A plan to fast-track approval of the Pfizer-BioNTech COVID vaccine for kids under 5 has failed, leaving parents and caregivers of young children in limbo once again. Initially, the U.S. Food and Drug Administration (FDA) planned to meet February 15 to decide if children under 5 could finally start receiving their long awaited initial doses of Pfizer’s COVID vaccine. Now, the meeting has been postponed and many caregivers are anxiously wondering what happens next. Here’s everything we know about what’s causing the delay and when a COVID shot for young kids can finally be expected to get approval.
Why are COVID vaccines for kids under 5 delayed?
Kids younger than 5 are the only remaining age group in the U.S. who doesn’t have access to a COVID vaccine. During initial trials by vaccine maker Pfizer-BioNTech, the standard two-shot COVID vaccine failed to produce an adequate immune response in this younger group; however, the makers believe a three-shot vaccine will provide the necessary protection. Given the hope that a third dose will be effective and the exponential rise in pediatric COVID cases during the month of January, Pfizer-BioNTech submitted their available data as part of a plan to fast-track vaccine approval using rolling submissions. First, the FDA would approve the two-shot vaccines, and then data and authorization for a third shot would hopefully follow.
Last week, the FDA put a hold on this plan, postponing their planned meeting until more data on a third shot can be reviewed. In a statement, the FDA said it believes “additional information regarding the ongoing evaluation of a third dose should be considered.”
Scott Gottlieb, a Pfizer board member and the former head of the FDA, tells CNBC there are “no new safety issues” with the vaccines for children under 5. Rather, the data is still evolving as the omicron wave continues, and officials are trying to accurately assess the effectiveness of the vaccines for kids as new data becomes available.
So, when will the vaccines be approved?
Pfizer-BioNTech expects to have data from clinical trials of the third vaccine dose in April. Once the data has been submitted, the FDA should have the required information to make a decision about authorization. Parents can also look forward to the possibility of a Moderna brand vaccine for kids ages 2-5. Moderna is currently testing lower doses for children in this age group and expects to report their data by March. The company has also applied for approval of their vaccines for use in the 6-11 and 12-17 age groups.
Vivek Murthy, the current U.S. Surgeon General, said the delay in authorizing vaccines for the youngest age group shows the FDA is “not compromising on its standards.”
Despite this reassurance, parents, caregivers and even some medical providers have expressed dismay at the FDA’s decision to push back vaccines for the youngest children once again. “Delay in under 5 COVID-19 vaccines is another punch in the gut that many of us did not need this week,” one doctor and parent writes on Twitter.
“Pfizer now to submit data in April. That means the earliest kids can be fully vaxxed is early August,” another person adds. “Many southern states start school then. Are we really going to send kids into another school year without protection?”
The omicron wave is subsiding across much of the U.S., but the American Academy of Pediatrics (AAP) reports that kids still account for more than 20% of new COVID cases. During the week of February 3, more than 298,000 pediatric COVID cases were reported, and nearly 4.5 million pediatric COVID cases have been reported since the beginning of January 2022.
The Centers for Disease Control and Prevention (CDC) reports that pediatric hospitalizations were four times higher during the omicron wave than during the previous delta wave, with the largest increase observed in the unvaccinated 0-4 age group. For adults and kids over 5, COVID vaccines can significantly lower the risk of contracting and spreading the virus or becoming severely ill. For many parents and caregivers who’ve waited months for kids under 5 to receive these same benefits, the FDA’s next vaccine meeting can’t come soon enough.
