(PresidentialInsider.com)- The Food and Drug Administration has delayed its review of Pfizer’s COVID vaccine for use on children under five because testing shows the two-dose vaccine is not working well in protecting against the Omicron variant.
The FDA was expected to approve the vaccine for younger children last week.
It should be noted that this is only a delay. The Food and Drug Administration is not scrapping the plan to make the COVID vaccine available to children under five. Instead, the FDA is requesting additional data from Pfizer before proceeding.
In December, Pfizer released an announcement indicating that trials of its vaccine in children ages two to five did not produce the level of protection expected. Pfizer stated that the trials would be “amended” to include a third dose of the vaccine given at least two months after the second dose to provide “high levels of protection” for children in this age group.
Officials from the FDA and Pfizer agreed it was better to wait for this additional data. This extra time would allow the FDA to assess the vaccine’s effectiveness in either two doses or three and also allow the agency to see how a third dose of the vaccine performs in children under five.
According to the FDA, the delay also allows the agency time to allow for “a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”
The FDA hopes to make its decision in the spring as Pfizer anticipates it will have additional data on three doses in early April.
The Wall Street Journal reported that the decision to delay “angered” parents who are eagerly awaiting the opportunity to inject their young children with the Pfizer vaccine.
In late 2021, after the FDA approved Pfizer’s vaccine for ages 5 to 11, a survey by the Kaiser Family Foundation found only 27 percent of parents were “eager” to vaccinate their 5 to 11-year-old children while 30 percent said they would “definitely” not give the vaccine to their kids. Another 33 percent said they would wait and see how the vaccines worked before getting their children vaccinated.