US on the cusp of COVID-19 vaccine authorization for young children

Anticipation is building that younger children will soon be able to get vaccinated against COVID-19, a major milestone on the path out of the pandemic. 

Barring any significant delays, the U.S. is on the cusp of having at least one COVID-19 vaccine available to children under the age of 12, a major public health victory that could also help the Biden administration politically. 

Pfizer and its German partner BioNTech on Thursday submitted a request for emergency authorization to use their coronavirus vaccine in children ages 5 to 11, and a Food and Drug Administration (FDA) advisory panel will meet Oct. 26 to vote on granting the authorization. 

A Centers for Disease Control and Prevention (CDC) advisory panel meeting will occur soon after, and official clearance could come as early as that same day.

The authorization would bring major relief to parents of school-aged children, many of whom have been anxiously awaiting the day they could protect their kids. 

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer said in a tweet announcing the submission.

No vaccine is currently available for children under 12, and the FDA has been under pressure to move quickly on the issue. The agency previously said it would review an application “likely in a matter of weeks rather than months.”

The FDA has already cleared the companies’ vaccine for individuals ages 12 and up, including full approval for those ages 16 and older.

“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” acting FDA Commissioner Janet Woodcock said when the advisory committee meeting was scheduled.

White House COVID-19 response coordinator Jeff Zients said on CNN Thursday the Biden administration is working with states to make it easy for parents to vaccinate their children by setting up convenient times and places to administer the shots, including pediatricians’ offices.

Zients also said the U.S. has enough supply to quickly distribute the vaccines as soon as the public health agencies give the green light.

COVID-19 infections in children have been rising due to the highly contagious delta variant, and spread has been noticeable in schools across the country, especially in areas of the country with low vaccination rates.  

There were almost 175,000 cases among children in the week ending Sept. 30, according to the American Academy of Pediatrics (AAP). 

Children currently make up about 27 percent of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to AAP. The more people who are vaccinated in a community, the harder it is for the coronavirus to spread to children.

Experts agree that vaccinating children as soon as possible is key to moving past the current pandemic and getting society back to a semblance of normalcy.

John Grabenstein, a vaccine scientist and consultant who was a former executive at Merck, said the benefits are clear, but don’t expect to reach a “magic number” for herd immunity.

“Personal protection is the most important thing, and every individual who [gets vaccinated] reduces the chance of transmission. It’s not like herd immunity is a magic number and then, everything stops,” he said.

While authorization is anticipated, regulators are likely to closely examine the potential for serious side effects like myocarditis, or heart inflammation. So far, there are no obvious safety concerns for kids getting shots.

Cases of myocarditis are rare, and usually mild, but new studies have noticed a profound difference in the rates among young males and females. 

The condition seems much more prevalent among young men and teenage boys between the ages of 16 and 19, and it occurs more frequently after the second dose of an mRNA vaccine than the first.

Grabenstein said the available clinical data on children is likely too small to be able to tell the impact of such rare side effects. He said the risks of side effects are balanced with the risk of infection.

“The adverse event rate needs to be compared to the myocarditis that happens after infection, which seems to be worse, both in frequency and its severity,” Grabenstein said.

He noted that while some European countries are using a single dose in children because of the possible risks, the FDA can only evaluate based on the trials conducted by the companies. 

Pfizer’s doses for the 5- to 11-year-old age group are planned for 10 micrograms, one-third the level given to older children and adults, but still spread across the same three-week interval.

As President Biden wrestles with a declining approval rating, he has maintained relatively higher marks on pandemic preparedness. Authorizing a vaccine for children before Thanksgiving could be a major boost.

A recent Quinnipiac poll found 48 percent of voters approve of Biden’s handling of the pandemic, while 50 percent disapproved. 

The numbers were the same as last month, but in August, the poll showed 53 percent said they approved of how the president has handled the pandemic. Overall, 38 percent said they approve of Biden’s job performance while 53 percent disapprove.