Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine Among Residents of Two Skilled Nursing Facilities Experiencing COVID-19 Outbreaks

Connecticut, December 2020-February 2021

Amadea Britton, MD; Kara M. Jacobs Slifka, MD; Chris Edens, PhD; Srinivas Acharya Nanduri, MD; Stephen M. Bart, PhD; Nong Shang, PhD; Adora Harizaj, MPH; Jillian Armstrong, MS; Kerui Xu, PhD; Hanna Y. Ehrlich, MPhil; Elizabeth Soda, MD; Gordana Derado, PhD; Jennifer R. Verani, MD; Stephanie J. Schrag, DPhil; John A. Jernigan, MD; Vivian H. Leung, MD; Sunil Parikh, MD

Disclosures

Morbidity and Mortality Weekly Report. 2021;70(11):396-401. 

In This Article

Abstract and Introduction

Introduction

Residents of long-term care facilities (LTCFs), particularly those in skilled nursing facilities (SNFs), have experienced disproportionately high levels of COVID-19–associated morbidity and mortality and were prioritized for early COVID-19 vaccination.[1,2] However, this group was not included in COVID-19 vaccine clinical trials, and limited postauthorization vaccine effectiveness (VE) data are available for this critical population.[3] It is not known how well COVID-19 vaccines protect SNF residents, who typically are more medically frail, are older, and have more underlying medical conditions than the general population.[1] In addition, immunogenicity of the Pfizer-BioNTech vaccine was found to be lower in adults aged 65–85 years than in younger adults.[4] Through the CDC Pharmacy Partnership for Long-Term Care Program, SNF residents and staff members in Connecticut began receiving the Pfizer-BioNTech COVID-19 vaccine on December 18, 2020.[5] Administration of the vaccine was conducted during several on-site pharmacy clinics. In late January 2021, the Connecticut Department of Public Health (CT DPH) identified two SNFs experiencing COVID-19 outbreaks among residents and staff members that occurred after each facility's first vaccination clinic. CT DPH, in partnership with CDC, performed electronic chart review in these facilities to obtain information on resident vaccination status and infection with SARS-CoV-2, the virus that causes COVID-19. Partial vaccination, defined as the period from >14 days after the first dose through 7 days after the second dose, had an estimated effectiveness of 63% (95% confidence interval [CI] = 33%–79%) against SARS-CoV-2 infection (regardless of symptoms) among residents within these SNFs. This is similar to estimated effectiveness for a single dose of the Pfizer-BioNTech COVID-19 vaccine in adults across a range of age groups in noncongregate settings[6] and suggests that to optimize vaccine impact among this population, high coverage with the complete 2-dose series should be recommended for SNF residents and staff members.

After identification of the first infected SNF resident or staff member through weekly surveillance testing, expanded facility-wide outbreak SARS-CoV-2 testing was performed frequently for residents and staff members at both facilities in accordance with CDC and CT DPH guidelines.[7] All residents who had not received a positive test result in the preceding 90 days, regardless of symptoms, received a once-weekly (facility A) or twice-weekly (facility B) polymerase chain reaction (PCR) test. Staff members were also tested regularly (once-weekly antigen and once-weekly PCR test at facility A, and once-weekly PCR test at facility B). At both facilities, supplementary antigen testing was performed immediately for any resident or staff member who developed COVID-19 symptoms and for residents who had known COVID-19 exposures.

A retrospective cohort investigation using data from electronic medical record chart abstraction was conducted to assess vaccine effectiveness. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy.§ The investigation period started on the date of each SNF's first vaccination clinic (December 29, 2020 for facility A and December 21, 2020 for facility B) and ended on February 9, 2021 and February 12, 2021, respectively. Residents were included if they were admitted at either facility during one or more rounds of facility-wide SARS-CoV-2 testing during the week before or any time after their facility's first vaccination clinic. Data on residents were abstracted starting on the date of their SNF's first vaccination clinic or their admission into the facility, whichever occurred later. Electronic medical record data included demographic characteristics, facility admission and discharge dates, vaccination dates, symptoms of COVID-19 occurring within 7 days before or 14 days after a positive test result, presence of underlying medical conditions associated with potential increased risk for severe COVID-19 illness, and measures of outcome, including hospitalization and death. SARS-CoV-2 test dates, test types, and results were also obtained from the electronic medical record.

A case was defined as any positive PCR- or antigen-based SARS-CoV-2 test result during the investigation period in a resident meeting the cohort inclusion criteria. Case date was defined as either the date of symptom onset or positive SARS-CoV-2 test result, whichever occurred earlier. Positive SARS-CoV-2 test results received before the investigation period were identified for each resident using the Connecticut Electronic Disease Surveillance System.

Person-time began on the date of the facility's first vaccination clinic or the date the resident was admitted, whichever occurred later. Residents stopped contributing person-time to the investigation on the case date, the final facility discharge date or date of death if applicable, or the final day of the investigation period, whichever occurred earlier. Resident person-time was categorized as 1) unvaccinated (days from cohort entry until receipt of first vaccine dose), 2) time before first vaccine dose effect (day 0 [date of vaccination] through day 14 after first dose), 3) partially vaccinated (>day 14 after first dose through day 7 after second dose), or 4) fully vaccinated (>7 days after second dose).

Assuming a common VE against SARS-CoV-2 infection at both facilities, a Cox proportional hazards model with baseline hazard rates stratified by facility was applied to estimate the VE, with VE = 100% × (1−hazard ratio); 95% CIs were calculated using robust CI methods.** Use of a time-to-event analysis was necessary to adjust for expected heterogeneity in risk for infection across the investigation period attributable to underlying outbreak dynamics. Kaplan-Meier curves of SARS-CoV-2 infection were constructed to visualize the cumulative infection-free proportion of residents; 95% CIs were calculated using Greenwood's method.†† Sensitivity analyses were conducted with exclusion of residents with past confirmed SARS-CoV-2 infection and using two alternative endpoints for partial vaccination (ending on second dose +0 days and second dose +14 days). The time before first dose vaccine effect was excluded from the analysis, because immune status could not be clearly categorized. Small sample sizes precluded separate analyses of VE against symptomatic or severe disease. R statistical software (version 4.0.2; The R Foundation) was used to conduct all analyses.

A total of 463 residents were enrolled, including 142 (31%) from facility A and 321 (69%) from facility B. Demographic characteristics such as age and race were similar in residents at each facility (although ethnicity could not be reported because ethnicity data were missing for 30% of residents); prevalences of underlying conditions that increase the risk for severe COVID-19 illness were also similar in residents at each facility (Table). The median number of high-risk conditions per resident was three; five (1.1%) residents had no underlying high-risk conditions. Among the 463 residents, 115 (24.8%) had confirmed SARS-CoV-2 infection before the investigation period; two of 34 (6%) residents at facility A and 68 of 81 (84%) residents at facility B with past confirmed SARS-CoV-2 infection had a positive test result ≤3 months prior to investigation start.

During the investigation period, 97 cases of SARS-CoV-2 infection occurred, including 40 (41%) at facility A and 57 (59%) at facility B (Figure 1). Including nonspecific symptoms such as malaise, lethargy, and decreased appetite, at least one COVID-19 symptom was reported in 86 (88.7%) cases.§§ By the date of discharge or the last day of the investigation, 304 residents (65.7%) had received 2 vaccine doses, 72 (15.6%) had received 1 dose only, and 87 (18.8%) had not received any doses. A total of 16,969 person-days were observed during the investigation period, with 39 cases occurring during 3,573 days categorized as unvaccinated person-time, 26 cases during 4,588 days of person-time before first vaccine dose effect, 25 cases during 4,147 days of partially vaccinated person-time, and seven cases during 4,661 days of fully vaccinated person-time.

Figure 1.

New SARS-CoV-2 cases* among residents of two skilled nursing facilities, by case date — Connecticut, December 21, 2020–February 12, 2021§
*Any positive SARS-CoV-2 polymerase chain reaction or antigen test result.
Symptom onset date or positive test result date, whichever occurred earlier.
§Investigation period was December 29, 2020–February 9, 2021 for facility A and December 21, 2020–February 12, 2021 for facility B.

Estimated effectiveness of partial vaccination in preventing SARS-CoV-2 infection was 63% (95% CI = 33%–79%) and was similar when residents with past SARS-CoV-2 were excluded (VE = 60%, 95% CI = 30%–77%). VE estimates were also similar in both partial vaccination endpoint sensitivity analyses (second dose +0 days VE = 66%, 95% CI = 29%–83%; second dose +14 days VE = 60%, 95% CI = 33%–77%). As a result of the course of the outbreaks at both facilities, most cases occurred toward the start of the investigation period (Figure 2), and because the cohort began at the first vaccination clinic, most of the unvaccinated person-time also occurred toward the start of the investigation period. Thus, once residents became fully vaccinated (second dose +7 days) toward the end of the investigation period, there were insufficient new cases and remaining person-time in the unvaccinated group to serve as a comparator for estimation of full 2-dose VE.

Figure 2.

Proportion of skilled nursing facility residents who remained uninfected with SARS-CoV-2 during the investigation period,* by COVID-19 vaccination status and facility — Connecticut, December 21, 2020–February 12, 2021
*Investigation period was December 29, 2020–February 9, 2021 for facility A and December 21, 2020–February 12, 2021 for facility B.
Vaccination status is classified as unvaccinated or partially vaccinated. Partially vaccinated refers to the time from day 14 after first dose of Pfizer-BioNTech COVID-19 vaccine through day 7 after the second dose. Greenwood's method was used to estimate confidence intervals around the Kaplan-Meier estimator.

§This investigation was defined as having met the requirements for public health surveillance as outlined in 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect. 552a; 44 U.S.C. Sect. 3501 et seq.
Conditions based on CDC guidelines identifying conditions associated or potentially associated with risk for severe COVID-19 illness. List of conditions available at https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.
**Halloran ME, Longini IM Jr, Struchiner CJ. Design and analysis of vaccine studies. Statistics for biology and health. New York, NY: Springer; 2009.
††Greenwood M. The natural duration of cancer. In: Reports on public health and medical subjects. London, United Kingdom: Her Majesty's Stationery Office; 1926:1–26.
§§Clinician judgement during chart abstraction was used to distinguish COVID-19 symptoms from those potentially associated with vaccination or other illness. Symptoms had to be new onset within 7 days before or 14 days after a positive test result. Symptom-onset date was available for 80 of 86 cases classified as symptomatic (93%). Among those 80 cases for which symptom-onset date was available, only four (5%) had a symptom-onset date within the 48 hours after receiving a vaccine.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....