Pfizer says COVID-19 vaccine safe, effective for kids 5-11: What parents should know

September 20, 2021

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(NEW YORK) — As millions of children across the country remain unvaccinated against COVID-19 due to their age, new data shows the Pfizer and BioNTech COVID-19 vaccine is safe and effective for children ages 5 to 11, according to the two companies.

“In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralizing antibody responses,” the companies said in a news release, sharing the results of a trial that involved more than 2,200 kids ages 5 to 11.

Pfizer and BioNTech also confirmed they plan to soon submit a request for emergency use authorization with the U.S. Food and Drug Administration (FDA).

The FDA approved the Pfizer vaccine for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.

The news from Pfizer and BioNTech about their vaccine comes as the U.S. faces a COVID-19 surge as the more contagious delta variant spreads and vaccination rates remain low for some age groups.

The surge is also happening as students are back in school and many remain unvaccinated, leading to a spike in pediatric cases.

More than 1.2 million children have tested positive for COVID-19 since they returned to classrooms in late July, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.

Here are 10 questions answered about the COVID-19 vaccines and kids as families seek to make the best decisions.

1. What is the science behind the COVID-19 vaccine?

Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the outside of the virus — a way for the body to learn and develop defenses against future infection.

The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.

This same type of vaccine has been authorized for Ebola, and has been studied extensively for other illnesses — and for how it affects women who are pregnant or breastfeeding.

Neither of these vaccine platforms can cause COVID-19.

2. What is the status of vaccine eligibility for kids?

In general, federal and industry officials said they expect the first vaccine shots for children ages 5-11 could happen by the end of this year or early 2022. Timing on a vaccine for children younger than 5 is less certain, but officials have said they hope a greenlight for toddlers and infants will follow soon after.

NIH Director Dr. Francis Collins told “Good Morning America” in August that he expects kids ages 5 to 11 will get access to the vaccine in “late 2021.”

Pfizer said it plans to submit its authorization request for 5 to 11-year-olds to the FDA “with urgency.”

Moderna filed for emergency use authorization with the FDA for its vaccine in adolescents in June but is still awaiting a decision. The company said it will submit vaccine safety data on 5- to 11-year-olds this fall.

Pfizer and BioNTech said results from two other ongoing trials — one of children ages 2 to 5 and one of children 6 months to 2 years old — are expected as soon as later this year.

3. Why do kids need to be vaccinated against COVID-19?

While there have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and just as importantly, they can transmit the virus to adults.

“There are really two big reasons why kids need to get the vaccine,” explained Dr. Jennifer Ashton, ABC News chief medical correspondent.

“One of them is that it is possible that they could be infected and then unknowingly pass COVID-19 to someone with a serious or underlying, pre-existing medical condition,” she said. “And also, though it’s very uncommon and unlikely, it is still possible that children infected with COVID-19 could become seriously ill or worse. We have seen that.”

“It’s important to think in ripple effects, outside the box,” Ashton added. “It’s not just your home environment that you need to worry about.”

4. Will kids experience the same vaccine side effects as adults?

In announcing its trial results, Pfizer and BioNTech said the vaccine was “well-tolerated” in kids ages 5 to 11.

Adolescents experienced a similar range of side effects to the vaccine as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in August.

Moderna has said its COVID-19 study with teens ages 12 to under 18 identified no “significant safety concerns.” The most common side effects from the vaccine were injection site pain, headache, fatigue, muscle pain and chills, according to the company.

The FDA will scrutinize Moderna’s clinical data before authorizing the use in anyone under 18.

5. Have there been vaccine complications reported for teens and young adults?

There have been more than 300 confirmed cases of heart inflammation in teens and young adults who have received COVID-19 vaccines, but the nation’s leading health experts say the Pfizer and Moderna vaccines remain safe for use.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), said on “Good Morning America” in June the benefits of the vaccine for young people “overwhelmingly outweigh the risk,” echoing the findings of researchers at a CDC advisory committee meeting in June on vaccines.

The rare instances of heart inflammation occurred about 12.6 times out of every million second dose administered and were mostly among younger males about a week after the second dose of the Pfizer or Moderna vaccines, according to researchers at the CDC advisory committee.

6. How effective are the vaccines in children?

Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.

Marks confirmed on May 10 that after a trial with over 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo.

No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.

Moderna’s COVID-19 vaccine is 100% effective in children ages 12 to under 18, the company said last month, in announcing results of their latest clinical trials.

In addition to its efficacy, the vaccine showed “no significant safety concerns” in the trial of more than 3,700 adolescent participants, according to Moderna.

7. Will kids get the same dose of the vaccines as adults?

Children ages 5 to 11 in the Pfizer and BioNTech trial still received two doses of the vaccine, but received a lesser dose than the amount given to people ages 12 and older, for the “safety, tolerability and immunogenicity” of younger children, according to the companies.

For 12- to 15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.

8. Could COVID-19 vaccines impact puberty, menstruation?

There is currently no clinical evidence to suggest the vaccines can have long-term effects on puberty or fertility, according to Ashton, a practicing, board-certified OBGYN.

Ashton noted that while there has been anecdotal discussion of the emotional event of finally receiving the vaccine temporarily impacting menstruation for adult women, the idea of the cause being from the vaccine itself “defies science and biology.”

It is really important to understand basic biology here,” Ashton said. “Women can have changes in their menstrual cycle and also have gotten the vaccine, that does not mean that one caused the other.”

“Right now there is no puberty concern. There is no fertility concern,” she added.

9. Will the Johnson & Johnson COVID-19 vaccine be available for kids?

Johnson & Johnson announced in April that it had begun vaccinating a “small number of adolescents aged 16-17 years” in a Phase 2a clinical trial.

As of April, the trial was enrolling participants only in Spain and the United Kingdom, with plans to expand enrollment to the U.S., the Netherlands and Canada, followed by Brazil and Argentina.

10. Will COVID-19 vaccines be required by schools?

It is up to each state’s government to decide whether a COVID-19 vaccine is required for school entry. Many colleges and universities in the U.S. are already requiring students to be vaccinated from COVID-19.

ABC News’ Sasha Pezenik, Anne Flaherty, Eric Strauss, Cheyenne Haslett and Jade A. Cobern, MD, a member of the ABC News Medical Unit, contributed to this report.