Announcements by both Pfizer and Moderna that their trial COVID-19 vaccines appear to be over 90% effective have led to a surge of interest by everyone, employers included, about exactly when and how a vaccine will save us from pandemic life. Here are some updated key questions and answers for employers about what to expect next.
Q: What exactly did Pfizer and Moderna announce?
Pfizer revealed preliminary results indicating that its vaccine appears to be 90% effective based on an ongoing human trial. The information comes from an independent board that is reviewing data while the trial continues.
How did they come up with 90% efficacy? The trial has about 44,000 participants and began July 27th. Half of them received the vaccine while half received a placebo (of course, participants did not know which they received). 94 of the participants eventually tested positive for COVID-19. 90% protection suggests that most of those who became infected must have been in the placebo group.
Although the trial is not complete, it involved a schedule of several interim analyses along the way. Each analysis was scheduled to occur once study participants reached a certain number of COVID-19 cases. As it turned out, study participants became infected so quickly after starting the trial that the independent review board was able to skip the first interim analysis. Based on the rapid spread of the virus, they expect to be able to complete the study soon, which can occur once they reach 164 cases in total.
Today, Moderna announced similar results, reporting that its vaccine is 94.5% effective based on studying 95 people infected in its 30,000-person trial.
Q: When will a vaccine be approved?
“Emergency Use Authorization” could come as early as December in the best-case scenario. While the Pfizer and Moderna announcements have everyone excited about a vaccine arriving soon, the optimistic timeline for vaccination appears not to have changed significantly. Vaccine makers have been saying for months that they hoped to identify a vaccine by the end of this year.
Experts are cautiously optimistic that at least one vaccine could be approved as safe and effective by the end of this year or the beginning of next year. But there can be hiccups. One trial paused recently when a patient had potential serious side effects. Once trials are complete, the FDA will need time to review and approve the vaccines, even on an emergency basis.
The good news is that there are a lot of irons on the fire. The Pfizer and Moderna vaccines are only two of 57 different vaccines undergoing human clinical trials (including a dozen already in Phase 3). But remember that there are still many hurdles to clear:
- November: More data collection. By late November, Pfizer believes it will have enough data to submit to the FDA review process for Emergency Use Authorization.
- December: FDA review and approval. This could take several weeks. Mid-December may be the earliest for Emergency Use Authorization.
- January: Initial distribution. If the vaccine obtains approval in December, the first doses might be administered in January (though it will take months to manufacture and distribute enough for the general population).
Q: Why does it take so long?
Vaccines normally take years to develop and approve. Even once researchers find a promising formula, testing is a critical and time-consuming effort to make sure the vaccine is both safe and effective.
Vaccine testing has several important steps: preclinical testing (on animals), Phase 1 safety trials (testing for efficacy and safe doses on a small number of people), Phase 2 expanded trials (involving hundreds of people in order to see how different groups respond), Phase 3 efficacy trials (involving thousands of people, who receive either the vaccine or a placebo to determine efficacy and side effects), and finally, FDA approval.
After testing, manufacturing and distribution will take months to generate the several billion doses needed worldwide.
Q: How long will it take to manufacture and distribute a vaccine broadly?
The short answer: Probably at least months, if not most of 2021 for mass vaccination. Experts say we’ll need at least 70% of the U.S. population to be immunized. That will take some time (though it could take less time if vaccines prove to be as surprisingly effective as the early news suggests).
The U.S. government intends to make vaccines available widely in the United States at little or no cost. It has invested $10 billion in research and development, effectively pre-ordering at least 100 million doses of each of several different drugs from different companies. It is also working to boost manufacturing capacities for approved vaccines, as well as for everything needed to administer them, including syringes, glass vials, PPE, and other critical supplies.
However, given limited quantities distribution probably will occur in phases, giving priority based on people’s jobs (such as healthcare workers) or health conditions (such as those with high risk of severe infection). One CDC-sponsored report by the National Academies proposes four phases of distribution. The first phase includes healthcare workers and high-risk individuals. Critical infrastructure workers would be part of Phases 2 and 3. The general public would not be vaccinated until Phase 4.
This schedule could accelerate if more vaccines receive approval. But it could also be delayed if there are obstacles in the trials, approval process, or distribution.
Q: What factors could delay vaccination?
There are many potential complicating factors, but here are just a few of the top ones:
1. Logistics will be complicated.
The Federal Government’s Operation Warp Speed is coordinating a plan for centralized distribution. But it involves partnering with some 64 state, local, tribal, and territorial jurisdictions, each of which may have its own “microplan.”
The Pfizer vaccine is a good example of complicated logistics. It likely will require each person to get two doses, several weeks apart. Plus, it needs to be stored in a deep freeze (minus 112 degrees Fahrenheit) until it’s injected, requiring special packaging, storage, and/or transport.
2. We should expect friction from the public.
If you thought cloth face masks were contentious, imagine how challenging it will be to reach consensus on widespread injections. Some Americans already are wary of immunizations generally. After COVID-19 vaccines became politicized during the election campaign, polls in September showed only half of Americans said they would get vaccinated if a vaccine were immediately available. Hopefully, a thoughtful approval process will earn more of the public’s confidence. But authorities may still have a sales job to convince some to get vaccinated.
3. Manufacturing capacity is limited.
There likely will be just 15-20 million doses in early 2021 even if a vaccine is quickly approved. The CDC and drug makers estimate that it could take until Labor Day 2021 to achieve mass vaccination. Of course, the more vaccines that are available sooner, the better.
Q: Once a vaccine is available, can employees be required to get it?
We still don’t know for sure what the rules will be for employers because key agencies like the Equal Employment Opportunity Commission (EEOC) and Occupational Safety and Health Administration (OSHA) have not yet answered this point directly in the case of COVID-19. There is some uncertainty about whether some employees might be exempt from a vaccination requirement under a number of laws.
EEOC: Consider encouraging vaccines
EEOC guidance to date leaves some uncertainty about how fully employers could require employees to be vaccinated, particularly whether some employees may be able to claim exemptions. In 2009 guidance, the EEOC said that under the Americans with Disabilities Act (ADA) and Title VII, some employees – such as those with religious or medical concerns – may be exempt from mandatory vaccination programs, even in the midst of a pandemic.
The EEOC could have a basis for deciding that these exemptions do not apply to COVID-19, however. For example, under the ADA, even employees with medical conditions may not be exempt if coming to work unvaccinated would present a “direct threat” (i.e., significant risk of substantial harm even with reasonable accommodation), a standard COVID-19 may meet.
Similarly, under Title VII, an employer must seek an accommodation for an employee who objects to vaccination because of a sincerely-held religious belief. However, there are limits. If the cost to the employer of providing an accommodation is more than “de minimis” (i.e., imposes more than a minimal cost), the employer can enforce the vaccination mandate. The costs to the employer can include increased safety or legal liability risks.
It’s possible that COVID-19 will provide the perfect storm in which these exemptions rarely, if ever, apply. In the COVID context, the EEOC has said that COVID-19 has been a “direct threat” (though that could change with circumstances) and reiterated its prior ADA and Title VII guidance.
But on vaccines, so far the EEOC has not provided more specific determinations. To date, it has suggested a voluntary approach: “Generally, ADA-covered employers should consider simply encouraging employees to get the influenza vaccine rather than requiring them to take it.” Of course, if and when a vaccine becomes available, the EEOC may offer much clearer direction.
OSHA: Beware whistleblower concerns
OSHA also has not weighed in on the implications of a COVID-19 vaccine in particular. But its past guidance suggests both that employers could require vaccines and that some employees might have a basis to refuse.
In 2009, OSHA issued a letter of interpretation in response to a question about whether an employer could require employees to get a flu shot. OSHA explained that it encouraged employers to offer flu vaccines to employees and that employees “need to be properly informed of the benefits” of the vaccines. It added that OSHA does not require vaccinating employees, but “an employer may” require it.
However, the same guidance letter said that an employer vaccine mandate could violate the Occupational Safety and Health Act under certain circumstances. For example, an employee could allege a whistle blower violation. According to OSHA, “an employee who refuses vaccination because of a reasonable belief that he or she has a medical condition that creates a real danger of serious illness or death (such as serious reaction to the vaccine) may be protected” as a whistle blower.
State law mandates?
In many states, healthcare workers already must get certain vaccines under employer and/or state mandates. Especially since so much of the burden of responding to COVID-19 has fallen to state and local governments, using their emergency powers to require vaccination may be tempting to state officials. On the other hand, it may be politically sensitive. Time will tell, and employers should stay abreast of their state and local authorities’ COVID guidance and requirements.
Yet more questions
Of course, the breadth of COVID-19 vaccination and the severity of the pandemic will surely put these rules to the test and raise many more questions, such as:
- Will states expect employers to assist with vaccination, including in early phases for healthcare and other critical industries?
- How will unions and collective bargaining agreements factor in?
- Can an older employee claim age discrimination?
- Can companies be liable for not requiring vaccination?
- What happens with workers’ comp if people claim to get sick from an employer-offered or required vaccination?
Employers would do well to begin considering how they would like to handle vaccination and which of these factors may impact their decision making. It may be helpful to share news updates with employees to help them understand the progress with vaccine development, as well as the benefits and safety of vaccination. This could help people get comfortable with what’s coming. Companies in healthcare and critical infrastructure may have to confront these issues as early as Q1 given their expected involvement in earlier phases of vaccine distribution.
If you have questions or need assistance with your vaccination policies and planning, please contact your Husch Blackwell attorney or Avi Meyerstein.