Parents Have Mixed Feelings About FDA's Delay in COVID Vaccines for Kids Under 5

Last month, the Food and Drug Administration (FDA) delayed a meeting where experts would choose whether to recommend the authorization of Pfizer’s COVID-19 vaccine for children aged 6 months to 4 years old. This move further holds up young children from receiving the vaccine.

According to Pfizer, the company chose to delay its FDA submission to wait for further data on whether a third dose of the vaccine, administered two months after the initial two doses, would provide more protection for this age group.

The news that a COVID-19 vaccine will not be available to young children as soon as expected is leaving many parents with mixed feelings about the inability to protect their young children from infection and exposure. Many parents understand safety comes first, but still feel frustrated by the delay.

“The majority of parents I’ve talked to are confused or upset that a vaccine for young children is delayed,” Alok Patel, MD, a pediatric hospitalist at Stanford Children’s Health, told Verywell via email. “Yet they’re understanding that a vaccine must show sufficient efficacy (and safety, which has already been demonstrated) prior to authorization, especially in young children.

Feelings of Frustration 

COVID-19 cases in children surged in January largely due to the Omicron variant. During the Omicron surge, hospitalizations among children less than 4 years old spiked dramatically, with the rate of hospitalizations among this age group peaking at four times the peak reported during the Delta surge.

While children aged 5 years and older received the green light to get vaccinated months ago, smaller children are not yet being given the same option, leaving them unprotected and vulnerable to the disease.

This has left many parents sad, angry and frustrated, especially since many states are now starting to lift COVID-19 related restrictions.

Parents of children with high-risk factors and medical conditions are especially concerned about the vaccination delay.

“In the hospital setting, I interact with many parents of children with serious medical conditions including conditions that can weaken immunity,” Patel said. “These parents are particularly anxious.”

Vaccinations are helping people get back to normal life and social activities. Having small children that are unvaccinated can hinder travel plans and long-awaited visits to see loved ones, with the underlying fear that your child may spread or catch COVID-19, putting them or others at risk.

“Many feel getting their young children vaccinated is the limiting factor for their families to be able to travel, make social plans without hesitation, and allow their children to leave the masks at home,” Patel said.

Parents Are Grateful for Safeguards

However, many parents are also grateful that Pfizer and the FDA were taking extra precautions to ensure the vaccine is both safe and effective before making it widely available to this younger population.

“I’m thrilled they chose to delay,” Cassi Donegan, a parent of three children, told Verywell. “There’s no way those who cannot consent should be given something that has not been proven safe and effective. No injection is one-size-fits-all. There is a risk versus benefit.”

Clinical trials involving children have to be safeguarded to ensure both clinical and ethical protocols are evaluated and followed. These steps include:

• Obtaining parent consent
• Conducting clinical trials on children only after safety has been proven in adults
• Factoring in the effects childhood growth and development have on vaccination outcomes

Ensuring these safeguards are followed may lead to delays in authorization, but are important to maintaining transparency with the general public.

“I’m not an anti-vaxxer by any means,” Traci Isler, parent of two children, told Verywell. “But I’m grateful for the delay, and hope it continues until they can prove without any doubts that this vaccine is safe and necessary.”

What Parents Can Do to Keep Their Children Safe

New data about vaccines in young children is speculated to be announced by early April.

In the meantime, parents should continue to take extra precautions to keep their child protected against COVID-19. To limit their child’s exposure to COVID-19, parents can continue to:

• Maintain physical distancing
• Ensure daycare and school settings are maintaining physical distancing
• Limit in-person play with other children
• Practice good hand hygiene
• Monitor their child for signs of COVID-19

The Omicron variant has been highly contagious for babies and small children, and monitoring them for signs of COVID-19 is important.

Parenting during a pandemic has been a large challenge. With work, childcare, and quarantine guidelines to follow, many parents are feeling exhausted. But good news surrounding vaccines may come in the next few months.

“It has been hard having a toddler in daycare these last couple of years,” Jennifer Hennessey, parent to a 3-year-old, told Verywell. “At times, it’s been almost impossible to continue to work. While I’m eager to get my daughter vaccinated, I appreciate the FDA taking the time to ensure the vaccine is effective and safe for young children.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.