COVID-19 vaccination passport: prospects, scientific feasibility, and ethical concerns

ABSTRACT

A vaccination passport (also known as “vaccination certificate,” “immunization passport,” or “digital health pass”) is a document that provides proof of vaccination and certifies that the holder is protected from illness. It is a more reliable and practical substitute for immunity passports since COVID-19 vaccination is considered a better correlate of protection. Vaccination passport can be considered as a tool offering the holder the privilege of traveling freely within countries without any restrictions. The majority of the countries that are dependent on travel and tourism have exhibited a positive inclination toward implementing COVID-19 vaccination passports, while others have a mixed opinion. The successful implementation of vaccination passports will be a complex task for the policymakers as it requires addressing several ethical, legal, and data security concerns outlined in this article. However, vaccination passports can offer economic and health benefits that will allow the gradual recovery of the economy.

KEYWORDS:

• COVID-19
• SARS-COV-2
• vaccine silos
• immunization passport
• vaccination certificate
• vaccination passport

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that emerged in Wuhan, China got rapidly spread across the international borders mainly through air travel.¹ The efficient human-to-human transmission of SARS-CoV-2 further challenged our capacity to control this ongoing pandemic.² The successful rollout of vaccines for coronavirus disease 2019 (COVID-19) has been followed by a global effort to achieve herd immunity. As of June 11, 2021, Israel has fully vaccinated 59% of its population, while the percentage of people vaccinated is 50% in Bahrain, 47% in Chile, 43% in the United Kingdom, 42% in the United States, and 23% in Italy (https://ourworldindata.org/covid-vaccinations).

The concept of “vaccination passport” (also known as “vaccination certificate,” “immunization passport,” or “digital health pass”) is gaining the attention of policymakers and has become a hot topic of debate. A vaccination passport is a document that provides proof of vaccination and certifies that the holder is protected from illness, and therefore, cannot act as a source of infection for others^3,4 and can be allowed to resume routine activities that involve social interactions and travel (both domestic and international) without substantially contributing to the transmission of SARS-CoV-2 within the community.^4,5 The implementation of vaccination passports will help us return to a pre-pandemic status where there are no restrictions on global travel and trade.⁵

Immunity passport or vaccination passport?

The immunity passport (also termed as “immunity license” or “immunity certificate”) is different from a vaccination passport as it provides documentation of the previous infection.⁶ It has several practical limitations, such as the high cost of testing and susceptibility to reinfection.⁷ Moreover, our limited understanding of how long does immunity lasts following SARS-CoV-2 infection makes immunity passports unreliable.⁶ Vaccination passports would hence be a more reliable and practical substitute since vaccination is considered a better correlate of protection.⁷ However, the emergence of novel SARS-CoV-2 variants (especially variant of concern) can affect the neutralizing potential of vaccine-elicited antibodies resulting in mild-to-substantial loss of efficacy.⁸ According to the Centers for Disease Control and Prevention (https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Concern), variant of concern is “a variant for which there is evidence of an increase in transmissibility, more severe disease (e.g., increased hospitalizations or deaths), a significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.”

Several countries and agencies have already started implementing vaccination passports in an effort to eliminate domestic and international travel restrictions (Table 1); travelers with vaccination passports will be exempted from testing and quarantine requirements. However, there is a lack of understanding on the impact of vaccination on the transmission of SARS-CoV-2.⁴ The two-dose regimen of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine conferred 95% protection against infection in individuals that are 16 years of age or older.⁹ Analysis of the real-world dataset confirmed that the inoculation with mRNA COVID-19 vaccine (BNT162b2) substantially reduced the viral load when the vaccinated individuals got infected 12–37 days after the first dose of vaccine.¹⁰ The findings give a hint on the role played by vaccines in lowering infectiousness. Vaccination can help to protect the susceptible population from both symptomatic and asymptomatic SARS-CoV-2 infection, thereby reducing the transmission of the virus within the population.^11,12 Although preliminary findings indicate that vaccination can help reduce transmission either by lowering the viral load during post-vaccination infections or by preventing asymptomatic and clinical infections, further studies are required to confirm the findings.^4,13 In addition to that, the ability of a vaccine to limit disease transmission will also depend upon the age and immune status of the individual, the number of doses and type of vaccine used, the interval since vaccination, and the circulating variants, transmission intensity, and superspreading events at the country of origin and destination.^8,14,15

Table 1. Major COVID-19 vaccination passport/certificate initiatives (arranged according to the alphabetical order)

(1) Aarogya Setu (Co-WIN portal) and DigiLocker – India The digital vaccination certificate can be downloaded from the Aarogya Setu and DigiLocker mobile application using the unique 13-digit beneficiary reference ID (see https://blog.wego.com/vaccine-certificate-india/).

(2) CommonPass – The Commons Project Foundation It is a document that records the result of the COVID-19 RT-PCR test and the vaccination status. The test results and vaccination records can be accessed via existing health data systems using mobile applications (see https://thecommonsproject.org/commonpass).

(3) Coronapas – Denmark It is a passport that contains information on COVID-19 vaccination status and proof of a negative RT-PCR test. It will also have information on previous COVID-19 infection (see https://www.vejle.dk/borger/mit-liv/corona/corona-pas/).

(4) Digital Green Certificate – European Union It is an initiative that facilitates safe and free movement inside the European Union during the COVID-19 pandemic. The Digital Green Certificate will contain three categories of certificates: COVID-19 vaccination certificate, test result certificate, and recovery certificate for individuals recovered from COVID-19 (see https://ec.europa.eu/commission/presscorner/detail/en/IP_21_1181).

(5) Digital Health Pass – International Business Machines Corporation (IBM) Developed for recording COVID-19 test results using an encrypted smartphone application but planning to include vaccination status of the user (see https://www.ibm.com/products/digital-health-pass).

(6) Excelsior Pass – New York State (USA) It is a digital document that can be used to prove COVID-19 vaccination status or negative test results (see https://covid19vaccine.health.ny.gov/excelsior-pass).

(7) Good Health Pass – Good Health Pass Collaborative It is an interoperable digital health pass system that can be used for generating digital health credentials (test results or vaccination certificates) (see https://www.goodhealthpass.org/).

(8) Green Pass – Israel (Ministry of Health) Green Pass is issued to any individual who has been vaccinated for COVID-19 (Vaccination Certificate – valid for six months) or recovered from COVID-19 (Certificate of Recovery) (see https://corona.health.gov.il/en/directives/green-pass-info/).

(9) IATA Travel Pass Initiative – International Air Transport Association It is an initiative to validate and authenticate all country-specific COVID-19 regulations and passenger travel requirements. It also enables the passengers to generate a digital passport based on their COVID-19 test result/vaccination status (see https://www.iata.org/en/programs/passenger/travel-pass/).

(10) My COVID Pass – Africa Centers for Disease Control and Prevention It is a tool that helps to verify public health documentation (COVID-19 test results and vaccination certificates) for travelers during exit and entry across borders (see https://africacdc.org/trusted-travel/).

(11) QDX HealthID – Quantum Materials Corporation The immunization passport and test results are issued through a secure mobile app. In addition, the certificate can be readily shared and authenticated using a QR code (see https://www.globenewswire.com/news-release/2020/04/13/2015143/0/en/Quantum-Materials-Announces-QDX-HealthID-to-Support-Back-to-Work-Immunization-Passport-Programs.html).

(12) Smart Vaccination Certificate – World Health Organization It is a document (smart digital certificate) that confirms that an individual has received the COVID-19 vaccine. The authenticity can be cryptographically verified by an interested party. Although developed for COVID-19, the platform can be used for Yellow Fever, Polio, and other major diseases (see https://www.who.int/publications/m/item/interim-guidance-for-developing-a-smart-vaccination-certificate).

(13) Vaccify – TrustNet Pakistan It is a digital certificate that records the COVID-19 RT-PCR test result and the vaccination status. The digital certificate can be stored in the Vaccify digital wallet application and can be later verified by an interested party (see https://vaccify.pk/).

(14) VaccineGuard – Estonia, Guardtime, and World Health Organization It is a digital platform that connects vaccine manufacturers, public health authorities, hospitals, vaccination certificate providers, and citizens. In addition, the platform can be used to generate smart vaccination certificates. (see https://guardtime.com/vaccineguard).

(15) WIShelter SafePass – WISeKey International Holding Facility for generating vaccination certificate was integrated into the WIShelter SafePass mobile application platform (see https://www.globenewswire.com/news-release/2020/11/09/2123062/0/en/WISeKey-s-Digital-Health-Passport-to-Include-a-Trusted-Vaccination-Digital-Certificate.html).

Which vaccines should be considered?

The certification of COVID-19 vaccines varies across countries. Therefore, it will be challenging to establish a universal system for approving vaccines due to vaccine nationalism. The available COVID-19 vaccines also differ extensively across the globe due to the lack of equitable access.^16,17 India has initiated a mass vaccination campaign using Covaxin, the indigenously developed inactivated COVID-19 vaccine.¹⁸ However, Covaxin is approved for emergency use in very few countries. The growing number of vaccine candidates along with the political concerns, will further add to the complexity of approving vaccines across different jurisdictions. China has recently altered its visa policy to allow foreigners who have taken Chinese-made COVID-19 vaccines to enter the country.¹⁹ The move to prioritize domestic COVID-19 vaccines over those approved by the World Health Organization (WHO) has resulted in the emergence of geopolitical vaccine silos. The world nations will be divided into different groups (silos) based on vaccine nationalism rather than medical necessity. This will have a direct impact on several countries as they will be forced to approve Chinese vaccines that have lower efficacy.²⁰ If other nations adopt a similar strategy, it might trigger a chain reaction and could leave the world in vaccine-based silos. Such a move will have a direct impact on the collective effort to counter the ongoing pandemic.

Data elements for vaccination passport

The vaccination passport should be accessible to all by making it affordable and portable. It should contain three key sections, each corresponding to a part of the core dataset: header, data elements for each vaccination event, and metadata.²⁰ The header section should contain data elements such as name, sex, date of birth, and a unique identifier that can be used to identify the vaccinated individual securely.²⁰ The data elements for each vaccination event should include vaccine brand or trade name, vaccine category (mRNA, inactivated, or other), vaccine manufacturer/market authorization holder, batch number, date of vaccination, dose number, administering center, country of vaccination, the signature of health worker (for paper vaccination passports), identification of health worker (for digital vaccination passports), disease or agent targeted (COVID-19 or SARS-CoV-2), and due date of next dose. The metadata will contain additional data elements that are linked to the passport but are not visible and accessible to the holder.²⁰ Vaccination passports can take the form of paper or digital records. Since “paper only” vaccination passports can be easily falsified, “digital twin” passports are better substitutes as they can be verified and validated using Quick Response (QR) code, barcode, or other reliable 2D data matrices. It can also be transformed into digital formats (pdf or jpeg format) and stored on a smartphone application or a cloud-based server.

Ethical concerns

Unless and until there is equitable access to COVID-19 vaccines across the globe, supply scarcity can unfairly exclude individuals who cannot access vaccines. However, once everyone has access to vaccines, there will be a strong ethical justification for implementing vaccination passports as it creates a safer environment to work, travel, and perform other routine activities.⁵ Limiting the validity of vaccination passports to certain vaccines can further exacerbate inequities based on access to these particular vaccines.^5,19 It is evident that the implementation of vaccination passports as a condition of travel would directly impact low- and middle-income countries as they lack adequate access to vaccine doses to vaccinate their whole population.^5,21 Majority of the countries that have not initiated COVID-19 vaccination campaigns are sub-Saharan African nations. Furthermore, the existing race-based health disparities will pose a persistent challenge in attaining global vaccination coverage.²¹ In addition, the historic distrust exhibited by certain minorities for their health system should not disqualify them from social and economic opportunities associated with vaccination passports.⁵

Challenges

Several nations and agencies have already started using digital COVID-19 vaccination passports for domestic and international travel using the existing framework and infrastructure.³ The expiration date of the issued COVID-19 vaccination passport should correspond to the duration of protection conferred by the specific vaccine. However, emerging SARS-CoV-2 variants will have an impact on the duration of the efficacy of vaccines that are currently approved for use. Therefore, provision to revoke/renew the passports has to be provided in situations where a novel variant has emerged that can escape the vaccine-induced antibodies. Measures have to be taken to prevent the forgery of vaccination passports.²¹ The authenticity of the digital passport can be cryptographically verified using the in-built QR code, and the interested party can access the data and metadata linked with the passport directly from the online server.²⁰ Although personal data security is a major concern associated with using digital passports, the data can be safely encrypted similar to that used routinely for financial and other sensitive transactions.³ The platform used for generating COVID-19 vaccination passports has to be internationally standardized and should be based on interoperable technologies to facilitate easy verification of credentials. Although the development of such an interoperable technology seems to be an easy task, the major issue will be to obtain clearance from the corresponding national competent authorities for its use.

Conclusion

Although the universal implementation of the COVID-19 vaccine passport requires overcoming multiple hurdles, it is clear that vaccine passports are essential for the long-term management of COVID-19. The majority of the countries that are dependent on travel and tourism have exhibited a positive inclination toward implementing COVID-19 vaccination passports, while others have a mixed opinion. However, it is unethical to force an individual to get vaccinated and to ban an unvaccinated traveler from entering a country. Therefore, a vaccine passport should be considered as a tool offering the holder the privilege of traveling freely within countries without any restrictions. Unvaccinated travelers will be subjected to restrictions upon arrival in a country and should undergo mandatory quarantine and RT-PCR testing as per the local requirements. The successful implementation of vaccination passports will be a complex task as it requires addressing ethical, legal, and data security concerns outlined in this article. However, vaccination passports can offer economic and health benefits until herd immunity is achieved, thereby allowing the gradual recovery of the economy.

Author contributions

KS conceptualized the manuscript; KS wrote the first draft with input from RT, KD, AAR, and SA; all authors contributed to revisions and approved the final manuscript.

Disclosure of potential conflicts of interest

All authors declare that there exist no commercial or financial relationships that could, in any way, lead to a potential conflict of interest.

Additional information

Funding

The authors received no funding in relation to this article.