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It’s hard to overstate the potential benefits of immunotherapy. These novel cancer therapies that effectively harness the body’s immune system to battle cancer can shrink tumors and wipe out many types of the disease.
But while immunotherapy is expanding patient options, especially for those aged 65 or older, who’s in charge of determining whether immunotherapy should be made available for children in very young children? That’s what they’re asking right now in Washington, D.C.
The debate is centering on the use of the cancer drug known as COVID-19. This immunotherapy vaccine was made by Pfizer and approved by the FDA for use in older patients in 2013. It is a monthly injection that’s designed to protect infants from contracting measles and varicella – a virus that causes chickenpox. But in the last few years, new clinical trials have shown the immune response from COVID-19 is greater in young children.
So far, the FDA has approved this new vaccine for a clinical trial in children aged 4 to 11, but the agency is currently reviewing new data about whether Immunodent-19 should also be used to vaccinate very young children against measles. The decision is expected in the next few months.
This debate is also being played out in several states. Colorado recently voted to ban the use of immunotherapy vaccines on very young children, arguing that using these medicines to prevent disease in children 10 or younger devalues “the reality of measles.”
Pfizer, one of the largest drug makers in the world, is urging the FDA to continue using COVID-19 for use in infants. Immunotherapy experts are also urging approval for children as young as four and to do a randomized trial as part of the FDA’s review.
The debate is playing out in two places – the FDA’s Center for Biologics Evaluation and Research and an HHS advisory committee on immunology and vaccines.