COVID-19 vaccine insights: The news beyond the headlines
Here is key intelligence on the recommended primary series, boosters, breakthrough infection, adverse events, special population vaccination, vaccine myths, and what the future might hold.
PRACTICE RECOMMENDATIONS
› Vaccinate all adults (≥ 18 years) against COVID-19, based on recommendations for the initial series and boosters. A
› Vaccinate patients against COVID-19 with evidence-based assurance that doing so reduces disease-related risk of hospitalization, myocardial infarction, stroke, need for mechanical ventilation, and death. A
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
Vaccine adverse effects: Common, rare, myths
Both early mRNA vaccine trials reported common minor adverse effects after vaccination (TABLE 121-24). These included redness and soreness at the injection site, fatigue, myalgias, fever, and nausea, and tended to be more common after the second dose. These adverse effects are similar to common adverse effects seen with other vaccines. Counseling information about adverse effects can be found on the CDC website.a
Two uncommon but serious adverse effects of COVID-19 vaccination are myocarditis or pericarditis after mRNA vaccination and thrombosis with thrombocytopenia syndrome (TTS), which occurs only with the Janssen vaccine.30,31
Myocarditis and pericarditis, particularly in young males (12 to 18 years), and mostly after a second dose of vaccine, was reported in May 2021. Since then, several studies have shown that the risk of myocarditis is slightly higher in males < 40 years of age, with a predicted case rate ranging from 1 to 10 excess cases for every 1 million patients vaccinated.30,32 This risk must be balanced against the rate of myocarditis associated with SARS-CoV-2 infection.
A large study in the United States demonstrated that the risk of myocarditis for those who contract COVID-19 is 16 times higher than it is for those who are disease free.33 Observational safety data from April 2022 showed that men ages 18 to 29 years had 7 to 8 times the risk of heart complications after natural infection, compared to men of those ages who had been vaccinated.34 In this study of 40 US health care systems, the incidence of myocarditis or pericarditis in that age group ranged from 55 to 100 cases for every 100,000 people after infection and from 6 to 15 cases for every 100,000 people after a second dose of an mRNA vaccine.34
A risk–benefit analysis conducted by the Advisory Committee on Immunization Practices (ACIP) ultimately supported the conclusions that (1) the risk of myocarditis secondary to vaccination is small and (2) clear benefits of preventing infection, hospitalization, death, and continued transmission outweigh that risk.35 Study of this question, utilizing vaccine safety and reporting systems around the world, has continued.
Continue to: There is emerging evidence...
