Let’s be real: last year was rife with horrors. (Murder hornets? Giant meteors? Really, 2020?). Now, 2021 is here and comes bearing gifts: The first vaccines for COVID-19 prevention. We sat down with Dr. Erik Vanderlip, ZOOM+Care’s Chief Medical Officer, and Dr. Thad Mick, Vice President of Pharmaceutical Programs and Diagnostic Services at ZOOM+Care, to help ease your fears and give you the facts.
Let’s be real: last year rife with horrors. (Murder hornets? Giant meteors? Really, 2020?). Now, 2021 is here and comes bearing gifts: The first vaccines for COVID-19 prevention.
Though hope is on the horizon, people actually have to get the vaccine for it to work—and many Americans are reluctant to do so. Recent polls suggest that as many as half of U.S. citizens would refuse a COVID-19 vaccine, though these numbers may be increasing as experience with the vaccines grows. Among the reasons for denial: government overreach, concerns about safety due to rapid development, and of course, side effects.
As with anything new in science, it’s only natural to have questions—and because COVID-19 vaccination is an essential tool in stopping the pandemic, it’s imperative you get answers. We sat down with Dr. Erik Vanderlip, ZOOM+Care’s Chief Medical Officer, and Dr. Thad Mick, Vice President of Pharmaceutical Programs and Diagnostic Services at ZOOM+Care, to help ease your fears and give you the facts:
Dr. Vanderlip: Healthcare workers, first responders, and nursing home residents are the first to be eligible for the vaccine—which will take up a fair bit of the first allotment. Even within healthcare, there is prioritization. People working in the ICU, E.R., hospitals, and nursing homes will be vaccinated before others working in lower-risk settings.
After the healthcare workforce is vaccinated, the public will be eligible. Even then, people with chronic conditions, high risk of exposure or at risk for bad outcomes, and minority and underserved populations disproportionately affected by COVID-19 will have priority. These groups will include older persons and essential workers.
The CDC’s Advisory Committee on Immunization Practices (ACIP) approved a prioritization recommendation for the initial and second phase of COVID-19 vaccine eligibility. However, each state independently governs its allotment of Government-purchased vaccine, dictating on a state-by-state basis the phases of eligibility. Most states are sticking to the CDC guidelines, but there are some minor exceptions.
Dr. Vanderlip: Not yet. The phase three COVID-19 vaccine trials follow individuals for up to two months post-vaccination to examine for bad outcomes and efficacy. As we move into this next phase of vaccination for the public, there is very close monitoring of infections and side effects post-vaccination. As more and more data comes in—and as more time elapses from the original trial—our confidence in the vaccine duration will change.
Dr. Vanderlip: Not completely, but early indications are promising that these vaccines could be highly effective at preventing infection for at least several months after administration. Both the Pfizer and Moderna vaccines are reported to be more than 90% effective at preventing COVID-19 in participants in phase three clinical trials. Furthermore, there is good evidence that the disease course was milder for those that acquired infection, and significantly fewer were admitted to the hospital. In the clinical trials, there were no deaths from COVID-19 in the vaccination group.
Dr. Vanderlip: For many people, the vaccine will be free. There is a small cost associated with administering the vaccine—related to the storage, handling, and staff required to inject it. The federal government has already purchased millions of vaccine doses to speed up production in anticipation of success. Those with health insurance or public insurance (Medicare, Medicaid) should expect coverage for the vaccine’s administration fee. The cash price is yet to be determined.
Dr. Vanderlip: Most of the Pfizer vaccine is going directly to hospitals with sufficient cold-storage to properly handle the vaccine without the risk of spoilage. Because of the Pfizer vaccine’s short shelf life, we see that the Moderna vaccine is easier to distribute. At ZOOM+Care, we can safely store the Moderna vaccine in our medical-grade freezers and refrigerators that we use for other vaccine products with risk of expiration. This helps us keep supply on-hand and distribute it both to our staff and eventually the public. However, even the Moderna vaccine has challenges. For instance, once a dose from a vial is extracted, you have to use the remaining nine doses within six hours. This presents a challenge when you’ve had to open a new vial—but don’t have exactly ten more doses to dispense. Many systems are working out these logistics. As we get more experience with these vaccines, we will develop better workflows to ensure our supply more adequately meets demand.
Dr. Vanderlip: In healthcare, some vaccines are considered a must-have for patient-facing staff. This includes vaccines like hepatitis B, for example. Traditionally, staff has either been required to show vaccination or sign formal paperwork declining it. This is because, as an employer, we are responsible for the safety of our staff and bear liability if they are infected with hepatitis B while undertaking their roles in patient care. For the vast majority, this isn’t an issue. This is the way the COVID-19 vaccine is rolling out—while it’s not mandatory, it’s strongly encouraged. Also, the FDA has not formally approved this therapeutic. Right now, it’s only under Emergency Use Authorization. Formal FDA approval would be required for any vaccine to be mandated. Personally, with the way some folks feel about vaccines, I think it’s unlikely for any employer to mandate it for their staff. It’s the same thing for the general public—strongly encouraged, but not mandatory. In the end, I think that peer pressure and seeing others being able to enjoy individual freedoms down the road, such as easier travel, not having to wear a mask, etc., will entice many to accept the vaccine. Hopefully enough to achieve successful herd immunity rates.
Dr. Vanderlip: Nothing related to COVID has gone through the usual regulatory channels we have in place for FDA approval. Most approvals for testing and vaccination are going through the FDA’s formal Emergency Use Authorization to fast-track the regulatory approval process. This process cuts out some additional requirements for peer review and transparency in data at times that would otherwise take months or years. Generally speaking, I’d say our system is working, and we are flexing our scientific muscles appropriately to speed the advancement of diagnostics and therapeutics to combat this unprecedented situation. As we gain more experience with the vaccine, we will improve our knowledge and understanding of its efficacy and duration.
Dr. Mick: While many are concerned about the COVID-19 vaccine, there are many benefits to getting vaccinated. [It’s important to remember that] these vaccines are being thoroughly evaluated and will only hit the market if any risks of the vaccine are outweighed by the benefits.
Dr. Vanderlip: The rollout and safety of the vaccine are being closely monitored and require intensive reporting for both providers and patients. For the vast majority of folks, the vaccines are safe and present only mild, flu-like concerns, such as localized injection-site soreness, muscle aches, a low-grade fever, and fatigue. Severe allergic reactions have rarely been reported.
Dr. Mick: In the process of building up [immune response to the vaccine], it’s normal to experience some side effects along the way.
[…] COVID-19 vaccine side effects may include muscle aches and joint pain. From what we know, most side effects will likely appear in the first day or two after receiving the vaccine but may potentially present later.
Dr. Vanderlip: Yes. There’s a difference between immunity from natural infection of COVID and immunity produced by the vaccine. There’s also some discussion about whether or not the immunity produced by immunization—in this case, the mRNA vaccine—may actually be SUPERIOR to natural immunity. The vaccine may not necessarily be recommended for persons who have had an infection in the preceding 90-day window, since there’s evidence of natural immunity extending to at least that long. The same protocol goes for persons who have received the mono or polyclonal antibody therapies for COVID-19. Generally, if they’re admitted to the hospital, they should probably hold off on being vaccinated for at least 90 days since they’ve had an artificial infusion of antibodies to help protect them during that length of time.
Dr. Vanderlip: That’s still to be determined. With the new English variant of COVID-19 now spreading, it could be higher. The English variant appears to be up to 70% more infectious, which is the natural state of evolutionary pressure on all viruses to become more infectious, but not necessarily more deadly, until immunity grows in a population. Herd immunity rates are dependent upon a few things: how infectious the virus is, the length of time someone can be contagious, whether they show symptoms during that contagious period or not, and how the virus is spread. For measles, the herd immunity rate to prevent widespread infection needs to be above 90-95%. In other words, because it’s so infectious (without vaccination, one person with measles could infect 12 others over time), nine out of ten people in a population need to be immunized to prevent a measles outbreak. COVID-19 isn’t as high as measles, but according to most experts, herd immunity rates will likely need to be 60-80% to prevent outbreaks within a population.
Dr. Vanderlip: Yes. The clinical trial data suggested a robust response for elderly populations.
Dr. Vanderlip: Not yet. If we’re able to achieve herd immunity rates, hospitalizations and deaths drop, and community spread appears to be under control—there’s hope that current masking and social distancing requirements will be lifted. That said, I’d caution anyone against getting their hopes up for that happening before at least the first six months of 2021.
Dr. Vanderlip: I think the development and distribution of the vaccine are two remarkably different things and point to the vast inadequacies of the current U.S. healthcare infrastructure. We have the most remarkable scientists in the world doing groundbreaking research in public and private laboratories, and the best minds able to produce groundbreaking therapeutics—but NO WAY to deliver even the basics to the population who needs it. ZOOM+Care is working to change that by taking the best therapeutics and delivering them quickly and effectively—but we, too, often find ourselves constrained by inadequate local, state, and federal public health resources. The best scenario is strong public-private partnerships to make the most of innovative healthcare service delivery, coupled with the scope and power of the federal and state government to protect its citizens. Hopefully, the distribution of the COVID-19 vaccine will help kindle these relationships for future needs.
It’s still largely up to the states to decide when phase one is adequately protected (healthcare workers, some essential workers, and nursing home residents), and when we’ll move on to phase two (for the general public). Stay up-to-date on state public health agencies for information on when this will occur—we expect later in January to mid-February. Many places offer sign-ups for vaccination, but this doesn’t mean they’ll get it, and it certainly doesn’t mean they have it yet. At ZOOM+Care, we’ll be offering vaccinations to the public when they’re available, and it’ll be a delightfully easy process—just like everything else we do at ZOOM+Care. If you’ve signed up for an account with us, you’ll be notified as soon as we have the vaccine available for the public.