By Stan Grogg, DO, FACOP, FAAP
AOA’s ACIP Liaison
Not only patients and their families, but we as pediatricians have suffered emotionally and financially by the COVID-19 pandemic. It is important for all of us to keep abreast of the Advisory Committee on Immunization Practices (ACIP) COVID-19 immunizations recommendations.(1)
As of the January 27, 2021 ACIP meeting, two COVID-19 vaccinations have been approved by the FDA with recommendations by the ACIP. First, the Pfizer-BioNTech vaccination was approved for 16 years of age and older and then the Moderna vaccine for 18 years of age and older. The Pfizer’s vaccine showed efficacy of 95% at preventing symptomatic COVID-19 infection at seven days after the second injection. The Moderna vaccine was 94.1% effective at preventing symptomatic COVID-19 infection at 14 days after the second dose. Both vaccines appeared to be equally effective across different ethnic and racial groups. (2) Both vaccines are based upon messenger (m) RNA as the major component. (2)
Other pharmaceuticals most likely to request the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) approval are AstraZeneca (AZ), Novavax, Janssen and Sanofi vaccines. The AZ vaccine was discussed at the January 27, 2021 ACIP meeting. AZ has enrolled 25,837 in the United Kingdom (UK), Brazil and South Africa.
In addition to efficacy, safety of the vaccines are of major concern. Safety reports received by the Center for Disease Control (CDC) since approval of the Pfizer and Moderna vaccines in December through January 18, 2021, revealed the most common adverse events were headache, fatigue, dizziness, nausea, chills, fever, injection site and extremity pain and dyspnea. These events lasted from 12 -72 hours after immunization. (4) Anaphylaxis was reported 5 per million doses administered of the Pfizer-BioNTech vaccine and 2.8 per million doses of the Moderna vaccine. All occurred within 30 minutes of the immunization. (4) Reports of deaths, due to any cause, following COVID-19 vaccination was 196 through January 18, 2021. All of the deaths were evaluated and felt to be temporally associated deaths and not due to the vaccination. (4)
Pediatric epidemiology was presented at the January 27, 2021 ACIP meeting by Angela Campbell, MD. As of January 26, 2021, there were 24,876,261 pediatric COVID-19 infections reported to the CDC with 416,010 pediatric deaths. The incidence of COVID-19 was lowest in children < 18 years of age. Younger children were less likely to be symptomatic and have fewer symptoms than adults. In addition, symptomatic children seem to transmit SARS-CoV-2 less than adults. Children exposed in the household had similar risk of SARS-CoV-2 infection as adults. Children <18 years have the lowest cumulative rate of COVID-19 associated hospitalizations. Children with certain underlying conditions such as asthma or chronic lung disease, diabetes, both type 1 and 2, genetic, neurologic, or metabolic conditions, sickle cell disease, heart disease since birth, immunosuppression, medical complexity, and obesity may be more likely to have severe illness from COVID-19. Likewise, 52% of children <18 years hospitalized with COVID-19 had at least one of these types of underlying conditions too. Fortunately, children <18 years hospitalized with COVID-19 are less likely than adults to experience mechanical ventilation or in- hospital death. COVID-19 mortality rates are lowest among individuals <18 years. (5)
Pediatric vaccination studies are necessary for the following reasons:
Several companies have begun Pediatric COVID-19 vaccine studies including Pfizer-BioNTech, Moderna, Janssen, AstraZeneca, Novavax and Sanofi. See table 1. (6) One of the most important reasons for the need of pediatric COVID-19 vaccination is the unusual disorder called, Multisystem Inflammatory Syndrome in Children (MIS-C). In April 2020, severe inflammatory syndrome was recognized in the UK, occurring in children with current or recent infection with SARS-CoV-2. Later in May 2020, cases were reported in New York State. On May 14, healthcare providers were requested to report patients <21 years old meeting MIS-C criteria to local, state, or territorial health departments.
The case definition for MIS-C is an individual aged <21 years presenting with fever, laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization with multisystem (at least two or more organs involvement) including cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological; and no alternative plausible diagnoses; and positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the four weeks prior to the onset of symptoms. Additionally, fever of at least or higher than 38.0 C for 24 or more hours including but not limited to one or more of the following: an elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen, procalcitonin, d-dimer, ferritin, lactic acid dehydrogenase (LDH), or interleukin 6 (IL-6), elevated neutrophils, reduced lymphocytes and low albumin. (5) Health department-reported cases of MIS-C are seen in Table 2. (5)
In summary, pediatricians and other healthcare providers need to be cognizant of ACIP recommendations for COVID-19 vaccinations. As COVID-19 vaccine research continues with pediatric patients, more ACIP recommendations will be approved and published. Although in general, pediatric patients have a higher incidence of asymptomatic or milder diseases than adults, MIS-C occurs and needs to be diagnosed with appropriate therapy. Our next hurdle will be protection from the COVID-19 variants from UK, Brazil, South Africa and other places. The present vaccines seem to provide at least partial protecting along with masks, social distancing and hand washing. Stay tuned for advice. (7)
Table 1 supplied by CDC at January 27, 2021 ACIP meeting. (6)
Table 2. Health-Department reported cases of MIS-C disorder. (5)