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      The effect of a proof-of-vaccination requirement, incentive payments, and employer-based mandates on COVID-19 vaccination rates in New York City: a synthetic-control analysis

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      Author(s): , MPP a , * , , MPA a , , MD b , , Prof, MD c , , Prof, MD d
      Publication date (Electronic):
      Journal: The Lancet. Public Health
      Publisher: City of New York. Published by Elsevier Ltd.

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          Abstract

          Background

          COVID-19 vaccines have been available to all adults in the USA since April, 2021, but many adults remain unvaccinated. We aimed to assess the joint effect of a proof-of-vaccination requirement, incentive payments, and employer-based mandates on rates of adult vaccination in New York City (NYC).

          Methods

          We constructed a synthetic control group for NYC composed of other counties in the core of large, metropolitan areas in the USA. The vaccination outcomes for NYC were compared against those of the synthetic control group from July 26, 2021, to Nov 1, 2021, to determine the differential effects of the policies. Analyses were conducted on county-level vaccination data reported by the Centers for Disease Control and Prevention. The synthetic control group was constructed by matching on county-level preintervention vaccination outcomes, partisanship, economic attributes, demographics, and metropolitan area population. Statistical inference was conducted using placebo tests for non-treated counties.

          Findings

          The synthetic control group resembled NYC across attributes used in the matching process. The cumulative adult vaccination rate for NYC (in adults aged 18 years or older who received at least one dose of an authorised COVID-19 vaccine) increased from 72·5% to 89·4% (+16·9 percentage points [pp]) during the intervention period, compared with an increase from 72·5% to 83·2% (+10·7 pp) for the synthetic control group, a difference of 6·2 pp (95% CI 1·4–10·7), or 410 201 people (90 966–706 532). Daily vaccinations for NYC were consistently higher than those in the synthetic control group, a pattern that started shortly after the start of the intervention period.

          Interpretation

          The combination of a proof-of-vaccination requirement, incentive payments, and vaccine mandates increased vaccination rates among adults in NYC compared with jurisdictions that did not use the same measures. Whether the impact of these measures occurred by inducing more people to get vaccinated, or by accelerating vaccinations that would have occurred later, the increase in vaccination rates likely averted illness and death.

          Funding

          None.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

            Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
            Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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              Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19

              Jerald Sadoff, Glenda Gray, An Vandebosch … (2021)
              Background The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. Methods In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×10 10 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe–critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. Results The per-protocol population included 19,630 SARS-CoV-2–negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe–critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe–critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe–critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe–critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19–related), and 16 in the placebo group (5 were Covid-19–related). Conclusions A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722 .)
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                Author and article information

                Journal
                Journal ID (nlm-ta): Lancet Public Health
                Journal ID (iso-abbrev): Lancet Public Health
                Title: The Lancet. Public Health
                Publisher: City of New York. Published by Elsevier Ltd.
                ISSN (Electronic): 2468-2667
                Publication date PMC-release: 31 August 2022
                Publication date (Print): September 2022
                Publication date (Electronic): 31 August 2022
                Volume: 7
                Issue: 9
                Pages: e754-e762
                Affiliations
                [a ]New York City Mayor's Office of Management and Budget, New York, NY, USA
                [b ]New York City Health and Hospitals, New York, NY, USA
                [c ]Weill Cornell Medicine, New York, NY, USA
                [d ]New York University, Grossman School of Medicine, New York, NY, USA
                Author notes
                [* ]Correspondence to: Ezra Cohn, New York City Mayor's Office of Management and Budget, New York, NY 10007, USA
                Article
                Publisher Item ID: S2468-2667(22)00196-7
                DOI: 10.1016/S2468-2667(22)00196-7
                PMC ID: 9433052
                PubMed ID: 36057274
                SO-VID: 78085106-e604-4fbf-b0d2-79859b7d52ec
                Copyright © © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

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