Pfizer’s fast-track approval of children’s vaccine hit a snag

2022-05-23 0 By

The United States Food and Drug Administration (FDA) and Pfizer announced on Saturday (Feb. 12) that they will delay the approval of vaccines for children under 5 until at least April.Children under five are currently the only age group not eligible for vaccination.The FDA has come under increasing pressure from parents and doctors to speed up vaccine approval as the omicron strain has led to an increase in hospitalizations of children with COVID-19.Pfizer and BioNTech have submitted data on the first two doses of the vaccine for children aged six months to four years at the FDA’s request.Data for a third dose should be completed and submitted to the FDA in the coming months, they added.But Peter Marks, head of the FDA’s vaccines division, said the latest data submitted by Pfizer and BioNTech were insufficient to support the plan.”It was a sudden decision, but it was science,” Marks admits.Marks explained that the FDA should not approve the first two doses of the vaccine without data on the third dose.Pfizer has begun trials of a third dose for children under five, but it will take some time to complete, with data expected in early April.This means that Pfizer’s plan to vaccinate children under 5 will be delayed until at least April.Acting Commissioner Janet Woodcock said, “FDA tries to act quickly to protect children from the effects of Omicron.But more information on the third dose remains to be learned about the efficacy and safety of the vaccine in children under 5.””We need to adhere to strict standards of effectiveness and effectiveness,” Woodcock said in the statement.Evaluating preliminary data is very helpful in our review of these vaccines, but information from the ongoing evaluation of the third dose should be taken into account at this time.”Paul Offit, a member of the FDA’s vaccine advisory committee, said the previous “fast track program” was based on the assumption that the third dose was safe and effective, but there was no guarantee that the final numbers would be. “Imagine that we approved it after two doses, then found out that the third dose was unsafe and had to withdraw it.””I’m pleased with the FDA’s decision,” Offit said. “It really should have waited until all the data were reviewed.”As of Thursday, about 75 percent of U.S. adults had received two doses of Pfizer’s vaccine, or two doses of Modena’s vaccine, or one dose of Johnson & Johnson’s vaccine, but the numbers were lower among minors.About 57 percent of people ages 12 to 17 are fully vaccinated, compared with 24 percent of those ages 5 to 11, according to the CDC.According to seven-day averages from the US Department of Health and Human Services (HHS), nearly 5,200 minors were hospitalized for COVID-19 on January 18.As of Friday, that number had fallen to about 3,000.The American Academy of Pediatrics (AAP) said in a statement that while the news of the FDA’s delay was frustrating for many parents, “a careful, robust and transparent evaluation process is critical in order for parents to have confidence in offering the vaccine to their children.”On Friday, the European Medicines Agency (EMA) was investigating Pfizer’s and Modena’s mrnas for COVID-19 vaccines and menstrual disorders in women, and it was unclear whether there was a causal link.The EMA added that “there is currently no evidence that mRNA vaccines affect fertility in women.”