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Johnson & Johnson COVID-19 Vaccine

On February 27, 2021, the Johnson & Johnson COVID-19 Vaccine has been Authorized by the FDA for emergency use. Which makes it the third vaccine to be authorized in the United States. The emergency use authorization was granted after 43,783 participants (18 years of age and older) with no evidence of prior COVID-19 infection were randomized to the vaccine group versus the placebo (saline) group. The trial was conducted in eight countries across three continents with a diverse and broad population. Overall, the vaccine was 66% and 67% effective in preventing moderate to severe/critical COVID-19 occurring after 2 and 4 weeks respectively. Moreover, it provided a 77% and 85% in preventing severe/critical COVID-19 occurring after 2 and 4 weeks respectively. Similar to the other vaccines, the most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea. It is still unclear whether the vaccine will decrease transmission of the virus. Additionally, the participants were only followed up for a median of 8 weeks, so long-term efficiency or safety is not available. One of the main advantages of this vaccine is that it is administered as a single shot.

In contrast to the Pfizer and Moderna vaccines which utilized messenger RNA. Johnson & Johnson’s vaccine used existing technology to add the gene for the COVID-19 spike protein to a modified Adenovirus. After receiving the vaccine, the body will be able to produce the COVID-19 spike protein to trigger the immune system to mount an immune response without causing the disease.

(Figure from Livingston EH, Malani PN, Creech CB. The Johnson & Johnson Vaccine for COVID-19. JAMA. Published online March 01, 2021. doi:10.1001/jama.2021.2927)

Although the Pfizer and Moderna Vaccines are very effective. Having an additional vaccine will accelerate the vaccination speed. Johnson and Johnson has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people. Additionally, Merck will be manufacturing this vaccine which will ramp up the production speed. So far, more than 50 million people have received at least one dose of the vaccine. It is expected that by the end of May 2021, vaccines will be available for the entire adult population in the United States. For the time being, we have to practice social distancing, wear a mask, and hope for the best!

References:

1) Livingston EH, Malani PN, Creech CB. The Johnson & Johnson Vaccine for COVID-19. JAMA. Published online March 01, 2021. doi:10.1001/jama.2021.2927

2)https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

3)https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

 

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A Roadmap for Understanding COVID Vaccines

Yes, we are still in the middle of the COVID pandemic. With the help of more people getting vaccinated and mask mandates in effect, a post-pandemic world is no longer a mere imagination. While waiting for the pandemic to be over, there are some doubts about whether the COVID vaccines should be cleared to facilitate a faster transition back to normal life.

  1.  What are the leading COVID vaccines?

    Figure: Overview of the diverse types of vaccines, and their potential advantages and disadvantages (Dong et al. 2020).

Currently, two COVID-19 vaccines are authorized and then recommended for use in the United States–the Pfizer-BioNTech COVID-19 vaccine(Polack et al. 2020) and the Moderna’s COVID-19 vaccine(Baden et al. 2020). Both of the vaccines used a cutting-edge technology, the messenger RNA (mRNA) vaccine which has been developed in the 1990s.

As of December 28th, 2020, three other COVID-19 vaccines are undergoing large-scale (Phase 3) clinical trials in the United States: AstraZeneca’s COVID-19 vaccine(Knoll and Wonodi 2021), Janssen’s COVID-19 vaccine and Novavax’s COVID-19 vaccine(Sadoff et al. 2021). Both the AstraZeneca COVID-19 vaccine and Janssen’s COVID-19 vaccines (Johnson& Johnson) used a weakened adenovirus vector strategy to tackle the spike protein on the SARS-CoV-2 virus. The weakened virus vector serves as a “Trojan horse” to deliver “information” to the cells in order to stimulate the memory of immune defense against SARS-CoV-2 virus. The adenovirus-based vaccines are relatively less foreign to the public, currently they are used against a wide variety of pathogens such as Mycobacterium tuberculosis, human immunodeficiency virus (HIV), and Plasmodium falciparum. The AstraZeneca COVID-19 vaccine has already authorized to use in Europe on January 12th, 2021 and possibly obtains approval in the United States early 2021. On January 29th, Johnson& Johnson announced its interim clinical Phase 3 trial results and a single-shot Janssen COVID-19 vaccine is on the way for FDA approval.

Novavax COVID-19 vaccine, a protein subunit-based vaccine, just announced its interim UK Phase 3 clinical trial results on January 28th, 2021. It shows promising protection to the SARS-CoV-2 virus, as well as the UK and South Africa variants. The company has already signed purchase agreements with many governments including Australia and Canada.

Two other vaccines– Russia’s sputnik V vaccine and China’s COVID-19 vaccine developed by Sinovac Biotech are also the lead runners in the vaccine race. The sputnik V vaccine which has obtained authorization to use in Russia back in November 2020, just published its Phase 3 data on February 2nd(Logunov et al. 2021). It’s an adenovirus-based vaccine, similar as the AstraZeneca COVID-19 vaccine and Janssen’s COVID-19 vaccine.

China’s COVID vaccine used a relatively well-understood technology: an inactivated SARS-CoV-2 virus. The inactivated virus vaccine approach has been implemented for a wide range of vaccines such as polio vaccine, hepatitis A vaccine, rabies vaccine and most flu vaccines. So far it received some inconsistent results from Brazil, Indonesia and Turkey and it’s not applicable in the United States. Overall, the efficacy is encouraging (50.38% to 91.25%) and requires more data to reach a more consistent result.

  1. How to understand the efficacy?

It’s a numbers game or is it? The high efficacy (95%) data released from Pfizer and Moderna at the end of last year received with great applause. The 70% protection starting after a first dose from AstraZeneca seems less impressive. The AstraZeneca COVID-19 vaccine confirms 100% protection against severe disease, hospitalization and death in the primary analysis of Phase 3 trial suggesting a total success. The recent Phase 3 trial results from Johnson& Johnson’s single-shot vaccine shows 72% effective in the United States and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination. The efficacy number simply cannot be interpreted as the higher the better. Like all of the clinical trials, compounding factors need to take into consideration. Their vaccine impact may depend on sex, age, genetics, geography, the timing of assessment of the end-point, the percentage of population affected by new variant compared to the original variant.

The thing matters the most is to reduce hospitalization and death. So far most of the leading vaccines have showed great promise. At the current stage, whatever vaccine is available to you could protect you from getting serious disease and prevent the virus spread to your loved ones one way or another. Herd immunity could finally be reached if enough people are getting vaccinated in the near future.

  1. mRNA technology: what is it? And is it safe?

Considering mRNA vaccine is the new kid on the block, it’s understandable that certain hesitancy and reluctance towards getting vaccinated. mRNA therapy has been developed and used to target certain types of cancer for more than twenty years. It has recently been used to target SARS-CoV-2 virus. The nucleic acid fragment of SARS-CoV-2 virus spike protein is packaged in a lipid nanoparticle. Like how most vaccine works, it tricks your body to formulate a defense memory using a small piece of information from the virus. When the actual attacks occurred, you are protected with a pre-programmed defense mechanism already. It does not change your DNA. It just helps your body to remember what it feels like to successfully combat the virus. Some of the side effects from clinical trials could be another reason to cause hesitancy. Don’t blame the messenger. The individual response elicited by the vaccines is just a small fraction of what you might experience when the real attack occurs. Some extreme allergic responses, a few reported in a million cases are rare. The chance is as similar as winning a Powerball or Mega Millions lottery. At the end of the day, the benefits still outweigh the risks.

  1. Early progress and new variants

Israel’s vaccination program shows encouraging outcome, results from a recently published preprint(Chodick et al. 2021). It’s in agreement with the Phase 3 clinical trial results from Pfizer. Data collected by Israel’s Ministry of Health shows a 41% reduction in confirmed COVID-19 infections in people aged 60 and order. Close to 90% of that age group has been administered with the first dose of Pfizer’s 2-dose vaccine. For people aged 59 and younger, the infected cases and hospitalization are also dropped.

Viruses like SARS-CoV-2 mutate all the time. There are 3 concerned variants: the UK variant (B.1.1.7), Brazil (P.1) and South Africa (B.1.351) have already been found in the United States. With the surge of new variants of SARS-CoV-2, the effectiveness of the COVID-19 vaccine also dropped. Some new data from Johnson& Johnson and Novavax suggest that the COVID-19 vaccines can prevent a lot of mild and moderate cases, and are still very effective against preventing hospitalization and deaths. Other company such as Moderna, has already developed booster shots to combat new variants. If most of the population got vaccinated, it will stop the virus’s replication and ultimately stop mutation completely. The recommended measure is to vaccine as many people as possible at current stage.

In conclusion, no matter which vaccine you got or are going to get, as long as it’s approved and authorized by the FDA, the chance of having effective protection is still very good. At the end of the day, the benefits outweigh the risks.

Reference

Baden, Lindsey R., Hana M. El Sahly, Brandon Essink, Karen Kotloff, Sharon Frey, Rick Novak, David Diemert, et al. 2020. “Efficacy and Safety of the MRNA-1273 SARS-CoV-2 Vaccine.” New England Journal of Medicine. https://doi.org/10.1056/nejmoa2035389.

Chodick, Gabriel, Lilac Tene, Tal Patalon, Sivan Gazit, Amir Ben Tov, Dani Cohen, and Khitam Muhsen. 2021. “The Effectiveness of the First Dose of BNT162b2 Vaccine in Reducing SARS-CoV-2 Infection 13-24 Days after Immunization: Real-World Evidence.” MedRxiv, January, 2021.01.27.21250612. https://doi.org/10.1101/2021.01.27.21250612.

Dong, Yetian, Tong Dai, Yujun Wei, Long Zhang, Min Zheng, and Fangfang Zhou. 2020. “A Systematic Review of SARS-CoV-2 Vaccine Candidates.” Signal Transduction and Targeted Therapy. https://doi.org/10.1038/s41392-020-00352-y.

Knoll, Maria Deloria, and Chizoba Wonodi. 2021. “Oxford–AstraZeneca COVID-19 Vaccine Efficacy.” The Lancet. https://doi.org/10.1016/S0140-6736(20)32623-4.

Logunov, Denis Y, Inna V Dolzhikova, Dmitry V Shcheblyakov, Amir I Tukhvatulin, Olga V Zubkova, Alina S Dzharullaeva, Anna V Kovyrshina, et al. 2021. “Safety and Efficacy of an RAd26 and RAd5 Vector-Based Heterologous Prime-Boost COVID-19 Vaccine: An Interim Analysis of a Randomised Controlled Phase 3 Trial in Russia.” The Lancet, February. https://doi.org/10.1016/S0140-6736(21)00234-8.

Polack, Fernando P., Stephen J. Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L. Perez, et al. 2020. “Safety and Efficacy of the BNT162b2 MRNA Covid-19 Vaccine.” New England Journal of Medicine. https://doi.org/10.1056/nejmoa2034577.

Sadoff, Jerald, Mathieu Le Gars, Georgi Shukarev, Dirk Heerwegh, Carla Truyers, Anne M. de Groot, Jeroen Stoop, et al. 2021. “Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine.” New England Journal of Medicine. https://doi.org/10.1056/nejmoa2034201.

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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To Vaccinate or Not Against COVID-19 During Pregnancy: A Pregnant Cardiology Fellow’s Humble Perspective

When news of the approval of the Pfizer vaccine surfaced, I felt a sense of anxiety. There was no data on pregnant women in the COVID-19 vaccine trials. As a medical professional, we have been trained to apply for evidenced-based medicine and baseline patient characteristics of trial participants to the patients we plan to treat. But what if your pregnancy status was not studied in the trial during a global pandemic? How might you weigh the unknown risks of the vaccine to your growing fetus with the risk of COVID-19 infection while pregnant?

Making the Decision

A few days passed when I received an email from Occupational Health that my cardiology fellowship program would be part of the Phase I distribution of the vaccine. The following day, my midwife conveyed to me that the OB department would align with the American College of Obstetrics and Gynecology (ACOG) Practice Advisory Statement:

“ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups.”

I felt a sense of relief that I would not be prohibited from getting the vaccine if I chose to do so yet also felt a sense of panic when I read the following:

“Vaccines currently available under Emergency Use Authorization (EUA) have not been tested in pregnant women. Therefore, there are no safety data specific to use in pregnancy.”

As a trained medical professional and protective mother, the overwhelming number of daily decisions we make to ensure the safety of our babies are overwhelming- no sushi, no wine, no retinoids or other harmful active ingredients found in our beloved skin care regimens, no hot tubs… I could go on.

However, the challenge of navigating the emotions of fear and uncertainty about the vaccine became incomparable to the following facts:

mRNA Does Not Alter Your DNA

These vaccines are not live virus vaccines and do not use an adjuvant to augment the efficacy of the vaccine. It does not enter the nucleus or alter human DNA.

Risk of Exposure

My job involves routinely interacting with patients and performing aerosolizing procedures, which places me at increased risk for exposure to COVID-19.

Symptomatic Pregnant Patients Infected With COVID-19 Are at Increased Risk of Severe Illness

This includes hospitalization in the intensive care unit (ICU), the need for intubation and mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and death.

I decided that getting vaccinated was safer than getting COVID-19. I also consulted with my partner who is also my husband and the father to our developing fetus. Although ultimately it was my decision to make, I felt comforted knowing he was 100% on board with me proceeding with vaccination based on the above as well.

Getting Vaccinated and the Side Effects

I received both doses of the Pfizer vaccine, the first dose at 20 weeks and the second dose at 23 weeks gestation. With the first dose of the vaccine, I only experienced arm soreness that peaked on day two. With the second dose, I experienced a mild headache and mild bilateral upper extremity soreness but with two doses of acetaminophen, I continued to work at full capacity and performed intraoperative transesophageal echocardiograms without issues.

I am now 25 weeks pregnant and feel a sense of pride that I made this decision to protect myself and my unborn child. I have received many texts and messages inquiring about how I made my choice. Questions such as “would your decision change if you were in your first trimester before organogenesis was complete?” or “would you get vaccinated while trying to conceive?” were a few memorable ones. I firmly believe it is your right as a woman to make this difficult decision when there is no safety data available.  Personally, yes, I would have still made the decision to vaccinate.

Lastly, I will join many of the other scientists and advocates out there who demand that pregnant and lactating women be included in future vaccine research trials http://vax.pregnancyethics.org/prevent-guidance. Track records of vaccine safety should exist for expectant mothers to help guide and improve vaccination rates.  Here is to hoping for a better year that allows each and every one of us access to the COVID-19 vaccine no matter what country, gender, pregnancy status, lact

ation, status, or employment status we bear.

Stay safe and stay healthy,

Kyla Lara-Breitinger, MD, MS

References:

https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19

https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.pdf

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

 

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COVID-19: Healthcare Workers vs The Vaccine

The mid-December rollout of two FDA-approved COVID-19 vaccines coincided with a surge in US infections, as we surpassed 21 million cases and 300k deaths. Amidst the hope for a recovery from the virus, that has captivated the world for the past 10 months, the vaccine rollout was met with stiff resistance from many Americans. Of these, healthcare workers comprise the largest group of those refusing vaccination (albeit, healthcare workers also comprised the majority of people offered the early doses). This theme has persisted over the past few weeks. I will review some of the ideas behind the refusal of vaccine acceptance.

First, the headlines (taken from Forbes):

  • Last week, Ohio Gov. Mike DeWine said he was “troubled” by the relatively low numbers of nursing home workers who have elected to take the vaccine, with DeWine stating that approximately 60% of nursing home staff declined the shot.
  • Joseph Varon, chief of critical care at Houston’s United Memorial Medical Center, told NPR in December more than half of the nurses in his unit informed him they would not get the vaccine.
  • Roughly 55 percent of surveyed New York Fire Department firefighters said they would not get the coronavirus vaccine, the Firefighters Association president said last month.
  • The Los Angeles Times reported that hospital and public officials in Riverside, Calif., have been forced to figure out how best to allocate unused doses after an estimated 50% of frontline workers in the county refused the vaccine.
  • Fewer than half of the hospital workers at St. Elizabeth Community Hospital in Tehama County, Calif., were willing to be vaccinated, and around 20% to 40% of L.A. County’s frontline workers have reportedly declined an opportunity to take the vaccine.
  • Nikhila Juvvadi, the chief clinical officer at Chicago’s Loretto Hospital, said that a survey was administered in December, and 40% of the hospital staff said they would not get vaccinated.

Distrust For The Government Among Black/LatinX

Frontline workers in the United States are disproportionately Black and Hispanic. It is no surprise to my readers, as mentioned briefly in my AHA recap article(s), that structural racism is (and has been) a pervasive force within healthcare. “I’ve heard Tuskegee more times than I can count in the past month — and, you know, it’s a valid, valid concern,” said Dr. Juvvadi. This forms the crux of the argument made by minority frontline workers against receiving the vaccine. A recent survey by the Kaiser Family Foundation found that 29% of healthcare workers were hesitant to receive the vaccine, citing concerns related to potential side effects and a lack of faith in the government to ensure the vaccines were safe. Furthermore, dissenters question the involvement of Black/LatinX participants in the clinical trials that led to the development and deployment of at least two FDA-approved vaccines at the time of this article. Dr. Juvvadi told NPR that “there’s no transparency between pharmaceutical companies or research companies — or the government sometimes — on how many people from.” In an op-ed published in the New York Times last week, emergency physicians Benjamin Thomas and Monique Smith wrote that “vaccine reluctance is a direct consequence of the medical system’s mistreatment of Black people,” exemplified by the unethical surgeries performed by J. Marion Sims and the Tuskegee Syphilis Study, that highlight “the culture of medical exploitation, abuse, and neglect of Black Americans.”

Altruism and Others More Deserving

Medicine is an inherently altruistic field, one that requires a dedication to the service and betterment of others. This theme has largely affected the sentiment concerning the acceptance of the COVID-19 vaccines. In an op-ed published earlier this week by Marty Makary MD MPH, a professor of surgery and health policy at the Johns Hopkins University School of Medicine, the case for delaying vaccination is made. Dr. Makary states:

“After a summer of corporate statements pledging that Black Lives Matter, America’s vaccine rollout is creating inequities stemming from a ruling class making rules to favor themselves. In the first two weeks after the FDA authorized the life-saving vaccine, hospital board members, spouses of physicians, cosmetic surgery receptionists, and young firefighters have been getting the vaccine ahead of our society’s most vulnerable. Low-risk Americans with access and power are cutting in the vaccine line and, by doing so, are essentially telling our society’s most vulnerable members ‘your life matters less.’”

Dr. Makary shares his experience as a physician who performs surgeries on COVID-negative patients in a sterile environment with the highest infection control precautions accounted for. Furthermore, he weighs his personal risk of having a complicated course of COVID-19 infection versus that of his elderly patients, many of whom have multiple comorbid medical conditions. He argues that low-risk healthcare workers, including those who have already been infected, defer their vaccination in order to allow for higher-risk individuals to receive a potentially life-saving intervention. This highlights the chasm in Medicine between altruism and self-preservation. Is it possible to do both?

I end with a quote from Dr. Makary, expressing his views on the matter:

“I’m not criticizing clinicians who get the vaccine — my personal decision might be different if I spent more time in the ICU, took more ER calls, or was at high risk of being a silent carrier of the virus, putting my patients at risk. But that’s not me. Given my very low personal risk of mortality and my very low risk of getting the virus in my clinical work, I have joined a growing chorus of healthcare workers who have taken a pledge to not get the vaccine until every high-risk American has been offered it first.”

Thank you for reading, and please feel free to reach out to me with comments or questions on Twitter @DrDapo.

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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The Inequity of the COVID19 Vaccine Distribution: The rich countries hoard vaccines while the poor countries struggle to get them

Last week at Cedars-Sinai, we received an email asking its employees interested in getting the vaccine against COVID19. I was very excited about this since it means a lot of things at once. The development of safe mRNA vaccines in a short period shows how much technology has advanced and highlights the importance of working together as the companies that manufactured the vaccines were not in a race against each other but against the virus. On the other hand, getting a notification that I was soon going to get vaccinated against this virus that has changed our world was pure joy, that sadly faded away.

As I told my friends and family the excitement that I was having because I would be vaccinated soon, all they did was ask me, but when are we going to get the vaccination for us? For our healthcare workers, grandparents, and grandmothers? We have heard in the USA with optimism how the government has secured millions of doses for its people, and it only makes sense that a government wants to put their citizens first but, at what cost? Where does the solidarity with other nations reside? These questions made me dig deeper into an issue that gets shadow by the hype of us getting vaccinated.

The People Vaccine Alliance, an international watchdog that includes Amnesty International, has warned that some countries have bought enough COVID vaccine to immunize their populations more than once. It highlights Canada as the top country on this matter that has reported over 400.000 cases of COVID19 has secured enough vaccinations to immunize its population at least five times. In contrast, poorer countries will only be able to vaccinate one in ten people. The Alliance data also showed that the deals that have been done between the governments and the eight leading vaccine candidates’ risk of leaving behind middle-low and low-income countries, as rich nations hoard on vaccine deals.1

A clear example of the disparity between the rich and the poor has been the Moderna and Pfizer vaccines’ inequitable deals, which have shown on their preliminary data to have the highest efficacy rate. Due to their promising results, the vaccine lots have been bought in a staggering 96% for Pfizer and 100% for Moderna by rich nations. With those impressive figures, the gap between the have and the have nots will stretch even further. The Director-General of the World Health Organization, Tedros Adhanom, warned during a press conference “Every government rightly wants to do everything to protect its people, but there is now a real risk that the poorest and most vulnerable will be trampled in the stampede for vaccines”.2

Nonetheless, international efforts have been made to achieve global vaccination, such as COVAX. This compact, composed of 189 countries, amongst which the USA and Russia resonate for their absence, has high and middle-income countries committing to provide funding to ensure access to vaccination and equitably manufacturing them. In contrast, poorer countries have signed to secure vaccines for their population. This effort will also be backed up by agencies such as the Bill and Melinda Gates Foundation.3 Efforts by the Oxford/Aztreneca are also of great importance to allow developing nations to get the vaccine, as they have pledged to five more than half of its doses to developing nations. Unfortunately, this would only reach 18% of the world’s population.4

I concur with Melinda Gates’s denomination of this phenomenon as vaccine nationalism, with the populist premise of “our citizens first,” that suffice its purpose of improving the polls for political gains. However, these actions go against one of the most powerful lessons this pandemic has taught us, the sense of community and working towards the benefit of all.

I firmly believe that vaccine allocation for a health crisis like this should prioritize global immunization for healthcare workers and elderly patients, rather than prioritizing country of residence or origin. It is not acceptable to have an effective vaccine, not reaching healthcare providers on the frontlines of developing countries fighting this virus without this indispensable weapon. In contrast, rich countries rely on an excess of vaccines and immunize low-risk citizens first.

This pandemic has shown us how fragile humanity. Now more than ever, the rich countries and their economic capacity must set an example of global leadership and outline a sensible policy that focuses on a global perspective rather than an exclusive, nationalistic one because this crisis won’t be over until everyone gets vaccinated.

 

References

  1. International. A and https://www.amnesty.org/en/latest/news/2020/12/campaigners-warn-that-9-out-of-10-people-in-poor-countries-are-set-to-miss-out-on-covid-19-vaccine-next-year/. 2021.
  2. https://abcnews.go.com/Health/rich-countries-hoarding-vaccine-report/story?id=74623521 A.
  3. https://www.cnn.com/2020/12/13/world/coronavirus-vaccine-developing-world-intl/index.html C.
  4. https://www.bbc.com/news/health-55229894 B.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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COVID-19 Vaccine: What We Need To Know

While we are living in the third peak of COVID-19 pandemic, we have been delighted to hear about the recent food and drug administration (FDA) approval of the COVID-19 vaccine, after trials involving hundreds or more of patients showed the vaccine safety and efficacy [1,2]. However, the COVID-19 vaccine is associated with some side effects, which in fact might be more common than the flu vaccine. Healthcare workers and first responders will have the priority to get the vaccine at many institutions given their high-risk work environment. So, I decided to share some knowledge about some of the side effects of the vaccine I recently read about and how institutions are planning to stagger the vaccines among their employees.

What are the side effects of the vaccine?

Side effects seem to be more common than the annual flu vaccine, with arm pain at the injection site, generalized fatigue and malaise, headaches, dizziness, fever, chills, nausea, vomiting, and diarrhea. Rare side effects include Bell’s palsy and temporary facial muscle paralysis. Most of these side effects are mild and resolve in a few days. These side effects occur more frequently after the second dose of the vaccine. These side effects actually suggest reactogenicity and that the immune system is responding to the vaccine [1,2].

Are there long-term adverse events of the COVID-19 vaccine?

This is still unknown and under close monitoring by FDA [1].

How will the vaccine change things from now on?

The COVID-19 vaccine is an additional protection layer, but it does not substitute the other protection measures we have been following; that means we should still conform to social distancing and follow hygienic instructions wherever we go till the pandemic is over. This pandemic has taught us all, as a healthcare professional and as members of the community, to be responsible for our actions toward each other and persist despite all the obstacles. The vaccine could be the first step that leads us back to “normal life” as long as we stay responsible for each other.

REFERENCES

[1] Walsh EE, Frenck RW Jr, Falsey AR, et al. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates [published online ahead of print, 2020 Oct 14]. N Engl J Med. 2020;NEJMoa2027906. doi:10.1056/NEJMoa2027906

[2] Yuan P, Ai P, Liu Y, Ai Z, Wang Y, Cao W, Xia X, Zheng JC. Safety, Tolerability, and Immunogenicity of COVID-19 Vaccines: A Systematic Review and Meta-Analysis. medRxiv [Preprint]. 2020 Nov 4:2020.11.03.20224998. doi: 10.1101/2020.11.03.20224998. PMID: 33173896; PMCID: PMC7654888.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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COVID-19 Vaccine & Cardiovascular Disease: What We Know So Far

It’s hard to believe the majority of 2020 was spent in a pandemic. The world came to a screeching halt and the entire scientific community worked tirelessly to find ways to keep each other safe. However, we all have experienced highs and lows due to COVID-19. But we were fortunate to have Operation Warp Speed to help produce and deliver millions of doses of safe and effective vaccines against the COID-19 virus.1

It is well known that traditional risk factors such as hyperlipidemia, hypertension, diabetes, and obesity are modifiable risk factors for coronary artery disease. Through the evolution of research, inflammation and infection were also discovered to play a role in developing an acute myocardial infarction (MI).2,3 After the epidemics of influenza in Europe and the US in the early 1900s, it was speculated that there is a relationship between influenza and MI. This was on the basis that excess mortality was due to other causes than influenza, such as heart disease.4 Mechanistically, influenza causes platelet aggregation leading to MI. This finding (along with others) led the American Heart Association and American College of Cardiology in 2006 to recommend influenza immunization as a part of comprehensive secondary prevention in persons with coronary and other atherosclerotic vascular diseases (class I, level B).5

Based on our past experiences of viral infections and the current pandemic-state, what emerged was that on November 20, 2020, Pfizer and BioNTech (the sponsor) submitted an Emergency Use Authorization (EUA) request to the FDA for an investigational COVID-19 vaccine. The purposed use under a EUA is for active immunization for the prevention of COIVD-19 caused by SARS-CoV-2 in individuals 16 years of age and older; with a 2 doses regimen, administered 21 days apart.1

There are many safety and side effects to discuss regarding the vaccine (any vaccine for that matter) but I’ll be focusing on the cardiovascular risk profile. The most frequent comorbidities were obesity (35.1%), diabetes (8.4%), and pulmonary disease (7.8%).1 Other baseline characteristics included: myocardial infarction (1%), peripheral vascular disease (0.6%), congestive heart failure (0.4%), and hypertension (24.5%).1

Of the serious adverse events, a total of 6 deaths (2 vaccines, 4 placeboes) from the total 43,448 participants occurred. Both vaccine recipients were >55, one experienced a cardiac arrest 62 days after the second vaccination dose and the other died from arteriosclerosis 3 days after the first dose. From the placebo group, only 1 patient died from an MI. Interestingly, 1 patient had ventricular arrhythmia but was known to have cardiac disease. Overall, there was no imbalance in severe adverse cardiovascular events. In general, serious adverse events were uncommon and represented medical events that occurred at a similar frequency in the general population.1

Some of the gaps from the safety reporting of the COVID-19 vaccine includes; duration of protection – as the participants are not more than 2 months out from initially receiving the vaccine, the et of immunocompromised individuals is too small to evaluate efficacy (i.e. heart transplant recipients ), children <16, and pregnant/lactating individuals.

Where does this leave us as leaders in the health community? We can recognize that the benefits do outweigh the risks and continued efforts will be made to monitor the health of Americans. At this point, I believe we can clearly communicate potential cardiovascular outcomes with our patients to help them make an informed decision.

References

  • Vaccines and related biological products advisory committee meeting. FDA briefing documents. Pfizer-BioNTech COVID-19 vaccine.
  • Epstein SE, Zhou YF, Zhu J. Infection and atherosclerosis: emerging mechanistic paradigms. Circulation. 1999;100:20-28
  • Syrjanen J. Infection as a risk factor for cerebral infacrtion. Eur Heart J. 1993;14:17-19.
  • Collins SD. Excess mortality from causes other than influenza and pneumonia during influenza epidemics. Public Health Rep. 1932;47:2159-2168.
  • Smith SC Jr, Allen J, Blair Sn, et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update. Circulation 2006;113:2363-72

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