Announcements by both
Q: What exactly did
How did they come up with 90% efficacy? The trial has about 44,000 participants and began
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,
Q: When will a vaccine be approved?
"Emergency Use Authorization" could come as early as December in the best-case scenario. While the
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
- November: More data collection. By late November,
- 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).
- 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?
Pfizer's Early Data Shows Vaccine Is More Than 90% Effective (The New York Times )Pfizer coronavirus vaccine could be cleared by mid-December following release of data showing it is more than 90 percent effective (TheWashington Post )- Coronavirus Vaccine Tracker (
The New York Times )
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
The
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
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
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
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
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
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
But on vaccines, so far the EEOC has not provided more specific determinations. To date, it has suggested a voluntary approach: "Generally,
In 2009,
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
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?
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
Additional sources
- Frequently Asked Questions about COVID-19 Vaccination (
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