Concerned about the impact of the omicron variant on children, the Food and Drug Administration had asked Pfizer for permission to use the extra-low dose vaccine. This was before it was clear if the infants would need two or three shots. This plan could have allowed vaccinations in as little as a week.
Friday's FDA decision was reversed. It stated that it had become obvious that the FDA needed to wait for data about how well a third shot worked for the youngest age group. Pfizer stated in a statement it expects the data to be available by April 1.
Dr. Peter Marks, FDA's chief vaccine officer, said that he hopes parents will understand that the FDA's decision was based on a careful scientific review of all evidence submitted by Pfizer so far.
Marks explained to reporters that this information made them realize they needed data from the third dose of the ongoing trial to make a determination. We take responsibility for the review of these vaccines very seriously as parents.
Only 18 million children below 5 years old are eligible for vaccination in the United States.
Rachel Perera, a mother to an 8-month old Los Angeles boy, described Friday's news as "like the rug got pulled from under me."
Perera met with her pediatrician to discuss the possibility of a vaccine being available in time for winter 2022. Perera, an education policy researcher, and her husband are taking care of their child to avoid the unpredictable and high-risk nature of child care in a pandemic. However, she must continue to work on her Ph.D. dissertation. D., she pursues while her child is sleeping. She also says that she has "decision fatigue" due to daily risk calculations.
Perera stated, "I'm just tired and it feels as if this is going to end." It feels like everyone around us is moving on with their lives and we are being left behind.
Experts in vaccines were concerned about the rush to evaluate Pfizer’s vaccine. Now they wonder what the parents will think of all the back-and forth.
Dr. Jesse Goodman, Georgetown University's former chief FDA vaccine officer, stated that "I believe they made the right choice to be cautious and wait for third-dose data."
He said, "It was wonderful to hear that there might have been some promising data from 2 doses, but it came out like, "Hey everybody! You can expect a vaccine within a few weeks," he continued. "I believe this messaging becomes very confusing for people.
This is not the first time this has happened. Pfizer had originally expected to find out by December end if the extra-low doses were effective for children under 5. However, Pfizer was disappointed to discover that it wasn't. Preliminary results from the study showed that two shots were strong enough to provide good protection for babies as young 6 months old. Two doses of the vaccine were not enough to protect babies from the effects of the second shot once they reached preschool age, which is between 2 and 4 years olds.
It was therefore not surprising that FDA had urged Pfizer (and its partner BioNTech) to apply a few weeks back. Next week, FDA's independent scientific advisors will debate whether it is okay to give tots two shots before they have proof that a third would provide them with the extra protection. This was a very unusual move.
Friday's FDA meeting was abruptly cancelled. However, they promised to hold it after Pfizer has submitted the third-dose evidence. Even if Pfizer submits the evidence by April 1, it will still take the FDA and other authorities several weeks to examine and vet the data.
FDA's Marks stated earlier this week that the agency would not cut corners, but also pointed out how quickly the pandemic was changing. No one had ever heard of omicron before Thanksgiving. However, last month, pediatric COVID-19 infection had reached an all-time high. Now, cases are falling as fast as the new mutant burns out.
The FDA must balance how long it takes to receive new vaccine data and how much they should require. The FDA is caught between the pressure to act faster against rapidly changing viruses and the risk of putting families off vaccinating their children.
Pfizer plans to give shots to children as young at 6 months old that are one-tenth the dose given to adults. This means two shots three weeks apart, followed by a third at minimum two months later.
This is a lower dose than what children aged 5-11 receive. It's also a third less than the adult dose.
Children are more likely to be vaccinated than other age groups. According to the American Academy of Pediatrics, only 22% of children aged 5-11 years old and half of those aged 12--17 years old were fully vaccinated as of last week. Nearly three quarters of all adults are fully vaccinated.
Last month, a Kaiser Family Foundation poll found that only 3 out of 10 parents with children younger than 5 would have their child vaccinated as soon after shots are authorized. About a quarter however said they would.
President of the pediatricians group, Dr. Moira Stilagyi, acknowledged parental frustration, but stated in a statement that doctors are committed to "a careful and robust process to evaluate evidence."
Dr. Natasha Burgert is a Kansas pediatrician who said that she was "just gutted." This protection is essential for our children.
She stated that some families feel relieved because they weren't able to make a decision without reliable efficacy data. Others parents cry out for a choice. Let us see what you have and make a decision. Let us have it!"
