We Asked an Immunologist Your Questions About COVID-19 Vaccine Safety

This content originally appeared on Beyond Type 1. Republished with permission.

By Lala Jackson

August 2021 is starting to feel like March 2020 – the COVID-19 delta and other emerging variants are more dangerous than the original virus, but what does that mean? Cases are rising rapidly, are we safe? Do we need to wear masks or not? Vaccines work, but do they for everyone?

To get some clarity, we spoke with Bernard Khor, MD, PhD, of the Benaroya Research Institute at Virginia Mason in Seattle, Washington. Dr. Khor’s laboratory is trying to find new ways to treat autoimmune diseases, specifically for people living with Down Syndrome as they are more likely to develop autoimmune diseases like type 1 diabetes. Because he spends so much time researching immune responses, we published his interview on whether type 1 diabetes means a person is immunocompromised and wanted to talk with him more about COVID-19 vaccine safety for people with type 1 diabetes.

Beyond Type 1: Are people with type 1 diabetes more likely to get COVID-19?

Dr. Khor: People who have autoimmune diseases aren’t necessarily immunocompromised; instead we can think of it as having a dysregulated immune system. That’s what causes the immune system to attack its own body. It does not necessarily mean that they don’t respond appropriately against infections.

What we do know is that, if they catch it, people with type 1 diabetes are more susceptible to worse outcomes from COVID. If it were my child or loved one living with type 1 diabetes, I would do everything I could to mitigate that risk.

What about the delta variant? How did we get here?

The delta variant and other variants we’re seeing start to develop are worse for everyone. These mutations happen because the virus has had time to persist and improve itself. If we were able to completely contain it, if everyone got the vaccines right now, we could stop this pattern by giving it nowhere to hide. But if the coronavirus is hiding in 30 to 40 percent of the population, it will come back and come back worse again and again. It’s just a matter of time.

That’s the thing about a virus – it’s not a one time threat. It’s an ongoing, adaptable threat. It’s a virus that mutates. It’s trying to survive. It can change and adapt to circumstances. There’s another variant coming out from Peru that’s getting more powerful – it’s affecting younger people, it’s leading to more rapid hospitalization, it’s a worse disease.

I cannot overstate how much COVID-19 needs to be respected. The writing on the wall was very clear from the beginning. We have seen outbreaks of diseases before and we have seen pandemics before. They are all agents that need to be respected immensely.

Other forms of coronavirus – SARS, MERS – were incredibly bad. In both cases we basically escaped worse outcomes because we got lucky; transmission rates of those viruses weren’t as high as COVID. Now we have COVID. We started off unlucky, and if we don’t respect it, it will get worse. It can cause death, it can cause disability, it can cause horrible outcomes. We’ve seen nursing homes decimated, it’s devastating.

We as scientists can make the best thing we possibly can, but it doesn’t matter if no one uses it. I see this as our generation’s World War event. We’re lucky that many of us are inside, that we have Netflix and ways to work from home. But the societal impact is every bit as serious.

Are people with type 1 diabetes more likely to have a particularly bad reaction to the vaccine?

All the data points to no. You’ll rarely hear a scientist say never—1 in millions is not never—but all the studies to date say no, and we can have confidence in that because there’s been a lot of post-marketing assessment of these vaccines. We have a lot of people who have taken the vaccines already worldwide to see how it’s working.

And that’s what we look at—the remarkably low rate of adverse reactions that are reported and tracked, versus the highly measurable rates of severe illness or death, or of long-term disability from long haul COVID.

What about the fear that vaccines in general can lead to new or more autoimmune issues? Can you explain the risk?

It’s a terrible thing to come down or have your child come down with a severe life-long illness. Type 1 diabetes is so diabolically difficult, and it’ll be different for different people. It’s a slog. So of course we want to know why it happens. Especially when you’re trying to find that important of an answer, our minds are programmed to look for patterns, but when you look from a single case, you’re only able to make the pattern from the single situation. Huge studies have uniformly debunked the idea that vaccinations commonly cause autoimmune issues.

That’s the benefit of our system – it’s very transparent. When there are adverse effects, we know about them. There are rare occurrences that have been seen; an example was a batch of flu vaccines in the 1970s, where several people came down with a rare autoimmune disorder called Guillain-Barré syndrome (GBS). Even in that instance, the risk of getting GBS was ten times less than the risk of death from flu. The cost benefit ratio is not even close.

Editor’s Note: There have been 100 reports of GBS among people who received the Johnson & Johnson vaccine, from approximately 12.5 million doses administered. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder. Whenever health issues like these do arise from vaccines, the FDA requires revisions to the information provided to vaccine recipients and healthcare providers so that they know about potential risks. No similar pattern has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines.

How can we trust vaccines that only have emergency use authorization (EUA) And are not fully approved?

Editor’s Note: Since this interview was published on August 10, 2021, the FDA has granted the Pfizer and BioNTech COVID-19 vaccine full approval for ages 16 and up, with the EUA still in effect for ages 12-15 and booster doses for immunocompromised individuals. 

I think it’s incredible that we have a vaccine ready as quickly as we did – that has been due to immense collaborative work from the entire global scientific community. That work happened because of the immense threat and impact of COVID-19.

In this case, scientists worked hard, building upon decades of existing research to make this thing work. In a sense, we also got lucky. We are so fortunate that these vaccines work as well as they do. We built this nice big shiny thing, now we have to walk on in. Because scientists can build the best possible solution and it means nothing if people don’t use it.

Lack of full approval—which we know is coming soon—is due to the fact that the FDA has a rigid and bureaucratic approval process. It’s not wrong. But it makes it very slow even once the medicine and science has been proven, as is the case with the COVID-19 vaccines we offer in the US.

But no corners have been cut—the data has been reviewed, the process has been transparent. Everyone understands the need for post-marketing surveillance, ongoing data from the vaccines as they are administered. No expense has been spared for that.

How do we know that people who take the COVID-19 vaccine won’t face health issues from it in twenty years?

I cannot think of a scientific mechanism to be worried about that. I do know that COVID is here and is a very real risk, right now. We fear the unknown; the fear of the known has become hard to remind people of. After more than a year, we’ve gotten used to the bear that’s in the house. We can get worried about how we’re dealing with the bear, or we can go ahead and get the bear out of the house.

We heard discussion a few weeks ago about the psychology of choosing to take the COVID-19 vaccine; that to humans, it’s scarier to face making a choice and something bad happening, like taking the vaccine and getting sick from it, and less scary if something bad happens to you passively, like getting COVID-19 when you are going about your daily life trying to be careful. It feels like less responsibility. What are your thoughts on this?

Choosing not to do something is as much a choice as doing something. It’s about the risk of not doing it, not taking the vaccine.

You can always be nervous about some infinitesimal risk of doing something, but there’s a true risk of not doing something in this particular case. And the risk is not just what might happen to you if you get COVID, it’s the risk of all the people you might pass COVID to, including grandparents and children.

Because it’s not a question of if you will be exposed to COVID-19, it’s a question of when.

Source: diabetesdaily.com

COVID-19 Vaccines and Diabetes: Vaccine Access Issues for People of Color

This content originally appeared on Beyond Type 1. Republished with permission.

By Kayla Hui, MPH

On April 21, 2021, the Kaiser Family Foundation released updated data that found that Black and Hispanic people received a smaller share of COVID-19 vaccinations when compared to their share of coronavirus cases and deaths. Throughout the pandemic, communities of color have borne the disproportionate burden of COVID-19, highlighting the importance of equitable vaccine access. Vaccine access is not only crucial for people of color, but for those with underlying medical conditions such as diabetes. When overlaid with disparities such as implicit bias, it creates a compounded healthcare issue for communities of color with diabetes.

Unfortunately, vaccine access for communities of color has been all but fair. In Arizona, Hispanic people have only received 14 percent of vaccines despite accounting for 40 percent of COVID cases and 31 percent of deaths. And in Michigan, Black people only received eight percent of vaccines despite comprising 23 percent of deaths.

“Because of long standing economic discrimination, communities of color are much more likely to find themselves in jobs where they can’t take off work without docking their pay. They have to work certain hours and aren’t able to get away for a vaccine appointment,” Michelle Andrasik, PhD, clinical health psychologist and affiliate assistant professor of Global Health at the University of Washington, tells Beyond Type 1.

Communities of color have an increased burden of COVID-19 for a variety of reasons including required exposure during work. For Black and Hispanic people, 24 percent were employed by service industries compared to 16 percent of whites. These industries include restaurant, hospitality, and retail work, all of which require people-facing interactions.

People of color are also more likely to live in multigenerational households and in densely populated urban areas and housing situations, further exacerbating coronavirus transmission. In urban counties across the U.S., people of color comprised 56 percent of the population. Additionally, data showed that four in ten Black people (41 percent), Hispanics (38 percent), and Asians (38 percent) lived in areas surrounded by multi unit residential buildings compared to 23 percent of whites.

Another driver of inequitable vaccine access is vaccine hesitancy due to broken trust in healthcare providers among communities of color. Mila Clarke Buckley, a diabetes and food blogger who created the Hangry Woman, was diagnosed in 2016 with type 2 diabetes–a condition where the body cannot properly use insulin. However, after months of failed medications and skyrocketing blood sugar levels, Clarke Buckley discovered—after taking an antibody test with an endocrinologist—she had type 1 diabetes. “I was misdiagnosed with type 2 diabetes which has given me a little bit of distrust in the healthcare system,” Clarke Buckley says.

Clarke Buckley is not alone in her experience. Phyllisa Deroze, a global diabetes patient advocate and blogger, shares that she wanted to get vaccinated, but did not want to be the first due to the legacy of the nation’s medical racism. “The field of gynecology in America was created on the wounds of Black women who were enslaved. And so there’s just really a long history in America of just not treating Black people like human beings and using them as experiments,” Deroze says.

Deroze was told by one healthcare provider that her electrolytes were off, which prompted her to ask her provider for an antibody test. But that provider was offended when Deroze asked to be tested for antibodies. “I was once again denied antibody testing. It was clear that the endocrinologist was offended by me even asking,” Deroze says.

Deroze was misdiagnosed twice for type 2 diabetes, once in 2011 and another time in 2018, albeit having type 1 diabetes. Her misdiagnosis led her to experience diabetic ketoacidosis. “My life was on the line. And that shouldn’t happen,” Deroze says. “If a person is diagnosed with type 2 diabetes, what is the harm in testing for antibodies just to make sure you’re treating the right condition?” It wasn’t until 2019 when Deroze was properly diagnosed with type 1 diabetes by her gynecologist

Clarke Buckley also recalls suggesting antibody testing on numerous occasions to medical providers. However, her idea kept getting shut down, putting her at risk for long-term complications as a result of untreated type 1 diabetes. These complications include: foot problems, urinary tract infections, eye disease, skin infections, heart disease, kidney disease, and even death. “It’s communities of color that are subjected to the system that essentially puts us at additional risk,” Clarke Buckley says.

Misdiagnosis of diabetes among people of color is not uncommon and is just one example of the bias of the medical system. Research shows that glycated hemoglobin (HbA1c)—a measure of average blood sugar over three months that can show evidence of diabetes—is not an adequate health measurement for all genetic ancestry groups. Particularly for African ancestry groups, additional screening may be necessary to diagnose diabetes. This leaves hundreds of thousands of African Americans with type 2 diabetes undiagnosed. Additionally, a high HbA1c measurement alone does not prove that a person has type 2 diabetes. It only proves that glucose levels are consistently high. Therefore, an autoimmune antibody test must be done to confirm or rule out type 1 diabetes. Because type 1 diabetes differs heavily from type 2 diabetes in that type 1 always requires insulin treatment, a misdiagnosis could be fatal and lead a person without insulin into diabetic ketoacidosis (DKA), a complication that occurs when the body does not receive enough insulin to break down glucose. DKA can lead to coma and even death.

Some states have made efforts to curb the unequal distribution of vaccines. For example, in Vermont, Black adults and other people of color were given priority status for vaccines. But despite these intentions, many state efforts have fallen short.

Kia Skrine Jeffers, PhD, RN, PHN, assistant professor at the University of California Los Angeles School of Nursing tells Beyond Type 1 that in California, the state distributed vaccine access codes to improve COVID-19 vaccine availability and access for hard-hit Black and Latino communities. “The special code that people of color could use to register to get the vaccine was being distributed among people who were not people of color,” Jeffers says. Instead, wealthier populations who work from home were misusing the system, the Los Angeles Times originally reported.

Anna Lopes, MD, family physician based in Southern California, explains that the underlying culprit of vaccine inequity is systemic racism. Lopes references the Tuskegee Syphilis Study, an ethically abusive study that failed to treat and inform Black men of syphilis in the 1930s and the forced sterilization of Puerto Rican women. “There was significant hesitancy in the Black community, and other communities of color, specifically because of institutional racism,” Lopes says.

Achieving Vaccine Equity

Jeffers suggests that to achieve health equity, health leadership must reflect and have representation from the communities they serve. “If you don’t have community stakeholders involved in the planning, then community perspective is often overlooked or underappreciated,” Jeffers explains.

In addition to having representation in health leadership, Jeffers and Andrasik add that equity involves recognizing and rectifying historical injustices and distributing resources like vaccines to populations that need it the most.

“What we have found in terms of access is that you really have to take the vaccine where people are. We have partnered with Black churches, community centers, and community organizations to open up vaccination sites,” Andrasik explains. “In doing that partnering, the vaccination sites then reach out to their local communities they have long standing relationships with.”

Still, people of color are struggling to access vaccines due to transportation, financial, language, and nebulous registration barriers. To achieve equity, Andrasik, Jeffers, and Lopes stress that states need to be more intentional with their vaccine rollout process to make equity intentional. “All of these access issues really create barriers that are easily mitigated when we really think outside the box and think about how we can do things differently, and in partnership with communities,” Andrasik says. Vaccine access for people of color with diabetes is just the first step toward equity.

Source: diabetesdaily.com

Diabetes + COVID Vaccines: What You Need to Know

This content originally appeared on Beyond Type 1. Republished with permission.

By Lala Jackson

COVID-19 vaccines are here. If you have diabetes and/or other underlying health concerns, you may have questions about timing, safety, and what to expect.

It’s important to remember that having well-controlled diabetes alone does not seem to put anyone more at risk for contracting the novel coronavirus, but other factors like older age, high-exposure employment, consistently elevated blood glucose levels, or other non-diabetes related health factors like obesity and hypertension may increase your risk of infection.

We also know that diabetes care itself is made far more complicated after contracting COVID-19 and protecting anyone with diabetes from getting COVID-19 is our ultimate goal. That’s why we encourage everyone with diabetes to get vaccinated as soon as possible.

Immediate side effects from the vaccines are similar to many people’s experience with the flu shot – soreness at the injection site, general muscle aches, some nausea, and tiredness. Some – but not all – people with diabetes are experiencing slightly elevated blood glucose levels. These side effects are typical, indicate the immune system is learning how to fight the virus, and go away within 24 to 48 hours.

Once you are able to get your vaccine, keep practicing safety measures. A vaccine protects you from severe outcomes from COVID-19, but it may still be possible to spread the virus to others. Keep wearing a mask and keep social distancing to help keep us safe until we’re all safe.

Want a deeper dive? Here’s everything you may want to know:

What Vaccines Are These?

In November 2020, Pfizer and BioNTech announced positive results from the conclusion of their COVID-19 vaccine clinical trials, quickly followed by Moderna. In February 2021, Johnson & Johnson’s announced the same.

Each has now been approved for use in multiple countries across the globe, with a few other vaccines rolling out on a country by country basis. Worldwide, more than 60 other vaccines are in various stages of clinical trials.

Each vaccine went through the standard three phases of clinical trials – Phase 1, where it is administered to a small number of people to show initial safety, Phase 2 to hundreds of people split into groups by things like age, ethnicity, and background to show how different types of people react to the vaccine, then Phase 3, in which it is given to tens of thousands of people, tested against a placebo. Because of the speed needed for development, both vaccines were approved to go through animal clinical trials at the same time as human Phase 1 clinical trials.

To be approved, the FDA requires the vaccine work in at least half of those who receive it. Early analysis from the National Institutes of Health independent data review board (DSMB) saw that 94-95% of those who received the Pfizer/BioNTech and Moderna vaccines in the trials became immune to the coronavirus. Johnson & Johnson’s vaccine showed 66% effectiveness against the virusMost importantly, all three vaccines provide significant protection against severe outcomes from the virus.

The Pfizer/BioNTech and Moderna vaccines are mRNA vaccines, a type of immunization that does not use the real virus in the vaccine, but instead employs a piece of genetic material to create antibodies against the novel coronavirus. Each of the mRNA vaccines requires two doses, given three to four weeks apart. The Johnson & Johnson vaccine is slightly different, which makes it easier to store and only requires one dose.

Other vaccines – different types of immunizations made by multiple companies – are currently in clinical trials with results expected early (and throughout) 2021. More than 50 vaccines are currently going through human clinical trials; in any trial where participants exhibit worrisome symptoms, the trial is paused and cannot proceed until any issues are corrected.

  1. More than 60 vaccines are under development worldwide. In the US, the three currently being distributed are from Pfizer/BioNTech, Moderna, and Johnson & Johnson, with some others being rolled out in certain countries.
  2. All three vaccines approved for emergency use in the US provide protection against severe complications or death from COVID-19. Each vaccine has a slightly different rate of protection against getting the virus at all, but each guarantees protection against the worst outcomes of the disease.
  3. The Moderna vaccine trials had a slightly more diverse participant group but both leading vaccine trials included participants from across races and ethnicities, age ranges, health conditions including type 1 and type 2 diabetes, etc. No specific populations experienced any major issues with the vaccines.

Do COVID Vaccines and Diabetes Mix Well?

People with diabetes in each of the vaccine’s trials have not reported major side effects (read this T1Ds experience in the Moderna COVID-19 vaccine trial). Overall, some clinical trial participants have reported mild side effects of the vaccines, much like how some people experience injection-site soreness, mild lethargy, a low-grade fever after other vaccines. These mild reactions some people experience after vaccines are typical and not cause for alarm – they are a result of the immune system going into action as purposely triggered by the vaccine, creating the ability to fight against the actual virus were a person to be exposed to it.

In the UK, two healthcare workers who received the Pfizer/BioNTech vaccine during initial general population rollout experienced severe allergic reactions for which they administered adrenaline autoinjectors. Both individuals had a history of severe anaphylactoid reactions for which they carry adrenaline autoinjectors anyway, so if you are a person who does tend to experience severe allergic reactions, it is recommended that you not receive the Pfizer/BioNTech vaccine at this time. Other vaccines may be better indicated for your use. If you do not have a history of severe allergic reactions, there is no reason to expect you will experience one from a vaccine.

Because of the mild symptoms experienced by some, it is important to stay vigilant about blood sugar levels for the first 24 to 48 hours after receiving the vaccine. The symptoms may impact your BG, so check your levels frequently, stay hydrated, and be familiar with your sick day routine. The mild symptoms you may experience after the vaccine are significantly safer and more easily managed than potentially getting COVID-19 itself.

As we currently understand, you are not more at risk to catch the novel coronavirus if you have diabetes, but if you do catch the virus, you may be more at risk for more severe complications from COVID-19, particularly if you have been experiencing consistently elevated blood sugar levels.

If you have specific concerns or worries, make sure you speak to a healthcare provider you trust (or keep tuning into Beyond Type 1 coverage of COVID-19 to hear from the healthcare providers we trust, like Dr. Anne Peters).

Read this T1Ds experience in the Moderna COVID-19 vaccine trial

Great, When Can I Get Mine?

While the vaccines rollout in the US started as a bit of a logistical mess, the process is finally starting to get more clear! As of March 31, the CDC classified all people with diabetes as part of priority vaccination groups, updating their previous guidance that only included type 2 diabetes. And as of April 19, the Biden administration has announced that all people aged 16 and above in the US are eligible for the COVID-19 vaccines.

The COVID vaccine rollout is being handled on a state by state basis, which has made finding vaccination appointments a bit tricky. Additionally, many states are falling short in equity – many vaccine appointments are only available online, and some states have limited and hard-to-get-to vaccine locations. If you’re trying to find a vaccine appointment, here are some recommendations:

  • VaccineFinder.org is a medical-professional vetted place to find a convenient vaccination appointment.
  • You can also look up your state health department’s guidelines. Each state generally has a special COVID-19 page where they then list out COVID-19 vaccine eligibility guidelines and locations. Many states have started working with local drug stores and pharmacies; if so, they are often linked to from the state health department website.
  • If it is unclear or you are unsatisfied with what you’ve found, go ahead and reach out to your healthcare provider. Particularly if you have a healthcare provider like an endocrinologist who helps you take care of your diabetes, they may have some insider information on how their hospital or practice is planning to distribute the vaccine. Remember to be kind and patient – healthcare providers are carrying an immense amount and they may not have an answer for you immediately.

What About Kids With Type 1 Diabetes (T1D)?

The Pfizer/BioNTech vaccine is currently approved for ages 16+; they also just requested clearance from the FDA to expand eligibility to ages 12 – 15. Initial COVID-19 vaccine trials were focused on the adult population – both because adults seem more susceptible to severe outcomes from COVID-19, and because trials for those under the age of 18 require a stricter review and approval process.

Starting in 2021 and beyond, more trials are including children so that they may be safely vaccinated against COVID-19 as well. Important to note is that children do not seem to be likely to contract coronavirus or have severe outcomes from the disease. However, as we’ve seen throughout the pandemic, disparities are abundant. Native Hawaiian, Pacific Islander, American Indian, Alaskan Natives, and Hispanic children have experienced significantly higher rates of infection than their peers. Non-Hispanic Black children with T1D who contract COVID-19 are four times more likely to also experience DKA.

So while generally children are less likely to contract the coronavirus, it is important to remain vigilant and continue practicing measures to protect everyone – like wearing a mask and social distancing – to keep everyone safe until we’re all safe.

Still Have Concerns?

Individuals have expressed some hesitation to personal vaccination for COVID-19. This is an understandable feeling – vaccines do not typically make it through development and approval this quickly.

Here’s what we know:

  1. The speed with which the vaccines were developed was unprecedented. However, the clinical trials these vaccines had to go through were strict and the reporting of their safety and efficacy had to be unequivocally proven and replicated. Three phases of clinical trials, including a Phase 3 with tens of thousands of participants, had to prove safety and effectiveness of the vaccines. Phase 3 of the clinical trials were also double-blind, meaning neither the trial participants nor the company that created the vaccine knew if participants were receiving the vaccine or a placebo. Data was reviewed by the National Institutes of Health independent data review board, and final approval for the vaccines must be provided by the FDA’s Vaccines and Related Biological Products Advisory Committee, composed of scientists who have no ties to the companies by which the vaccines were produced.
  2. The Moderna COVID-19 vaccine trial focused on creating a diverse trial participant group, knowing that this is vital to ensuring the vaccine works as intended across populations. 37% of the trial’s participants were from communities of color, which is similar to the US population. The Pfizer and BioNTech trial had less representation, and many of the ongoing trials are not reporting diversity numbers at all. It is vital that each and every trial not only focus on recruiting diverse – across age, race, ethnicity, health background, and more – trial participants to prove safety and effectiveness, but also proactively communicate the effects of their vaccines across groups.
  3. Black, Native (including Pacific Islander), and Latinx communities have been hit hardest by COVID-19 because of systemic and medical racism, with Black Americans dying from COVID-19 at twice the rate of white Americans. Ensuring equitable distribution of the COVID-19 vaccines is vital to work against the deep impact of systemic and medical racism, but this must be coupled with understanding distrust due to violent medical racism throughout the US’s history.
  4. We don’t know for sure what percentage of the population needs to be vaccinated in order to achieve herd immunity, but we do know that the more people who are immune to carrying or spreading the virus, the better. Those who are willing and able to take the vaccine are helping to protect everyone in their community.
  5. If, after doing research from reputable, science-based sources (we recommend science communicators like Jessica Malaty Rivera for easy-to-digest and accurate information), you are still not comfortable taking the vaccine as it becomes available to you, continue to practice safe health measures to protect yourself and others from the novel coronavirus. Until the majority of the population is vaccinated, we cannot rely on herd immunity. We must keep those most vulnerable among us safe until we’re all safe, practicing simple actions like wearing a mask and social distancing to do so.

2020 has been hard; at many times, scary and filled with grief. Working toward getting our communities safe and healthy is important for a multitude of reasons, and will take a united effort. Ensuring you have a plan for when you will get vaccinated once you can is vital to keep yourself and those most vulnerable among us safe until we’re all safe.

Source: diabetesdaily.com

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