During a system upgrade from Friday, Dec. 5, through Sunday, Dec. 7, the AAFP website, on-demand courses and CME purchases will be unavailable.

COVID-19 Vaccine Safety and Efficacy Data Overview

Updated February 1, 2021

Vaccines for Children: The FDA issued emergency use authorization (EAU) for the Pfizer/BioNTech COVID-19 at a lower dose. This formulation is different from the one used for adolscents and adults. This dose was recommended by the CDC’s Advisory Committee on Immunization Practices, which was reviewed and approved by the AAFP.

Booster Doses: The CDC approved booster dose recommendations after reviewing analyses of potential benefits and harms of a booster dose given 6 months after the primary two-dose series of Moderna and a booster dose given 2 months after the initial dose of the J&J vaccine.

Vaccines for Adults and Adolescents: The FDA issued emergency use authorizations (EAU) for three vaccines. EUAs were given for mRNA vaccines from Pfizer/BioNTech and Moderna in December 2020. The third EUA was issued on February 27, 2021 for the Janssen (J&J) COVID-19 vaccine, which uses a non-replicating adenovirus vector. These vaccines were recommended by the CDC’s Advisory Committee on Immunization, which was reviewed and approved by the AAFP. Additionally, the FDA has licensed the Pfizer-BioNTech vaccine, Cominarty, for individuals aged 16 and older and the Moderna vaccine, SpikeVax.

Safety and Efficacy Data Overview

Vaccine	BNT162b2 (Pfizer-BioNTech)^1,5	mRNA-1273 (ModernaTX)²	Ad26.COV2.S (Janssen)³
Type of Vaccine, Dosing	mRNA^a, 2 doses (30 ug each) with 21 days between doses Children age 5-11, mRNA (10 ug), 2 doses with 21 days between doses Booster dose: 30 ug for specific populations; 1 injection	mRNA^a, 2 doses with 28 days between doses Booster dose: half of original dose, 1 injection	Non-replicating adenovirus vector^b, single dose Booster dose: 1 injection of original dose for adults aged 18 and older
Populations included in trial^c	Non-pregnant persons 16 years and older (total enrolled = 43,488) Age: 21.4% of participants were >65 years of age. The median age was 51 years. Sex: 49.4% female Race/ethnicity: 81.9% White, 9.8% Black or African American, 4.4% Asian participants, and <3% from other racial groups; 26.2% of groups; 26.2% of participants were Hispanic/Latino Most frequently reported comorbid conditions: obesity, diabetes, pulmonary disease An additional study was conducted in individuals aged 12-15 (n = 2,260)4: Sex: 49.9% female Race/ethnicity: 85.9% White, 4.6% Black or African American, 11.7% Hispanic/Latino, 6.4% Asian, and 0.4% American Indian/Alaska Native Phase 2/3 Study in children 5-11 (n = 4,367) Sex: 48% female Race/ethnicity (vaccine group): 79.3% White, 5.9% Black or African-American, 21% Hispanic/Latino, 5.9% Asian, and 0.8% American Indian/Alaska Native	Non-pregnant persons 18 years and older (total enrolled = 30,351) Age: 25.3% of participants were >65 years of age. The median age was 53 years. Sex: 47.4% female Race/ethnicity: 79.4% White, 9.7% Black or African American, 4.7% Asian participants, and <3% from other racial groups; 20% of participants were Hispanic/Latino Most frequently reported comorbid conditions: obesity, diabetes, pulmonary disease, cardiovascular disease	Non-pregnant persons 18 years and older (total enrolled = 43,783) Age: 20.4% of participants were >65 years of age. The median age was 53 years. Sex: 44.5% female Race/ethnicity: 62.1% White, 17.2% Black or African American, 3.5% Asian participants, and 8.3% American Indian or Alaska Native; 45.1% of participants were Hispanic/Latino Most frequently reported comorbid conditions: obesity, diabetes, pulmonary disease, cardiovascular disease
Efficacy^d	All ages (16 and older)—95% (CI 90.3 - 97.6) Vaccine group = 8 cases Placebo group = 162 cases Over age 55: 93.8% (80.9 - 98.8) 65-74 years of age: 92.9% (CI 53.2 - 99.8) Females: 4 cases Males: 4 cases Race/ethnicity: 7 cases in white individuals, 1 case in Asian individual No significant differences between those with or without comorbid conditions.In ages 12-15: 100% efficacy Vaccine group = 0 cases Placebo group = 18 cases In ages 5-11: 90.7% efficacy (CI 67.4 – 98.3%) Vaccine group = 3 cases Placebo group = 16 cases This data is from a descriptive data set that included 2,186 participants (1450 in vaccine group; 736 in the placebo group)	All ages —94.1% (CI 89.3 - 96.8) Vaccine group = 11 cases Placebo group = 185 cases Over age 65: 86.4% (61.4-95.5) Females: 4 cases Males: 7 cases Race/ethnicity: 10 cases in white individuals, 1 case in other race/ethnic groups Only four cases in the vaccine group were related to comorbid conditions	All ages—66.9% (CI 59.0 - 73.4) Vaccine group = 116 cases Placebo group = 348 cases Over age 65: 76.5% (CI 59.1 -87.3) Females: 88 cases Males: 85 cases Race/ethnicity: 94 cases in white individuals, 37 cases in Black or African American individuals, 6 cases in Asian individuals No significant differences between those with or without comorbid conditions
Safety (adverse events) ^e	Local injection site reaction (pain, swelling) 1^st dose: 78.6% vs 12.8% (vaccine vs placebo) 2^nd dose: 73.1% vs 10.6% Systemic reaction within 7 days 1^st dose: 59.1% vs 47% 2^nd dose 69.9% vs 33.8% Most commonly reported adverse events after 2^nd dose: injection site pain (66.1%), fatigue (59.4%), headache (51.7%), chills (35.1%), muscle pain (37.3), joint pain (21.9%), fever (15.8%) Withdrawal and death due to serious adverse events were rare and no differences were observed between groups In ages 12 -15: Local and systemic reactions in the vaccine group were similar to rates in adult population Most commonly reported adverse events after 2^nd dose: injection site pain(78.9%), fatigue (66.2%), headache (64.5%), chills (41.5%), muscle pain (32.4), fever (19.6%) In ages 5-11: Local and systemic reactions in the vaccine group were similar or lower to rates in adult and adolescent population Most commonly reported adverse events after 2^nd dose: injection site pain (71%), fatigue (39.4%), headache (28%), chills (9.8%), muscle pain (11.4%), fever (6.5%) NOTE: Post EUA safety surveillance has identified an increase risk of myocarditis/pericarditis in adolescents and young adults. However, cases are rare and the majority resolved with minimal therapeutic intervention. There has also been a small increased risk for Guillain-Barre Syndrome in adults, but cases were rare.	Local injection site reaction (pain, swelling) 1^st dose: 84.2% vs 19.8% (vaccine vs placebo) 2^nd dose: 88.8% vs 18.8% Systemic reaction within 7 days 1^st dose: 59.4% vs 42.2% 2^nd dose 79.3% vs 36.5% Most commonly reported adverse events after 2^nd dose: injection site pain (88.4%), fatigue (67.6%), headache (62.8%), chills (48.3%), muscle pain (6.1), joint pain (45.2%), fever (17.4%) Withdrawal and death due to serious adverse events were rare and no differences were observed between groups NOTE: Post EUA safety surveillance has identified an increased risk of myocarditis/pericarditis in adolescents and adults. However, cases are rare and the majority resolved with minimal therapeutic intervention. There has also been a small increased risk for Guillain-Barre Syndrome in adults, but cases were rare.	Local injection site reaction (pain, swelling) 50.2% vs 19.4% (vaccine vs placebo) Systemic reaction within 7 days 55.1% vs 35.1% (vaccine vs placebo) Most commonly reported adverse events: injection site pain (48.6%), headache (38.9%), fatigue (38.2%), myalgia (33.2%), nausea (14.2%), and fever (9.0%) Withdrawal and death due to serious adverse events were rare and no differences were observed between groups NOTE: Post EUA safety surveillance has identified 15 reports of Thrombosis with Thrombocytopenia Syndrome (TTS) after Janssen COVID-19 vaccination.

Source: ¹Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020 FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine, ²Vaccines and Related Biological Products Advisory Committee Meeting December 17, 2020 FDA Briefing Document ModernaTX COVID-19 Vaccine, ³Vaccines and Related Biological Products Advisory Committee Meeting February 26, 2021 FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 VID-19 Vaccine, and ⁴Fact Sheet for Healthcare Providers Administering Vaccine.

^aNote the mRNA vaccine platforms use a small piece of messenger RNA that serves as a blueprint for cells to make a viral protein which causes production of neutralizing antibody. This platform is not an actual virus and will not give recipient COVID-19.

^bNote the adenovirus vaccine platforms use a replication deficient adenovirus that has been modified to include a piece of double-stranded DNA that is the blueprint for the production of the SARS-CoV-2 spike protein which causes production of neutralizing antibody. These platforms do not replicate in cells and do not cause disease due to adenoviruses or COVID-19.

^cDemographic information was pulled from the source report.

^d Vaccine efficacy was a measurement of confirmed COVID-19 cases in the vaccine group compared to the placebo group. CI = 95% confidence intervals. Therefore, the endpoint measured the prevention of disease and not the prevention of infection.

^e Adverse events are represented by percentages of participants reporting an event in the vaccine group.