Seven weeks ago, on May 10, 2021, the U.S. Food and Drug Administration (FDA) gave Emergency Use Authorization for the Pfizer CoViD19 Vaccine for children 1215 years of age. The scientific basis for this comes from 2260 children in this age group who are part of a clinical trial involving over 46,000 patients. The study yielded 18 cases of CoViD19 in placebo (normal saline) recipients and no cases in those who received two doses of vaccine.
The safety profile of this vaccine is good with the usual side effects of vaccines, slightly more common after the second dose. These results have been reviewed in public meetings by advisory committees for the FDA and Center for Disease Control and Prevention (CDC) each consisting of 15 vaccine experts. The major results of the clinical trials are detailed in peerreviewed publications in the New England Journal of Medicine December, 2020. In Oklahoma, 3.2 million doses of messenger RNA vaccines have now been administered. The decrease in cases and deaths of CoViD19 in Oklahoma as a result of vaccination, masks, distancing and hygiene has been dramatic, though in recent weeks, the case counts and hospitalizations have been increasing.
While most of the 8,400+ deaths associated with CoViD19 in Oklahoma have occurred in persons over 55 years of age, 11.4% of the laboratoryproven cases have occurred in children 517 years of age. Fortunately, only 0.04% of Oklahoma deaths from CoViD19 have occurred in children, but almost 4000 cases of Multisystem Inflammatory SyndromeChildren (MISC) have been reported nationwide.
Recently, a rare side effect has been reported after messenger RNA vaccines: myocarditis. This has been reported most often in persons 1235 years, more commonly in males and more often after the second dose. Using the Vaccine Adverse Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) surveillance systems, a rate of myocarditis after the second dose has been estimated of 3.26.7 cases per 100,000 doses of vaccine. Most cases resolve quickly with conservative treatment. However, since the cumulative incidence of CoViD19 disease is highest in Oklahomans 1524 years of age (14,944/100,000 population), the benefit of vaccine far outweighs the risk of this very rare side effect, a conclusion endorsed by fourteen organizations of the nation’s leading doctors, nurses and Public Health Leaders.
There are several reasons children 12 years and older and their parents should consider the Pfizer vaccine. First, the vaccine is highly effective in preventing infection and illness in children and adults. The infection itself may result in myocarditis and MISC. Second, experience with the vaccine over the past eleven months indicates a good safety profile. Third, blocking transmission of CoViD19 by preventing infection will help quell the pandemic. Fourth, vaccine is the best method to prevent another surge of CoViD19 disease from the CoViD19 variants now circulating in Oklahoma from the United Kingdom, Brazil, South Africa and India, countries currently experiencing massive outbreaks.
Blaine County lags behind other counties with 37% of persons ≥ 12 years completely vaccinated. If a person does not want to take the vaccine, that should be respected. However, vaccination is the most effective way to prevent this highly infectious virus which has resulted in 20 deaths in Blaine County, over 8,400 deaths and 27,000 hospitalizations Oklahomawide.
Joe P. Bryan, MD
Board Certified in Internal Medicine and Infectious Diseases Retired US Navy, US Department of State, US Centers for Disease Control and Prevention