What is the status of clinical trials on people under the age of 18? Which other countries have approved COVID vaccination for children?
the story So FarPrime Minister Narendra Modi announced that from January 3, Vaccines will be available for those over the age of 15, Boosters will also be available on prescription for health care workers, frontline workers and people over 60 with co-morbidities.
What is the significance of Prime Minister Modi’s announcement?
Mr Modi’s announcement came minutes after the Drug Controller General of India approved Covaxin used by people over 12 years old, This makes it the second Indian vaccine later ZyCoV-D, a DNA plasmid vaccine, to be approved for people above 12. ZyCoV-D by Zydus Cadilla, is a three-dose combination, while Covaxin by Bharat Biotech is a two-dose vaccine that is administered at intervals of four weeks. One big difference is that ZyCoV-D is no longer available on the market despite getting approval in late August, while Covaxin has been around for a year. The company also says that due to an inactivated whole-viral vaccine, the dosage for children is the same as for adults.
What tests have been done on Vaccines for Children?
Bharat Biotech was testing Covaxin on 525 volunteers aged 2-18 years, according to information from the Clinical Trials Registry of the Indian Council for Medical Research (ICMR). They will be divided into three groups: 2-6 year olds, 7-12 year olds, 13-18 year olds. In each of these groups, vaccines will be administered at four-week intervals and will be assessed on the amount of antibodies produced, whether severe reactions appear, whether adverse events have occurred following vaccination. The trial has not been determined to measure efficacy, or whether the vaccine measurably protected a vaccinated group compared to a non-vaccinated group.
Participants are to be followed for 208 days. Bharat Biotech started the recruitment on May 26 and the study, on paper, was expected to be completed on January 26, 2022. However, during the pandemic it has become routine for companies to approach the regulator with initial data (on a four-week basis). appraisal) in the hope of an approval. Bharat Biotech submitted the data in the first week of October, although there is no research paper or public information on the vaccine’s performance.
ZyCoV-D underwent a phase 3 clinical trial involving 28,000 participants and showed an efficacy of 66.6% against symptomatic COVID-19 as well as against moderate disease after three doses of the vaccine and against severe illness or death after two doses. Against claimed 100% efficacy. However, this was announced through a company press release and there is no public information about how effective and safe the vaccine was when broken down by age groups. While Bharat Biotech explicitly presented data that included children over the age of 2 and the Zydus Cadila over the age of 12, it is not clear what led to Mr. Modi’s announcement to restrict vaccination to those 15-18. What was the reason
Are Vaccines Necessary for Children?
Few issues have sparked so much debate. The World Health Organization’s most updated position on this as of 22 December is: “WHO is not currently recommending general immunization of children and adolescents because of the low burden of serious disease in these age groups and high coverage yet to be achieved.” achieved in all countries among groups that are at highest risk of serious disease.” However, this is a statement made with reference to supplies. In the United States and the United Kingdom – two countries that significantly impact India’s COVID response – vaccines have been approved in people aged 12 and above, and in the US, people aged 5 and above. However, these are countries with virtually unlimited supply and, because global evidence is that the protective effect from vaccines in all age groups outweighs the potential risk from adverse events and that a small fraction of children are vulnerable to disease, if available Vaccines can be administered is not a hindrance.
However, constraints on supply are among the deciding factors for approving vaccines by expert groups in India as about 40% of India’s adults still have to be fully vaccinated and the high infectivity of the Omicron variant and the delta variant. The ongoing threat means they are at a far greater risk than people under the age of 18.
Which countries have approved vaccines for children?
Several countries in Europe as well as Canada, Bahrain, Israel, Oman, Saudi Arabia, Egypt and China are among countries that have approved vaccines in people under the age of 12.
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