6 min read.Updated: 26 Oct 2021, 12:55 AM ISTRobbie Whelan, The Wall Street Journal
What to know after the FDA expanded use of Pfizer’s Covid-19 vaccines to children 12 to 15 years old, and is nearing a decision to widen use to kids as young as 5 years old
Pfizer Inc. and BioNTech SE said on Sept. 20 that their Covid-19 vaccine was found safe to use among children 5 to 11 years old and generated a strong immune response in them, bringing shots for more children a step closer to distribution. On Oct. 7, the companies asked the Food and Drug Administration to authorize the shot’s use in children.
The FDA has already authorized Pfizer’s vaccine for use in children 12 to 15 years. The shot is the first cleared for administration in the younger age group, after the FDA last December approved the vaccine for age 16 and up. Here is what you need to know about Covid-19 vaccines and children:
When will children get the Pfizer Covid-19 vaccine?
Some 64% of people in the U.S. age 12 and over are fully vaccinated against Covid-19, according to the Centers for Disease Control and Prevention. Some older people and people with compromised immune systems have begun to receive booster shots as well.
Vaccination among children age 5 to 12 could start within weeks, if the FDA issues the authorization requested by Pfizer and BioNTech. That could mean the companies’ Covid-19 vaccine is cleared for the young children between Halloween and Thanksgiving, a person familiar with the matter told The Wall Street Journal. Pfizer said results of a study of younger children, age 6 months to under 5 years, could come by the fourth quarter this year.
Do we need to vaccinate children?
Yes, according to most infectious-disease experts. Children can and do get sick from Covid-19, though research shows they typically experience milder cases and are much less likely than adults and the elderly to be hospitalized or die from the virus. Some hospitals across the country reported treating more children than ever this summer, which the CDC said reflected the rampant spread of the highly contagious Delta variant in much of the country.
In addition, scientists say children need to be vaccinated to achieve the communitywide, or herd, immunity that renders spread of the virus unlikely. “Vaccines give us the opportunity to really turn the tide on this pandemic, and children and teens really need to be a part of that strategy," said Lisa Costello, a pediatrician and president of the West Virginia chapter of the American Academy of Pediatrics.
How effective is the vaccine?
The Pfizer-BioNTech vaccine—the only vaccine authorized for emergency use in children age 12 to 15 and fully approved for anyone age 16 and over—was 93% effective against hospitalization with Covid-19 among 12-to-18-year-olds, the CDC reported in October.
Pfizer and its partner BioNTech released new data on Oct. 22 showing the vaccine was 90.7% effective at preventing symptomatic Covid-19 in a study of children age 5 to 11. The companies also said the vaccine was safe during the testing.
A review of the data by FDA staff Oct. 22 found that the Covid-19 vaccine from Pfizer-BioNTech met the agency’s criteria for immune responses in the study of children age 5 to 11 years.
The agency flagged the risk of heart-inflammation conditions including myocarditis associated with the vaccine but said the overall benefits, in preventing Covid-19 disease and hospitalizations, would outweigh the risk of the heart conditions.
The Biden administration recently said it would make Covid-19 vaccines available to children age 5 to 11 at more than 25,000 pediatric offices and primary care sites and at pharmacies and schools, should it be approved by federal regulators.
The Biden administration said it has procured enough doses of the Pfizer-BioNTech vaccine to inoculate the nation’s children and will begin shipping them across the country if and when the vaccine is cleared for use.
Moderna, which is also seeking authorization to widen the use of its shots to 12 years and older, has said its Covid-19 vaccine was generally safe and induced the desired immune responses in children age 6 to 11 in a clinical trial.
Will vaccination be required for school?
The CDC urged all school staff and eligible students to get vaccinated ahead of the school year. Some universities required students to get vaccinated to return to campus this fall, and school districts including New York City have required teachers and staff to get the shots. Most school districts in the country already require students to have received vaccinations for mumps, measles and rubella, as well as polio, diphtheria and chickenpox, though many districts grant exemptions to students with pre-existing health problems or religious beliefs conflicting with the mandate. “If you’re in a district that has a lot of vaccine requirements already, I wouldn’t be surprised to see the Covid-19 vaccine just lumped in with those others," said Noelle Ellerson Ng, associate director of advocacy and governance for AASA, the School Superintendents Association, a national umbrella group that represents school districts. Some districts might require Covid-19 vaccinations just for a year or two, until the pandemic dies down, some other school experts say.
What are children’s Covid-19 symptoms?
The symptoms are pretty much the same for children as they are for adults, according to the CDC. The symptoms include fever or chills, cough, loss of sense of taste or smell, and headaches. Doctors have also been probing links between Covid-19 and a rare inflammatory condition that causes stomach pain, skin rashes and a high fever. One reason why doctors and public-health experts say they hope children will get vaccinated is research indicating they can carry and transmit the virus even if they don’t show any symptoms.
Does the vaccine pose any risks to children?
Any vaccine comes with the risk of an adverse reaction, and the Covid-19 shots are no different, doctors and vaccine experts say. So far, however, researchers haven’t found evidence the vaccines pose any additional or different risks to children versus adults. The most common side effects to the vaccine, according to the CDC, are flulike symptoms such as fever, muscle aches and chills. Many recipients also experience arm soreness or bruising after receiving the shot.
In extremely rare cases, people who have received a Covid-19 vaccine have experienced severe allergic reactions, including anaphylaxis related to chemicals that help package the main ingredient in the Pfizer-BioNTech and Moderna Inc. vaccines, a compound known as mRNA.
Experts advising the CDC have said there appears to be an association between the mRNA vaccines and a rare inflammatory heart condition called myocarditis in some younger people, including young adults.
The CDC and other health authorities still recommend Covid-19 vaccination for those 12 years and older, given the greater risk from Covid-19, which itself can cause myocarditis and other complications.
Citing the risk of myocarditis, Norway has advised that all people under 18 years shouldn’t be given the Moderna vaccine, even if they had already received one dose, and recommended that men under 30 consider getting the Pfizer-BioNTech vaccine instead. Norwegian officials referred to U.S., Canadian and Nordic data, saying the absolute risks remain low and calling the advice a precautionary measure.
Studies indicate there aren’t safety risks for pregnant mothers or their unborn children from the vaccines, and that expectant mothers can pass on immunity-boosting antibodies to their fetuses after getting the shots. “Some parents will be skittish about the [Pfizer] vaccine because it’s a new technology, but that just means there’s a lot more educating to be done on the topic," said Peter Hotez, a pediatrician and virology expert at Baylor University. “The safety profile looks about the same for children as it does for adults."
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