Nearly a full year has passed since the first COVID vaccines were made available to adults in the U.S. The moment that millions of parents have been waiting for is here: The U.S. Food and Drug Administration approved the Pfizer BioNTech mRNA vaccination against COVID for children ages 511.
The FDA approved the vaccine for young children today after a close vote of the FDA advisory committee. Next week, the Centers for Disease Control and Prevention advisory committee will meet to discuss the data and recommend the vaccine for all children aged five to 11.
Nathali Rodriguez, a Grand Prairie mother of two, said she will call her pediatrician this week in order to get their vaccine on the first day that it becomes available. Rodriguez said that she wants to give them the vaccine as soon possible. It feels like we are at the end. Knowing that they will be vaccinated helps me to breathe easier. With the holidays approaching, I feel safer having them all around me.
According to Kawsar Taraat, an epidemiologist at Johns Hopkins Bloomberg School of Public Health, the vaccine was thoroughly tested in children following FDA guidelines. The vaccine is safe and generates a good immune response.
Talaat states that it is particularly important to get vaccines for children now that they are back at school. This is due to the increased disease rates associated with the Delta variant surge. It has also led to more pediatric hospitalizations, as well as more deaths. Talaat cites data from the CDC that shows 41 children died in September. Although severe disease is not common in this age group of children, Talaat notes that a small number of 1.1million is still a large number of kids being admitted to the hospital. Talaat also points out that 41 deaths are a lot of children dying from a disease that should be prevented by vaccines in the coming weeks.
COVID was mild enough to be seen in children early in the pandemic. Their viral transmission rates were low enough that vaccines were not considered a priority in this age group. Paul Offit is an infectious disease pediatrician at Childrens Hospital Philadelphia and the director of the Vaccine Education Center. He notes that while children accounted only for 3 percent of cases when the pandemic began, they now account for close to 27 percent. Offit, who is a member of the FDAs Vaccines and Related Biological Products Advisory Committee that reviewed the Pfizer data, believes you can reasonably consider it a disease of children. He adds that COVID is more severe than a respiratory illness like influenza.
This virus is unique among all respiratory viruses in that it causes an immune response against your own blood vessels. Offit said that he has never seen anything similar before. One in 3,000 children who have had confirmed SARS-CoV-2 infection, even if they are not symptomatic or mild, will develop multisystem inflammatory syndrome. This is a condition that affects the lungs, heart and liver. It can last from four to six weeks. Offit said that he doesn't know of any respiratory viruses that could cause this.
Pfizer provided data to the FDAs advisory panel. The vaccine trial involved 1,518 children who were vaccinated and 750 who were given a placebo. Based on 16 infections in patients who received the placebo and three very mild infections in those who were vaccinated, the vaccine was 90.7 percent effective at preventing symptoms of COVID. The placebo group had more severe infections.
The majority of infections occurred between August and September when Delta was dominant. The effectiveness of the treatment in preventing asymptomatic infection was not measured.
Data also revealed that children aged five to eleven responded to a 10 microgram (mcg), lower dose, just as well as those 16 to 25, who responded to the adult 30 mcg dose. The average antibody levels of children who received the lower dose were actually a little higher than those in teens and young adults, but by less than 5%.
Three COVID-related diseases have become vaccine-preventable for children. Permar also highlighted the importance of the vaccine for children with COVID infections. Permar states that natural immunity does not provide long-term protection against severe diseases. Even if a child is infected, it's possible that they won't have the full protection that vaccine can offer.
There are fewer side effects
Study data showed that vaccine side effects in children younger than 12 years old were similar to those seen in adolescents, but less severe and closer to what was observed in older adults over 55. Fever, fatigue, headache, and chills were less common in children than in teenagers and young adults. Joint pain was also less common than in older adults. One in three children felt tired after the first dose and one in five experienced a headache.
The rates of fatigue (39%%) and headache (28%%) were slightly higher after the second dose. However, the side effect that was most frequently reported by younger children than older adults was redness at the injection site. This occurred in between 10 and 20% of the children who received the vaccine. Three quarters of the children who participated in the trial experienced pain at the injection site. There were no serious side effects or allergic reactions to the vaccine.
Myocarditis and pericarditis were not reported in any of the young adults or adolescents who received the vaccine. Pericarditis is inflammation of the heart muscle, or the lining around it. These conditions are very rare in adolescents and young adults. Permar states that although Pfizer was criticised for not having enough participants in its trial to detect myocarditis, there is no large enough trial to detect the rare side effects associated with the vaccine. The risk of developing myocarditis in the most at-risk group, 16-17 year old boys, is one in 5,000. Permar states that there is good reason to expect these possible side effects in younger children as the dose was specifically designed for them. The doses are 10 mg each, three weeks apart. This is in addition to the 30-mcg recommended for adults and teens.
The FDA advisory committee reviewed the Pfizer data and determined that vaccines would protect enough COVID patients to outweigh the potential risk of vaccine-related myocarditis. This is despite the fact that myocarditis rates in children aged five to eleven are the same as in older children. Talaat states that this is unlikely due to the lower dose. Talaat states that myocarditis is more common in adolescents than it is in young adults, regardless of vaccination. It seems that they are at greater risk. The same risk does not exist for children aged five to 11. So, it is not surprising that myocarditis rates should be lower, regardless of whether or not the vaccine was administered.
Offit reminds parents who are still worried about myocarditis that cardiac problems can also occur with MISC (a complication from COVID), and at higher rates that those caused by the vaccine. He says there are no safe choices. There are only choices that can be made to take different risks. Although myocarditis may occur in very rare cases, it is possible to vaccinate. However, there has been no evidence that this vaccine causes any long-term side effects.
Multiple benefits to vaccination
The greatest benefit of vaccinating your children is to prevent them from getting sick. Permar states that vaccinating children also reduces gaps between the immune system and the risk of new viruses developing.
She says that we will all do our part to ensure the population is immune, which will reduce virus spread and prevent the next dominant variant. Children are part the virus transmission chain. You can protect those with immune-compromising conditions and people who are not responding to vaccines by vaccinating your children.
It is important to get your vaccine authorizations before any winter family gatherings, as this will increase the chance of transmission. Permar states that if you get your vaccine now, there might be an additional dose before your holiday gatherings.
For millions of families, the greatest benefit of the vaccine is the ability to regain the freedom that their children had more than a decade ago. Rodriguez, whose husband suffers from a high-risk condition, is happy that her family can now attend church again. They stopped attending church when the congregation stopped masking. Her five-year old son can play soccer after almost two years of beggarly playing.
We can get back to normal by knowing there is a vaccine available. It gives me some hope that I won't worry so much.
The vaccine will bring relief to rural Alaskan children of Elizabeth W., a mother who requested to keep her last name secret because she has friends and family who are against vaccination. Her 6-year-old daughter, who has hemophilia, takes immunosuppressants for Crohn's disease. Her 10-year old son is on Crohns medication. Her son, who is now 12 years old, has been so isolated from her that she begged her for the vaccine. He and his sister are now able to get vaccinated and can return to church and visit family in other parts.
Elizabeth Harman is a Princeton University philosophy professor. She says that her 11-year old daughter is eager to return to basketball after last year's disappointment. She participated with her five-year old sister in the Pfizer pediatric trials, but she didn't know if she received the vaccine or placebo. Pfizer will now be blinding all participants after the FDA issues the EUA.
Harman states that the girls participated in the trial partly to get vaccinated sooner than expected, to keep them and us safe, but also to help end the pandemic.
Harman states that vaccinating your children is one way we can all help end the pandemic. Your children are doing something concrete to end the pandemic. It's a great thing that you can do for others.
