TrialSite recently shared some data prompting a need for at least a quality and safety review of mRNA-based vaccines. The Pfizer-BioNTech vaccine has been approved for adolescents aged 12-15 in both the United States and now Europe. Just a couple weeks after the May 10 Emergency Use Authorization (EUA) in America was announced, various state departments of health, including Maryland, communicated to licensed physicians to make them aware that the Centers for Disease Control and Prevention (CDC) recently identified increased cases of myocarditis and pericarditis in the United States after mRNA-based COVID-19 vaccination (e.g. Pfizer-BioNTech and Moderna) especially in adolescents and young adults. The CDC generated a report called “Clinical Considerations Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults,” which was made available online here. In both cases, the body’s immune system is responding to an infection or some trigger and is directly related to the jabs. The incidents, typically occurring within several days after mRNA COVID-19 vaccination, seem to concentrate in male young adults 16 years old and up and seem to occur more after the second dose. The CDC recently communicated that in “most” cases, these mostly young male patients respond well to medication and rest, evidencing prompt improvement of symptoms. The CDC’s risk-benefit calculus still favors vaccination for everyone 12 years and up considering the risk of other serious complications, including death, with COVID-19 infection.
Myocarditis represents an inflammation of the heart muscle, and the symptoms can include shortness of breath, chest pain, decreased ability to exercise, and irregular heartbeat. Complications can lead to heart failure due to dilated cardiomyopathy or cardiac arrest. While Pericarditis represents inflammation of the pericardium (fibrous sac around the heart) and symptoms can include a sudden sharp chest pain, which can also reverberate down the shoulders, in the neck or back.
For more on the CDC advisory, see the link.
Current Risk Levels Reported by CDC
According to the CDC in “COVID-19 Trends Among Persons Aged 0-24 Years—United States, March 1—December 12, 2020,” COVID-19 cases were already on the rise by January 2021. During one reporting period, a total of 2.87 million laboratory cases of COVID among ages 0-24 were confirmed in America. The breakdown among age was as follows:
- 18-24 (57.4%)
- 14-17 (16.3%)
- 11-13 (7.9%)
- 5-10 (10.9%)
- 0-4 (7.4%)
Among this age group (again 0 to 24 years of age), actual adverse event data was available in 41.9%, 8.9% and 49.1% of cases for hospitalizations, intensive care unit (ICU) admissions, and deaths respectively.
So for the data that was available for these adverse events, the CDC was able to report the following outcomes:
- Hospitalization (30,229 or 2.5% of the data available)
- ICU Admission (1,973 or 0.8$)
- Death (654 or <0.1%)
- Among the age group of 0-24, the largest percentage of hospitalizations (4.6%) and ICU admissions (1.8%) occurred among children aged 0-4 years).
Given the data available, the CDC recommends COVID-19 vaccination at this stage for everyone 12 years and above given what the agency describes as “the greater risk of other serious complications related to COVID-19, such as hospitalization, a multisystem inflammatory syndrome in children (MIS-C) or death.”
Equity & Healthcare
Recently, the Acting Deputy Administrator and Director for the Center for Medicare and Medicaid Services issued a CMCS briefing titled “COVID-19 Vaccine Update,” which reminded states that the vaccine is available for adolescents aged 12 through 15 and that states must be mindful of the importance of health equity, that is the “important role outreach and education can play in ensuring equitable access to a COVID-19 vaccination for those newly able to receive the Pfizer-BioNTech COVID-19 vaccine.”
According to the Kaiser Family Foundation (KFF)’s “Latest Data on COVID-19 Vaccinations Race/Ethnicity,” the vaccination programs have been not quite representative of the U.S. population as a whole.
As of May 25, the CDC has identified the race/ethnicity for 56% of those who have received at least one dose of a COVID-19 vaccine. In total, 62% have been administered to whites, while 14% have been Hispanic/Latino and 9% Black and 6% Asian for example. Among the total U.S. population, about 18% are Hispanic/Latino and approximately 13% of the population is Black. Hence the proportion of COVID-19 vaccinations in total for the available data is not quite near parity with the overall population.