Approval for the use of Pfizer's COVID-19 vaccine in children ages 5-11 is expected soon, as the White House on Oct. 20 detailed its plan for quickly vaccinating this age group. Many parents are apprehensive about vaccinating their young children against COVID-19, so Becker's gathered advice on the matter from chief pharmacy officers at health systems across the country.
Editor's note: Responses have been lightly edited for clarity and style.
Susan Mashni, PharmD. Senior Vice President and Chief Pharmacy Officer at Mount Sinai (New York City): The CDC and FDA are in agreement that the Pfizer COVID-19 vaccine is both safe and effective in children 5 through 11. We are awaiting the review by the Advisory Committee on Immunization Practices, anticipating that they will give the same approval. All these groups have used the data to reach the conclusion that any risks are far outweighed by the benefit of protecting kids 5 to 11 from serious COVID-19 infection and hospitalization.
There is a lower dose for children, and a smaller needle, and our pediatric providers are anxiously awaiting the opportunity to provide this important protection against COVID-19 to children — both patients and their own children alike! As always, talk with your child's pediatrician about any of your concerns about the vaccine. I feel very comfortable suggesting to my friends and family to have their kids immunized against COVID with the pediatric Pfizer vaccine.
Elie Bahou, PharmD. Senior Vice President and Chief Pharmacy Officer at Providence (Renton, Wash.): What we know now is that children can be infected by the SARS-CoV-2 virus, and in some cases, they can become seriously ill because of it, even requiring hospitalization. Children will have less risk for contracting COVID-19 and transmitting it to other people after they are fully vaccinated. Both the FDA and CDC have been very responsible for both safety and efficacy reviews for all vaccines in adults and children. I am confident that they will do the same for this very important vaccine for our young children.
Pfizer and BioNTech have officially submitted their phase 2/3 study data for both the FDA and European Medicines Agency. The scientific data indicated that Comirnaty (COVID-19 mRNA vaccine of Pfizer and BioNTech) displayed strong immune repose in children 5 years to less than 12 years of age.
The dosage studied for pediatric patients was one-third of the adult dose. The FDA is scheduled to review all scientific data submitted Oct. 26, so we will learn more at that time. The FDA's Vaccines and Related Biological Products Advisory Committee will also evaluate the vaccine's safety and efficacy thoroughly, as they do with any other vaccines that the FDA has approved.
Onisis Stefas, PharmD. Vice President and Chief Pharmacy Officer at Northwell Health (New Hyde Park, N.Y.): In September, children made up about 30 percent of the COVID-19 cases in the U.S. Children may not be as likely to develop severe COVID-19, however, they are still at risk, especially since the delta variant has resulted in more hospitalizations in children compared to the previous strains. There have also been reports that children who contract a mild case of COVID-19 may not develop antibodies to the virus afterwards.
The Pfizer vaccine, which is currently authorized for 12 and older, will soon be available for children as young as 5 years of age. For children from 5-11, the dose will be one-third the adult dose and was chosen as it was the safest, well-tolerated and produced the same immune response seen in adolescents and adults against COVID-19. The children will also require a second dose, similar to adults, 21 days after receiving the first dose to complete the regimen.
The side effects to the vaccine are also similar including fatigue, muscle pain, chills, fever, and pain, redness and swelling at the injection site. Rare side effects include myocarditis and pericarditis, which typically occurs several days after the second dose. Signs to look out for include chest pain, shortness of breath or an elevated heart rate. If your child has any of these symptoms, seek medical care, and most kids recover quickly. Once approved through the FDA and CDC, I would feel comfortable recommending all children without a contraindication 5 years of age or older to receive the vaccine.
Indu Lew, PharmD. Executive Vice President and Chief Pharmacy Officer at RWJBarnabas Health (West Orange, N.J.): The FDA has stated that the COVID-19 vaccine from Pfizer-BioNTech met the agency's criteria for immune responses in a study ages 5-11 years. The vaccine was at least 90 percent effective at preventing symptomatic COVID-19 disease and hospitalizations; these benefits outweighed the rare reported risks of heart inflammation. Hundreds of millions of people over the age of 12 and more than 2,200 children ages 5-11 years have received the two-dose regimen.
According to the American Academy of Pediatrics, there are more than 28 million children between the ages of 5 and 11 in the U.S. While the risk of severe COVID-19 is much lower in children than adults, many have been hospitalized, and there have been at least 146 reported COVID-19 deaths of children in this age group. The vaccine will help to prevent the risk of severe COVID-19 and also may help prevent children from transmitting the virus, including transmission to older and medically vulnerable adults.
The vaccine regimen is two shots, each one-third the dose given to adults and teens, administered three weeks apart. Vaccinations are planned to be available at pediatricians and primary care offices, hospitals and health systems, pharmacies, schools, and community health clinics.
For parents that have specific questions about the COVID-19 vaccine for children, they should speak with their child's pediatrician or pharmacist to talk about their concerns and the vaccine studies.
Amir Emamifar, PharmD. Vice President and Chief Pharmacy Officer at Temple University Health System (Philadelphia): We expect the FDA and CDC’s decision on Pfizer’s COVID-19 vaccine for kids ages 5-11 in the next few weeks. Nearly 5.9 million children have tested positive for COVID-19, according to data from the American Academy of Pediatrics and the Children's Hospital Association. There have been nearly 850,000 new pediatric cases over the past four weeks.
Investigators tested the lower-dose Pfizer-BioNTech vaccine in 2,268 children, and their data demonstrate it is safe and produces a significant immune response. The results from a phase 2/3 trial showed a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 micrograms administered 21 days apart, a smaller dose than the 30 microgram dose used for people 12 and older.
The currently available vaccine product with a purple cap has not been studied in children under 12 and therefore should not be used for this age group. The vaccine vials for ages 5-11 years will have orange caps and borders to differentiate them.