Story at a glance
- Earlier this month, the FDA postponed a meeting that could have authorized two doses for children under 5.
- Researchers conducting the clinical trials are collecting data on third doses, especially for children between 2 and 5 years old.
- Vaccinating this age group could allow a return to a more normal life and reduce transmission.
On Feb. 11, the FDA postponed the committee meeting to discuss the request for emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine as two doses for children 6 months through 4 years old. As part of its rolling submission to FDA, Pfizer informed the agency of new data from the ongoing clinical trials. The postponement means that they will wait for data on third doses before submitting for authorization.
Data from the trials suggest that children in the trial who are 2 years up to just under 5 years old are not getting the level of immunity from the first two doses that researchers hoped for. The clinical trial teams are giving those children a third dose, which would count as part of the primary series and not as a booster, and waiting to see the results.
Researchers are hopeful the clinical trials will suggest it is effective at preventing severe illness in this age group. They do expect that effectiveness might be lower with the omicron variant, but overall effectiveness should be high.
“Every vaccinated person reduces the potential for the virus’s spread, even if the vaccines do not prevent it perfectly,” said Tara Smith, a professor at the College of Public Health at Kent State University, in an email to Changing America.
There’s a lot of anxiety around getting as many people vaccinated as possible because we know it’s an important tool to respond to and curb ongoing transmission, said epidemiologist Delivette Castor of the Department of Medicine at Columbia University.
“With children it’s complicated because we know that the disease severity has been much lower in children and so the risk/benefits that parents and people are weighing is a bit different because the disease hasn’t been as severe.”
“I view that having vaccines for children is critical to help control the pandemic and to get our children back to having a normal life,” said pediatrician Janet Englund of Seattle Children’s hospital, one of the researchers involved in clinical trials of the Pfizer/BioNTech vaccine in children.
However, given that the current proportion of eligible 5- to 11-year-olds who have gotten the jab is low, Smith said she isn’t sure that having the younger group added will do much to drive the virus toward endemicity. Though, it could help parents to know if their children are better protected against serious illness.
“It’s really important to ensure that we let the science play out, that we have adequate data that helps us understand if that third dose will be immunogenic enough for children, particularly those between two and less than five,” Castor said.
Once the data from the third doses is collected collected, it’ll need to be analyzed before it can be submitted to the FDA for emergency use authorization.
“So, how long will that take? I mean, my team is working 12 hours a day, six days a week,” Englund said. Her team is one of 40 around the world working on the double blinded clinical trials. “Families are being incredibly, incredibly responsive in terms of coming to get their third dose in, even when they have to miss work and miss school and things like that.”
Smith said that to “de-fang” the virus we need to massively increase vaccination in adults around the globe by sharing vaccines and technology with developing countries. But if large numbers of children under five can get vaccinated, life could get back to more normal, said Englund. And that’s what people really want.
However, to achieve that on a large scale, there may also need to be a shift in perspective for some folks.
“Right now, all we tend to think about is how is it going to benefit me? That has not always been the case. And it should not be the case in my opinion. We also need to think how can we also help other people,” Englund said. “And I think you start with your family and that that’s pretty important.”
But first, she wants to see the data, and for that we’ll have to wait.
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