Summary

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• Comirnaty (COVID-19 vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
• This summary is based on the review of 57 systematic review(s)/meta-analysis(es). ^[1-77]
• BNT162b2 demonstrated the highest efficacy in preventing symptomatic SARS-CoV-2 infection, with a SUCRA value of 0.02, and showed a VE of 56.17% in children and 95.2% in Caucasians, 100% in Afro-Caribbean or African Americans, 94.2% in Hispanic or Latinx, and 95.4% in non-Hispanic, non-Latinx individuals. VE against the Delta variant was 55% after the first dose and 81% after the second dose, with a pooled VE of 92.4% against symptomatic COVID-19.
• For preventing hospitalization and severe disease, BNT162b2 showed a VE of 75.3% in children, 94.3% against COVID-19-related hospitalizations, and a high VE against severe disease, with a decrease of about 10 percentage points by 6 months post-vaccination. Another review reported a VE of 73% against hospitalization after the second dose of mRNA vaccines.
• VE against COVID-19-related mortality for BNT162b2 was reported at 96.1%.
• Heterologous BNT162b2 boosters improved immunogenicity and VE compared to homologous regimens, with booster doses providing a VE of 73% against Omicron infections.
• BNT162b2 was associated with common side effects, including fever, fatigue, headache, injection-site pain, redness, and swelling. 8. mRNA vaccines, including BNT162b2, showed the highest reactogenicity, particularly following the second dose.
• No higher incidence of serious adverse events (SAEs) was observed with BNT162b2 compared to placebo.
• Specific adverse effects noted with BNT162b2 included rare cases of myopericarditis, more common in males after the second dose, and possible herpesvirus reactivation, with incidences of 14 per 1000 for VZV and 16 per 1000 for HSV.
• BNT162b2 showed the highest efficacy in preventing symptomatic SARS-CoV-2 infection in the elderly and provided moderate effectiveness against infection and hospitalization in children. Males, particularly younger males, were at higher risk for myocarditis following BNT162b2 vaccination. 12. mRNA-1273 demonstrated improved clinical effectiveness compared with BNT162b2 in immunocompromised populations. Cancer patients receiving ICIs did not show an increased risk of irAEs post-vaccination, though those with hematological malignancies had lower antibody response rates compared to solid tumors or healthy individuals.