Dr. Kimi Kobayashi, UMass Memorial Chief Quality Officer
As the hospital continues its push for employees to be vaccinated, SHARE wants to make sure that members have access to answers regarding their questions and concerns about the vaccine itself. Dr. Kimi Kobayashi recently took SHARE up on our invitation to talk with us about the science and safety of the COVID-19 vaccine at a pair of online meetings. Below, we’ve posted a summary of the questions and answers combined from both sessions.
Introduction
SHARE: Thank you for being with us today to represent the hospital and help us understand what it has to say about the COVID-19 vaccine and why the hospital has chosen to require employees to be vaccinated.
Dr. Kobayashi: I’m delighted to answer your questions. I should also say that sometimes people have questions and aren’t comfortable raising them in this kind of format. If you want to set up a phone call or email me, I’m happy to do that as well. I should make clear that I’m an Internal Medicine doctor, and have been participating in decisions around COVID 19 because the Infection Control department reports to me. I work closely with Dr. Ellison, UMass Memorial’s hospital epidemiologist. I also want to say we’ve been making decisions during a pandemic with an emergent disease, which means we are constantly reviewing new information coming out to evaluate and adjust any decisions we make.
General Vaccine Safety
SHARE Member: How do we know the vaccine is safe? How can we predict that it won’t have unforeseen, bad consequences later? Especially since it was developed so rapidly?
Dr. Kobayashi: You’re right that the vaccines are relatively new. The speed with which they were developed has caused concern for people. The standard for approving the COVID-19 vaccines, however, has been the same as that to approve all other vaccines. There are a number of reasons that this vaccine could be developed more rapidly than others. Because it was a worldwide pandemic, a lot of scientists dropped everything to work on this. Everyone was racing. Much of the research behind this vaccine had already been in the works for many years. Some of these new technologies allowed for faster production. And the entire world got involved, it wasn’t just a niche interest.
The approval standard was just as rigorous as ever. Many patients were enrolled in trials before the vaccine approvals. When you develop a vaccine, you need to have enough patients to test it, which takes a long time for rare diseases. But in a pandemic, the testing and the results naturally come faster. This allowed for widescale studies to be done at a faster pace than previous vaccine studies. And now we’ve seen these vaccines widely used in the real world. 6.4 billion doses have been administered, including 400 million doses in the US so far. For comparison, each year 10 million doses of the MMR (measles/mumps/rubella) vaccine is administered, so the scale is a lot bigger for the COVID-19 vaccine. We have lots more info and data on this. I can’t predict the future with one hundred percent certainty, of course, but we have a lot of real-world and scientific data to work from.
SHARE Member: How do you compare risks of getting the COVID-19 vaccine against getting COVID-19, the disease itself?
Dr. Kobayashi: In every case I can think of, the side effect is worse with the disease than with the vaccine. For example, a side effect of the Johnson & Johnson (J&J) vaccine is that females can be more slightly more likely to develop a blood clot – but among all people who get the disease, the risk of getting a blood clot is astronomically higher. So we need to weigh those against each other.
Why Should I Get the Vaccine?
SHARE Member: Why does the hospital require the vaccine if an employee can still get COVID-19 afterward, and transmit COVID-19 to others?
Dr. Kobayashi: The vaccines have proven to be over 90% effective at reducing hospitalization, and very effective at reducing death. There have been breakthrough cases among vaccinated people, but that’s uncommon (approximately 1/2-5000), and there are various reasons for this. It could be because their antibody response wasn’t very strong. Or they have chronic medical conditions that render them less able to generate a response. We don’t want our employees to get COVID-19 and that’s the reason why the vaccine is being mandated. The disease is much more mild if you’ve had the vaccine and most of the deaths seen from COVID-19 remains predominantly among those who are unvaccinated. Also, our patients expect us to be vaccinated, I see it in patients’ comments and questions. It’s something that our patients are demanding of us.
SHARE Member: I’ve already had COVID-19: why isn’t my own natural immunity sufficient? Why do I have to get the vaccine, too?
Dr. Kobayashi: I get this one a lot. The vaccine offers more protection than the disease itself. We know from studies now coming out that you are twice as likely to get reinfected than if you get vaccinated. We think you are protected for a couple months if you’ve been infected. The immunity is shorter-lasting than for the vaccine, which is more protective for a longer duration.
SHARE Member: I’ve worked directly with COVID-19-positive patients throughout the pandemic and have not gotten sick. Why aren’t PPE and my own hygiene practices sufficient so that I don’t have to get the vaccine?
Dr. Kobayashi: Social distancing and PPE help. But those aren’t going to be as effective as the vaccine because the vaccine protects both against getting it and against getting a severe case or dying from the disease. If you knew three things could protect you, why would you just use one? I like to draw an analogy to seat belts and airbags: both save lives, and you use both. You wouldn’t say that I don’t need a seatbelt because I have an airbag. We rely on multiple layers for the best protection.
SHARE Member: I work from home and don’t see patients, why do I need to get vaccinated?
Dr. Kobayashi: If you come in to work onsite, we want you to be protected. For Medical Center employees there are situations where even caregivers working from home might be called in to campus. More fundamentally though we also just want you to be protected from COVID-19, period. Being defined as “health care workers” allowed millions of people to be put at the front of the line to get the vaccine initially, ahead of teachers and other front-line workers. We are therefore all healthcare providers and we need to make sure we’re doing everything we can to protect our patients.
How Can We Know If Information Is Reliable?
SHARE Member: Where is UMass Memorial getting the data indicating vaccines are safe and effective?
Dr. Kobayashi: We’ve treated it like any emerging disease. As a physician, I use peer-reviewed literature to make sure we are acting on studies that were done in a good way. Governing bodies like the CDC synthesize these studies and use emerging data that is being generated by scientists. If you want to know the best source of information, it’s the CDC. That’s because they’ve got to put their recommendations out there and then have folks like me ask, “But what about this?” They are subject to scrutiny by hundreds, thousands of experts. The CDC site will show what studies they are using to support their recommendations. There are other sources of information out there that don’t use rigorously studied data and/or do not cite their supporting evidence for the claims they are making.
SHARE Member: To clarify, when you say “peer-reviewed study,” what do you mean?
Dr. Kobayashi: “Peer-reviewed” means that the data and the findings from the study is subject to review and critique by other experts in the field. When a study is subject to peer-review other experts review the study to ensure that the methods that were used and the findings that are presented are valid. It could even be called “expert review.” Wikipedia, on the other hand, is a source that’s subject to review by other people, but the content isn’t controlled in the same way. Information that withstands peer-review can be considered the gold-standard.
SHARE Member: The CDC VAERS [the Centers for Disease Control’s Vaccine Adverse Event Reporting System] webpage states that thousands of people have died after having received the vaccine. Shouldn’t we be alarmed about this?
Dr. Kobayashi: There were 8,638 reports of death in the VAERS system. We have to remember that VAERS is a passive reporting system meaning that events are self-reported by patients and providers are obligated to report deaths even if they do not feel that the death was attributable to the vaccine. So, just because a death was reported in VAERS, doesn’t mean someone died because they got the vaccine. They could have had a heart failure or other diseases unrelated to vaccine. The VAERS system doesn’t provide a causal database, it’s meant to be a wide-encompassing database on purpose. That way we can pick up even small signals. So far, there have been about 400 million doses, and eight thousand deaths following those doses, without causation. That’s a very small fraction. In the rigorously conducted trials studying the vaccine there were no deaths among those that received the vaccine.
[SHARE note: according to the CDC website, “Reports of death after COVID-19 vaccination are rare. More than 396 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through October 4, 2021. During this time, VAERS received 8,390 reports of death (0.0021%) among people who received a COVID-19 vaccine. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths pdf icon[1.4 MB, 40 pages].”
Dr. Kobayashi: One more thing: I often use a seat belt analogy for understanding this. People continue to die in cars, but we don’t say, “Let’s get rid of seat belts.” Just because someone was using a seat belt when they died doesn’t mean the seat belt killed them.
SHARE Member: Some people might be scared to report to VAERS. Has the CDC underreported deaths?
Dr. Kobayashi: VAERS is not perfect, it’s not omniscient. If a symptom doesn’t get reported, it doesn’t get picked up. I’m not here to say VAERS is a perfect system, but it’s better than nothing. Critics have said that the CDC reporting could be an undercount or an overcount. There’s a back and forth about the data that we participate in as well. We do know that COVID-19 is a very deadly disease that kills a lot of people.
What Do We Know about the Vaccines Themselves?
SHARE Member: If I’m nervous about the new technology, is the Johnson & Johnson shot a good alternative? Is the technology of that vaccine more like the flu shot?
Dr. Kobayashi. In short: yes. It’s a great vaccine. It’s delivered in a single shot, which is great if you don’t like needles. Johnson & Johnson does have good brand recognition, so folks might take comfort in that. There is a slightly higher risk of blood clots with the J&J vaccine. The technology is more like the flu vaccine in terms of how it triggers an immune response. I don’t have any recommendation on one brand over another, though.
SHARE Member: What are the ingredients in the vaccines that use the newer technology?
Dr. Kobayashi: The mRNA vaccines are pretty basic in terms of the components. They contain the mRNA and lipids, the fats that carry the mRNA into the body. It’s a pretty basic formula compared to vaccines that carry the converted virus contents, and are a little more complicated. You can see the ingredients here.
Special Cases: Pregnancy, Long-COVID-19, and Historical Trauma
SHARE Member: What do we know about the vaccine’s impact on female reproduction? What should we make of the vaccine’s impact on menstrual cycles? What is the risk if I defer the vaccine until after I’m pregnant, trying to get pregnant, or breastfeeding?
Dr. Kobayashi: About pregnancy, some people have said, “Isn’t pregnancy a contraindication, a reason not to get the shot?” But actually, it’s the opposite. Pregnant mothers should get the vaccine. It’s protective.
I don’t know that there’s a clear correlation between disruption of menstrual cycles and vaccine. There are studies currently underway to investigate whether there is a linkage.
SHARE Member: If I’m pregnant, is there a better or worse trimester to get the vaccine?
Dr. Kobayashi: The data around pregnancy has been pretty clear. Getting the disease is far worse than getting the vaccine. Complications for the unvaccinated among those who get COVID-19 while pregnant are terrible including premature birth and severe COVID-19. 97% of pregnant patients getting COVID-19 in a recent study were unvaccinated. Based on the studies, you should get the vaccine as early as you can. The vaccine is also strongly recommended by the professional societies for OBGYN.
SHARE Member: With Pfizer and Moderna, what's the value of getting the second shot, especially if you've already got natural immunity from having had the disease itself?
Dr. Kobayashi: The studies used to approve the vaccines showed that the first dose was not sufficient to generate full protection, even if you have had the disease. The reason for that is because your body is built in such a way that when it’s already seen something, it provokes a much stronger response. In order to get that full effect, you really need that second dose.
SHARE Member: What do we know about long-COVID-19 and the vaccine? If I'm already experiencing some effects of long-COVID-19 (e.g., Postural Orthostatic Tachycardia), is there evidence that the vaccine might exacerbate those conditions?
Dr. Kobayashi: Long COVID-19 stimulates your immune system, and causes a lot of inflammation and symptoms around the body. We don’t have any evidence that the vaccine would exacerbate those symptoms. One of the things that’s been interesting about COVID-19 is that it causes a lot of inflammation in the body. We’ve seen kids get Multi-system Inflammatory Syndrome, for example. When you get the vaccine, you get an immune response, as opposed to the inflammatory response you get from the virus. The inflammatory response is exponentially higher from the disease. That’s what causes all those complications.
SHARE Member: Why does the hospital not provide an exemption for systemic racism or historical trauma related to medical science?
Dr. Kobayashi: We need to make sure there aren’t systemic barriers to getting the vaccine. I’ll take a leap and say I am assuming the concern here is about experimentation. People of color have been less likely to get vaccine. But if we were to say, “Okay, if that’s your reason, you don’t have to get it,” then I personally feel that we would be increasing disparities, not decreasing them. We’d be creating a double-standard that would perpetuate that inequity.
About the Federal Government Mandate
SHARE MEMBER: Has the hospital administration received any formal documentation from the federal government, OSHA, etc. that has formalized and validated the press release statements from Joe Biden, or are we operating these mandates under press-driven hearsay?
Dr. Kobayashi: The White House has released their mandate. That is what we’re working from, certainly not a press release. We’ve received guidance from CMS [Centers for Medicare & Medicaid Services], but the enforcement details are still forthcoming.
SHARE Member: There is not a federal law mandating vaccines. UMass is doing this under their own rules and OSHA has made no statement regarding vaccine mandates. Who has the authority to compel the hospital?
Dr. Kobayashi: The government has made clear its full intention to follow through on its mandate. The enforcement mechanisms haven’t been announced: will licenses be at risk? Fines? I don’t know enough about legislature to predict the details, but the government is enforcing this through CMS which is a mechanism that impacts all hospitals across the country.
SHARE Member: We’ve read that OSHA doesn’t direct the mandate in the healthcare settings, that non-compliant institutions will be fined or have Medicare/Medicaid withheld by the CMS?
Dr. Kobayashi: That’s right. Medicare & Medicaid makes this relevant to almost every healthcare employer in the country. Almost every healthcare institution gets funding through them.
About Flu Shots & Booster Shots
SHARE Member: Can I get the flu shot and the COVID-19 shot around the same time?
Dr. Kobayashi: The original guidance was wait two weeks between the vaccines before getting the other. That guidance has changed and you can get the shots at the same time. The commonly reported side effects of both vaccines are similar: headache, sore arm, etc., so you’re more likely to feel a little bad if you get them the same day. But there’s no medical reason you can’t get them at the same time.
SHARE Member: Can you talk about booster shots? Can I get one? Should I get one?
Booster shots have been approved for Pfizer and I expect the others to come soon. It’s been approved for immunocompromised conditions. Healthcare workers have also now qualified for a booster shot. We’re putting together a booster strategy at UMass Memorial. If you don’t want to wait, you can get it at retail pharmacies six months after your second dose. You can locate the sites on the vax finder on the mass.gov site. That’s a very different situation than when we initially gave vaccine back in January. They now have thousands of locations. I also want to be clear that UMass Memorial does not currently require a booster.
SHARE Member: If you get the booster, do we know how long it will be effective for?
Dr. Kobayashi: We don’t yet know when you would need a booster-booster. That information is being actively collected now. My question is: will this be something like a flu vaccine, something that we just get every year? Every year the flu is not the same. Epidemiologists try to predict the future and create the vaccine based on that prediction. We’re lucky that this vaccine is so effective against mutant strains.
Learn More
We’re publishing this first set of questions and answers which cover the most common and general questions from SHARE members to get information out as quickly as possible. More questions and answers will follow. If you would like to ask additional or follow-up questions to be answered in an upcoming SHARE blog post, please email share.comment@theshareunion.org
Please note, too, that the hospital will be hosting its own sessions to address caregiver concerns about the vaccine as they relate to race & ethnicity (Tuesday, October 19 at 4:30pm) as well as pregnancy & breastfeeding (Friday, October 22 at noon).