5:02 p.m. ET, September 20, 2021
There are still 4 steps that must happen before younger children receive Covid-19 vaccines
From CNN's Jacqueline Howard
After Pfizer and BioNTech announced that a Phase 2/3 trial of their Covid-19 vaccine was found to be safe and generated a “robust” antibody response in children ages 5 to 11, there are still several steps before vaccines will be available for that age group.
First: Pfizer needs to ask the US Food and Drug Administration for the emergency use authorization (EUA) of its Covid-19 vaccine to include children ages 5 to 11.
"The company needs to submit a request to amend its EUA to include the additional population," an FDA spokesperson told CNN in an email on Monday.
Dr. Scott Gottlieb, former commissioner of the FDA and a board member at Pfizer, said on CNBC's Squawk Box on Monday morning that Pfizer could file to the FDA "very quickly,” and then FDA’s process would begin.
"The data came a little earlier than some were expecting, and depending on how long the FDA takes to review the application, whether it's a four-week review or a six-week review, you could have a vaccine available to children as early as probably by the end of October, perhaps it slips a little bit into November," Gottlieb said.
Second: The EUA for Pfizer’s vaccine for people ages 12 to 15 needs to be extended to include younger ages.
"When a completed request for EUA or approval has been received by the FDA, the agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months," Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a previous statement earlier this month about vaccines for young children.
“However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers,” Woodcock and Marks said. “Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of COVID-19 vaccines in children will not cut any corners.”
The FDA’s Vaccines and Related Biological Products Advisory Committee likely will meet to discuss Pfizer and BioNTech’s data. In that meeting, committee members could vote on whether they recommend the EUA be amended to include children ages 5 to 11.
"Once we see a timeline for that actual meeting occurring, that will give us a good idea of when we might potentially see approval," Dr. Evan Anderson, a physician at Children’s Healthcare of Atlanta and a professor of pediatrics and medicine at Emory University, said during a call with reporters Monday. "That meeting of advisers will then need to occur. FDA would then need to either agree with or disagree with their external group of advisers about potential approval."
Third: The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices needs to recommend the shots.
If the vaccine is authorized by the FDA, the CDC’s vaccine advisers will evaluate vaccine data to decide whether it should be recommended for ages 5 to 11.
"That has typically occurred within a couple days of FDA approval, and I think that that would likely occur here again," Anderson said.
The CDC director generally accepts ACIP’s recommendation shortly after, which makes the recommendation official.
Fourth: Once the FDA and CDC sign off, a rollout of vaccines for children ages 5 to 11 could start.
Although many adults got their shots through nursing homes or mass vaccination sites early on, the rollout looked a bit different by the time the youngest children so far – those ages 12 to 15 – were vaccinated.
For those young people, the focus was on pharmacies and doctors’ offices, and that’s likely to be the case with even younger children, too. Some places may begin vaccinating younger children immediately, and some might need to open appointments or increase staffing.