Pfizer/BioNTech has applied to the Food and Drug Administration (FDA) for approval of their vaccine in children. This is the first vaccine requesting approval in children ages 5 to 11.
The Wall Street Journal reports the companies had filed data with the FDA showing the vaccine was 90.7% effective in this age group in clinical trials. The companies also say the vaccine was safe and tolerable. A meeting is scheduled Tuesday, October 26th by the FDA to consider the application by a committee of vaccine experts. The panel, known as The Vaccines and Related Biological Products Advisory Committee, will meet to review the evidence of the vaccine’s safety and effectiveness and vote to recommend whether the FDA should authorize its use.
The vote of the committee is not binding on the FDA, but their recommendation will have a strong influence. The FDA could authorize the vaccine within days.
There are more than 28 million children ages 5 to 11 in the U.S. according to the American Academy of Pediatrics (AAP). Earlier reports by Pfizer/BioNTech in September said the vaccine was well-tolerated and induced strong immune responses in a study of nearly 2,270 children in the 5 to 11 age group. The vaccine induced neutralizing antibody levels in younger children that were comparable to those seen in teenagers and adults ages 16 to 25 who served as a control group in the study.
The study results indicated three children receiving the vaccine became sick with Covid-19, while 16 cases occurred in those who received a placebo. This data calculated the 90.7% efficacy. Concerns about cases of heart inflammation, seen in some teenagers, didn’t materialize as none were seen in this younger age group. Pfizer also tested the vaccine in an even lower age group, as young as six months, with lower dosages. No adverse effects were reported.
The Biden administration has reported plans to distribute the Pfizer vaccine to children at doctors’ offices, pharmacies, and schools if the FDA approves the shot. Since the vaccine must be stored at extremely low temperatures, this could prove a logistical challenge. Moderna and Johnson & Johnson are also studying the use of their Covid-19 vaccines in young children, but at present they are only authorized for people age 18 and older.
Some 64% of people in the U.S. ages 12 and over are fully vaccinated against Covid-19, according to the Centers for Disease Control and Prevention (CDC). Many older people and people with compromised immune systems have recently received booster shots, either Pfizer or Moderna, as well.
Do your young children need to be vaccinated?
This is the critical question every parent of young children needs to ask. Many infectious disease experts say Yes! Children can and do get sick from Covid-19, though typically they experience milder cases than adults. As I wrote recently (Vaccines for Young Children?), the
AAP reports about 125 deaths in children ages 5 to 11 due to Covid-19. This is a very small percentage of the roughly 5.9 million Americans ages 18 or under who have acquitted Covid-19. Yet it is a tragic event in every one of these families.
The decision for parents may be impacted by vaccine requirements of some schools. Most school districts in the country already require students to receive vaccinations for mumps, measles and rubella, as well as polio, diphtheria and chickenpox. Some districts grant exemptions for pre-existing health conditions with a doctor’s approval, or on religious grounds, though abuse of these exemptions in some states have led to local epidemics. The same may happen with Covid-19.
