Monday, February 8, 2021

My Journey as a Clinical Trial Participant

    The COVID 19 pandemic has been trying for the entire planet and especially so for those working on the front line caring for those in the hospital. They worry that their patients may not live until the end of their shift. They talk to family members, sometimes with reports of their loved ones improving, too often to deliver the worst news. They’ve watched colleagues succumb to this disease, and sometimes have mourned the loss of their own. I have watched this with the luxury of being slightly off-sides. I work in a private practice, only having to occasionally round in the hospital. I see the stress and anxiety of my colleagues, worrying about their patients, their colleagues, whether there is enough PPE to keep them safe. My heart aches for them and I longed for a way to help make a difference for them, for those who survived this disease but will live with long term complications and those we have lost to it. Then, the opportunity to make a difference presented itself to me. I had the opportunity to enroll in a clinical trial for one of the COVID Vaccine candidates.

  
 
I live in New Jersey. I got my masters degree from Rutgers University. I used to do infections disease rounds in Robert Wood Johnson University Hospital, attached to Rutgers. And once again, I am a Rutgers student in their Doctor of Nursing Practice Program. When the university announced that they were seeking volunteers to participate in a clinical trial for the Janssen (Johnson & Johnson) vaccine, I jumped at the chance. All I needed to do was to fit it into my work/school schedule.

    I responded to an email sent out by the university and answered preliminary questions that the study team wound evaluate to determine if I were an appropriate candidate to participate in the trial at the end of October. On November 12, I was informed that I was approved for inclusion in the trial and I made my first appointment with the study team for December 3.

    The study team emailed me a copy of the informed consent form ahead of time to review. It was 35 pages long and very detailed. The email did state that a member of the trial team would be reviewing the whole form with me at my appointment. The trial participants would be followed for two years after receiving their injection. As with any randomized double blind placebo controlled study, neither I, nor the people at the trial site would know if I were getting a real vaccine or a placebo. With other vaccines on the verge of receiving emergency use authorization, I was well aware that by enrolling in the trial there was a very real chance that I wound not be eligible to receive another vaccine while participating in this trial, and again there was a 50/50 chance that I would get a placebo. Still, I was very excited to be a part of this process.

    On December 3rd, I pulled into the Robert Wood Johnson Hospital parking lot and made my way into the atrium. I was quite familiar with the building having done infectious disease rounds there for a couple of years. It was almost like coming home. I made my way to the research center and met a lovely nurse named Fey. We bonded over Star Trek (I as wearing my Starfleet medical insignia mask). She went over all the details of the consent form with me. She paid special attention to the part that talked about the one serious adverse event that had been documented with the vaccine in trail arm in Europe and made sure I was ok with continuing to proceed. I was, of course, still on board. We went over my complete medical history and current medications.

    Then I went into another room and my vital signs were checked, a Covid nasal swab was done and blood drawn. Next a nice young man came in and helped me download register on the trial participant app that I would use to track any symptoms I may have while participating in the trial.

    
Finally, I went to another room, sat in a recliner and another nurse gave me my shot. I barely felt a thing. I was told to wait there for the next 15 minutes for observation before I went on my way.

    A week later the Pfizer vaccine was approved for Emergency Use Authorization. Front line health care providers were first on the list. Since I occasionally do hospital rounds for vascular patients, I was on that list. BUUUUTTTT, I’m in a trial. What a conundrum! Well, I had decided to wait. I joined a Facebook group for people participating in various clinical trials. The question had come up and some frontline health care workers participating in trials for other vaccines reported that they had been unblinded so that they could get a vaccine and be protected, since they had the received a placebo in their trial. At my follow up visit I will ask what the study coordinators for my trial have in mind for us. I could of course drop out of the trial, but I’m hoping to avoid that as I entered the trial not to get a vaccine, but to contribute to the science. We’ll see what happens in a couple of weeks….


Lori Boyle, MSN, APN, CWS, WCC
Lori has been in nursing for more than 20 years. While in graduate school, she became aware of how many people were misunderstanding the science of vaccination and falling for misinformation. Since that time she has made it her mission to help people understand that the value and safety of vaccination as recommended, far outweighs the risks. In addition to Nurses Who Vaccinate she is also a member of Voices for Vaccines and the NJ Immunization Network.

Sunday, November 15, 2020

A NWV Nurse's First Hand Account of COVID Vaccine Trial

                I am a nurse, like many, working in the hospital during this pandemic. I see the weight nurses carry as we all continue to adapt to demands of hospital administration as we grapple with patient surges, short staffing, with no reprieve. As a strong supporter of immunizations and public health, active in volunteer groups such as Colorado Parents for Vaccinated Communities, the COVID vaccine is the only light I see at the end of the tunnel. When I saw the JANSSEN ENSEMBLE COVID vaccine trial needing volunteers, I became very interested in helping.

I never anticipated being a nurse in a pandemic. I never volunteered for a medical trial before the ENSEMBLE trial. But I have been working in the hospital during this entire pandemic, and thankfully, luckily, unbelievably almost, have not contracted COVID yet. Once I do, I would be ineligible for the study. I felt like I could not waste my health to miss this opportunity. I reached out via email, and had a health screening on the phone, followed by a pre consent phone appointment that lasted about an hour to ensure I understood my rights, the ethics and legalities of the study, as well as any risks. 

Next, I had an in person appointment in the clinic, where I had more consent discussions, nasal swabs, a pregnancy test, blood work, a physical exam, as well as training and education on the study process. It is a randomized, double blind study, so once it was determined that I was a candidate, I was randomized and the pharmacy made my injection, which had a 50/50 chance of being either placebo or the immunization. 

The next day, I felt crummy and woke up with a low grade fever, muscle aches, and soreness that improved toward the end of the day and resolved completely within 24 hours. I am hopeful this means I received the vaccine! I am in the study for the next two years, voluntarily and able to leave at any time. I have 5 visits in the first year, with 2 in the second year. I will be unblinded at the end, which could be sooner than 2 years. I have an app on my phone by IQVIA to monitor my symptoms and should I contract COVID, a home health agency is contracted with the researchers for extra support. Overall, it was a good experience and I am so glad that I was able to do it!




Elizabeth Brown lives in Colorado where she works as a charge nurse in Women’s Services and a clinical adjunct professor in nursing, while raising three children with her spouse, who is in the military. She is an advocate in all areas of her life- for her children, for her nursing students, for her patients, and for her fellow healthcare staff.  

Monday, October 19, 2020

Petrificus Influenzus! #FightFlu

It’s that time of year again! Time for what you say? Time for Nurse Lori’s annual Flu Vaccine Meme! This year I am channeling my inner Professor McGonagall, that calm and wise mentor to young wizards and witches. 

Muggle Please!
#GetYourFlooShot
#NursesWhoVax
#VaxWithMe
#FluFighter


We don’t need any fancy spells or incantations to protect ourselves and others from the flu. But we do need to follow some basic guidelines:

• Avoid close contact with people who are sick.
• While sick, limit contact with others as much as possible to keep from infecting them.
• Cover your nose and mouth with a tissue when you cough or sneeze. Throw it in the trash
after you use it and wash your hands.
• Wash your hands often with soap and water for at least 20 seconds. If soap and water are not
available, use an alcohol-based hand rub.
• Avoid touching your eyes, nose and mouth. Germs spread this way.
• Clean and disinfect surfaces and objects that may be contaminated with germs that can cause
respiratory illnesses like flu.
• For flu, CDC recommends that you (or your child) stay home for at least 24 hours after the
fever is gone except to get medical care or for other necessities. The fever should be gone
without the use of a fever-reducing medicine. The stay-at-home guidance for COVID-19 may be
different.
• In the context of the COVID-19 pandemic, local governments or public health departments
may recommend additional precautions be taken in your community. Follow those instructions.
And most importantly, the best potion for protection is your annual Floo Shot!

This year as with the previous three years memes (Wonder Woman, Danaerys Targaryen and
Princess Leia), my goal is to be fun and engaging and use familiar and fun characters to remind
people to do what they can to protect themselves and others from this devastating illness.
This year was more important for me to vaccinate against flu than ever before. CoVid19 has put
added emphasis on the need for flu vaccine this year.

As an adult/geriatric nurse practitioner, I lost more patients than I want to think about to CoVid19. Influenza circulating in the community on top of CoVid19 has the potential to be disastrous. So, ensuring that I, and those I love, and patients I care for are protected against flu is some of the most important healthcare work that I do.

This has become a tradition for me now and I hope to keep it up for at least a few more years,
as long as I have ideas and costumes!


Do you have a vaccine selfie you want us to share? Email us at NursesWhoVaccinate@gmail.com or tag us on social media! Find us on Twitter, Instagram, Facebook!




Lori Boyle, MSN, APN, CWS, WCC
Lori has been in nursing for more than 20 years. While in graduate school, she became aware of how many people were misunderstanding the science of vaccination and falling for misinformation. Since that time she has made it her mission to help people understand that the value and safety of vaccination as recommended, far outweighs the risks. In addition to Nurses Who Vaccinate she is also a member of Voices for Vaccines and the NJ Immunization Network.

Monday, May 11, 2020

Even in a Pandemic, We Cannot Forget the Importance of Routine Immunization

In the midst of the COVID-19 pandemic, we’re focused on this one, novel infection. It’s almost as if time has stopped and we’ve forgotten about the many childhood diseases that, thanks to science, we can prevent! Is it just me, or does it feel like flu season was eons ago? But it’s our job to remember.



During the school year, I’m a substitute school nurse for kids from K-12. I was shocked in September when I started seeing flu cases in many of my students. Multiple kids were coming into my clinic in one day with fevers and malaise, and I’d find out that whole families were later diagnosed with flu. I felt awful for these kids missing so much school and the cases continued to rise throughout the season. In fact, many of my close friends and their kids ended up contracting influenza this season.
To my dismay, of those I asked who had contracted influenza, most hadn’t received their influenza vaccine. People either don’t see it as a priority, or they have fears based on the massive amount of misinformation available online.

For years I worked in pediatric hospitals and one sound I’ll never forget is an infant struggling to breathe with respiratory illnesses such as influenza and whooping cough. My heart would break for the babies as well as the parents because nothing is worse than watching your child suffer. I always worried for the children we had to transfer to the Intensive Care Unit (ICU), knowing they may suffer long-term effects to their little lungs.

I know that we need to be concerned about more than influenza and whooping cough, too. Growing up, I never met anyone my age who experienced measles, whooping cough, mumps or any of the other vaccine-preventable illnesses that we’re starting to see reoccur today. I’m old enough to remember the torture that was chickenpox. I spent a good week bathing in calamine lotion and I still have the scars on my face to show for it. I’m actually looking forward to hitting the age where I can get the shingles vaccine!


Throughout this pandemic, we’re hearing stories of all sorts of vaccine trials but in actuality, a widely-available COVID-19 vaccine is likely years away. Experts are estimating that about 60%+ of the population will need to be infected before we can achieve herd immunity. Knowing this, you may be asking yourself if you even can bring your kids in for routine vaccinations.

I have an adorable 5-year-old boy and a 3-year-old girl. We’ve been fortunate enough since Florida’s safer-at-home order was implemented not to need to visit our pediatrician. We’re due for a well-check in the summer, and our doctor announced that they’re seeing routine/vaccine appointments in the mornings and sick visits in the afternoons. They’ve been great about keeping us updated on how they’re handling the pandemic. Because of their transparency, I trust that we have the ability to take the kids into their office if we do need to be there, even for routing exams and vaccinations. I encourage you to talk with your pediatrician to learn of their office hours and rules for seeing non-sick patients for routine visits.

In this scary, uncertain time, I can imagine that thinking about something as routine as childhood vaccinations may not feel like a priority. Just remember: What we’re going through right now with lockdowns, quarantines, and a lack of uncertainty, this is all due to just ONE novel disease in our community without herd immunity. Our lives have been changed, our kids aren’t going to school or having their normal play dates. And this is from just one disease where the community doesn’t have herd immunity. How much more awful and isolating would this experience be if COVID-19 been as contagious as measles? If this has taught me anything, it’s that we need to keep encouraging parents to keep their kids up to date on their shots. If you’re feeling powerless to protect your children right now, this is one small thing you can do to protect them and the public as a whole.

This guest blog has also been posted our partners Voices for Vaccines in honor of Nurses Week

Shannon Keever is a Certified Pediatric Nurse with a background in pediatric and maternity nursing. She is currently a substitute school nurse with a passion for educating families about children's health. When she's not working in schools, she enjoys spending time with her 3 children and husband at their home in sunny Bradenton, Florida. Shannon has been a member of Nurses Who Vaccinate since 2018. 

Monday, April 13, 2020

NWV Fights COVID-19 Misinformation




It is hard to escape the very serious situation that has been going on around the world these past few months and will likely continue for several more. To add to the actual medical problem are the rebound effects of social distancing and isolation. Humans by their very nature are social beings and remaining this isolated for this long is difficult even for the introverts of the world. One of the benefits of the 21st century in this regard is the internet and social media. It keeps us together in the virtual world despite having to remain physically apart. Social media and other healthcare related apps have allowed medical providers to implement telehealth to continue to see and treat patients without undue risk, allowed isolated nursing home residents to “visit” with family members and allowed government and medical institutions to rapidly disseminate critical information.

Sadly, along with the good comes the bad. There have been numerous posts on social media with incorrect, unverifiable information copied and pasted repeatedly. Often, they start with leading statements such as “From a Stanford Researcher” or “From a John’s Hopkins Infectious Disease expert”. Many offer ways to avoid infection with supplements, herbal remedies or alkaline diets. Some offer ways to prevent getting sick if you are exposed using gargling, specific diets or supplements, allowing a high fever to continue to kill the virus, etc.

We at Nurses Who Vaccinate are no strangers to the way in which misinformation can spread like wildfire across social media and often appear to be credible at first glance. We have been dealing with dispelling misinformation regarding vaccination for years and the way CoVid19 misinformation spreads is no different. Many who share these “copy/pasta” posts are well intentioned. People are concerned and some downright frightened by what they see on the news. They want to help and want people to feel like something is still within their power to fight this disease that is cruelly ravaging the world. What concerns us at Nurses Who Vaccinate is that sharing misinformation is at best useless, and at worst can cause harm by giving people false hope, avoiding appropriate medical care or direct injury by using non evidence-based remedies.



Please be wary of any posts on social media that claim to be from credible medical authorities without a link to the institution mentioned. DO NOT share any of them without verifying the source and the source’s source. We at Nurses Who Vaccinate promise to only share accurate, evidence-based information, from credible sources with citation to support them. If we do not have the answers at the ready, we do have access to numerous credible resources that can help us find accurate information.

As always, we encourage you to continue to vaccinate your children and yourselves as per recommendations from the ACIP and your physician. Now is not the time to skip vaccines as a measles outbreak on top of CoVid19 would be especially devastating

Below are several links to credible sites addressing some misinformation currently circulating on social media.

Coronavirus: Johns Hopkins Expertise- Coronavirus Myths, Rumors and Misinformation

WHO Coronavirus disease (COVID-19) advice for the public: Myth busters

Harvard University Health Publishing- Be careful where you get your news about coronavirus

CDC’s Coronavirus Disease Page - Facts about coronavirus disease

Our thoughts are with you all during this difficult time

Love to you all from 6 feet away,

Lori Boyle, MSN, APN, CWS, WCC
Lori has been in nursing for more than 20 years. While in graduate school, she became aware of how many people were misunderstanding the science of vaccination and falling for misinformation. Since that time she has made it her mission to help people understand that the value and safety of vaccination as recommended, far outweighs the risks. In addition to Nurses Who Vaccinate she is also a member of Voices for Vaccines and the NJ Immunization Network.

Thursday, October 3, 2019

Princess Leia Joins the Resistance to Fight.... the Flu

A long time ago in a galaxy far, far away...



It is a period of increasing flu activity.


Rebel forces, striking from local doctors offices and pharmacies, have won their first victory against the evil Galactic Influenza Virus.


During the battle, Rebel spies managed to vaccinate against the Virus's ultimate weapon, Influenza, a debilitating virus with enough power to incapacitate healthy people.


Pursued by the Virus's sinister strains, Princess Leia races home aboard her starship, custodian of quadrivalent vaccine that can save her people and maintain health in the galaxy...


There are a few things in my life that define me. I am a mother and a wife, I am a nurse, and I am a geek and a glutton for attention.  Several years ago I joined Nurses Who Vaccinate and became a fierce vaccine advocate, eventually having the honor of being appointed Advocacy Coordinator. I strive to dispel misinformation and help people understand the benefits of vaccination. But, I have to be me!

As a self proclaimed geek and attention glutton I probably have more costumes than a woman of advancing years should. It seems only natural to combine my passions! I recently began putting out an annual pop culture flu vaccine advocacy meme. This year’s theme is Star Wars, specifically Princess Leia. Leia is a leader, fighting to lead her people through difficult times. Sometimes she just knows that she just has to tell people like it is. That was what I was hoping to achieve this year. 

Tell it like it is. 

Flu can be deadly.

While the vaccine may not always prevent flu, it can reduce hospitalizations by 74% for children, 57% for the elderly, 79% for diabetics and 52% for those with chronic lung conditions. It can also protect newborns if the mother is vaccinated while pregnant

So listen to Leia. 




Roll up your sleeve flyboy! 

Get your flu shot! 

And May The Vax Be With You!


Lori Boyle, RN, MSN, AGPCNP-BC, WCC, CWS
Lori has been in nursing for more than 20 years. While in graduate school, she became aware of how many people were misunderstanding the science of vaccination and falling for misinformation. Since that time she has made it her mission to help people understand that the value and safety of vaccination as recommended, far outweighs the risks. In addition to Nurses Who Vaccinate she is also a member of Voices for Vaccines and the NJ Immunization Network.

Sunday, June 9, 2019

Measles in Hampton Bays: Why the Public Should Wake-Up and not Wake-Field

On Saturday, April 20, 2019, Suffolk County Health Officials confirmed that Hampton Bays residents were exposed to an individual with measles. This case was isolated from the outbreak in Rockland County, NY as the individual was briefly visiting the area from outside of the United States where he was exposed to measles.


The Rockland County Health Department has dealt with an eight-month outbreak leading to a total of 259 confirmed cases. Even more startling than the number of cases is the fact that more than 79% of those infected have not been vaccinated with even one dose of the Measles, Mumps, Rubella (MMR) vaccine.

The Centers for Disease Control (CDC) reports that from January 1 to May 31, 2019, 981** individual cases of measles have been confirmed in 26 states. The CDC states that this is the greatest number of cases reported in the U.S. since 1994, and since 2000 when measles was declared eliminated in the U.S. The resurgence of measles is no coincidence; the story begins with a fraudulent (and now unlicensed) doctor and ends with the public mistakenly believing that measles is just a “harmless childhood disease.” This couldn’t be further from the truth.


Dr. Bruce Farber, Chief of Infectious Diseases at North Shore University Hospital, delivered an important comment to Newsday regarding this measles case: “There are cases cropping up all over and the solution is vaccination… Measles is extraordinarily contagious. It is one of the most contagious, if not the most contagious infectious disease.”


Dr. Farber thankfully represents the majority of the public’s consensus that vaccinations are safe, effective and necessary against all infectious diseases in their aim to eliminate preventable suffering. While all vaccines recommended by the Centers for Disease Control are necessary to avoid public health outbreaks and global pandemics, MMR vaccination is quite possibly the most important public health initiative.


The measles virus, described since the 9th century, is a highly communicable infection of the nose and throat which spreads through coughing and sneezing and is airborne for up to two hours. The  CDC reports that “measles is so contagious that if one person has it, up to 90% of the people close to that person who are not immune will also become infected.” More than 92% of the population must be vaccinated against measles to maintain “herd” immunity against this virus which spreads like wildfire.


The misconception that measles is just a “harmless childhood disease” is dangerous; while measles can be a harmless infection for most, it can cause serious complications and even death. Measles can cause ear infections, diarrhea, pneumonia, encephalitis, premature births and low-birth-weight.

Measles kills one to two children out of every 1,000 infected. Perhaps the worse complication associated with measles is Subacute sclerosing panencephalitis (SSPE), a rare but fatal central nervous system disease which develops 7 to 10 years after a person has been infected with measles.

So how on earth did this misconception of measles being a “harmless childhood disease” come to be? It all started with the fraudulent activity of a former British Gastroenterologist, Dr. Andrew Wakefield, whose unethical behavior is likely to go down as one of the most serious crimes in medical history.


In 1998, Dr. Andew Wakefield and 12 colleagues published a case report in the British medical journal, the Lancet, which claimed that the MMR vaccine caused autism. The case study was fundamentally flawed, as proper consent was not obtained from the invasive testing that a small group of children underwent outside of medical facilities. Following Wakefield’s Lancet publication, numerous large-scale studies were conducted which profoundly refuted the link between the MMR vaccine and autism.


Shortly after the original publication in the Lancet, 10 of the 12 authors removed themselves from the
case study and the Lancet retracted the article in February 2010, admitting the failure to disclose the financial interests of Dr. Andrew Wakefield who was a paid expert for parents in litigation with manufactures of the MMR vaccine over claims that it caused their children’s autism. What’s more is that Wakefield was submitting a patent for his own version of the MMR vaccine. Based on all of his fraudulent activity, Dr. Andrew Wakefield was stripped of his medical license; he currently resides in
Texas and often contributes commentary for the anti-vaccine movement which has named him their
martyr. Andrew Wakefield just might be Public Health Enemy Number One, as every single measles
outbreak following his retracted publication has been linked to unvaccinated children.


The evidence in support of vaccinations is profound. Vaccines are the most studied medical
intervention, ever, and they have been proven to be safe and effective. There is no doubt that
vaccination programs are the key to preventing global pandemics. The MMR vaccine is safe and effective and families should refer to the CDC’s recommended schedule of vaccines and have a discussion with their provider if they have any concerns. If you are unsure of your vaccination status, please speak to your provider so that titers can be drawn to determine the potential need for additional vaccination.

“Scientists who publish their research have an ethical responsibility to ensure the highest standards of research design, data collection, data analysis, data reporting, and interpretation of findings; there can be no compromises because any error, any deceit, can result in harm to patients as well harm to the cause of science, as the Wakefield saga so aptly reveals. We sincerely hope that researchers will keep this ethical responsibility in mind when they submit their manuscripts...” 
--T. S. Sathyanarayana Rao and Chittaranjan Andrade, of the Indian Journal of Psychiatry


You can stay up-to-date about Rockland County’s measles outbreak here:
http://rocklandgov.com/departments/health/measles-information/

You can read the Newsday article which quoted Dr. Bruce Farber here:
https://www.newsday.com/news/health/measles-suffolk-county-1.30243740

You can read more about Dr. Andrew Wakefield here:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3136032/

Angela Daly is a Cardiovascular Research Nurse at Southampton Cardiology. She is also a Board Member for Nurses Who Vaccinate, a Long-Island based Non-Profit which aims to position nurses as strong public health advocates for their families, their patients, their communities and the world.


**Cases as of May 31, 2019. Case count is preliminary and subject to change.