Immunizing children against COVID-19: What you need to know

As you're probably aware, the Food and Drug Administration recently granted expansion of the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine for adolescents ages 12 to 15 years.

The vaccine, previously authorized for those aged 16 and older, was reported in March by Pfizer to be "safe and 100% effective in this age group. Children ages 2 to 11 could potentially be eligible for a COVID-19 vaccine this fall."

The American Academy of Pediatrics continues to advocate for pediatric vaccine trials in children and adolescents. By the end of April, children made up 22.4% of new COVID-19 cases, a percentage that has continued to increase, according to data from the AAP and Children's Hospital Association. The pandemic also has taken a toll on children's mental and emotional health, social well-being and educational experience.

Amita Health pediatric and family physician leaders support the Centers for Disease Control and Prevention guidance that the COVID-19 vaccine is safe, effective and should be given to all who are eligible. But you may still have some questions on what this means for your children. Here are some answers from our experts for some of the most common questions we've heard.

Q: Is the COVID-19 vaccine safe for my child?

A: The FDA has granted a vaccination extension for the 12- to 15-year-old age group, first authorized in December. Clinical trials showed the Pfizer-BioNTech vaccine was 100% effective and presented no serious safety concerns in adolescents in that age group. Pfizer and BioNTech conducted clinical trials in 2,260 adolescents with half randomized to receive the vaccine - two doses, three weeks apart - and half to receive a placebo. Participants were followed for two months. Among 1,005 vaccine recipients, there were no cases of COVID-19, and 16 cases reported among 978 placebo recipients. An immunogenicity analysis in 190 participants also showed the immune response for 12- to 15-year-olds was just as favorable as the response for those ages 16 to 25 years.

Q: Is there a difference in side effects for 12 to 15-year-olds?

A: The most common side effects in adolescents were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain, all consistent with trials in older teens and adults. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first. The vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis, to any component of the vaccine. A full listing of the side effects is available on the FDA's website and a summary is found in the fact sheet provided to everyone who receives the vaccine.

Q: What is the safety testing that has been done on COVID-19 vaccines? How do we know it is safe long-term?

A: The safety follow-up for COVID-19 vaccines is consistent with all other vaccine trials. As part of the original authorization request, Pfizer submitted a plan to continue monitoring the safety of the vaccine as it is used. This plan has been updated to include the newly authorized 12- to 15-year-old population, and includes longer-term safety follow-up for participants enrolled in ongoing clinical trials, as well as other activities aimed at monitoring the safety of the vaccine, ensuring any safety concerns are identified and evaluated in a timely manner. The expectation for the adult phase 3 trials is two years of safety follow-up, longer than for most vaccines during development. It is impossible to know the very long-term safety profile of vaccines that have only been used in humans for several months, since December. That said, no licensed vaccines have been found to have an unexpected long-term safety problem years or decades after introduction.

Q: How quickly after immunization does the vaccine protect the recipient, and how long does immunity last?

A: For the mRNA vaccines developed by Pfizer-BioNTech and Moderna, studies reported vaccine efficacy at seven to 14 days after the second dose, which is likely how long it takes to get very high levels of neutralizing antibody. Studies to date have shown that both mRNA vaccines maintain high efficacy levels over a six-month period.

Q: If my child already had COVID-19, should they get the COVID-19 vaccine?

A: Yes, children of eligible age should get the COVID-19 vaccine regardless of whether they have had COVID-19, as experts do not yet know how long they are protected from getting sick again after recovering from the virus. Even if they have already recovered from COVID-19, it is possible, though rare, they could be infected again. Vaccination of children with known current infection should be deferred until they've recovered from the acute illness - that is, if they have symptoms - and they have been allowed to discontinue isolation. This recommendation is for both children with infection before receiving any vaccine dose and those infected after the first dose, but before the second.

Q: Why is it important to vaccinate children when most who have been infected with COVID-19 have had mild symptoms?

A: Since March 2021, about 1.5 million adolescents ages 11 to 17 years have been diagnosed with COVID-19, according to the CDC. Although most children have mild symptoms, we know they can infect adults in their families as well as others outside the home. Some of these adults may be at high risk of serious complications. From what we understand so far, it seems older children are spreading the virus more easily than younger children; therefore, it makes sense to move toward immunizing the population of these children who may be contributing most to transmission. Furthermore, although infrequent, some children do get very sick from COVID-19 and prevention of serious illness in children is an important goal of vaccination.

Q: Where can I go to get my child a COVID-19 vaccine?

A: We recommend you contact your primary care physician or pediatrician's office to determine the best location for your child to receive a COVID-19 vaccine.

• Children's health is a continuing series. This week's article is courtesy of Amita Health.