Johnson & Johnson announced new results from the larger study to date on the durability of COVID-19 vaccines in the United States (U.S.), showing that a single shot of the Johnson & Johnson COVID-19 vaccine resulted in long-lasting protection for up to six months against COVID-19 breakthrough infections, hospitalizations, and intensive care unit (ICU) admissions. The study was sponsored by the Janssen Pharmaceutical Companies of Johnson & Johnson and conducted in partnership with the Department of Science-Aetion, Inc, and the Division of Pharmacoepidemiology, Department of Medicine at Brigham and Women's Hospital and Harvard Medical School. The new study posted on medRxiv comprehensively looked at the durability profiles for all three vaccines authorized or approved in the U.S. using the same methodology across three outcomes of interest: COVID-19 breakthrough infections, hospitalizations, and ICU admissions.

The study showed that the effectiveness of the Johnson & Johnson COVID-19 vaccine against breakthrough infections and hospitalizations remained durable. The mRNA vaccines (two-doses) showed waning effectiveness for hospitalizations and breakthrough infections. All three vaccines showed no evidence of waning protection against COVID-19-related ICU admissions at any point, showing strong sustained protection against critically severe disease.

The study was not designed to compare the durability of vaccines. Comprehensive studies to date on the durability of all vaccines authorized or approved for use in the U.S. have been limited, with many focusing on high-risk populations or specific geographic regions or states. This is the larger COVID-19 real-world effectiveness durability study to date in the U.S., and the first to analyze the durability of baseline protection up to six months for all three U.S. authorized or approved vaccines, and for three COVID-19 outcomes of interest (breakthrough infections, hospitalizations, and ICU admissions).

Researchers utilized national claims, laboratory, and hospital data covering 168 million individuals to conduct a matched case-control study between January 1 and September 7, 2021 for 17 million fully vaccinated individuals matched on calendar time, 3-digit zip code, age, sex, and comorbidity scores. The study assessed durability by measuring the Odds Ratio (OR), which represents the odds of a fully vaccinated individual having an outcome (breakthrough infection, hospitalization, or ICU admission) in each month relative to the odds of having an outcome in the first month after full vaccination. An OR greater than one indicates waning of the vaccine protection over time for that outcome.

The study authors acknowledged that direct comparisons of OR between vaccines should not be made as there may remain baseline differences including initial effectiveness between the three vaccine cohorts. The Johnson & Johnson COVID-19 vaccine demonstrated a profile that showed durability of effectiveness up to 6 months for hospitalizations and ICU admissions across the study period, with a modest increase in breakthrough infections starting in month 4. The initial level of effectiveness at month 1 after full vaccination was found to be 81% (95% CI: 76%-82%) for hospitalizations and 74% (95% CI: 72%-75%) for breakthrough infections. Durability: There was no evidence of waning protection against COVID-19-related hospitalization during the study period (OR = 1.25, 95% CI [0.86, 1.80] in month 5+).

There was no evidence of waning protection against breakthrough infection in the first three months of follow-up, with modest waning of protection against breakthrough infection observed in month 4 (OR = 1.16, 95% CI [1.04, 1.29]) and in month 5+ (OR = 1.31, 95% CI [1.18, 1.47]). There was no evidence of waning protection against COVID-19-related ICU admissions at any point (OR = 1.40, 95% CI [0.43, 4.55] in month 4). There was not sufficient follow-up to include a category for 6+ months for breakthrough infections and hospitalizations.

BNT162b2 demonstrated a profile that showed an increase in hospitalizations and breakthrough infections starting in month 2, with no waning of effectiveness for ICU admissions over the study period. The initial level of effectiveness at month 1 after full vaccination was found to be 89% (95% CI: 88%-90%) for hospitalizations and 88% (95% CI: 87%-88%) for breakthrough infections. Durability: There was evidence that protection waned against COVID-19-related hospitalization over time as compared to the first month of follow-up from vaccination (OR = 3.97, 95% CI [3.26, 4.83] in month 6+).

There was evidence that protection waned against breakthrough infection, where the waning was successively higher for each month of follow-up (OR = 2.93, 95% CI [2.72, 3.15] for BNT162b2 in month 6+). There was no evidence of waning protection against COVID-19-related ICU admissions at any point (OR = 1.36, 95% CI [0.80, 2.30] in month 4). mRNA-1273 vaccine effectiveness (two doses 28-42 days apart) mRNA-1273 demonstrated a profile that showed an increase in hospitalizations in month 3 and breakthrough infections in month 2, with no waning of effectiveness for ICU admissions over the study period.

The initial level of effectiveness at month 1 after full vaccination was found to be 94% (95% CI: 93%-95%) for hospitalizations and 92% (95% CI: 91%-92%) for breakthrough infections. Durability: There was evidence of modest waning in protection against COVID-19-related hospitalization over time as compared to the first month of follow-up from vaccination (OR = 1.66, 95% CI [1.26, 2.19] in month 6+). There was evidence that protection waned against breakthrough infection, where the waning was successively higher for each month of follow-up (OR = 2.76, 95% CI [2.51, 3.04] in month 6+).

There was no evidence of waning protection against COVID-19-related ICU admissions at any point (OR = 1.17, 95% CI [0.64, 2.13] in month 4).