Opinion | I monitor meetings of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) for the National Vaccine Information Center (NVIC). On May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in the U.S. to include administration to children as young as 12 years old.1 On May 12, 2021, I listened to the emergency meeting at which the ACIP voted 14-0 with one abstention (due to conflicts of interest) to recommend the Pfizer vaccine for adolescent children.2
The evidence that ACIP used to make their recommendation was based on results of a very small Pfizer clinical trial that the FDA has stated included:
2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.3
Based on less than 1200 adolescents who were administered the Pfizer COVID-19 vaccine, the ACIP voted to recommend that the experimental vaccine can be given to every adolescent in the U.S. and said it can be given simultaneously with every other vaccine recommended by the CDC for adolescent children. So the CDC says it is okay for a 12-year-old to get the experimental Pfizer COVID-19 vaccine along with vaccines for influenza, HPV, Tdap and meningococcal on the same day.4
No Information on Co-administration of Pfizer COVID-19 Vaccine with Other Vaccines
The FDA’s May 10 Fact Sheet for Health Care Providers states that, “There is no information on the co-administration of the Pfizer/BioNTech COVID-19 vaccine with other vaccines.”5
Where is the scientific data to support safety of the ACIP recommendation that adolescents can get the Pfizer COVID-19 vaccine simultaneously with other vaccines? Or that adults, including pregnant women, can receive a COVID-19 vaccine at the same time as any other recommended vaccine?
There is none.
The CDC reported that the recommendation to administer COVID-19 vaccines independently of any other vaccine product, with a minimum interval of 14 days before or after administration of any additional vaccine, was done to gain a better understanding of potential reactions associated with these novel vaccines. They are now reporting that “substantial” safety data has been collected on COVID-19 vaccines and went on to justify the change in their recommendation by stating:
Extensive experience with non-COVID-19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone.6
In other words, we give multiple vaccines all the time, so why should administering the COVID-19 vaccine with any other vaccine be problematic? …