The US Food and Drug Administration (USFDA) has postponed its decision to authorize Pfizer Inc.’s covid-19 vaccine for children aged 6 months to four years. Do vaccines make sense for healthy children or should other vaccines be prioritized for kids? Mint explains:
Why did USFDA postpone its decision?
Pfizer has been running clinical trials for its covid-19 vaccine for children for over three months. The USFDA decided to hold off its decision saying it was specifically reviewing data on the three-shot vaccine instead of two shots. This was because Pfizer-BioNTech found that their two-shot vaccine did not show efficacy in the age group of children it was studying—six months to four years. The federal agency had taken up Pfizer’s application as the recent surge in covid-19 cases due to the Omicron outbreak had seen a notable increase in hospitalization among the youngest children.
What does the evidence say?
Experts are divided on the issue of vaccinating children. Coronavirus infection among children aged under five is unlikely to lead to severe disease, but some kids are more vulnerable than others. However, the idea behind vaccinating children is that if given the opportunity even a small number of children should not be allowed to fall sick, let alone contract severe disease. In certain countries such as the UK, children have already been diagnosed with covid-19 and experts are of the opinion that having a vaccine for them would only provide marginal benefit.
Which are the approved vaccines for children?
The inactivated vaccines by India’s Bharat Biotech International Ltd and China’s Sinopharm and Sinovac are approved for use. Also approved are Pfizer’s mRNA shot for children over five years, Moderna’s jab for children over 12 years, and India’s Zydus Cadila for children over 12 years of age. Cuba and Venezuela are vaccinating children over 3 with the local Soberana 2 vaccine.
What about the Indian context?
The country has only approved Covaxin, an inactivated vaccine platform, for children over the age of 2 years. Vaccine expert Gagandeep Kang said though it is possible to argue that inactivated vaccines provide broader protection, there isn’t enough evidence to say they provide longer protection. Kang said people should be careful about going for vaccines with such characteristics when evidence is low. Trade-offs among other essential vaccines should also be considered.
What is the pipeline for paediatric shot in India?
Biological E has sought emergency approval for its covid-19 vaccine for use in children aged 12 to 18. The vaccine uses the same platform that is used to make the Hepatitis B jab, which is used in routine immunization among children. Serum Institute of India that has tied up with US vaccine maker Novavax said it too is working on a vaccine for children. Overall, India’s paediatric pipeline is for four vaccines for children over 12 years of age and two vaccines for those who are 2 years and above.
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