Pfizer's vaccine for kids under 5: 'I have not yet seen the data,' CDC director says
Many parents of young children are anxiously awaiting the FDA and CDC's decisions on the Pfizer (PFE)/BioNTech (BNTX) vaccine for children ages 6 months through 4 years next week.
CDC Director Dr. Rochelle Walensky said the approval process is similar to that of previous vaccine authorizations, including advisory committees of each agency weighing in on the decision.
"I have not yet seen the data from the Pfizer study," Walensky told Yahoo Finance Tuesday.
"The data that will be presented are for two doses. And there is always an opportunity for a third dose as well," she added.
The unusual request by the FDA, asking Pfizer to submit its data for two doses for the cohort, after the company already acknowledged two doses were not effective in ages 2 through 4, has been cause for concern in some circles.
An FDA spokesperson recently said the data available publicly to-date does not include data the FDA has seen that support the three dose option and moving forward with the emergency use submission.
The FDA's advisory committee is slated to meet February 15 to discuss the data.
The expedited process comes at a time when the country has seen low levels of vaccinations for other eligible kids groups. Just over 20% of kids aged 5-11 are vaccinated, while 55% of children 12-17 are vaccinated, according to the CDC.
In a recent White House COVID-19 Response Team briefing, U.S. Surgeon General Dr. Vivek Murthy noted that the "same rigorous process" was being used to weigh the benefits and risks of the youngest eligible cohort for vaccines.
"If and when the FDA and CDC decide to move forward, we will work closely with our trusted community partners to ensure that families have accurate science-based information about the vaccine so they can make the best decisions for their children," Murthy said.
At the same briefing, White House Coronavirus coordinator Jeff Zients highlighted the potential process if all goes well next week.
"Following FDA authorization, we would immediately begin packing and shipping doses to states and healthcare providers. And in short order, following CDC recommendations, parents will be able to get their kids under five vaccinated at convenient locations, locations they know and trust," he said.
"We cannot begin actually packing and shipping until the FDA authorization, and then there’s the CDC ACIP [Advisory Committee on Immunization Practices] process, which generally takes place a matter of days after the FDA," he added.
Dr. Anthony Fauci, Biden's chief medical adviser and director of the National Institute for Allergies and Infectious Diseases, recently hinted that the process will run smoothly.
"We’re anticipating we will get a vaccine efficacy signal that would allow for the use of this vaccine in children," he said.
If two doses are authorized, similar to the process for adding boosters for adults, a third dose can be added after a specified amount of time for the age cohort that warrants it, Walensky said.
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