On Jan. 19, Grand Rounds hosted our first vaccine “fireside chat” webinar in a 3-part series, “Navigating the Vaccine Release,” with myself who was joined by Dr. Ernst, Chief of the Division of Experimental Medicine at UCSF. The Q&A session, which covered key topics related to the COVID-19 pandemic, was intended to help employers and plan sponsors better safeguard their members’ health with the vaccine rollout.
Following are just a handful of the many questions employers and plan sponsors have been asking and that Dr. Ernst and I answered.
COVID-19 Vaccine Candidates
Q: How should employers be thinking about the COVID-19 vaccines, and which vaccines should they encourage their members to take?
Dr. Ernst: The simplest answer to that question is they should encourage their employees to take the vaccines. Right now, we have two available. … There are two more vaccines that are probably going to be available [soon]. I think the timeline on both of those is a bit unknown, but I would imagine it’s in the next couple, maybe three months.
Q: Can you speak to the timeline for development of the vaccines that are in the market today? How do those compare to other vaccine trials?
Dr. Ernst: From the time that the virus was first described until clinical trials began and the emergency use authorization [took place] is unprecedented [in terms of speed to market]. If I recall correctly, the fastest vaccine development prior to this was about four years. I think it’s really important to emphasize that there weren’t any shortcuts taken. The reason things went so rapidly was really largely because of commitment and being able to operate many different steps in parallel.
For example, thanks to federal funding, it was possible to produce millions of doses of vaccine before the clinical trial data was even in. Now, that is not the way business is usually done. Usually, a vaccine is proven to be efficacious, about to be approved by the FDA, and then production ramps up. And that’s really one of the reasons that it usually takes so long.
Clinical Trials and Side Effects of the COVID-19 Vaccine
Q: How would you address concerns about the long-term effects of the COVID-19 vaccine?
Dr. Ernst: We know that each of the components of the two vaccines currently are metabolized fairly rapidly by the body. In other words, we’ve got mechanisms that our bodies use to essentially get rid of the components of the vaccine after they’ve done their job.
That said, the long-term effects of vaccines generally manifest themselves in the first six weeks to couple of months after they’re administered. Even when those are rare, they’re more often for things like live viral vaccines rather than the kind of vaccines that we’re talking about in every case for COVID-19. So, I think the chance that we’re going to discover untoward effects that are long-delayed down the line is really, really remote.
Q: Can you talk about what’s been going on with the AstraZeneca trials?
Dr. Ernst: The AstraZeneca phase 3 trial was a bit complicated. There was an unexpected or unanticipated protocol deviation, [which] resulted in a certain number of people in the trial getting half the dose that was intended for their first dose. Then, ironically, that group seemed to be better protected than the balance of the group that got both full doses of the vaccine. There are a lot of potential explanations that have been discussed, but the … protocol violation [along with the] unexpected difference in efficacy has really delayed the FDA’s ability to evaluate the results of that trial.
That’s unfortunate, because we really need more vaccine doses available, but I think everyone wants to be on the cautious side. We do know quite a bit from other vaccine trials that resembled the AstraZeneca vaccine, which is based on an adenovirus backbone, and those have been safe. So there’s every reason to think this will be safe. There’s also every reason to think that it will be efficacious. But we need more data before that can be concluded.
COVID-19 Vaccine Safety and Efficacy
Q: Was the number of people included in clinical trials enough to assume these vaccines are safe?
Dr. Ernst: Between the phase 3 trials for the Moderna and Pfizer vaccines, there were about 70,000 participants. Half of them in each case got the vaccine and half got placebo. So, 35,000 people were studied intensively. Meanwhile, since the emergency use authorization, there’ve been 10.5 million people who’ve received at least one dose of these vaccines. The safety profile still looks very, very good.
Q: How effective are these vaccines in preventing severe COVID-19 disease?
Dr. Ernst: This wasn’t the main focus [for either the Moderna or Pfizer trials]. However, the observational results from the two vaccine trials imply that they’re about 90 or more percent efficacious in preventing severe COVID-19 disease. So, they prevent symptomatic disease, but they also prevent severe disease from developing.
Q: Can people who have been vaccinated still be carriers of the coronavirus and infect others?
Dr. Ernst: There’s a lag between the time somebody’s been given the first dose of the vaccine and the time that an immune response kicks in and protects them. During that time interval, people can get infected and can shed and transmit the virus to others. We don’t have a lot of data yet about whether asymptomatic transmission is interrupted by vaccination.
On a population level, we can certainly expect that the more people that are vaccinated, the less virus will be circulating and there should be a reduction of transmission. We also know that a small fraction of people who were vaccinated still got symptomatic infection. We don’t know whether those people shed less virus or not. In the absence of more information, it’s best to assume that if somebody develops infection despite [getting the] vaccine, they will be shedding and transmitting virus as well.
Q: Throughout the pandemic, we’ve heard a lot about herd immunity. How should we be thinking about that relative to the COVID-19 vaccines?
Dr. Ernst: Herd immunity is really community immunity. In other words, a large fraction of the population has immunity and is protected. If a large fraction of the population is immunized, vaccinated and protected, then a given person who gets infected and potentially can transmit, their virus will basically run into people who are already protected, and it will be unsuccessful.
There are several ways to get herd immunity, and there are certain things that modify how much of the population needs to be immune in order to generate herd immunity. A lot of that variable has to do with the efficacy of a vaccine, and it also has to do with the transmissibility of the virus.
We know the [Pfizer and Moderna] vaccines are really efficacious—93 to 95% is really impressive efficacy. So far, the virus hasn’t mutated to escape that vaccine immunity. However, many of you may know that the virus has mutated and is continuing to mutate to become more transmissible. The more transmissible the virus is, the higher the fraction of the population needs to be in order to keep herd immunity and prevent another expansion of the outbreak.
Q: Does the data point to what percent of the population needs to be vaccinated to “get back to normal” relative to COVID-19?
Dr. Ernst: There are estimates, but they’re pretty broad estimates. I think the original estimates were about 70% of the population needs to be immune in order for this pandemic to subside. I think that’s been modified a bit because of the emergence of viral variants that are more highly transmissible.
Workplace Policies to Combat COVID-19
Q: Employers have implemented workplace strategies around COVID-19 such as wearing masks, hand washing and remote work. How should they be thinking about changing this in light of the vaccine’s rollout?
Dr. Ghosh: As Dr. Ernst mentioned, the two vaccines available in the U.S. were studied to see if they prevented people from getting sick with COVID-19, so having symptoms. What they didn’t do is study whether people could still have asymptomatic infections and pass the virus on to other people after getting the vaccine.
What that means for employers is that we know that the vaccine will protect the individual employee who got the vaccine from getting sick or hospitalized. What we don’t know is if the vaccine will prevent that employee from spreading the virus to other employees. That’s why we need to continue with mask policies in the workplace, along with social distancing and the other measures that you’ve already taken. These need to stay in place to protect unvaccinated people until we can achieve herd immunity.
Q: Can employers require employees to get a vaccine to protect against the coronavirus?
Dr. Ghosh: The U.S. Equal Employment Opportunity Commission recently said that employers will be allowed to mandate vaccination or require documentation of vaccination in certain situations. So, as a company, you need to determine what your stance is on a vaccine mandate. And even if you choose to avoid a vaccine mandate, think through how you will support your employees’ access to vaccines.
So, will you offer navigation services to help them make appointments? Will you have partnerships with local pharmacies or mobile nursing services that come to work sites or homes, or will you offer vaccines at your employee health clinic? Deciding on those policies right now can really help you avoid confusion when the vaccine is available to your employees.
Communicating Information to Employees
Q: What should employers and plan sponsors expect of their vendor partners in order to drive a consistent and synergistic approach to the COVID- 19 pandemic?
Dr. Ghosh: Your employees will need support through [the vaccine rollout]; this is confusing and for some people, scary. People are nervous about these vaccines. … Providing access to additional clinical support and guidance, if your vendors offer that, could be a way to help ease these concerns, especially if they can do so virtually. Also, consider working with vendors that either offer worksite vaccination services to make things easier for your employees or services that help your employees schedule appointments for vaccines, which might be tricky depending on where they live.
Keeping on top of the information around the vaccines is almost a full-time job. There are different things happening in different locations and if you have multiple locations, you might want to designate your own employees to monitor what’s happening at state and local health department websites on a daily basis, or you might want a vendor to stay on top of shifting vaccine policies and shifting eligibility in different states. Some states have actually designated decision-making down to the county level.
Q: Can you share the work you’ve been involved in at Grand Rounds, supporting our customers?
Dr. Ghosh: Knowledge management is very important in this pandemic. So, we’re looking at this in terms of different buckets of knowledge that we need to be able to best support employees and employers. One bucket of support is clinical.
Grand Rounds has a team of clinicians, over 200 at this point, to be able to offer that type of support. … We have whole teams of physicians that are constantly monitoring literature and science, and are trained to stay up to date with CDC and OSHA guidelines. There’s so much information; things change almost on a daily basis.
There’s also navigation. Navigation, of course, is a key to what Grand Rounds does. Our role is often being a navigator, connecting employees to their different benefits, connecting them to the healthcare system. So, it’s a natural extension of what we already do, to play the role of navigator and help people get access to the vaccine or appointments for the vaccine as they need.
These questions and many more were covered in the fireside chat. As the COVID-19 vaccine rolls out to more and more regions across the U.S., learn more about what you can do to help keep your workforce healthy and productive.