years . This makes it the second Indian vaccine after ZyCoV-D , a DNA plasmid vaccine, to be approved for those above 12. ZyCoV-D, by Zydus Cadilla, is a three-dose combination whereas Covaxin by Bharat Biotech is a two-dose vaccine to be administered four weeks apart. A major difference is that ZyCoV-D inspite of being cleared in late August is not available in the market whereas Covaxin has been around for nearly a year. The company also says that being an inactivated whole virion vaccine, the dosage for children is the same as those for adults.
What tests have been done on the vaccine for children?
According to information on the clinical trials registry of the Indian Council for Medical Research (ICMR), Bharat Biotech was testing Covaxin on 525 volunteers from 2-18 years of age. They would be segregated into three groups: 2-6 year olds, 7-12 year olds, 13-18 year olds. In each of these groups, vaccines would be administered four weeks apart and they would be evaluated on the quantum of antibodies produced, whether they manifested severe reactions, whether there were adverse events following immunisation. The trial does not set out to measure efficacy, or whether the vaccine measurably protected a vaccinated group compared to an unvaccinated group.
The participants are meant to be followed up for up to 208 days. Bharat Biotech began recruitment on May 26 and the study, on paper, was expected to be completed on January 26, 2022. However, it has been routine during the pandemic for companies to rush to the regulator with early data (based on four weeks of evaluation) in the hope of an approval. Bharat Biotech submitted data first week of October though there has been no research paper or public information on the vaccine’s performance.
ZyCoV-D conducted phase 3 clinical trial involving 28,000 participants and claimed an efficacy of 66.6% against symptomatic COVID-19 as well as 100% efficacy both against moderate disease following three doses of the vaccine and against severe disease or death after two doses. However, this was announced via a company press release and there is no public information on how effective and safe the vaccine was when broken by age groups. While Bharat Biotech ostensibly submitted data that included children over 2 years and Zydus Cadilla in those over 12, it is unclear what rationale guided Mr. Modi’s announcement to restrict vaccination in those 15-18.
Are vaccines necessary for children?
Few issues have stirred up as much debate. The World Health Organization’s most updated position on this, as of December 22, is this: “WHO is currently not recommending the general vaccination of children and adolescents as the burden of severe disease in these age groups is low and high coverage has not yet been achieved in all countries among those groups who are at highest risk of severe disease.” This however is a statement made in the context of supply. In the United States and the United Kingdom — two countries that significantly influence India’s COVID response — vaccines have been approved in those over 12 and in the U.S., those 5 and above are eligible. However, these are countries with virtually unlimited supplies and because, the global evidence is that the protective effect from vaccines across age groups outweigh potential risk from adverse events and that a small fraction of children may be vulnerable to disease, vaccines may be administered if availability is not a constraint.
However, constraints on supply are among the factors guiding decisions by expert groups in India to approve vaccines because nearly 40% of India’s adults are still to be fully vaccinated and the extreme infectiousness of the Omicron variant and the continuing threat from the Delta variant mean that they are at far greater risk than those under 18.
Which are the countries that have approved vaccines for children?
Several countries within Europe as well as Canada, Bahrain, Israel, Oman, Saudi Arabia, Egypt and China are among those that have approved vaccines in those even younger than 12.
