TOPLINE Pfizer plans to imminently submit its data on Covid-19 vaccinations for five- to 11-year-olds for governmental approval, CEO Albert Bourla said Sunday, which means the shots could potentially be available for kids later this fall after initial data suggested the vaccine produces a “strong immune response” in children.
Bourla said on ABC’s This Week that the company intends to submit its trial data for five to 11 year olds for approval “pretty soon,” adding it is “a question of days, not weeks.”
Once they submit the data, it will be “up to the [Food and Drug Administration]” to determine whether the vaccine should be approved, Bourla said, but Pfizer “will be ready with our manufacturing to provide this new formulation of the vaccine” if it is.
Pfizer released initial trial data earlier this week, which has not yet been peer reviewed, that found the child Covid-19 vaccine—which is one-third the dose that’s given to adults—is “safe” and “well tolerated” among five- to 11-year-olds.
The data suggested the vaccine provokes an immune response in children similar to that of fully vaccinated 16- to 25-year-olds despite the smaller dose, and also similar mild side effects like pain at the site of the injection, fever, fatigue and chills.
Former FDA head Dr. Scott Gottleib, who serves on Pfizer’s board, said on CBS Sunday he expects the agency’s review of the Pfizer data to take approximately four to six weeks, putting the timeline for potential approval somewhere between Halloween and mid-November.
U.S. Surgeon General Dr. Vivek Murthy said earlier in September the government is ready to “process that [data] quickly” as soon as Pfizer submits it.
5.5 million. That’s the approximate number of Covid-19 cases that have been reported in children as of September 16, according to the American Academy of Pediatrics, the most recent date for which data is available. Children make up 15.7% of all U.S. Covid-19 cases, but cases have been particularly on the rise among kids in recent months amid the highly infectious delta variant’s spread. The AAP reports child cases made up 25.7% of the cases reported the week of September 9-16, and the total number of Covid-19 cases in children since the start of the pandemic increased by 9% just in the span of two weeks, between September 2 and September 16.
WHAT TO WATCH FOR
Moderna is testing Covid-19 vaccines in children but has not yet released any of its findings, and Pfizer is also undergoing trials of its shot in children under five years old. That trial data is expected to come by the end of the year, Pfizer said earlier this week. Johnson & Johnson is so far only testing its vaccine among adolescents, and AstraZeneca has also started trials of its vaccine in children as young as six, though it was paused in April pending a safety review due to concerns about blood clots.
Bourla’s comments Sunday are in line with previous estimates on the FDA approval process for child vaccines, with Gottleib predicting earlier in September the shots could be approved by Halloween under a “best-case scenario,” which he reiterated Sunday. Leaders at BioNTech, which developed the vaccine with Pfizer, also said September 10 they planned to seek approval for their vaccine “in the next few weeks.” Covid-19 vaccines in children have become a particularly urgent issue in light of the delta variant, which has fueled numerous outbreaks of the coronavirus in schools—particularly those without mask mandates and other mitigation measures—and left unvaccinated populations like children particularly vulnerable. Studies have indicated children are less susceptible to severe illness and death from Covid-19, but pediatric hospitalizations have nevertheless been on the rise, and children are also at risk of developing “long Covid,” in which debilitating symptoms may persist for months. (Recent research suggests the incidence of long Covid may be lower than previously thought, but the data remains inconclusive.) Parents have pushed for more information on the FDA approval process and for the vaccine to be available to kids as soon as possible as a result, with more than 100 lawmakers sending a letter to the FDA in August seeking answers about the timeline for the shot.
Bourla also said Sunday he believed “within a year,” people will be able to “come back to within normal lives” despite Covid-19, echoing comments made earlier this week by Moderna CEO Stéphane Bancel, though he believes new variants of the coronavirus will continue to emerge. While Bourla acknowledged “we don’t know really” what the future of the pandemic will look like, the CEO suggested future Covid-19 vaccines designed to combat emerging variants could “last at least a year” and predicted people will have annual Covid-19 vaccinations.
Pfizer-BioNTech To Seek Approval For First Covid Vaccine For Young Children ‘In Next Few Weeks’ (Forbes)
By Alison Durkee, Forbes Staff