Insights and Analysis

Considerations for the food industry when developing a COVID-19 vaccine strategy

Image
Image

Now that the U.S. Food and Drug Administration (FDA) has authorized a COVID-19 vaccine, and with additional vaccine candidates in the pipeline (including a second authorization expected shortly at the time of this writing), the fight against COVID-19 has entered a new, more optimistic phase. But getting a vaccine from a drug manufacturer to a company’s workforce raises a number of complex legal and practical considerations. The following are among the key questions a food company should be considering when developing a vaccine strategy.

When will the food industry receive the vaccine? 

The COVID-19 vaccine is being distributed under an FDA Emergency Use Authorization (EUA). Under the Pfizer-BioNTech EUA, vaccine distribution is being directed by “Emergency Response Stakeholders” (in effect, state health authorities), who in turn coordinate with “Vaccination Providers” to actually administer the vaccine. Emergency Response Stakeholders are expected to oversee vaccine distribution pursuant to their individual state’s COVID-19 vaccine distribution plan. It’s therefore critically important to understand both your state’s plan and what entity or entities will be administering the vaccine in your state.

Under the EUA framework to date, states are given considerable discretion in determining how to prioritize vaccine distribution. The federal Centers for Disease Control and Prevention (CDC) has developed guidance and recommendations for a national framework, but states are not necessarily obligated to follow the CDC guidance. CDC’s Advisory Committee on Immunization Practices (ACIP) has suggested that many essential workers (which would include much of the food industry) be placed into category “1b,” behind health care workers and residents of long-term care facilities for vaccine priority. However, there are tens of millions of essential workers, and states will likely need to prioritize within this group, at least at first. Further CDC recommendations on prioritizing within this group are expected in the next few days. 

Although ACIP has been providing regular recommendations to CDC for prioritization, which will likely inform CDC and in turn, state policy, states will likely retain significant discretion. Therefore, it is critical to understand the distribution plans and priorities for each state in which a company operates.

Will you make the vaccine optional or mandatory for your workforce?  

Federal law does not clearly prohibit an employer from mandating workers get a COVID-19 vaccine, although the Equal Employment Opportunity Commission (EEOC) has recently released updated guidance addressing COVID-19 vaccination programs that employers should evaluate if considering making vaccines mandatory. Likewise, individual state laws need to be considered. Note that even though a vaccine generally can be mandated as a condition of employment under federal law, FDA authority to issue an EUA requires that individuals to whom a vaccine is administered must be informed of the option to accept or refuse administration of the product, which is specified in the Patient Fact Sheet, stating that it is the patient’s choice to receive or not receive the vaccine. 

If you mandate a vaccine, consider whether it will be mandatory for all employees or just certain employees who face greater workplace transmission risks, and be prepared to justify any decision around employee groupings. Consider also whether employees will actually have access to a vaccine if it is being mandated—a mandatory program cannot be implemented unless employees have access. Additionally, the EEOC guidance confirms that employers must consider disability- and religious-based exemptions from mandatory vaccines and outlines the steps for doing so, which can be burdensome if a significant number of employees seek exemptions. A company also should consider how to address situations where employees are unwilling to get a vaccine for other reasons, such as vaccine skepticism. These situations could raise particular employment-law issues requiring careful consideration.

Unionized workforces will present additional considerations that will have to be addressed in the context of the particular collective bargaining agreement and legal jurisdiction. More information about employment considerations related to mandatory vaccination programs is available here.

Who among your workforce will get the vaccine?  

The number of essential workers will likely outstrip available vaccine doses for a period of time. Companies may need to consider whether and how to prioritize vaccinations within their workforces, and if the company is requiring or facilitating access to vaccines, how to do so in a way consistent with employment law requirements. Issues such as employee morale may be important as well. It also will be important to understand both which workers might receive priority vaccine access within the state’s distribution plan, and to understand which workers operate in workplace environments where they face a higher risk of workplace transmission. For example, a manufacturing-floor worker might get priority over an office worker capable of performing work remotely. 

How will your employees access the vaccine?  

There could be various distribution and vaccination models, ranging from using onsite company resources to temporary or mobile vaccination clinics to encouraging or requiring workers to obtain vaccines on their own. Each approach may have varying levels of feasibility and risks depending on the jurisdiction. Again, it’s important to understand a given state’s distribution plan and approach to delivering the vaccine. Significantly, according to the EEOC, employers considering administering the vaccine themselves or contracting with a provider to administer the vaccine (as opposed to having workers obtain it on their own) may need to meet a heightened legal standard in order to ask screening questions that are required to be asked before administering the vaccine—a standard that need not be met if employers require employees to obtain vaccines independently.  

It’s also possible that different states could approach vaccine access differently among essential workers, or even among food industry essential workers. Companies with significant operations in multiple jurisdictions—or with highly varied types of operations—may need to consider how to best align company policies across multiple states. 

How will you verify compliance?  

Consider in advance what steps the company will take to verify whether employees have in fact obtained the vaccine, and be mindful of potential legal restrictions on what types of medical questions may be asked of workers. For vaccines requiring multiple doses to be effective, consider whether the company would take a role in helping employees remember to, or facilitating access to, the follow-up dose at the appropriate time. 

How will costs be handled?   

A company may need to evaluate financial considerations, such as whether the company will bear any costs associated with the vaccine, what insurance coverages may apply, whether employees would need to be paid for their time spent getting the vaccine, whether to offer employees an incentive for getting the vaccine, and whether to provide transportation to get the vaccine. Employment law considerations may affect some of these decisions.  

How will you communicate the ongoing need for mitigation measures?    

COVID-19 mitigation measures will likely need to remain in place for some time after vaccines are made available. Companies should consider how to reinforce appropriate mitigation steps during and after vaccination programs.   

Next steps    

The roll-out of a vaccine in the U.S. is a promising new development in the fight against COVID-19, but it also raises a number of importance considerations and presents a staggering logistical challenge. Food companies should begin developing plans now for how to incorporate vaccines into their COVID-19 mitigation strategies. These plans could raise a number of important legal issues, including certain employment law and liability questions associated with administration of the vaccine. If we can help you navigate these and other issues, or if you have any questions, please contact us.

 

Authored by Brian Eyink, Elizabeth Fawell, George Ingham, and David Horowitz. 

Search

Register now to receive personalized content and more!