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 matter for healthy children or should other vaccines for children be preferred? Mint explains:
Why did the USFDA postpone its decision?
Pfizer has been running clinical trials for its COVID-19 vaccine for children for more than three months. The USFDA decided to withhold its decision, saying it was specifically reviewing data on a three-shot vaccine, rather than two shots. That was because Pfizer-BioEntech found that their two-shot vaccine did not show effect in the age group of children it was studying — six months to four years. The federal agency took down Pfizer’s application because of the recent Omicron outbreak that saw a significant increase in hospitalizations among the youngest children of Covid-19 cases.
What does the evidence say?
Experts are divided on the issue of vaccinating children. Coronavirus infection in children under five is unlikely to cause serious illness, but some children 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 ill, let alone a serious illness. In some 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 be of marginal benefit.
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What are the approved vaccines for children?
Inactivated vaccines have been approved for use by India’s Bharat Biotech International Limited and China’s Sinopharma and Sinovac. In addition, Pfizer’s mRNA shot for children above the age of five years, Modern’s jab for children above the age of 12 years and Zydus Cadila from India for children above the age of 12 years have also been approved. Cuba and Venezuela are vaccinating children over the age of 3 with the local Sobrana 2 vaccine.
What about the Indian context?
The country has only approved an inactivated vaccine platform, Covaxin, for children over the age of 2. Vaccine expert Gagandeep Kang said that although it is possible to argue that inactivated vaccines provide broad protection, there is not enough evidence to say that they provide long-term protection. Kang said people should be cautious in applying vaccines with such characteristics when the evidence is low. Trade-offs between other essential vaccines must also be considered.
What is the pipeline for pediatric shots in India?
Biologicals E has sought emergency approval for its COVID-19 vaccine for use in children aged 12 to 18 years. The vaccine uses the same platform used to make the hepatitis B jab, which is used in routine immunization among children. Serum Institute of India, which has tied up with US vaccine maker Novavax, said it is also working on a vaccine for children. Overall, India’s pediatric pipeline is four vaccines for children above 12 years of age and two vaccines for children aged 2 years and above.
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