More children in Georgia have been infected by the coronavirus’s highly contagious delta variant in recent weeks than in any of the other three prior surges. But Pfizer-BioNTech’s recent announcement that its vaccine is safe and effective for youths age 5 to 11 sets the stage for the U.S. Food and Drug Administration to possibly authorize its use for younger children by Halloween.
The pharmaceutical companies say early results of a trial indicate the vaccine — tested at a much lower dose, about a third of the amount given to adults — establishes a strong antibody response that will help children fight the virus.
The FDA already has given emergency use authorization that allows children ages 12 through 15 to receive the Pfizer-BioNTech vaccine. Last month, the FDA granted full approval to the Pfizer vaccine for people 16 and older. Older children have been vaccinated at lower rates than adults in Georgia.
The need for expanding eligibility of the vaccine is urgent, public health experts say.
The delta variant is sending more children to hospitals and intensive care units across the state than earlier waves in the pandemic. According to the latest federal data, 236 children in Georgia were admitted to a hospital for COVID-19 during a seven-day period ending Sept. 20. Only two other states in the country – Texas and Florida — reported more children hospitalized during that same time period.
Pfizer-BioNTech plans to apply to the U.S. Food and Drug Administration by the end of September for authorization to use the vaccine in younger children. Regulatory review processes for older adults and children took about a month.
The FDA released a statement earlier this month saying the agency is “working around the clock to support the process for making COVID-19 vaccines available for children” but that it will not cut corners.
Thursday, Children’s Healthcare of Atlanta hosted a Facebook Live to answer questions about the vaccine use in the younger age group.
The panel included its chief medical officer, Dr. James Fortenberry, and its division chief of Pediatric Infectious Disease, Dr. Andi Shane.
Here are excerpts from that session.
Q: Dr. Shane, you have an elementary school-aged child. Will your child be getting the vaccine when it becomes available?
Shane: Having the opportunity of taking care of a number of children who had acute COVID-19 illness and children with post-COVID complications, I absolutely have no hesitancy about having my son vaccinated. I can not emphasize enough the importance of vaccination for the prevention of severe infection and hospitalization. We will be first in line as soon as it is available for his age group.
Q: Do you have concerns about any long-term side effects from the vaccine?
Shane: These vaccines have been studied in clinical trials, and there are currently trials going on to make sure they are looking at safety and efficacy. And, based on the studies that have been done and the early results recently put out by Pfizer, it really appears they are completely safe in the short term and the long term.
Fortenberry: The risk of complications is exceedingly small from the vaccine. What we see are the results of COVID-19 causing illness, not the result of the vaccine causing complications.
We are seeing a significant increase in Multisystem Inflammatory Syndrome in Children, which is a rare but potentially very significant complication of COVID-19. It is typically seen four to six weeks after initial infection. I am an ICU doctor and, unfortunately, we are seeing this in some of our ICU patients. The vaccine could prevent your child or teen from getting COVID in the first place.
Credit: Rebecca Wright
Credit: Rebecca Wright
Q: My kids are healthy and have no preexisting conditions. Kids who get sick with the coronavirus generally have mild illnesses. Do my kids really need the vaccine?
Fortenberry: We recommend the vaccine for every age-eligible patient because, even though for most children and for most teens it is a mild condition, there is the potential of having significant conditions. So, the value of getting that vaccine is really important. The other piece of it is, even if you are not that sick, there’s the impact of getting ill with COVID. It impacts the child’s life. They are out of school, away from sporting activities, clubs and are isolated as a result of it. So, for the potential of getting significantly ill from COVID-19 and also the impact on their regular lives, we recommend the vaccine.
Q: Do children who have already had COVID-19 really need the vaccine?
Shane: Absolutely. We don’t know how long protection lasts after natural infection, and one of the issues with the virus is that it is very variable. With some children, the illness may be very mild. And some children may not even know they have been infected. But, in some children, it may be much more severe and require hospitalization. Because the virus is so unpredictable, a vaccine is absolutely recommended once a child or an adult has recovered from a coronavirus infection. We have seen a few situations where children have had a re-infection.
Q: With only about a third of kids in the 12 to 17 age group fully vaccinated, should I feel safe sending my kids to school?
Shane: Obviously, vaccination is the foundation of everything we do in terms of prevention, but there are other steps that can be taken to prevent transmission. First is wearing a mask, certainly outside the home in any indoor situation.
Individuals who are vaccinated should wear a mask in any indoor setting and then whatever the requirement is in terms of the school. People who are unvaccinated should wear a mask all of the time.
Second is hand hygiene, and that is a mainstay of ... preventing any type of transmission of any type of illness. And finally, physically distancing as much as possible between people, so schools can arrange classrooms so that can be maintained.
Q: Was the vaccine development rushed?
Fortenberry: This COVID vaccine is very safe and this vaccine. I am sure it has been studied more than any other vaccine in the history of mankind. We think of it as happening very quickly, but it is the result of 20-plus years of research around this mechanism to protect us. This is the result of an incredible amount of science and expertise coming together.
Staff writer J. Scott Trubey contributed to this article.