COVID-19 Vaccine Update Legal & Practical Considerations For

Home , Mask refusal, Vaccination and religion, Vaccination policy

COVID-19 Vaccine Update Legal & Practical Considerations for Employers January 21, 2021

Angella Castille Susan Kline Partner Partner

James Vergis, Ph.D. Charlotte Marshall Director, Science & Associate Technology Introduction to COVID-19 Vaccines

Presented for Example Company - August 31, 2019 SARS-CoV-2

Small Envelope Protein (E)

Membrane Protein (M)

Spike Protein (S)

RNA

Adapted from an COVID‐19 image by Desiree Ho for the Innovative Genomics Institute COVID-19 Vaccine Technologies: Traditional

Protein Subunit Live, Attenuated Virus

Inactivated Virus Virus‐like Particle

Adapted from an COVID‐19 image by Desiree Ho for the Innovative Genomics Institute COVID-19 Vaccine Technologies: Next Generation Technologies

RNA Replicating Viral Vector

DNA Nonreplicating Viral Vector

Adapted from an COVID‐19 image by Desiree Ho for the Innovative Genomics Institute COVID-19 Vaccine Development Status

Phase II (39) In Use (9)*

Phase III (20) Phase I (42) Preclinical (220) * • Vaccines typically take * 10–15 years to be * developed and licensed • COVID‐19 vaccines from * Moderna and Pfizer were approved in 8 months after trials started

Data from https://www.covid‐19vaccinetracker.org/ and World Health Organization Current* Vaccines Approvals Around the World

# Vaccine Technology Doses Efficacy Countries Other Considerations

mRNA‐1273 RNA‐based 2 95% Canada, EU, Israel, US • $33/dose (Moderna) • Standard freezer BNT162b2 RNA‐based 2 95% Bahrain, Canada, Chile, EU, Kuwait, Mexico, • $20/dose (Pfizer/BioNTech) Oman, Saudi Arabia, Singapore, UK, US • Ultralow freezer CoronaVac Inactivated Virus 2 50‐91% China, Indonesia • $30/dose • Standard refrigeration AZD1222 Nonreplicating Viral 2 62%– Argentina, Dominican Republic, El Salvador, • $4/dose (AstraZeneca) Vector 90% India, Mexico, Morocco, UK • Standard refrigeration

Sputnik V Nonreplicating Viral 2 91% Russia • $10/dose Vector • Standard refrigeration AD5‐nCOV Nonreplicating Viral 1 ?? China • Standard refrigeration Vector Unnamed Inactivated Virus 2 ?? China and UAE • Standard refrigeration (Sinopharm‐Wuhan) BBIBP‐CorV Inactivated Virus 2 79%– Bahrain, China, Egypt, UAE • Less than $75/dose 86% • Standard refrigeration EpiVacCorona Protein subunit 2 ?? Russia • Standard refrigeration

Covaxin Inactivated Virus 2 ?? India • $2–$4/dose • Standard refrigeration * Updated as of January 21, 2021

Data from https://www.covid‐19vaccinetracker.org/ and World Health Organization COVID-19 Vaccine (Yet) Unanswered Questions • How long is an individual protected? • Will annual boosters be needed? • Are the vaccines safe for children? Pregnant or breastfeeding women? • Are the vaccines effective against new/mutated strains of the virus? • When can social distancing, mask‐requirements, and other mitigation strategies be relaxed or ended? U.S. Landscape

Presented for Example Company - August 31, 2019 Mandatory U.S. COVID-19 Vaccination

• May U.S. employers require COVID‐19 vaccination of all employees? Two key considerations: – Exposure risk level – Accommodation for: • Medical contraindication, including due to pregnancy or breastfeeding • Religious objection ADA Considerations

• The Americans with Disabilities Act (ADA) allows qualification standards (such as vaccination) to prevent direct threats to health and safety • Because a vaccination requirement would screen out individuals with disabilities at a higher rate than others, the employer must be prepared to show that the risk cannot be sufficiently mitigated by other measures (masking, distancing, installing barriers, remote‐work arrangements, etc.) Exposure Risk Levels – The Spectrum • High end –front line health care workers, onsite teachers, law enforcement officers • Low end –entirely remote workforce • Somewhere in the middle – Onsite workers in essential industries experiencing high absenteeism? – High‐public‐contact jobs? – Close‐contact jobs – laboratories, clean rooms, construction/installation functions? – Jobs requiring significant interstate or foreign travel? • The less the exposure risk that cannot be addressed by other measures, the greater the risk of a mandatory vaccination requirement. • For many or most employers, the analysis should be by job responsibilities. Accommodation Obligations • CDC guidance (prevaccination checklist) as of Jan. 12, 2021 – Screening questions cover: • Current sickness • History of allergic reaction • Weakened immune system caused by something such as HIV infection or cancer • Bleeding disorder or taking a blood thinner – Not necessarily disqualifying; instructions provide guidance for HCPs Accommodation Obligations (cont.)

• The duty to reasonably accommodate should follow a standard process – Additional mitigating measures such as greater distancing? – Work from home? – Leave of absence? – Reassignment to an open and available position? • Employers may require health care provider verification of restrictions (treated confidentially) Accommodation Obligations (cont.)

• Pregnancy or breastfeeding – A “healthy pregnancy” is not a disability, but a number of U.S. states and localities require accommodation of pregnancy‐related restrictions in a manner similar to disability‐related restrictions – Current CDC guidance — limited data is available on the safety of COVID‐19 vaccines administered during pregnancy; no data on the safety of the vaccines for lactating women, their breastfeeding infants, or milk production/excretion Accommodation Obligations (cont.) • Faith‐based objections – Employers must accommodate short of undue hardship —defined as more than de minimis cost or burden – Any request for supporting evidence of the faith‐ based grounds for objection must be based on an objective reason for questioning the religious nature or sincerity of a particular belief, practice or observance – The definition of religion is broad and may extend to belief systems not widely viewed as organized religions • For example, one federal district court has held that veganism might reflect “a sincerity equating that of traditional religious views” May Employers Require Proof of Vaccination, Absent an Exemption? • The Equal Employment Opportunity Commission (EEOC) says yes — merely requesting proof of vaccination is not a restricted disability‐related inquiry • But prescreening inquiries such as allergic reaction histories are disability‐related inquiries and must be job‐ related and consistent with business necessity – The employer is responsible for compliance with this requirement even if it outsources its vaccination process – Questions about family medical history could also run afoul of the Genetic Information Nondiscrimination Act (GINA) • Inquiries about why someone did not get vaccinated may also be disability‐related inquiries What Other Considerations are Important in Decision Making on Mandatory Vaccination?

• Employees who believe vaccination is unsafe may submit complaints to OSHA or state OSH agencies, despite FDA authorization for use – Good communication about the benefits of vaccination is key • Suspected adverse side effects or later complications could lead to workers’ compensation claims and OSHA recordable injuries • The administration process may require significant resources • Confidentiality must be observed — including as to who has been vaccinated • Be on the lookout for any federal, state or local legislation that may ban or require employer vaccination requirements • Consider a carrot rather than a stick, with wellness incentives (considering applicable incentive limits, accommodation requirements and tax considerations) U.K. Perspective

Presented for Example Company - August 31, 2019 U.K. Vaccination Programme • Vaccines in the U.K. are being rolled out by the National Health Service (NHS) according to priority group • It is anticipated that the majority of the working population will not receive the vaccine until late summer/early autumn • Unlikely that the vaccine will be available in the private sector in the U.K. until the NHS has completed a significant part of its rollout Can U.K. Employers Mandate that Their Workforce Receives the Vaccine? • In the U.K., employers have a duty to ensure the health and safety of their workforce as far as reasonably possible • BUT a policy of mandatory vaccination could have legal implications Legal Implications of a Mandatory Vaccination Policy in the U.K. • A mandatory vaccination policy carries a risk of discrimination and/or constructive dismissal claims if an employee refuses to be vaccinated because of a characteristic protected under U.K. law • Mandatory vaccination could also infringe employees’ right to privacy under article 8 of the U.K. Human Rights Act 1998 • Employers should consider the data protection implications of processing information about whether employees have had the vaccine since the U.K. has strict rules on processing of health data Additional Considerations • Instead of mandatory vaccination, employers could introduce a vaccine policy to encourage employees to receive the vaccine • Employers should also continue to consider other protective measures International Considerations

Presented for Example Company - August 31, 2019 Overview of Selected Jurisdictions • Survey of Jurisdictions – Information furnished by – Canada: Blake, Cassels & Graydon LLP – China: Faegre Drinker Biddle & Reath LLP – Germany: Noerr Partnerschaftsgesellschaft mbB – Mexico: Basham, Ringe y Correa, S.C. Overview of Selected Jurisdictions (cont.) • Is the COVID‐19 vaccine government‐mandated? – Canada: No, except for certain health care or long‐ term care services – China: No, because it isn’t included in “Immunization Program Vaccines” designated by the State Council/provincial government – Germany: No, the vaccine is voluntary – Mexico: No, but the federal government adopted a COVID‐19 Vaccination Policy which establishes priorities for vaccination Overview of Selected Jurisdictions (cont.) • Can employers require vaccination and/or proof of vaccination? – Canada: Yes, for specific workers in health care or long‐ term care services. Otherwise, mandatory vaccine policies must be tied to a legitimate business interest, including protecting employee, client, and patient health and safety. Employees may be required to be vaccinated before returning to work where there is a risk of COVID‐ 19 transmission in the workplace. If an employee refuses and is able to work from home, the employee may be required to continue doing so. If an employee cannot work from home, then the employee may be required to take a leave of absence, paid or unpaid. They may also be permitted to return to work while following COVID‐19 safety protocols. The federal government will not be providing vaccine passports, but some provinces may do so. Overview of Selected Jurisdictions (cont.) • Can employers require vaccination and/or proof of vaccination? – China: No, but employers can request that an employee be vaccinated if the requirement is incorporated into an employee handbook – Mexico: Yes, however, the employer must bear all costs related to the administration of the vaccines. Any refusal may trigger such employee´s termination with cause – Germany: No, unless legislation is passed to require the vaccine, employers can only encourage employees to receive the vaccine Overview of Selected Jurisdictions (cont.) • Are there any exemptions from required vaccinations? – Canada: Yes, if: • based on a protected ground of discrimination (religion, disability, sex, pregnancy) • medical reasons exist (allergies or underlying conditions that could result in adverse reactions to the vaccine) – Employers have a duty to accommodate persons based on these reasons for refusing the vaccine Overview of Selected Jurisdictions (cont.) • Are there any exemptions from required vaccinations? – China: Yes, if someone: • is allergic to vaccine ingredients • suffers from an acute disease • suffers from a chronic disease that becomes acute during the outbreak • has a fever • is pregnant Overview of Selected Jurisdictions (cont.) • Are there any exemptions from required vaccinations? – Germany: Not applicable. – Mexico: Yes. Persons: • responsible for minors are required to ensure that they minors receive vaccinations • with allergies or at risk medically Overview of Selected Jurisdictions (cont.) • Who is prioritized? – Canada: As of now, vaccines are only available from the government • Residents and staff of shared living setting providing care for seniors • Adults 70 years of age and older as follows: – First, adults 80 and older – Decreasing the age limit by 5‐year increments to age 70 as supplies become available • Health care workers not included in the initial roll out Overview of Selected Jurisdictions (cont.) • Who is prioritized? – Canada (cont.): • Residents and staff of all other shared living settings, such as: – Homeless shelters – Correctional facilities – Housing for migrant workers – Essential workers who face additional risks to maintain services for the functioning of society, including those in food testing labs and those working in food safety. Overview of Selected Jurisdictions (cont.) • Who is prioritized? – China: • Key population (Stage 1) – Workers in cold chain logistics – Customs & border patrol workers – Medical and disease prevention/control workers – Farmers’ market/seafood markets workers – Public transportation workers – Marine pilotage workers – Flight crew – Other public service sector workers (for ex., community workers) – People who need to travel to medium/high‐risk countries for work or study. Overview of Selected Jurisdictions (cont.) • Who is prioritized? – China (cont.): • High‐risk population (Stage 2) – Those more likely to develop into serious cases once infected (e.g., elderly, those with chronic conditions) • General population (Stage 3) Overview of Selected Jurisdictions (cont.) – Germany: • Highest priority, Group 1 – Individuals 80 years old or older – People who work with seniors/people in need of care – Persons working with infected persons (ER, intensive care units, vaccination centers) – Persons working with high risk of morbidity in case of infection (cancer and transplant patients) Overview of Selected Jurisdictions (cont.) – Germany (cont.): • High priority, Group 2 – Persons aged 70 and older – Persons at high risk if infected (trisomy 21, dementia or mental disability, organ transplant recipients) – Close contacts of persons in need of care or pregnant women – Persons working with mentally disabled persons, working in medical institutions – Police officer – Persons in health administration – Persons living in homeless shelters, asylum seeker shelters and comparable shelters Overview of Selected Jurisdictions (cont.) – Germany (cont.): • Increased priority, Group 3 – Persons aged 60 and older – Persons with certain diseases causing possible poor outcome of disease (diabetes, cancer, lung diseases) – Works in relevant positions in public institutions or critical infrastructure • Normal priority, Group 4 – Anyone who doesn’t belong to another prioritized group and who lives or works in Germany Overview of Selected Jurisdictions (cont.) – Mexico: • Individuals serving in health care who have direct exposure to patients with COVID‐19 (Phase 1, December 2020 –February 2021) • Persons 60 years of age or older (Phase 2, February –April 2021) • Individuals age 50 to 59 (Phase 3, April –May 2021) • Individuals age 40 to 49 (Phase 4, May – June 2021) • The rest of the population (Phase 5, June –March 2022) Overview of Selected Jurisdictions (cont.) • Can employers obtain vaccine on behalf of employees? – Canada: No, they are only available from the government. – China: Yes, employers of those designated as “key population” can report to the local government and employees can then obtain the vaccination. – Germany: No, the vaccine is only available from the government. – Mexico: No. Overview of Selected Jurisdictions (cont.) • Challenges to Distribution – Canada: There’s only limited availability of the vaccine as of now. – China: • Production capacity –only three companies have mass production lines. • Risk of revocation of license –currently licenses are either conditional or temporary to address major public health emergency. Can be withdrawn if conditions for license determined not to be met. Overview of Selected Jurisdictions (cont.) • Challenges to Distribution – Germany: There’s only limited availability of the vaccine as of now. – Mexico: • Cold supply chain –some States have little or no equipment needed to adequately store the vaccine. • Corruption –poses a threat to the prioritization schedule. • Insecurity –Theft is a problem. Vaccines are provided free if received according to the government program. If stolen, they’ll be sold to those not entitled to receive them under the plan. • Reachability – Approximately 23% of the Mexican population resides in rural areas of the country and in many of these areas, medical facilities, equipment and medical personnel are lacking. Questions? Thank You!