Pfizer and BioNTech on Friday said they were postponing their request to the Food and Drug Administration to approve their Covid-19 vaccine for children under 5 until early April, pending more data on the effectiveness of the third dose.
“Given that the study is progressing at a fast pace, companies will be awaiting data on the three doses as Pfizer and BioNTech continue to believe it may provide higher levels of protection in this age group,” Pfizer said in a statement. Pfizer said it needed more data “because infection and disease rates among children this age remain high” due to the omicron variant.
The Food and Drug Administration said it was postponing Tuesday’s meeting to review the children’s data.
The delay is a disappointment for parents who are looking forward to getting their children vaccinated against Covid. Children under 5 are the last remaining age group in the United States not eligible for vaccination.
Braden Burton, 3, plays with child life specialist Maggie Cale, CCLS, during treatment for coronavirus disease (COVID-19) at Children’s Hospital of Georgia in Augusta, Georgia, USA January 14, 2022.
Hanna Beyer | Reuters
Dr. Peter Marks, head of the FDA’s vaccine safety division, said data from Pfizer and BioNTech is coming in quickly, indicating it’s best to wait for a third dose. He said the sudden decision to delay approval should reassure parents that the FDA is working hard to make sure the vaccine is safe and effective for children.
“Instead of forcing anyone to question the process, I hope it reassures people that the process has a standard, that this is the process we follow, and we follow the science to make sure everything that we authorize, has the safety and efficacy that people expect from our regulatory review of medical products,” Marks told reporters during a press conference on Friday.
Marks said parents will have to rely on mitigation measures to protect their children while they wait for a vaccine to be approved in the coming months. These measures include wearing masks and ensuring that all eligible family members are vaccinated.
U.S. health regulators are facing mounting public pressure to allow vaccinations as hospitalizations for children with Covid surged during an unprecedented wave of omicron infections. The FDA initially asked Pfizer and BioNTech to file an authorization request for the first two doses of the vaccine while they complete data collection on the effectiveness of the third dose.
Pfizer and BioNTech, at the request of the FDA, applied last week to authorize the first two doses, citing an “urgent public health need” for young children during the omicron wave. However, Pfizer CEO Albert Burla said at the time that children under 5 will eventually need a third dose to have the highest level of protection against omicrons and future options.
In December, Pfizer amended its clinical trials for young children to study a third shot after the first two doses failed to elicit an adequate immune response in children aged 2 to 4 years. Young children will receive a lower dose of 3mcg compared to the 30mcg approved for adults.
White House Chief Medical Adviser Dr. Anthony Fauci said last month that he hopes the FDA will expand vaccination eligibility for young children in February.
The Centers for Disease Control and Prevention has already begun laying the groundwork for vaccine distribution this month, telling state and local health officials earlier this week they could receive their first batches by February 21. However, the CDC said supplies will only begin when the FDA clears the vaccine, and vaccinations cannot begin until the CDC gives its approval.
The CDC plans to roll out 10 million doses in three phases once the FDA clears the lower doses, Pfizer and BioNTech 3-microgram shots for children 6 months to 4 years of age, according to a new planning document released Sunday. State and local health officials may start pre-ordering the first doses on Monday.