WHY Florida’s New COVID-19 Vaccination Guidance Could Hurt Kids

This time, Time says it best. Posting this here for your review:

https://time.com/6156007/florida-covid-19-vaccination-kids-guidance/

via @Jamie_Ducharme and thank you to my friend, Dr Mobeen Rathore for standing up for the children of Florida!

Florida Surgeon General Dr. Joseph Ladapo sparked controversy this week by recommending against COVID-19 vaccination for healthy children—contrary to the advice of health organizations and plenty of data that suggest the shots are safe and effective.

Florida “is going to be the first state to officially recommend against the COVID-19 vaccines for healthy children,” Ladapo said at a roundtable on March 7.

Official guidance released the next day softened that stance somewhat, saying that “healthy children aged 5 to 17 may not benefit from receiving the currently available COVID-19 vaccine” due to their low risk of severe disease and the possibility of rare side effects. Parents of kids with underlying medical conditions should consult their pediatricians, the guidance says.

While the guidance does not prevent parents in Florida from vaccinating their children if they wish, some doctors fear it could have a chilling effect on a pediatric vaccine campaign that has already moved more slowly than experts had hoped.

“The Florida Surgeon General’s decision to recommend against COVID-19 vaccination for healthy children flies in the face of the best medical guidance and only serves to further sow distrust in vaccines that have proven to be the safest, most effective defense against severe COVID-19 disease, hospitalization, and death,” said Dr. Daniel McQuillen, president of the Infectious Diseases Society of America, in a statement.

Dr. Mobeen Rathore, past president of the Florida Chapter of the American Academy of Pediatrics and associate chair of the University of Florida Health Jacksonville’s department of pediatrics, calls Ladapo’s remarks dangerous. “Any time people in power…make a statement, some people will believe that,” he says. “This could result in some children dying.”

He recommends that pediatricians in Florida and elsewhere encourage vaccination among all patients who are eligible. “All children should be vaccinated,” he says. “This is the only way we’re going to get out of this morass of the pandemic.”

Read MoreMy Kids Can’t Get Vaccinated Yet, and I’m Barely Keeping It Together

Following the U.S. Food and Drug Administration (FDA)’s authorization of Pfizer-BioNTech’s COVID-19 vaccine for 5- to 11-year-old children last fall, the CDC recommended COVID-19 vaccination for everyone in the U.S. ages 5 and older, as did the American Academy of Pediatrics. However, just 26% of children ages 5 to 11 are now fully vaccinated. The vaccination rate for 12- to 17-year-old children is higher, at 58%, but that’s still well below the adult rate of 75%.

Reports from the Kaiser Family Foundation (KFF), which has tracked attitudes toward vaccination throughout the pandemic, suggest that many parents fear side effects and unknown, hypothetical harms of COVID-19 vaccines, despite numerous studies that have found both the two-dose series and the boosters to be safe and effective. “The younger the age group, the more cautious [parents] are in terms of proceeding with vaccination,” says Liz Hamel, KFF’s vice president and director for public opinion and survey research.

In February, KFF asked U.S. parents if they felt they had enough information about the safety and effectiveness of COVID-19 vaccines. Of parents with kids ages 12 to 17, 66% said they did, compared to 61% of parents with kids ages 5 to 11 and 43% of parents with kids younger than 5.

The hesitation is understandable among parents of very young children, given that vaccines have not yet been authorized for kids under 5 and the FDA recently delayed its review of Pfizer’s shot while waiting for more data. (Early indications suggest it is safe for young children, but there are outstanding questions about its efficacy.) Among older age groups, though, COVID-19 shots have proven safe “not only in research, but also in the real world,” Rathore says.

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee, says that much of the reluctance among parents stems from the belief that children—especially those without preexisting medical conditions—do not need to be inoculated because they are very unlikely to get severely ill or die from COVID-19.

That rationale came up during the roundtable at which Ladapo recommended against COVID-19 vaccination for healthy kids. Ladapo also mentioned a recent preprint study from New York, which found that, during the Omicron wave, vaccine protection waned more quickly among 5- to 11-year-old children than it did among older kids—perhaps because of the smaller dose given to the younger age group.

However, a CDC report based on data from 10 states (and published shortly after the New York study) concluded that differences between age groups could be explained by timing. Omicron, which is extra-contagious and better at outsmarting vaccines than previous variants, emerged shortly after vaccines became available for 5- to 11-year-old kids. While both papers found that vaccines get worse at blocking infections over time, particularly against the highly transmissible Omicron variant, the CDC report estimated that they were between 73% and 94% effective at preventing COVID-19 hospitalization.

That benefit alone makes vaccination worthwhile, Offit says. It’s true that kids develop severe disease much less often than adults, but exceptions happen. More than 100,000 kids have been hospitalized with COVID-19 since the pandemic began, according to CDC data, while others have developed complications including Long COVID and the inflammatory disorder MIS-C.

“When I was working in the hospital in the middle of December, we admitted 18 children that week,” Offit says. “Five of them went to the intensive care unit. If you can avoid that safely [through vaccination], then avoid it.”

Offit, however, doubts that Florida’s guidance will have a major effect on pediatric vaccination rates in the state or more broadly. It’s “a political statement” more than a public-health policy, he says, and most people have by now made up their minds about whether they plan to vaccinate their children. “I don’t know what people are waiting for, at this point,” he says.

But data show that at least some parents are still undecided. As of February, 10% of parents with 5- to 11-year-old kids said they were going to “wait and see” about vaccination, according to a recent KFF report. That suggests there is still some wiggle room—and anything that further confuses or concerns parents could sway them against vaccination, Rathore says.

One-on-one conversations with loved ones and trusted sources—which, for parents, often means their child’s pediatrician—can make the biggest difference in vaccine intentions, Hamel says. “One big question is, how do pediatricians interpret [Florida’s] advice and filter that to their patients?” she says.

On Twitter, several Florida pediatricians voiced support for vaccination. “As a Florida pediatrician I could not recommend the covid vaccine for eligible children more,” tweeted Dr. Chelsea Torres. “I am beyond myself as a pediatrician in Florida,” tweeted Dr. Lindsay Thompson. “This will have ripple effects on all vaccines and children will end up suffering and dying.”

Rathore says he hopes his colleagues ignore the guidance. “Anyone who cares for children, advocates for them, and stands for them,” he says, “would want them to get vaccinated and get protected.”

WHY Covid may be hardest on the kids

The last two years have been challenging for all and devastating for many. No one could have predicted that a virus reported in China at the end of 2019 would result in months of prolonged lockdowns, store and office closures, and virtual school for Americans. Though we have all been victims of this pandemic, there is a massive spectrum of impact across our country. While the adults slowly crawl out from under mask mandates and office reorganization, there is a growing concern that the kids have been left behind and many will continue to struggle to catch up. We do not yet know the final consequences of the pandemic on our children, but there are some early clues that what they have lost academically, socially, and psychologically may cause long-term damage.

In Nevada, where graduation rates were already lower than most other states but had been trending up, we saw a critical 1.3% drop from 2020 to 2021 (from 82.6% to 81.3%). Washoe County, where I live, reported a graduate drop of 2.6%. The 2021 class only had a year of pandemic to deal with. As we approach graduation day 2022, we are crossing our fingers and hoping that we have been successful in supporting our seniors through two years of off and on instruction.

On the other end of the spectrum, kindergarteners started this school year without the benefit of socialization through daycares and preschools. Teachers have been reporting a return to basics with this year focused on learning to sit in chairs and follow basic rules. Major analyses have shown that K-12 students finished last year up to five months behind in math and 4 months behind in reading compared to previous scores. Just when schools started to catch up again this year, the Omicron variant rolled in and disrupted things all over again.

Studies are beginning to roll out internationally showing decreased engagement and increased behavioral issues in K-12 kids. Rates of depression and anxiety were already growing prior to the pandemic. The isolation of lockdown and increased screen time has done nothing to improve this trend. In 2021, there was a 31% increase in teenage suicide attempts seen in our emergency rooms across the country. Add to this stress a lack of school psychologists– about one for every 5000 students in Nevada. Across the country, Maine is the only state that currently meets the recommendation of one professional for every 500 students.

Academic success requires both physical well-being and mental health support. In order to lift our students up, we must return them to school and their friends with strong bodies and minds. The good news is that due to the mental health crisis, there is now more attention being given and less stigma attached to having mental health issues. Everyone is talking about the deficiencies in services, and resources are slowly being directed to mental health. It will require our entire village to prioritize and contribute to the recognition and treatment of depression and anxiety for our kids and their caregivers.

On the physical health side, we have a long way to go, but the solutions are in reach. Early on in the pandemic, children only made up about 4% of all Covid cases with minimal hospitalization and almost no reported mortality. We now know that children were protected against the early strains due to differences in their innate immunity. Unfortunately, mutations have created new strains that are now defeating the pediatric immune system. We are now seeing an increase over the last surge with kids making up 25% of all new cases. Over 12 million children have now tested positive with most of these in the last few months. Children remain vulnerable to post-Covid disease like MIS-C (multi-system inflammatory syndrome) and long Covid which both result in disruption to physical and mental health.

Vaccination, masking, and testing programs have been proven this year to be effective methods of keeping kids in school and healthy. We now have examples of school districts who focused money and resources on vaccination and testing and survived this year without school closures. Adults have protected themselves — over 85% of Americans over age 18 have received at least one vaccine dose and 74% are “fully vaccinated”. We have not done so well by our children, however. Only about 56% of 12-17 year-olds and 23% of 5-11 year-olds are fully vaccinated as of February 2022.

A study in Pediatrics in January 2022 found that kids most at risk for severe Covid are those with chronic disease, obesity and diabetes. If we can at least start with protecting our most vulnerable with vaccination, then we will be making progress. I encourage everyone to pay attention to our little ones, promote increased services and resources for children and schools, and do what you can to protect our kids before they become the next “lost generation”.

Picture credit: Allen J. Schaben Los Angeles Times via Getty Images

References:

https://www.npr.org/sections/health-shots/2021/01/28/960901166/how-is-the-covid-19-vaccination-campaign-going-in-your-state

https://www.census.gov/library/stories/2021/12/who-are-the-adults-not-vaccinated-against-covid.html

https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html

https://publications.aap.org/aapnews/news/19048

https://www.cdc.gov/media/releases/2021/p0924-school-masking.html

https://www.kqed.org/news/11851837/sfs-in-person-learning-hubs-had-zero-covid-19-outbreaks-what-does-this-mean-for-reopening-public-schools

https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12-guidance.html

WHY do some people get long COVID?

As if it isn’t bad enough to get sick with COVID (caused by the SARS-CoV-2 virus) and have to take a few days off work or school, more and more people are reporting ongoing symptoms lasting for weeks and even months. These symptoms can range from body aches to fatigue, chronic cough, “brain fog”, loss of taste and smell, and heart problems. This is being called “long Covid” in the press, or post-acute sequelae of Covid (PASC) by physicians. With the big volume surge of Omicron, I am predicting that more people will be diagnosed with long Covid in the next couple months.

First of all, if this is happening to you right now — YOU ARE NOT CRAZY! Many of these symptoms are noted in other autoimmune and poorly researched diseases like chronic fatigue syndrome, fibromyalgia, and POTS (postural orthostatic tachycardia syndrome). Many of us in medicine have been skeptical of these diseases in recent years, but I am ready to stand corrected. Something about the Covid virus seems to be setting off our own immune systems and causing many inflammatory and autoimmune-type diseases. As I have said before – it’s not always the cancer that kills you, but often the chemo. Same with Covid – it’s not always the virus, but instead, your body’s reaction to it, that makes you sick. Yes – that means that in the end, the cancer and the Covid started everything. But some of us respond differently to the initial insult than others. Some reports state that 10-30% of people who get infected with Covid will experience chronic symptoms. This equates to about 15 million people in the US and even more globally. The average age of these patients, according to the CDC, is 40 years old.

So why do some of us get so sick while others just get a runny nose? Researchers are currently scrambling to figure this out. Hot off the presses this week is a study published in the journal, Cell (all references below), that is proposing that there may be four factors that put some people more at risk for long Covid than others:

  1. Having type 2 diabetes
  2. Having EBV (Epstein Barr Virus – causes “mono”) in your system – either a recent infection or reactivated one when you are sick with Covid
  3. Having a high viral load at time of Covid diagnosis – most of us just test positive or negative, but labs can determine your “viral load” on a PCR test, if requested
  4. Having a strong autoantibody response to Covid infection – the strongest factor of all of these

Obviously, there is nothing that you can control about any of these things. It is what it is. If you have type 2 diabetes, or have a family history of autoimmune disease, you may be more at risk for more chronic symptoms. What is interesting about this study is the new understanding that if you have a patient with this underlying risk factor, and you then make the effort to measure their viral load at time of diagnosis, then you may be able to recognize an “at risk” patient. Or maybe we need to measure everyone’s viral load (not just those with autoimmune disease) and their autoantibody levels to determine if they are “at risk”.

The next research question could then be: what if your “at risk” patient was then able to receive additional therapies to decrease their risk of chronic infection? We have yet to do the outcomes research (study of the data) on this, but I can only imagine the impact that long Covid is having on individuals, their families, the companies they work for, and the national economy. As of this month, over 100 million people worldwide and over 15 million in the US have been reported with and are being followed or treated for long Covid. This number likely underestimates the actual number as not everyone is seeking care for their symptoms. 15 million people who are previously young and healthy suddenly having symptoms that disrupt their ability to work or care for their families is a devastating blow to our workplaces and households. The financial impact of this must be compared to the cost of lab testing of patients at time of diagnosis and providing them with novel therapies. My guess is that we could save a lot of money at the local and national level by determining and treating “at risk” patients.

Of course, the treatment of long Covid is still being researched and trialed. There are teams treating long Covid patients with everything from vitamin supplements to Covid vaccines to monoclonal antibodies. There has been some research that shows that with or without treatment, long Covid symptoms are improving after three to four months. Other studies show a much longer duration of disability.

Per the CDC: As of July 2021, “long COVID,” also known as post-COVID conditions, can be considered a disability under the Americans with Disabilities Act (ADA). Learn more: https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/guidance-long-covid-disability/index.html#footnote10_0ac8mdc

References:

https://www.cell.com/cell/fulltext/S0092-8674(22)00072-1

Logue JK, Franko NM, McCulloch DJ, et al. Sequelae in adults at 6 months after COVID-19 infection. JAMA Netw Open 2021;4(2):e210830-e210830

https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html

New journal on PASC: https://www.medrxiv.org/content/10.1101/2021.11.15.21266377v1.full.pdf

https://www.webmd.com/lung/news/20211118/millions-worldwide-long-covid-study

WHY is Omicron an issue for kids?

With so much information coming out every day, I have started this blog multiple times and had to immediately give up as something new hit my Twitter feed. I don’t believe that there is any reason for me at this point to educate about Omicron as so much has been posted and argued over already. Instead, today, I would like to summarize a couple of my own opinions and important facts, and leave you with a list of media reports that can help to answer specific questions. I have been grateful to be interviewed for many of these — grateful for the opportunity to share important information and hopefully help parents, schools, and physicians make good decisions for our kids.

First of all… this is what I know:

— Omicron is much more contagious than previous strains, so masks are even more important to protect you as you walk by strangers inside or outside.

— Omicron is a big problem for two specific populations: hospitals (due to the sheer volume of infections) and the un/undervaccinated.

— Omicron is getting into our bodies differently and causing a different type of infection than previous strains. Delta went directly to your lungs and caused a “pneumonitis”, or inflammation of the lungs that was difficult to treat. Patients experienced respiratory failure and often ended up on ventilators. Omicron is causing some upper airway inflammation — this means, congestion, sore throat, slight cough, maybe headache and body aches. Even for those of us that are vaccinated, we can experience many of these symptoms, but we are protected from severe disease and hospitalization. The unvaccinated and undervaccinated are still at risk for severe disease — mostly the high risk immunocompromised and elderly population.

— The first two vaccinations appear to offer some protection, but people who have had a third (“booster”) shot have the best protection against severe disease.

— Even though the sheer numbers of children testing positive for SARS-CoV2 is much higher with Omicron than previous strains, kids continue to fare better than their adult counterparts. Yes, there are more kids being hospitalized. Yes, some of these kids are even ending up in the ICU. Many of these kids, however, are coming into the hospital for different reasons (wintertime is always busy in the PICU) but end up testing positive for COVID. Most of us in the PICU are not seeing the high numbers of acute illness that we were worried about.

— I believe that keeping our children in school is absolutely crucial to their academic potential and emotional health. This pandemic has been unprecedented in the damage it has done to our school age kids — from preschool through college. We are already seeing standardized testing scores fall and mental health admissions surge. Our children deserve to be the focus of ongoing intervention, funding and protection. Otherwise, this will truly be a “lost generation”.

— Each district and school will need to make individual decisions based on support available from their state, county, and community. County supervisors and principals will need to make decisions for their schools based on testing available, space available, and staff available to carry out local mandates. There are school districts who have prioritized aggressive testing (i.e. LA County, SF) and have had very low levels of positivity and almost no school closures or virtual classes required. There are other counties, like mine, who are doing their best but do not have the resources to routinely test. These schools have been more likely to see higher numbers of infections and have more often had to transition to virtual learning.

— The pediatric COVID vaccine is safe. Millions of children have received the vaccine with incredibly low reports of side effects with the lower dose given. However, only 17% of children 5 – 11 years old have been vaccinated nationally (14% in my area, Washoe County). If we can support and educate and promote pediatric vaccination, then schools will stop being a focus of controversy and instead return to centers of learning and socialization. Kids will be able to take their masks off and be kids together again.

— Politicians and political parties have created a black and white spectrum of truth and lies with both sides exaggerating at times to make their points. The truth is usually in the gray. Educate yourself and listen to the science. Ask a doctor, if you know one, to answer your questions. If you don’t know one, feel free to ask me! I will continue to do my best to post the latest science and research in the most unbiased way that I can.

Those are my thoughts today.

I offer more information through these recent media stories:

Good Morning America — I was interviewed by reporter Katie Kendelan about isolation and quarantine for kids with COVID infection or symptoms, Jan 14, 2022: https://www.goodmorningamerica.com/wellness/story/pediatricians-answer-parents-questions-covid-19-isolation-testing-82250739

Low rates of vaccination in kids, Jan 12, 2022, PBS news: https://www.pbs.org/newshour/nation/covid-19-rates-for-children-are-low-experts-say-parents-are-taking-an-enormous-risk

Healthline, Jan 6, 2022 — Julia Ries (@namesjules) on how Omicron is affecting kids:

From Asher Lehrer-Small (@small_asher) in the 74 (@The74) on school issues: https://www.the74million.org/ask-the-doctor-navigating-the-new-math-of-omicron-in-schools/

Medpage today, Jan 12, 2022 — excellent interview with Dr Paul Offit (CHOP, Peds ID) by Emily Hutto (@EmAndEdits): https://www.medpagetoday.com/publichealthpolicy/healthpolicy/96635

Official updates to CDC guidelines on when to isolate and quarantine, Jan 13, 2022:

Parents magazine, Dec 2021 — What Parents need to know about Omicron by Nicole Harris:

Side effects of Covid vaccine for kids in VeryWell Family, Nov 2021 by Wendy Wisner (@WendyWisner): https://www.verywellfamily.com/what-are-the-side-effects-of-the-kids-covid-vaccine-5209790

References:

https://www.cdc.gov/coronavirus/2019-ncov/variants/omicron-variant.html

https://www.theatlantic.com/health/archive/2022/01/should-teens-get-booster-omicron/621222/

https://www.reuters.com/business/healthcare-pharmaceuticals/jj-booster-85-effective-against-omicron-1-2-months-safrican-study-2022-01-14/

https://www.medicalnewstoday.com/articles/covid-19-mrna-booster-vaccine-offers-best-protection-against-omicron

https://www.nytimes.com/2021/12/28/health/omicron-kids-hospitalizations.html

https://www.usatoday.com/story/news/health/2022/01/13/hospital-bed-shortages-covid/9176531002/?gnt-cfr=1

https://www.npr.org/2022/01/03/1069907437/officials-are-determined-to-keep-schools-open-despite-omicron

Picture credit: https://acs-h.assetsadobe.com/is/image//content/dam/cen/99/44/WEB/09944-leadcon-variant-new.jpg/?$responsive$&wid=700&qlt=90,0&resMode=sharp2

WHY will the COVID19 vaccine for babies take longer to be released?

Two posts from me this week as so much information is rolling out about vaccines and variants. First of all, let’s look at the news this week that vaccines for our smallest little people will be delayed. Why is this?

In testing vaccine doses and regimens for children ages 6 months to 5 years of age, researchers have found that the level of immune protection granted by the two-shot interval tested in older children and adults is not as high as expected. In order to understand this, let me step back and review where we are at this point with vaccine intervals and boosters.

In the rush to roll out a safe and effective vaccine for adults last year, initial studies revealed excellent efficacy in study participants after two doses of vaccine. The initial group of adults given 2 doses of either Pfizer or the Moderna vaccine had over 90% protection against moderate to severe disease from COVID19. Whereas many of our traditional vaccine series require a three-dose regimen, there was some excitement around the data showing excellent protection after two shots. There was no time to wait an additional six months to see if there was additional protection with a 3rd booster dose. It was more important to protect our population as quickly as possible and release the vaccine series.

Ongoing studies over the past year have now shown that the effectiveness of the vaccine and protection it provides has decreased. Vaccinated people continue to be protected from severe disease (hospitalization), but breakthroughs with mild to moderate symptoms continue to increase over time. Most of us are not surprised by this. This is consistent with what we see for other vaccine series, i.e. the first two Hepatitis B shots are given a month apart followed by a booster six months later to fully protect against Hepatitis B infection. As we have gained more experience, collected data, and vaccinated billions of people (8.5 billion doses given worldwide as of today), we now know that a third dose given six months after the second dose increases our immune response to the COVID19 virus. This is why a booster shot is now recommended for everyone in our country over the age of 16 (approved Dec 9, 2021)—references below. Adults over the age of 18 years should receive either a Moderna or Pfizer vaccine – mixing and matching is approved and should be guided by your physician and individual health concerns/risks. For 16-17 year olds, only the Pfizer vaccine is approved as a booster. A full dose of Pfizer is given as a 3rd dose, whereas a half dose of Moderna is used as a 3rd dose.

The adult dose of Pfizer-BioNTech vaccine (Comirnaty) is 30 micrograms (mcg) and has full approval from the FDA (August 23, 2021). The pediatric dose of Pfizer was recently approved for emergency use (EUA) on October 29, 2021. Pfizer and BioNTech have recently asked the FDA to fully authorize their vaccine for 12 to 15 year olds. This dose is 10mcg given in a two-dose series. In studies of this dosing regimen reviewed by the CDC and FDA, this series is 90.7% effective at preventing COVID19 infection. It is too early to say if these kids will need a third shot, but my guess is that they will – similar to the adult population and the other vaccines that they receive.

In the background, studies have been ongoing (by Pfizer) to evaluate a safe and effective dose for smaller children – ages 6 months to 5 years of age. These studies have been carefully done due to the variety of weights and vulnerability of these small children. We have heard that a 3mcg dose has been tested in this population, and we were hoping for approval and release of this vaccine in January 2022.

This week, we had some updates from the researchers involved that this two-dose regimen has not been as effective as the others. This is tested by drawing blood from the children given the shots and testing their antibody response post-vaccine. In the 6-month to 2-year-olds tested, there was a good level of immunity produced (data reviewed by internal board, not yet released to the public). However, in the 2- to 5-year-old population, the expected/necessary level of immunity was not seen. Because of this, a third dose has now been added to the vaccine series for this age group. This means it will take additional time to see the outcomes and safety profile of this full series, delaying further review and approval. The last I heard, they are hoping for release in “the first half of 2022”.

One other update for everyone — the CDC has now received 8 reports of myocarditis in 5 to 11 year olds after receiving the Pfizer vaccine. I will update again when more information is released, but the CDC has said that these cases were mild and reported at time when over 7 million doses had been given. Please see my previous posts about post-vaccine myocarditis which discuss this risk, usually in young men.

I fully recognize that parents of young children are absolutely disappointed that they will have to wait longer to protect their kids. However, I am grateful that the researchers are taking the time to get this right and make sure that if we are going to put shots into the arms of our kids, that this shot will be the right dose and interval to protect them.

I hope this helps to clarify some of the confusion around pediatric shots. Please leave me comments if you have any other questions about this (I’ll do my best!) or ideas for further posts – I love hearing from everyone. I will continue to do my best to keep up on the news and research and provide clear summaries on this information in the most nonbiased way that a physician can! Be well!

Photo image credit: UNICEF/UNI346553/Karahoda

References:

https://www.cdc.gov/media/releases/2021/s1208-16-17-booster.html

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

Data that 3rd dose increases immunity: https://www.nejm.org/doi/full/10.1056/NEJMoa2114255

Difference between “booster” and “additional dose” language: https://www.muhealth.org/our-stories/covid-19-vaccine-what-you-need-know-about-third-doses-and-booster-shots

Failure of smaller doses in smaller children: https://www.cnn.com/2021/12/17/health/pfizer-vaccine-children/index.html

Omicron info for parents:

Getting flu and COVID19 vaccine for kids: https://www.forbes.com/sites/leahcampbell/2021/10/31/vaccinating-for-flu-and-covid-19-what-parents-need-to-know/?sh=559452c24e63

Myocarditis cases: https://www.reuters.com/world/us/eight-heart-inflammation-cases-seen-among-young-kids-who-got-covid-19-shot-us-2021-12-16/

WHY are so many people afraid of the COVID19 vaccine?

As millions of people across the world are gaining access to and choosing to receive the COVID19 vaccine, I remain hopeful that at some point soon, we will be able to dial back many of the lockdowns and social restrictions that remain in place due to our fear of infection. This fear is real – over 770,000 people in the US have died due to COVID19 infection, and we know that many more died of other causes likely exacerbated by recent infection. This number is the same as the entire population of Northern Nevada (outside of Las Vegas). Every one of those who have died left behind family and friends. Many were elderly and frail, but many were young and healthy, and some were children.

For those of us who have lost, or have been around the losses, the rapid development of a vaccine nine months after initial reports of infection in the US was an absolute miracle. Or at least, incredibly impressive. Many of us in healthcare were the first in line to get the vaccine – I received mine on December 19, 2020. For all of us that chose the jab, the benefits of this new vaccine outweighed the risks of the vaccine and the risks of not being protected. Of course we were concerned – a new vaccine, what was mRNA doing in our bodies?, stories of fever and even allergic reactions – it was all scary. But what we were doing and taking care of in the hospital every day was even scarier. It was a leap of faith, but I chose to trust science and trust the vaccine. As millions of people have now received COVID19 vaccines (over 200 million in the US alone), we continue to learn more about it. For those of us in healthcare, this data has been reassuring. The vaccine is just as safe, or safer, than any of the other vaccines, medications, or therapies that we dispense daily.

Yet, there are still millions of people who are choosing not to get the vaccine. I have chosen to try to understand what the concerns are in an effort to provide facts and education around those fears. Initially, many people felt like this was a political divide. I no longer feel that way as I know intelligent people on both edges of the political spectrum who have decided not to vaccinate. When I ask why, the answers are usually based in fears – fears about the ingredients, the side effects, the long-term effects, and fears around personal health issues. This I can understand. I face these fears every day as I take care of individual patients with lots of questions about their medicines, chemotherapy, antibiotics, radiation, etc. So today, I would like to address some of these fears. Here are some of the concerns:

Medical Reasons. First of all, there is a very small population of people who should not get the shot. Yes, I said that. There are specific diseases and conditions that are absolutely high risk for a reaction to a vaccine. For instance:

  • If you have ever had anaphylactic shock after receiving a vaccine, then you should probably not get this one. I would direct you to your physician to have an important conversation about your specific risks.
  • If you had an acute allergic reaction (anaphylaxis) to a COVID vaccine, then you should not get the same version again – talk to your doc about options.
  • If you just had COVID and had an antibody product (like Regeneron) then you should defer vaccination for 90 days.
  • If you developed myocarditis after your first dose, then you should not get the second.
  • If you are currently acutely ill, then you should wait until you are well.

Religious exemptions. I’m hearing that thousands are checking the “religious exemption” box when faced with an employer mandate. I didn’t realize so many people were Scientologists. Not judging. Just saying that most churches and church leaders nationally are supporting the vaccine to enable their parishioners to safely return to church! There is a specific list of religions here that do object: https://www.vumc.org/health-wellness/news-resource-articles/immunizations-and-religion

Ingredient concerns. Well, I have watched A LOT of videos in the past few months of campaigns, talks, interviews, etc, that are anti-vaccine and warn their audiences of all kinds of badness in the shots. I’ve really tried to listen and understand. I hear some really good information and some really bad information. Some of these speakers found a medical textbook and put a bunch of words together that absolutely make no sense. Others express real concerns about specific ingredients, but don’t seem to understand the dosing or use of these ingredients.

Let’s go through a couple:

  • mRNA. This is the only “active” (meaning has any effect on your body) ingredient in the Pfizer and Moderna vaccines. The few other ingredients (below) are “inactive” and have no impact on your body and are quickly cleared. One of the better descriptions of the mRNA component is here:

“There are rumors that mRNA vaccines will alter our DNA because the RNA molecule can convert information stored in DNA into proteins. That’s simply, not true. It’s critical to note that the mRNA vaccines never enter the nucleus of the cell, where our DNA is stored. After injection, the mRNA from the vaccine is released into the cytoplasm of the cells. Once the viral protein is made and on the surface of the cell, mRNA is broken down and the body permanently gets rid of it, therefore making it impossible to change our DNA.” (ref below)

  • Lipids are used a as a fatty layer to protect the mRNA piece and help it enter the cell. One of the four lipids used is a small piece of cholesterol.
lipid structure
  • The one that has received the most attention is a form of polyethylene glycol. Yes, it’s in the Pfizer shot. A similar substance, polysorbate 80, is in the J&J vaccine. Most of us know it as “PEG” or Miralax. When concentrated, it works well as a laxative. It has thousands of other uses (check Wikipedia!) including thickening uses in toothpaste and shampoo and binding to proteins as a carrier to last longer in the bloodstream. There is a tiny amount used in the lipid wall surrounding the mRNA piece to deliver it to the cells. There was initially concern that people allergic to PEG (or Miralax) may be the ones who have an allergic reaction to the vaccine. I have not found any follow up data on this, but if you have allergies to any medications, please discuss this with your doctor to determine if the vaccine is safe.
  • One of the other lipids used by Moderna that has received A LOT of attention is SM-102. I’ve seen accusations that SM-102 is somehow able to carry GPS signals and even magnets and electrical charges. Pretty impressive, and completely untrue. SM-102 is another little tiny lipid that forms the wall of a coating around the mRNA to protect it from immediate destruction. It’s just not that cool… More info here: https://www.factcheck.org/2021/05/scicheck-vaccine-ingredient-sm-102-is-safe/
SM-102
  • Salts and sugar. That’s it.

The vaccine does NOT contain:

  • Fetal cells
  • Blood products, like red blood cells, white blood cells, plasma or platelets
  • COVID-19 virus cells
  • Mercury
  • Egg
  • Latex stoppers
  • Pork products
  • Preservatives
  • Microchips      

— Sometimes there are microchips on the outside of a syringe (usually in a bar code), so the health care professional can scan it quickly for digital records. The world’s tiniest microchip is still much too big to insert into an immunization shot.

The oldest and newest fear has been infertility. The doubts came up early and fast due to the possibility that a protein on the placenta, syncytin-1, could be could have a similar spike protein that would cause the body to attack it after vaccine. This miniscule possibility has been evaluated by multiple reproductive health teams and found to be near impossible (one study ref below). I placed a nice article from Missouri below addressing this concern if you would like more references.

Most significant to me, I have had parents tell me that they are worried the vaccine will make their children infertile long-term. Again, I understand the fear — my 18yo and 20yo daughters received the vaccine, and I had to do my research. There is no scientific away, no mechanism of the vaccine, no rare mutation of the mRNA, that can cause infertility in our kids. You know what can cause infertility? Infections. STDs, bacterial sepsis, and …. COVID19. So, if you want to help protect your children’s reproductive future, then educate them appropriately and get them the COVID19 vaccine.

Lastly, the CDC has added a nice “Myths and Facts” page to their website. Check it out: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html

I hope this helps! Happy to take any questions or comments below. If you like this material, I encourage you to hit the “Follow” button as I have been trying to keep up and post weekly. Thanks so much for all of your encouragement!

References:

Full CDC site with ingredients listed in “Appendix C”: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html?s_cid=10492:covid%2019%20vaccine%20ingredients:sem.ga:p:RG:GM:gen:PTN:FY21#Appendix-C

Ingredient breakdown:  https://www.hackensackmeridianhealth.org/HealthU/2021/01/11/a-simple-breakdown-of-the-ingredients-in-the-covid-vaccines/

PEG concerns:  https://www.science.org/doi/full/10.1126/science.371.6524.10

SM-102: https://www.nebraskamed.com/COVID/sm-102-moderna-vaccine

https://www.nebraskamed.com/COVID/you-asked-we-answered-are-covid-19-vaccine-ingredients-public

Infertility: https://www.muhealth.org/our-stories/does-covid-19-vaccine-affect-fertility-heres-what-experts-say

syncytin-1 study: https://www.nature.com/articles/s41577-021-00525-y

https://www.nbcnews.com/health/sexual-health/covid-vaccine-doesnt-cause-infertility-disease-might-rcna2868

COVID and pregnancy: https://www.ama-assn.org/delivering-care/public-health/what-doctors-wish-patients-knew-about-covid-19-vaccines-and-pregnancy

Photo credit: Creator: AndreyPopov | Credit: Getty Images/iStockphoto

WHY are pediatricians so excited about childhood COVID19 vaccination?

On November 2, 2021, in a unanimous vote, the CDC Advisory Committee of Immunization Practices (ACIP) recommended approval of the Pfizer vaccine for children ages 5 to 11 years of age. The CDC, and its director, Rochelle Walensky, immediately acted on this approval, and the shots are on the way. For most pediatricians, this is better than our birthdays! We have been waiting for this day. We have been waiting to have more to offer to protect our patients and our communities against COVID19.

Pediatricians are just as tired of the pandemic as everyone else is. There are days that I am wearing an N95 for over 12 hours at a time, pushing big plastic goggles on and off my face, washing my hands until they are red and raw – all to protect myself, my patients, and my families. If there is a magic exit door to this pandemic with a road behind it to normalcy, I will be the first to line up! This vaccine offering for children is now beginning to feel like a dim light at the end of a dark hallway.

As many of you have also, I have had my doubts about vaccinating children. As I have said before, everything that I do in pediatrics comes with risks and benefits. In reviewing all of the data and experience around a protocol, drug, or procedure, I have to be convinced that the benefits of what I am doing to a child or recommending to their parent absolutely outweighs the risks. This pandemic has been a scary time for all of us as there is so much that is unknown and so much that we still need to figure out.

Internationally, 4600 children aged 5 to 11 years of age were included in this latest Pfizer trial—3100 receiving the actual vaccine and 1500 receiving the placebo (blinded). This number was arrived at by epidemiologists (data scientists) as the acceptable number to study in order to get a broad enough range of age, race, and ethnicity, and to be able to see signals of side effects. As the vaccine is released, we will continue to study and follow the effects, and will hopefully soon have hundreds of thousands of children vaccinated providing even more data about the shot. Though different doses were considered and trialed, Pfizer arrived at a 10 microgram dose – one third of the adult dose (30 mcg)—for each vaccine. Children who received this dose then had their blood drawn and were found to have a robust immune response to the vaccine – this means, IT WORKS! They have determined that the efficacy of the vaccine is 91%. This means that in their trials, they found that 91% of these vaccinated children are protected against severe disease and mortality from COVID19.

Just like with the adult trials, we believe that children may still get infected with COVID19 even if they are vaccinated, but with this protection it should not make them very ill or require hospitalization. What we will need to evaluate over time is the effectiveness of the vaccine – or how well it protects the general population in the real world. As we have discovered with the initial adult vaccine rollout, even though the efficacy of the Pfizer vaccine in trials was 96-97%, once it was given out to a wide range of people with exposures to different strains of the virus, we found that the effectiveness of the vaccine has been declining—even to 42% in one study. Despite this, it has still been found to be over 90% protective against severe disease and death. I’ve added a video link to the bottom of this post that has a fantastic explanation of the difference between efficacy and effectiveness.

The best news rolled out this week is that the pediatric vaccine appears to be very safe. There were no cases of myocarditis in this study group (see my previous posts on this). I say “Hallelujah!!!”  This does not mean that there will not be cases reported over the next few months as the vaccine rolls out to hopefully millions of children. We will keep our eyes out and follow and report all concerns. CDC models predict that this childhood vaccination will prevent up to 600,000 infections by next March (2022). Based on the trial data, I feel very comfortable recommending this lower dose vaccine on the 3 week, 2-dose schedule now approved by the FDA and CDC. Pfizer is the only vaccine available for children at this time, but Moderna is quickly seeking approval for their own version. The J&J team is just starting to study their vaccine in children, so this will take much longer to be evaluated.

Quick update on the Pfizer vaccine already available to our 12 to 17 year olds… as we continue to give out vaccines and study their effectiveness in the real world, things are looking good! Vaccination in this age group has decreased the risk of hospitalization by 93%. This new was shared with pediatricians this month if you are interested: https://www.aappublications.org/news/2021/10/19/pfizerhospitalization101921

Today, I am grateful to all of the healthcare workers at major children’s hospitals who enrolled their own children in trials to identify the right dose of vaccine and to evaluate the side effects. These healthcare providers felt strongly enough about this mission to consent to having their own children be the “guinea pigs” in this new world, so that the rest of us didn’t have to be. If no one else says it, I will – THANK YOU!

References:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html

https://www.npr.org/sections/health-shots/2021/11/02/1051301705/cdc-advisors-recommend-pfizers-covid-vaccine-for-children-ages-5-through-11

Dr Fauci on protecting kids: https://www.cnn.com/2021/09/06/health/us-coronavirus-monday/index.html?utm_source=twCNNi&utm_medium=social&utm_content=2021-09-07T03%3A29%3A04&utm_term=link

This is one of the best videos I have seen explaining why “efficacy” is different than “effectiveness”:

This German website (dw.com/science) has some great videos using science, not rumors, to spread information and has another great explanation of the difference.

Photo credit: Creator: gregory_lee | Credit: Getty Images/iStockphoto

WHY you need (or don’t need) a booster shot (part 2)

So much to catch up on… let’s start with a reminder from my last blog regarding the most recent recommendations for booster shots, then we will dive into some updates. As always, please make your own decisions hand in hand with your healthcare provider. My opinions are my own and not necessarily those of the organizations I work for.

In my September post, the official advice was:

  • No booster shot is currently recommended for adolescents or adults with healthy immune systems.
  • For adolescents and adults over the age of 12 years with moderate to severe immune compromise (autoimmune diseases requiring medication, chronic steroid use, cancer patients, etc), a third dose of the Pfizer vaccine is available (announced Aug 12, 2021 through an amendment to the Emergency Use Authorization)
  • For adults over the age of 18 years with severe immune compromise, a third dose of Moderna is available
  • Third shots should be given at least 28 days after the second dose

New updates rolled out a couple weeks later to include third Pfizer shots for those who have received 2 Pfizer doses at least 6 months ago and who are:

I am emphasizing “Pfizer” as there are currently no official recommendations for Moderna or J & J boosters though these are in the works. As you can imagine, millions more people suddenly became eligible for a third vaccine with the latest CDC update. You can click on the definitions above to get more clarification on what the CDC considers a “high-risk setting”, for instance. I have also included a link at the bottom of the page for the CDC site that details their data and details.

Examples of workers who may get Pfizer-BioNTech booster shots:

  • First responders (e.g., healthcare workers, firefighters, police, congregate care staff)
  • Education staff (e.g., teachers, support staff, daycare workers)
  • Food and agriculture workers
  • Manufacturing workers
  • Corrections workers
  • U.S. Postal Service workers
  • Public transit workers
  • Grocery store workers

The CDC published this list, but notes that there may be other professions/jobs not on this list who may also benefit from a booster.

WHY BOOST???

To emphasize and educate, I remind everyone that the mRNA (Pfizer/Moderna) and adenovirus-vector (J&J/Astra-Zeneca) vaccines were all developed and tested for efficacy in decreasing the risk of severe disease (hospitalization and death) from COVID19. It is less effective (similar to the flu shot) at protecting us from mild to moderate disease, and over time we are seeing this protection decrease even more.

I think of it this way…. No vaccine is powerful enough to block your skin from contacting a virus or bacteria. That’s what masks and social distancing are there for. Because you may still come in contact with the virus through air droplets, aerosols, or direct skin contact, the virus may get into your body and bloodstream. As it starts to infect you, the virus begins to make lots of copies of itself (replication). Your immune system then kicks in to blunt/stop the copying process and tries to kill the virus. If you have been vaccinated, you have additional antibody support to attack the virus and rid it from your body.

While all of this is going on, you may (or may not) experience symptoms. For instance, when your immune system is exposed to foreign material, it sends a signal to warm up your body. Viruses typically do not like warm weather, and your body is smart and knows this. A fever can be a good thing — it can kill the virus that is trying to infect you. A fever is often a sign that your immune system is doing the right thing and sending the right signals. So you may not feel great for a couple days, but if you are vaccinated and have a good immune response, COVID19 will hopefully not completely kick your ass.

There has been more and more data indicating that the lovely immunity granted to those of us who have chosen to vaccinate may wane (decrease) over time. Per the CDC, “This lower effectiveness is likely due to the combination of decreasing protection as time passes since getting vaccinated (e.g., waning immunity) as well as the greater infectiousness of the Delta variant.” We now have data from a (small) clinical trial by Pfizer (fully picked apart and “peer reviewed” now) that shows that an additional (third) shot can boost and improve our immunity.

Again, the original vaccine series for all of the vaccines currently available remain effective against severe disease, hospitalization and death. The concern has been all of the “breakthrough” infections that we have seen in vaccinated people with this last Delta variant surge. I know many vaccinated coworkers and friends who tested positive for COVID19 over the past couple months despite getting their vaccines. For 90+% of them, this meant some low grade fever, cough, and aches for a couple days. I also know a handful of unvaccinated people who were REALLY sick this time around and are now dealing with a chronic cough or even Long Covid (reference below). No thank you.

As a quick sidebar, I also get lots of questions for people who ask if they need the vaccine if they already had COVID infection. The answer is YES. The vaccine has been shown in multiple (small) studies to boost immunity even after natural infection. I’ve included a couple references below.

I received my third Pfizer shot about a month ago without side effects or even a sore arm. I have had many colleagues tell me that they felt awful for a day or two after their booster, but that’s about the extent of any side effects that I have personally heard of. I am a big fan of the VAERS (Vaccine Adverse Event Reporting System), but I would encourage you to be careful about what you see on that website. The site contains raw data — unfiltered, for the most part. I can sit down and type in that I grew a second head and gave birth to an alien baby after my shot and have it show up on the site (I’m exaggerating, of course, but not…). I’ve noticed a bunch of social media and misinformation about what is found on this site (more obvious when they don’t even spell VAERS correctly). I’ve included the official disclaimer/description from the VAERS site at the end of this post if you need any more convincing. This data needs to be reviewed and studied, but if you want to take a look, here is the website: https://vaers.hhs.gov/. Never be afraid of the truth!

Currently, Moderna and J&J are pushing for approval for boosters. There is also more and more data being released as we study “crossing” vaccines — getting a J&J and then a Pfizer, for instance. I’ll dive more into this in my next blog. Thanks for reading and sharing if you like this information. I try to stick to the facts, but as a healthcare worker in an ICU seeing sick COVID patients, I will remain a bit biased. I believe that’s my right.

Thanks for any comments and questions! Stay healthy!

References:

Details from the CDC:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html

Cavanaugh AM, Spicer KB, Thoroughman D, Glick C, Winter K. Reduced Risk of Reinfection with SARS-CoV-2 After COVID-19 Vaccination — Kentucky, May–June 2021. MMWR Morb Mortal Wkly Rep 2021;70:1081-1083. DOI: http://dx.doi.org/10.15585/mmwr.mm7032e1external icon.

Some media links summarizing latest research:

VAERS Disclaimer (from their website):


Disclaimer

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.

Key considerations and limitations of VAERS data:

  • Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause.
  • Reports may include incomplete, inaccurate, coincidental and unverified information.
  • The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.
  • VAERS data is limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available.
  • VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information.

VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.

Picture credit: Getty images

WHY you need (or don’t need) a booster shot (part 1)

Hot topic these last couple weeks is news about the availability of a booster shot against COVID19. Due to some delays and further reviews by the FDA, the availability of these shots is again – confusing. What’s new? In this post (and the next), I will review what is known and currently recommended and run through some scenarios with my recommendations. As always, please make these decisions hand in hand with your healthcare provider. My opinions are my own and not necessarily those of the organizations I work for.

First, a pandemic update (i.e. the stats I find important). Currently in the United States, 80 million people remain unvaccinated. The latest health department data shows a 300-fold risk of hospitalization if you are unvaccinated. That is terrifying. There are some areas of the country that have seemed to peak, i.e. Florida. However, the kids just went back to school last week mostly unmasked, so let’s see how long it takes for the numbers to go back up.

Over 80% of all ICU beds across the country are full. That means, potentially, no room in the inn for your heart attack or COVID infection. I’m hearing stories of families driving from hospital to hospital looking for a bed. In more than 1 out of 4 states (25% of our country), more than 90% of ICU beds are full. That includes mine, Nevada, along with Oregon and Idaho. We are now overflowing into our surrounding states. In Idaho, where the governor is opposed to mask mandates, the state is completely overrun and is now transporting patients out of state for care, stressing neighbors like Spokane, Washington (all story links below).

For most of the vaccinated, there is a feeling of helplessness and now, even anger, building against the unvaccinated. All of the current stress and death could have been avoided if a greater number of our population had done the right thing (as they did with polio and smallpox, for instance). So if we can’t control the unvaccinated filling our hospitals, how do we avoid breakthrough infections? Booster shots? Maybe, and maybe not.

Let’s start with the positive – as of Sept 7, 2021, more than 176 million Americans have been vaccinated (out of a total population of about 330 million). That’s not bad… but not great (and, by the way, not enough to achieve “herd immunity” if you have been waiting for that!). There are many studies currently underway or freshly published that show that the immunity achieved from the current recommended dosing is more than adequate. The vaccinated continue to be protected from severe disease, ICU admission, and death. Yes, breakthrough infection is real, and now feels very common. But if you have had the vaccine and get COVID, you are most likely going to have a crappy couple days or week and then get back to work.

The vaccinated that are actually ending up in the ICU have so far been the very frail or those with underlying serious health conditions. The latest report (link below) shows that 87% of the 2675 reported deaths in vaccinated people were in people > 65 years of age. This isn’t comforting for anyone, but we also understand that with increasing age, comes increasing risk and health issues. 21% of those reported deaths (493 of the 2675) didn’t have COVID symptoms and/or were not due to the actual infection. There have been 665,000 deaths reported due to COVID19 in the United States so far — just to give you a perspective on that 2675 number in vaccinated people.

For most adults, the protection has been reliable. In South Africa, they have now reported some really good news about the one-dose J&J vaccine:  

“ In the trial, called Sisonke, the researchers evaluated one dose of the Johnson & Johnson vaccine in nearly 500,000 health care workers, who are at high risk of Covid-19. The vaccine has an efficacy of up to 95 percent against death from the Delta variant, and up to 71 percent against hospitalization, the researchers reported.”

However, we are also continuing to see evidence of waning immunity over time (though this is also the subject of much discussion/argument!). Because of these concerns, the discussion around boosting immunity with a third (or second) shot started early on. Here are the current recommendations:

  • No booster shot is currently recommended for adolescents or adults with healthy immune systems.
  • For adolescents and adults over the age of 12 years with moderate to severe immune compromise (autoimmune diseases requiring medication, chronic steroid use, cancer patients, etc), a third dose of the Pfizer vaccine is available (announced Aug 12, 2021 through an amendment to the Emergency Use Authorization)
  • For adults over the age of 18 years with severe immune compromise, a third dose of Moderna is available
  • Third shots should be given at least 28 days after the second dose

That’s it. That’s the official word right now (today, September 15, 2021).

Okay, so what qualifies as “immunocompromised”? According to the CDC, people with immune compromise make up about 3% of the population. This population is at risk of getting and dying from COVID19 as their infection-fighting cells don’t work well. This includes:

  • Solid organ transplant patients
  • Patients receiving cancer treatment or chemotherapy for other diseases
  • Patients with inherited or acquired immunodeficiency (DiGeorge Syndrome, HIV)
  • Patients requiring long term steroid treatment or other medications that suppress the immune system

The CDC has reported that many of the breakthrough infections in vaccinated people that have required hospitalization have included many of the people in this category. That’s why we are absolutely recommending vaccination for this group along with a third shot.

For the rest – stay tuned for my next post!

References:

Idaho outbreak: https://www.nytimes.com/2021/09/13/us/coronavirus-hospitals-washington-idaho.html

CDC info on breakthrough cases: https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/why-measure-effectiveness/breakthrough-cases.html

Unsure if J&J will need booster: https://www.nytimes.com/2021/08/06/science/johnson-delta-vaccine-booster.html

WHY are children getting chest pain after the COVID19 vaccine?

This post is the best summary I can create from the data currently available regarding myocarditis after COVID19 vaccination in children. As with everything COVID, this is preliminary data and may be out of date or completely contradicted with new data within the month. That being said, I would like to present the current data and opinions being published. As always, my opinions are my own, and my conclusion after reading through all currently available information is that teenagers age 12 to 18 years of age should get the 2-dose Pfizer vaccine series.

As previously discussed, the Pfizer/BioNTech vaccine is currently the only series approved through an emergency use authorization (EUA) for teenagers ages 12 to 17 years. Moderna is applying for approval to be given to teens, but their authorization is currently only for age 18 and above. Johnson & Johnson is just beginning trials of their vaccine in children. Full FDA authorization of the Pfizer vaccine was just granted today, but only for teens and adults 16 years and older. Younger teens will still be offered the Pfizer vaccine under the EUA.

Pfizer received its EUA in December 2020 and immunization campaigns quickly took off while they were beginning to study their vaccine in teenagers. On May 10, 2021, they received authorization from the FDA to offer the vaccine to teens age 12 years and over. Soon after, reports of adults and teens presenting for care with chest pain began to hit the media, medical discussion boards, and journals. One of the first large studies in Israel reported 275 cases of myocarditis in 5 million vaccinated people. What was unique about this report was that this adverse effect appeared mostly in men aged 16 to 19 years and occurred mostly after the second dose. A similar report affecting a young, healthy military population soon followed with 23 male patients reporting myocarditis (20 after second vaccine dose) out of a total of 2.8 million doses given to this group. I have included more references below along with a Washington state report from May and updated VAERS reporting (national vaccine side effect reporting). Though these are small numbers, the adverse effect got attention as there have been more people affected than researchers expected.

Most authors speculate that a “hyperimmune” response to the second dose of the vaccine is a plausible cause for the myopericarditis. Symptoms typically occur within 4 days after receiving the second dose of an mRNA vaccine and are almost always mild. For most patients, symptoms resolve within 1-3 days. Many hospitals are now implementing protocols in their emergency rooms to evaluate and arrange for outpatient follow-up for affected patients as we are learning that most of these cases are mild. The DHHS, CDC and other medical organizations recently released a joint statement on myocarditis and pericarditis: 

An exceedingly small number of people will experience myocarditis or pericarditis after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. Myocarditis and pericarditis are more common if one gets COVID-19, and the risks to the heart from COVID-19 infection can be more severe.

Back to my opinions. Yes, this is concerning, and as I discussed in previous blogs, myocarditis can be serious. As we learn more about these patients and the reports, there has been some discussion about modifying the vaccine series for young males. This might mean spacing the two shots further apart or decreasing the doses given. As with all good research, this is going to take some time to study and sort out. In the meantime, what I KNOW to be true, is that the heart problems that we are seeing in patients who have active COVID infection are much more serious with a much higher risk of mortality than what is being described after vaccine. Unvaccinated people put everyone around them at risk and are potentially causing others to get sick.

Young men and their parents have a difficult decision to make. Young women also have to consider the risks involved with the Aztra Zeneca and J&J vaccines as we continue to review reports of blood clots in this population after vaccination. It is incredibly important to keep up on the latest news and read as much as you can in order to help you make these decisions.

Almost everything I do in the ICU carries risk. Every day I have to weigh the risks and benefits of a medicine, imaging order, or treatment as I partner with my patients to care for them. Even Tylenol has side effects! It is always important to consider risks in light of the possible benefits to make decisions about care. So far, to date, everything I know about the benefits of getting a COVID vaccine outweighs the risks for MOST people. As always, please discuss your own health and risk factors with your physician in order to help you make the best decision for yourself (and your children).

Teenagers and adults who experience chest pain after COVID19 vaccination should immediately speak with their healthcare provider and/or seek emergent medical care to evaluate. Emergency providers must stay informed about these reports and have a low threshold for considering myocarditis and pericarditis in vaccinated patients.

As always, please send me any questions, comments, or corrections! We are all doing our best to stay on top of the latest information available, and I want to make sure that what I am sharing is relevant and accurate.

Photo credit: Getty Images

References (more always available on request!):

Israeli study: https://www.gov.il/en/departments/news/01062021-03

Military report: https://jamanetwork.com/journals/jamacardiology/fullarticle/2781601?alert=article

Washington State Health Dept: https://www.doh.wa.gov/Newsroom/Articles/ID/2803/Statement-from-Washington-State-Department-of-Health

VAERS reports: Preliminary reports of myocarditis/pericarditis

As of June 11, 2021, the Vaccine Adverse Event Reporting System (VAERS) had received 1226 (0.000038%) preliminary reports of myocarditis and pericarditis after about 300 million doses of the Pfizer and Moderna vaccines. There were 233 (0.006427%) cases of myocarditis or pericarditis after 3,625,574 second doses administered to men aged 18-24. Based on population cohort studies 2 to 25 cases would have been expected.

After 5,237,262 doses administered to women in this age group, 27 (0.000516%) cases were reported; 2 to18 would have been predicted.

A similar pattern of risk was seen in children 12-17 years old. The crude reporting rates of myocarditis or pericarditis decreased with increasing age as did the gender differences.

CDC/HHS statement: https://www.hhs.gov/about/news/2021/06/23/statement-following-cdc-acip-meeting-nations-leading-doctors-nurses-public-health-leaders-benefits-vaccination.html

AAP letter Aug 5: https://downloads.aap.org/DOFA/AAP%20Letter%20to%20FDA%20on%20Timeline%20for%20Authorization%20of%20COVID-19%20Vaccine%20for%20Children_08_05_21.pdf

Schauer J, Buddhe S, Colyer J, Sagiv E, Law Y, Chikkabyrappa SM, Portman MA, Myopericarditis after the Pfizer mRNA COVID-19 Vaccine in Adolescents, The Journal of Pediatrics (2021), doi: https://doi.org/10.1016/j.jpeds.2021.06.083

Long SS, Important insights into myopericarditis following Pfizer mRNA COVID-19 vaccination in adolescents, The Journal of Pediatrics (2021), doi: https://doi.org/10.1016/ j.jpeds.2021.07.057