Pfizer has applied for emergency use authorization of its coronavirus vaccine in kids ages 5-11, and U.S. health officials have pledged to act quickly on the request. Questions about vaccine safety, dosages and requirements in children are swirling as the U.S. moves closer to administering the shots in kids under the age of 12.

Pfizer this week became the first vaccine maker to ask the Food and Drug Administration to authorize emergency use of its coronavirus vaccine in children ages 5-11, a development that could open up the shot to 48 million more people.

The request is made even more urgent as children enter the fall and winter months of in-person learning, which could see flu outbreaks on top of coronavirus cases.

Children are at lower risk of severe infection and death from COVID-19 than older populations, but it does still happen.

According to a recent report, nearly 5.9 million children have tested positive for COVID-19 since the start of the pandemic, and the number of new cases in children “remains exceptionally high,” making up nearly 27% of new infections.

Data from the Centers for Disease Control and Prevention shows that more than 600 children have died from the coronavirus.

“In this latest wave of COVID-19, particularly down south, there have been thousands of children hospitalized,” Peter Marks of the FDA’s Center for Biologics Evaluation and Research said at a town hall in October. “And, frankly, it’s an embarrassment in a developed country to have even 100 children, like we’ve had, die of infectious disease that’s preventable.”

When Will the COVID-19 Vaccine Be Approved for Kids?

Pfizer, which produced the first COVID-19 vaccine to gain full FDA approval, is the furthest along in the process. The company last month submitted data to the FDA on the effectiveness of its shot in children ages 5-11.

The company in October submitted a request for emergency use authorization for the shot in the age group. FDA and CDC officials have pledged to act quickly on the request.

Even before the application, the FDA had scheduled a meeting of its vaccine advisory committee scheduled to discuss the subject on Oct. 26 “in anticipation of the request.” The agency could authorize the shot in late October or, more likely, in November.

“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 in a statement about the meeting.

Meanwhile, Moderna is also studying its vaccine in children ages 5-11, and its trial results are expected later this year.

Is the COVID-19 Vaccine Safe for Children?

In September, Pfizer announced “positive topline results” from its trial in children ages 5-11. It reported that the vaccine was “safe, well-tolerated and showed robust neutralizing antibody responses.”

Specifically, the trial results showed that children in the age group mounted a similar antibody response to those who were vaccinated in the 16-25 age group. The Pfizer vaccine studied in children aged 5-11 is still delivered in two shots spaced apart by 21 days, but it is only a third of the dosage given to those ages 12 and older.

The smaller dosage was “carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” the company said in a press release.

Children need a smaller dose because, among other things, they have “very active immune systems,” according to William Schaffner, a professor of infectious diseases at the Vanderbilt University Medical Center.

“At different stages of life, one’s immune system responds differently,” he says. “Infants and children have a wonderful immune system. It can respond vigorously to vaccines, for example.”

The Pfizer trial enrolled nearly 2,300 participants ages 5-11. It could be carried out with a smaller number of participants than the trials involving older people because the company did not have to start from scratch. Previous data from older participants proved the vaccines were effective at preventing COVID-19, so the trial with younger kids didn’t need to prove the vaccine worked – just that it prompted a similar level of antibodies and was safe.

“We can do a trial that lasts only months, demonstrating that the kids who got the vaccine developed a sufficient amount of antibody – quite comparable to what the teenagers and young adults develop,” Schaffner says. “That will be sufficient information for us because we’ve already established those levels of antibody are associated with protection.”

U.S. health officials promise to fully evaluate the shot’s safety in kids.

“We want to be sure beyond a shadow of a doubt that the evidence indicates a strong safety profile and strong immune response in children,” Surgeon General Vivek Murthy said at a recent press conference. “That’s why it matters that thousands of kids are enrolled in each trial, and that they are carefully monitored for at least two full months after they receive their second dose.”

What Are the Vaccine’s Side Effects in Children?

Pfizer hasn’t published much data on the side effects children can expect after receiving the shot. It did say in a press release that the side effects are “generally comparable to those observed in participants 16 to 25 years of age.”

That means that some children can expect sore arms, fatigue and other generally mild side effects, Schaffner says.

“These are small prices to pay in order to get protection against a virus that at its worst, can kill an even healthy, normal child,” he says.

Are Many Parents Expected to Get Their Kids Vaccinated?

Parental consent will be required for kids to receive the shots.

About one in four parents say they definitely won’t get their 5-11-year-olds vaccinated against COVID-19, according to a recent poll from Kaiser Family Foundation performed before Pfizer announced its topline trial data for the age group.

About a third of parents say they will get their kid vaccinated “right away.” Another third said they will “wait and see.”

If the vaccination rate for 12-15-year-olds is any indication, it could be an uphill battle.

Despite the Pfizer vaccine gaining emergency use authorization for people ages 12-15 in May, the age group continues to report the lowest vaccination coverage, according to CDC data. Just over 43% of this age group is fully vaccinated compared to a national rate of 56%.

Will Schools Require Kids to Get the Vaccine?

Perhaps unsurprisingly, California recently became the first state to announce it will require students in public and private schools to get the vaccine.

The requirement would take effect one semester after the FDA granted the vaccine full approval for an age group. Currently, only the Pfizer vaccine meets that threshold for people ages 16 and older.

“The state already requires that students are vaccinated against viruses that cause measles, mumps, and rubella – there’s no reason why we wouldn’t do the same for COVID-19,” California Gov. Gavin Newsom said in a statement.

But it is unclear how many jurisdictions will follow the Democratic state’s lead. Vaccine mandates have proven to be a controversial topic, and many school boards have already had a hard time grappling with pushback to mask requirements.

Is There a Vaccine for Children Younger Than 5 Years Old?

Pfizer expects to release results in children under the age of 5 later this year. Participants in this trial received an even lower vaccine dosage – about one-tenth of what was given to adults.

“Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year,” Pfizer reported in September.

Moderna is also studying its vaccine in children under the age of five.

Cecelia Smith-Schoenwalder

Source: https://www.usnews.com/

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