Pfizer and BioNTech seek emergency use authorisation of the first coronavirus vaccine for children under 5 in the US

Pfizer and BioNTech said Tuesday that they were seeking emergency-use authorisation for the first coronavirus vaccine for children younger than 5 in the US and have begun submitting data on the safety and efficacy of the first two doses of a planned three-dose regimen.

The Food and Drug Administration asked the companies to apply for authorization of their vaccine, and in an email, FDA spokeswoman Stephanie Caccomo said the omicron surge had generated new data “impacting the potential benefit-risk profile of a vaccine for the youngest children.”

In December, Pfizer and BioNTech announced that the immune response generated by the vaccine in children between 2 and 4 years old was not sufficiently robust. But the companies said the vaccine had provoked a strong enough response in children 6 months to 2 years old. A third shot was added to the trial to increase the immune response.

An earlier vaccine trial in children 5 to 11 years old was also focused on showing that those children had adequate immune responses after vaccination. In addition, there were enough cases of illness in that study population to determine that the vaccine was 91% effective in preventing symptomatic illness.

The companies said Tuesday that the FDA requested they move forward with an application because of the “urgent public health need in this population,” noting that 1.6 million children under the age of 4 have tested positive for the coronavirus.

“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

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Source: The Washington Post, 1 February 2022