Early effectiveness of BNT162b2 Covid-19 vaccine in preventing SARS-CoV-2 infection in healthcare personnel in six Israeli hospitals (CoVEHPI)

Katz, Mark A; Harlev, Efrat Bron; Chazan, Bibiana; Chowers, Michal; Greenberg, David I.; Peretz, Alon; Tshori, Sagi; Levy, Joseph W.; Yacobi, Mili; Hirsch, Avital; Amichay, Doron; Weinberger, Ronit; Dor, Anat Ben; Taraday, Elena Keren; Reznik, Dana; Chayat, Chen Barazani; Sagas, Dana; Zvi, Haim Ben; Berdinstein, Rita; Rashid, Gloria; Avni, Yonat Shemer; Mandelboim, Michal; Zuckerman, Neta S.; Rainy, Nir; Akriv, Amichay; Dagan, Noa; Kepten, Eldad; Barda, Noam; Balicer, Ran D

doi:10.1016/j.vaccine.2021.11.092

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Early effectiveness of BNT162b2 Covid-19 vaccine in preventing SARS-CoV-2 infection in healthcare personnel in six Israeli hospitals (CoVEHPI)

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Author(s): Mark A. Katz ^a ^, ^b ^, ^c , Efrat Bron Harlev ^d ^, ¹ , Bibiana Chazan ^e ^, ^f ^, ¹ , Michal Chowers ^g ^, ^h ^, ¹ , David Greenberg ⁱ ^, ^j ^, ¹ , Alon Peretz ^k ^, ¹ , Sagi Tshori ^l ^, ^m ^, ¹ , Joseph Levy ^a , Mili Yacobi ^a , Avital Hirsch ^a , Doron Amichay ^j ^, ⁿ , Ronit Weinberger ⁿ , Anat Ben Dor ⁿ , Elena Keren Taraday ⁿ , Dana Reznik ^d , Chen Barazani Chayat ^o , Dana Sagas ^p , Haim Ben Zvi ^q , Rita Berdinstein ^m ^, ^r , Gloria Rashid ^s , Yonat Shemer Avni ^t , Michal Mandelboim ^u ^, ^v , Neta Zuckerman ^u , Nir Rainy ^w , Amichay Akriv ^a , Noa Dagan ^a ^, ^x ^, ^y ^, ^z , Eldad Kepten ^a , Noam Barda ^a ^, ^x ^, ^y ^, ^z , Ran D. Balicer ^a ^, ^b ^, ^*

Publication date (Electronic): 10 December 2021

Journal: Vaccine

Publisher: Elsevier Ltd.

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Abstract

Background

Methodologically rigorous studies on Covid-19 vaccine effectiveness (VE) in preventing SARS-CoV-2 infection are critically needed to inform national and global policy on Covid-19 vaccine use. In Israel, healthcare personnel (HCP) were initially prioritized for Covid-19 vaccination, creating an ideal setting to evaluate early real-world VE in a closely monitored population.

Methods

We conducted a prospective study among HCP in 6 hospitals to estimate the effectiveness of the BNT162b2 mRNA Covid-19 vaccine in preventing SARS-CoV-2 infection. Participants filled out weekly symptom questionnaires, provided weekly nasal specimens, and three serology samples – at enrollment, 30 days and 90 days. We estimated VE against PCR-confirmed SARS-CoV-2 infection using the Cox Proportional Hazards model and against a combined PCR/serology endpoint using Fisher’s exact test.

Results

Of the 1567 HCP enrolled between December 27, 2020 and February 15, 2021, 1250 previously uninfected participants were included in the primary analysis; 998 (79.8%) were vaccinated with their first dose prior to or at enrollment, all with Pfizer BNT162b2 mRNA vaccine. There were four PCR-positive events among vaccinated participants, and nine among unvaccinated participants. Adjusted two-dose VE against any PCR-confirmed infection was 94.5% (95% CI: 82.6%-98.2%); adjusted two-dose VE against a combined endpoint of PCR and seroconversion for a 60-day follow-up period was 94.5% (95% CI: 63.0%-99.0%). Five PCR-positive samples from study participants were sequenced; all were alpha variant.

Conclusions

Our prospective VE study of HCP in Israel with rigorous weekly surveillance found very high VE for two doses of Pfizer BNT162b2 mRNA vaccine against SARS-CoV-2 infection in recently vaccinated HCP during a period of predominant alpha variant circulation.

Funding

Clalit Health Services.

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Most cited references 10

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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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Prevalence of Asymptomatic SARS-CoV-2 Infection

Daniel P Oran, Eric Topol (2020)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly throughout the world since the first cases of coronavirus disease 2019 (COVID-19) were observed in December 2019 in Wuhan, China. It has been suspected that infected persons who remain asymptomatic play a significant role in the ongoing pandemic, but their relative number and effect have been uncertain. The authors sought to review and synthesize the available evidence on asymptomatic SARS-CoV-2 infection. Asymptomatic persons seem to account for approximately 40% to 45% of SARS-CoV-2 infections, and they can transmit the virus to others for an extended period, perhaps longer than 14 days. Asymptomatic infection may be associated with subclinical lung abnormalities, as detected by computed tomography. Because of the high risk for silent spread by asymptomatic persons, it is imperative that testing programs include those without symptoms. To supplement conventional diagnostic testing, which is constrained by capacity, cost, and its one-off nature, innovative tactics for public health surveillance, such as crowdsourcing digital wearable data and monitoring sewage sludge, might be helpful.

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SARS-CoV-2 Transmission From People Without COVID-19 Symptoms

Michael Johansson, Talia Quandelacy, Sarah Kada … (2021)

Key Points Question What proportion of coronavirus disease 2019 (COVID-19) spread is associated with transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from persons with no symptoms? Findings In this decision analytical model assessing multiple scenarios for the infectious period and the proportion of transmission from individuals who never have COVID-19 symptoms, transmission from asymptomatic individuals was estimated to account for more than half of all transmission. Meaning The findings of this study suggest that the identification and isolation of persons with symptomatic COVID-19 alone will not control the ongoing spread of SARS-CoV-2.

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Author and article information

Journal

Journal ID (nlm-ta): Vaccine

Journal ID (iso-abbrev): Vaccine

Title: Vaccine

Publisher: Elsevier Ltd.

ISSN (Print): 0264-410X

ISSN (Electronic): 1873-2518

Publication date PMC-release: 10 December 2021

Publication date (Electronic): 10 December 2021

Affiliations

[a ]Clalit Research Institute, Innovation Division, Clalit Health Services, Ramat Gan, Israel

[b ]School of Public Health, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel

[c ]University of Michigan, School of Public Health, Ann Arbor, MI, USA

[d ]Schneider Children's Medical Center of Israel, Petach Tikvah, Israel

[e ]Infectious Diseases and Infection Control Unit, Ha'Emek Medical Center, Afula, Israel

[f ]Rappaport Faculty of Medicine, Technion, Haifa, Israel

[g ]Infectious Diseases, Meir Medical Center, Kfar Saba, Israel

[h ]Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel

[i ]Pediatric Infectious Disease Unit the Pediatric Division, Soroka University Medical Center, Beer Sheva, Israel

[j ]Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel

[k ]Occupational Medicine Clinic, Rabin Medical Center, Petah Tikva, Israel

[l ]Research Authority, Kaplan Medical Center, Rehovot, Israel

[m ]The Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel

[n ]Clalit Central Laboratory, Clalit Health Services, Tel Aviv, Israel

[o ]Multidisciplinary Laboratory, Schneider Children's Medical Center of Israel, Petach Tikvah, Israel

[p ]Clinical Microbiology Laboratory, Ha'Emek Medical Center, Afula, Israel

[q ]Microbiology Department, Rabin Medical Center, Petah Tikva, Israel

[r ]Microbiology Department, Kaplan Medical Center, Rehovot, Israel

[s ]Department of Clinical Laboratories, Meir Medical Center, Kfar Saba, Israel

[t ]Virology, Soroka University Medical Center, Beer Sheva, Israel

[u ]Central Virology Laboratory, Chaim Sheba Medical Center, Ministry of Health, Ramat Gan, Israel

[v ]Department of Epidemiology and Preventive Medicine, Sackler Faculty of Medicine, School of Public Health, Tel Aviv University, Tel Aviv, Israel

[w ]Laboratory Division, Shamir Medical Center, Zerifin, Israel

[x ]Software and Information Systems Engineering, Ben Gurion University, Beer Sheva, Israel

[y ]Department of Biomedical Informatics, Harvard Medical School, Boston, MA, USA

[z ]Ivan and Francesca Berkowitz Family Living Laboratory at Harvard Medical School, Boston, MA, USA

Author notes

[* ]Corresponding author at: Clalit Research Institute, Innovation Division, Clalit Health Services, Arlozorov St 101, Tel Aviv, Israel.

[1]

These authors contributed equally to the study.

Article

Publisher Item ID: S0264-410X(21)01580-2

DOI: 10.1016/j.vaccine.2021.11.092

PMC ID: 8662353

PubMed ID: 34903372

SO-VID: 4bb666bf-9ab5-4f2f-8258-c16254a16794

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.

History

Date received : 9 August 2021

Date revision received : 24 November 2021

Date accepted : 29 November 2021

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Early effectiveness of BNT162b2 Covid-19 vaccine in preventing SARS-CoV-2 infection in healthcare personnel in six Israeli hospitals (CoVEHPI)

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Abstract

Background

Methods

Results

Conclusions

Funding

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Novel Coronavirus Disease COVID-19

Most cited references 10

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Prevalence of Asymptomatic SARS-CoV-2 Infection

SARS-CoV-2 Transmission From People Without COVID-19 Symptoms

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