SARS-Cov-2 S-protein encoded mRNA + lipid nanoparticle vaccine
0.3 mL IM on Day 0 and Day 21
Fact Sheet for Providers administering vaccine: Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019.
Comment: This is the phase I, placebo-controlled, observer-blinded, dose-escalation trial conducted in the United States in which participants aged 18 - 55 or 65 - 85 were randomized to receive either placebo or one of two vaccine candidates (BNT162b1 or BNT162b2). The primary endpoint was safety, and immunogenicity was the secondary outcome. Vaccine responses elicited in both groups were similar in terms of dose-dependent SARS-CoV-2–neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples. The incidence of adverse effects was lower in the BNT162b2 subset, and this was chosen to move forward in the phase 2/3 study.
Comment: In this ongoing, multinational, placebo-controlled, observer-blinded efficacy trial, participants 16 years of age or older were randomized to receive 2 doses given 21 days apart of BNT162b2 or placebo. The primary endpoint was the efficacy of the vaccine against lab-confirmed COVID-19, as well as safety. 21,720 participants received the vaccine candidate while 21,728 received placebo. There were only 8 cases of COVID-19 disease that occured at least 7 days after the second dose of the vaccine compared to 162 cases in the group who received placebo, translating to 95% efficacy. Similar vaccine efficacy was observed across subgroups (age, sex, race, ethnicity, baseline BMI), although it should be noted that 83% of all participants were Caucasian. The incidence of adverse events was similar between groups, with the most frequently reported adverse events being injection site pain, fatigue, headache and diarrhea.
Comment: MMWR report providing ACIP interim recommendations endorsing the Pfizer-BioNTech EUA from the FDA. The committee agreed that robust clinical trial data support the administration of the two-dose vaccine series on Day 0 and Day 21 for the prevention of COVID-19 disease in those 16 years of age and older.
Comment: American Academy of Pediatrics discussion on the CDC confirmation of more than 220 cases of myocarditis or pericarditis in those age 30 and younger occurring within 1 week of receiving the second dose of the COVID-19 mRNA vaccines. Although this incidence is rare, it is higher than what is expected. Greater than 80% of patients have made a full recovery. The CDC recommends that myocarditis or pericarditis be considered in any patient who develops acute chest pain, heart palpitations, and/or shortness of breath within 1 week of receiving their second vaccine dose.
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