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CDC Approves Pfizer-BioNTech COVID-19 Vaccine for Emergency Use Authorization (EUA) in Children Ages 5-11

November 03, 2021
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Q&A with Pediatrician Dr. John O’Reilly on the COVID-19 Vaccine

America is taking another step forward in the battle against COVID-19. The Centers for Disease Control and Prevention (CDC) announced on Nov. 2 that they have approved for emergency use authorization (EUA) the Pfizer-BioNTech vaccine for children ages 5-11.

“Pediatricians and parents should be very excited about the approval of the COVID-19 vaccine for children ages 5-11. Some parents may be reluctant to have their children in this age group vaccinated, but if a day of soreness can get your child safely back to playing with friends and visiting relatives, then the benefits clearly outweigh the discomfort,” said Dr. John O’Reilly, chief, General Pediatrics, Baystate Children’s Hospital.

The Baystate Children’s Hospital pediatrician noted children have been suffering physically, emotionally, and developmentally throughout the pandemic, and that having them vaccinated is a great first step to getting them back safely to a normal life.

“We are in the midst of a pediatric mental health crisis, with a dramatic increase in the number of children presenting to pediatrician offices and emergency rooms with depression, anxiety, substance use and suicidality. These mental health conditions have been exacerbated by the stress and social isolation of the pandemic. Having our children vaccinated will help get them out of the unhealthy isolation of their rooms and back into sports and after-school programs where they can start to enjoy fun activities with friends,” said Dr. O’Reilly.

Dr. O’Reilly provides answers to your important questions below regarding children being vaccinated for COVID-19:

Why is it important for children to be vaccinated against COVID-19?

Most children infected with COVID-19 experience mild symptoms, however, since the pandemic began in 2019, about 1.9 million children ages 5-11 years have been infected, about 9% of all U.S. cases. More than 8,300 in this age group have been hospitalized, with about a third requiring ICU care, and 94 have died, according to federal data. Children ages 5-11 who are Black, Native American, or Hispanic are three times more likely to be hospitalized with COVID than White children. The death toll in the past year puts COVID in the top 10 causes of death for this age group. Also, several thousand children infected with the virus have developed severe cases of inflammation throughout their bodies known as multisystem inflammatory syndrome (MIS-C), while others are reporting long COVID symptoms similar to adults such as headache, cough, fatigue and more.

Parents who vaccinate their children not only protect them, but they also protect everyone their children come in contact with. In school, it protects vulnerable classmates and adult staff whose medical conditions put them at risk for severe COVID 19. It also protects family members, and makes visiting at-risk family members at the holidays safer for everyone. Vaccinating our kids also helps to protect our communities. The higher our community immunization rates, the lower the risk of COVID-19 rapidly spreading through our at-risk community members.

Can every child of appropriate age get the COVID-19 vaccine or is it just for high-risk children?

The vaccine is for all children, not just those at high risk. It is critical for our children with asthma, obesity, diabetes, hypertension, immunocompromised states, and any chronic medical condition to get vaccinated against COVID-19. These conditions put those youth at risk of getting serious COVID-19, and the vaccine will help keep our most vulnerable youngsters from getting sick enough to be hospitalized.

The only children who should not get the COVID-19 vaccine are those with a proven allergy to the vaccine components, which is exceedingly rare. If you have concerns about whether your child should get the COVID-19 vaccine, talk to their pediatrician.

How safe is the vaccine for this younger age group – has it been rushed to market?

As a pediatrician, I have been hoping for this approval for months. I was very glad that the FDA took the time to be sure that the vaccine was safe and effective for children in this age group before it was approved. The trials looked at a number of vaccine dosages to be sure that the two 10 mcg doses administered 21 days apart, and 1/3 of the dose of adults and older teens, was the safest. Clinical trials of over 3,000 children who received the vaccine found it produced protective levels of antibodies with only mild reactions to the shot, such as pain at the injection site, fatigue, and headache.

There has been a lot of misinformation about the development of the mRNA vaccines, especially focused on how fast the COVID vaccines were rolled out. The truth is that we have been working on the development of mRNA vaccines for decades. The basic scientific advances in gene sequencing and gene modeling allowed companies to quickly adapt mRNA technology to the COVID-19 virus.

Vaccine development is very expensive, and companies developing other vaccines would be slower in developing them because of the cost. “Operation warp speed” gave companies billions of dollars in support and guaranteed purchases, allowing companies to use those funds to quickly ramp up clinical trials and manufacturing. The trials themselves followed the highest standards of research, and the FDA has reviewed all of the trial data to be sure that the COVID- 19 vaccines are safe and effective.

What about myocarditis which has been seen mostly in males under 30 years?

The FDA and the CDC have a well-developed system to monitor adverse events following vaccination. That surveillance found a rare association of myocarditis, an inflammation around the heart, with mRNA vaccination in older teens and younger adults, particularly in men.

The risk of developing myocarditis from a vaccine is far lower than the risk of getting myocarditis from a COVID-19 infection. This is particularly true for this 5-11 age group, who are at risk for the multisystem inflammatory syndrome (MIS-C) that can follow even a mild COVID-19 infection.

How effective is the vaccine and is it effective against the delta variant.

The vaccine was proven to be 90.7% effective in clinical trials, including against the widespread delta variant. That is an amazing level of protection for our kids, which will keep them safe in school, in their after-school programs, and when they visit relatives over the holidays.

Will children eventually need booster shots similar to adults?

Pediatricians and parents are used to infants and children getting booster shots for other vaccines, and we will likely have to do boosters for COVID-19 as well. The timing of the booster shots will depend on how long the COVID vaccine will provide protection to kids in each age group. As part of the clinical trials, patients will continue to be monitored for the long-term safety and effectiveness of the vaccines. Those ongoing studies will tell us when kids will need COVID-19 boosters.

Do children need to be vaccinated even if they have had the coronavirus?

Yes. Studies have shown that people who have been infected with COVID-19 are at least twice as likely to be re-infected with COVID-19. Vaccination results in the creation of immune memory cells. Those cells help the immune system fight off any future COVID-19 infections and protect them from serious illness and hospitalization.

Do children still need to get the flu shot if they are vaccinated for COVID-19?

Yes. Influenza is still a very serious respiratory illness. In our last full influenza season 2019-2020, 199 pediatric patients were killed by influenza and tens of thousands of pediatric patients were hospitalized. We are worried about the “twindemic” of influenza and COVID-19 illnesses in quick succession. Since last year, there was little influenza illness in our area, so our younger children have no natural immunity to influenza and are more likely to get seriously ill. Getting your child their flu vaccine as soon as possible will help protect them from serious illness, hospitalizations, and death. And, they can get the COVID and flu vaccines at the same time.

Where will these COVID-19 vaccines be administered?

Pediatric and family medicine practices, as well as some retail pharmacies, will be administering the vaccine for children 5-11.

At Baystate Health, the Pfizer vaccine for ages 5-11 will be available to established patients at Baystate Mason Square Neighborhood Health Center, Baystate General Pediatrics, Baystate Brightwood Health Center, Baystate Family Medicine Northampton, Baystate Family Medicine Greenfield, and Quabbin Pediatric Medicine. These sites will shortly be announcing specific clinic dates for this vaccine to their patients.

“I can’t emphasize enough how important it is for parents to make the right decision to vaccinate their children. It can be life-saving for your child and further protect those in your household as well as the community from this terrible disease that spares no one. I am looking forward to a holiday season when kids are fully vaccinated and we can all gather with friends and family to celebrate being together without fear of COVID,” said Dr. O’Reilly.

Learn more about COVID-19 vaccinations.

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