Brimhall Pediatrics

SIDE EFFECTS OF COVID VACCINES IN CHILDREN

Vaccines for 5-11 year olds: Your FDA meeting cliff notes Today VRBPAC (an external scientific advisory committee to the FDA) voted in favor of the Pfizer COVID...19 vaccine for 5-11 year olds. VRBPAC was the second stop in a long process to get the vaccine authorized for emergency use. (This is copy and pasted from my newsletter. There are lots of figures and data sources and hyperlinks. For better viewing go here: https://yourlocalepidemiologist.substack.com/p/vaccines-for) This was a much anticipated meeting for two reasons: 1. Originally, the FDA hinted they would not consider an EUA for kids <12 years. But, Delta and pandemic resurgence caused the FDA to change perspectives. 2. The VRBPAC step was not conducted for the adolescent Pfizer vaccine; VRBPAC doesn’t have to be called for an EUA amendment. But they were called for the vaccine for 5-11 year olds. So, today 18 members of VRBPAC met to discuss hundreds of pages of data. These members are a mix of pediatricians, immunologists, virologists, epidemiologists, and other scientists across the nation. There were also presentations from the sponsor (Pfizer), FDA, and the CDC. Here was the agenda. Here are all the powerpoints. And here are your cliff notes ***Need*** Kids aren’t spared from the harm of COVID19. CDC presented the epidemiology of COVID19 outcomes among 5-11 year olds. These are close to real-time numbers: Infection: More than 1.9 million 5-11 year olds have been infected by COVID19 during the pandemic. During Delta, there was a sharp increase in cases; 5-11 year olds represented 10.6% of cases in the week of Oct 10 (they make up 8.7% of the population). There are still kids susceptible to COVID19. Only 42% of kids aged 5-11 years have antibodies from natural immunity. Hospitalization: There’ve been >8300 COVID19 hospitalizations of 5-11 year olds -Over 30% of 5-11 year olds hospitalized did not have an underlying condition. -When compared to other kids, 5-11 year olds had the least number of hospitalizations. But, starting in August, they had the highest rate since the beginning of the pandemic. -Once hospitalized, 1/3 of kids ended up in the ICU. -There were exceedingly low (only 9) hospitalizations for flu during 2020-2021. At the same time, there were significantly higher COVID19 hospitalizations. Had mitigation measures (masks, closed schools) not been in place, these numbers would have been much higher. -MIS-C (multisystem inflammatory syndrome in children) is highest among 5-11 year olds. This is a condition where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. There’s been 5,217 MIS-C cases reported as of October 4, 2021. 60-70% of patients are admitted to ICU and 1-2% died. Death: There have been 94 5-11 year olds that have died from COVID19. For context, this places COVID19 as the 8th leading cause of death for this age group. More recently (during Delta), COVID19 jumped to the 6th leading cause of death in this age group. Long COVID19: 7-8% of kids experience long COVID19. The following symptoms occur among kids for more than 4 weeks: fatigue, headache, insomnia, trouble concentrating, muscle and joint pain, and cough. There are also impacts on quality of life: Limitations of physical activity, feeling distressed about symptoms, mental health challenges, decreased school attendance/participation. Secondary outcomes -In-person school: COVID-19 in children leads to lost in-person learning and other adverse outcomes. This has resulted in 2,074 schools closed, 1,069,116 of students and 68,718 teachers affected. -Transmission: Kids also significantly contribute to the spread of the virus. Secondary transmission from young school age children can and does occur in both household and school settings ***Clinical Trial Results*** The clinical trial was organized into two cohorts: 1. 2,268 trial participants (including 1,518 vaccine recipients) followed for at least two months past the 2nd dose 2. A safety expansion group of an additional 2,379 participants (1,500 vaccine recipients) followed for a median of 2.4 weeks after the second dose. This was done per the FDAs request to allow for more robust assessment of serious adverse events and other adverse events of interest. First Pfizer presented their results. Then the FDA presented their results. The FDA always analyzes data themselves to ensure there is no conflict of interest. This is normal practice. ***Safety*** During the clinical trial, the most common adverse events (AEs) was fatigue (39%), followed by headache (28%) and muscle pain (12%). -Most AEs were mild or moderate and resolved 1-2 days after -Interestingly, fever and chills was less frequent compared to older kids/adults -Adverse reactions was higher for dose 2 compared to dose 1 There are two other adverse events linked to the vaccine: 1. Lymphadenopathy (swelling of lymph nodes): 13 vaccine participants vs. 1 placebo participant. We saw this in adult clinical trials too. 2. Hypersensitivity: Such as rash and dermatitis after the vaccine compared to the placebo There were 5 severe adverse events. None were linked to the vaccine: -Ingestion of a penny (1 person in the vaccine group) -Fractures (2 people in the vaccine group and 1 in the placebo) -Infective arthritis (one person in vaccine group) There were no cases of myocarditis (heart inflammation), anaphylaxis or deaths among ages 5-11 in the clinical trials. ***Effectiveness*** Does the vaccine work for 5-11 year olds? The FDA required Pfizer to prove immunobridging. Pfizer also included data on two other outcomes: Immunobridging: This is a process that compares antibodies among 5-11 year olds to another age group (in this case 16-25 year olds) in which the efficacy of a vaccine is already established. The clinical trial found that antibody numbers were comparable to the older age group. In other words, the vaccine works. Effectiveness against Delta: Pfizer also included data on a subsample of participants’ (34 participants) to assess the effectiveness of the vaccine-induced antibodies on specific variants. The vaccine worked great against Delta. COVID19 disease: Pfizer also showed efficacy. During the clinical trial there were 19 cases of COVID19: 3 cases in the vaccine group and 16 cases in the placebo group. This equates to a 90.7% efficacy. ***Myocarditis*** No myocarditis cases were reported in the clinical trial. This is great news but expected. The clinical trials were not nearly large enough to capture such a rare event. Myocarditis is the principal concern that people have with mRNA vaccines with children. So, CDC presented everything we know about vaccine-induced myocarditis. Key take home points: 1. Myocarditis is a true safety signal, but rare. There have been 877 cases of vaccine-induced myocarditis among 12-29 year olds (out of more than 100,000,000 vaccinated). Of these, 829 were hospitalized and 77% recovered. At the time of analysis, 5 people were in the ICU. No myocarditis cases reported and investigated by the CDC have resulted in death. 2. Not all myocarditis should be treated the same. Classic myocarditis (opposed to vaccine-induced myocarditis) has a relatively high mortality rate and can even result in sudden death. Classic myocarditis also impacts on how well the heart pumps blood (called ejection fraction). We don’t see mortality or ejection fraction reduction with vaccine-induced myocarditis. It’s a much more mild form of disease. 3. Long term effects of vaccine-induced myocarditis. Kids tend to bounce back very well. A key study followed a subset of adolescents with vaccine-induced myocarditis. Adolescents fully recovered from symptoms and arrhythmias ~35 days. Data is limited, but continues to be studied. Unfortunately we are at the mercy of time. 4. Why is this happening? We don’t know yet. Only 2 of the myocarditis cases among children have been biopsied. We think genetics and hormones may play a role. The FDA conducted an extensive benefit/risk assessment through a series of six models. Because we can’t see into the future, biostatisticians ran different scenarios based on varying three variables: COVID19 cases (pandemic could get worse or better); real world effectiveness of vaccines (we think this will be high, but could vary depending on waning and variants); and rate of vaccine-induced myocarditis among this age group (we think it will be lower than adolescents but we don’t know). All of these risks are deliberately conservative. In other words, they looked at worse case scenarios for myocarditis risk and vaccine efficacy. This is what they found -For five scenarios, the benefits of a vaccine clearly outweigh the risks of myocarditis: -Scenario 1: Used number of COVID19 cases on Sept 11, 2021 -Scenario 2: Used number of COVID19 cases at the Delta peak (worse case scenario) -Scenario 4: Used a high real-world effectiveness of the vaccine -Scenario 5: Used high COVID-19 death rate -Scenario 6: Used a lower estimate of myocarditis rate than adolescents (this is the likely scenario given the impact of hormones on myocarditis and given classic myocarditis among this group is so low) There was one scenario (#3) where benefits didn’t outweigh risks. In this model, the FDA used the lowest level of COVID19 cases like we saw in June 2021. Using this, the model predicts more excess hospitalizations due to vaccine-related myocarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined. It’s important to keep in mind that there are benefits to the vaccine beyond hospitalization. There was quite a bit of discussion around the limitations of the risk/benefit analysis. For 5 to 11 year olds, 18% of COVID19 hospitalizations are not COVID19 related. The FDA risk/benefit ratio didn’t take this into account. The risk/benefit analysis also did not take into account natural immunity protection. ***Discussion*** As you can imagine, there was a robust discussion among voting members: Make it available to certain 5-11 year olds? Two members voiced frustration that this was a binary choice: all or nothing vaccine for 5-11 year olds. Some asked whether they could rephrase the question for specific kids, like obese or immunocompromised. Some pointed to the number than 42% of kids have natural protection and that vaccines may not help that much. On the other hand, others pointed out that 32% of kids hospitalized don’t have a comorbidity, and we have no idea where the pandemic will go. We have a flu vaccine to prevent 100 deaths a year and kids are dying at higher rates from COVID19. And, most importantly, this isn’t a decision for VRBPAC. VRBPAC decides whether the vaccine is safe and effective. Defining the policy (i.e. who gets the vaccine) is ACIP’s job. If VRBPAC doesn’t authorize EUA for kids, then no kid can get the vaccine. Should 11 year olds wait for the 12 year old dose? This was specifically asked by the members because of the 3 breakthrough cases in the clinical trial: 10, 10 and 11 years old. Pfizer said that the effectiveness of the smaller dose works the same whether you are 5 or 11. They think breakthrough cases were older because they were more exposed to the virus. Pfizer hasn’t tested this dose among 12 year olds. So, ultimately, they don’t know if parents should wait. CDC should weigh into this next week. Does the vaccine prevent transmission? Pfizer did not assess asymptomatic disease (and thus transmission) in the clinical trials. So, technically, they don’t know. They do know that adult vaccines reduce transmission. But adults had a higher dosage, does this matter? We don’t know, but we hypothesize that pediatric vaccines reduce transmission to some degree. ***Vote*** So, VRBPAC needed to vote: Based on the totality of scientific evidence available, do the benefits of the PfizerBioNTech COVID-19 Vaccine when administered as a 2-dose series (10 g each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age? Yes: 17 votes No: 0 votes Abstain: 1 vote The ball now goes to the FDA. Then, it goes to the ACIP and CDC next week. If all goes well, vaccines in arms for 5-11 year olds will come at the end of next week. Love, YLE I joined the President of the American Academy of Pediatrics last week for a Q&A regarding the vaccine for 5-11 year olds. See the recording here. Other Q&A questions for parents answered in my newsletter here Here are common vaccine concerns for parents and how to address them. If you’re a paying subscriber and want the PDF, just reply to this email. The latest draft is for adolescents specifically, but I’m happy to update for 5-11 year olds if helpful.

We have COVID vaccine slots available tomorrow so pls call 6615878882 for appointment (11am - 5 pm). We are vaccinating 12 y and up including parents.

Heartbreaking!! COVID doesn’t discriminate!! Pls get vaccinated for the sake of your children!!

What you wear can help protect your skin from sunburns! When possible, dress yourself and your children in cool, comfortable clothing that covers the body such ...as lightweight cotton pants, long-sleeved shirts, and hats. Learn more here: https://www.healthychildren.org//at-/Pages/Sun-Safety.aspx See more

I am telling you, this is my Bob Marley song.

Is it eczema or something else? Learn the facts about Atopic Dermatitis here. And don't forget to call your pediatrician if you have any concerns about your child's health. https://www.healthychildren.org//co/skin/Pages/Eczema.aspx

Employee appreciation taco lunch with the best taquero in town!!! Thanks to our staff for choosing to stay and work with us this pandemic year!! Thanks to all our patients for your understanding since we have to limit our appointment slots. Let’s all stay safe and healthy this year and the coming years. Merry Christmas to all!!

Get to know vaccine preventable diseases for your babies!

Have you put up your holiday decorations yet? When you think of children and holiday decorations, you have to be sure that everything is as safe as possible. C...hildren have a way of finding trouble. What is the best way to childproof your holiday set-up without sacrificing the magic of your decorations? Here are some pediatrician-approved tips. Full article on my blog: https://thepediatricianmom.com/ten-childproofing-tips-for-/ follow me on Instagram: www.Instagram.com/thepediatricianmom

Saw this very adorable patient with a very cute bow. I asked mom where she got it and she said she made it and is selling them. I got her permission to take photos and post it so we can help support her small business in our community!! Pls check her FB and IG page if you wanna order cute bows for your baby girls. @Sweet & Sassy Bows And More

Fun educational activities to stimulate your kids’ sensory development!!

Halloween lunch at Brimhall Pediatrics!!

SKEETER SYNDROME is an allergy to MOSQUITO saliva. It can present with extreme swelling, itching, blistering, infection, fever and in some cases anaphylactic shock, asthma and cellulitis. Most people will experience some level of allergic reaction, with itching and redness, individuals who suffer from skeeter syndrome experience a very extreme reaction. The swelling that results from a mosquito bite in people who have a mosquito bite allergy is similar to a bee sting. In so...me cases the swelling is so extreme that the affected limb doubles in size, eyes swell shut, and the area feels hot and hard to the touch. Sometimes the bite will blister and ooze. The swelling can be painful, and can present with a low grade fever and general malaise. In extreme cases a mosquito bite can lead to anaphylactic shock, asthma and other life threatening complications. Skeeter syndrome can affect people of all ages. The most commonly affected group seems to be young children, toddlers and seniors. What causes Skeeter Syndrome? The condition is a result of an allergy to the polypeptides in the mosquito’s saliva that it injects to thin the blood during its bite. Because human blood is too thick for a mosquito to be able to siphon, the mosquito first injects a thinning agent into the victim. The thinning agent, the mosquito’s saliva, is what causes the allergic reaction. The body reacts to the enzymes and results in the swelling, discomfort and blistering. The allergic reaction isn’t always instant, and can develop up to 48hrs after the original bite. Individuals who have no prior history of an adverse reaction to mosquito bites have been known to develop Skeeter syndrome symptoms suddenly. The reason for developing the allergy isn’t known, and although it has been linked to an autoimmune reaction to the enzymes. There is no known reason why someone might develop an allergy to mosquito bites suddenly, with no prior allergy history. Mosquito bite allergies are treated topically to help reduce swelling and relieve itching. Antihistamines can also be taken orally to provide longer relief from itching and have been know to help reduce swelling in the affected area. There are also many natural home remedies and treatments that can help relieve the discomfort associated with skeeter syndrome. See more

This is why we request parents and older patients to keep their mask on inside the exam rooms!

Social distancing still enforced , pls bear with us if we’re unable to see as many patients as we did before. We want to protect you as well as our staff. Pls wear your mask in the waiting room as well as inside the exam rooms. Since seating is limited it will also help if some of you can wait in your cars until you get called . We are still doing virtual visits and telemedicine as much as possible. #covid

Let’s hope we all get through all these. #mentalhealth #counseling . Most insurance do not require for you to see your pediatrician if you need referral to a psychiatrist or psychologist. Just check the back of your insurance card and call the number under mental health.

Aside from social distancing, handwashing and wearing masks, there are other ways for us to prevent COvid infection and complications. Always try to have healthy balanced diet (avoid high fructose diet like sodas etc),exercise and good amount of sleep. You can also take the vitamins and medicines listed below. No data for safe doses in kids but if we keep adults healthy we’re also saving our children staying home. They can still take recommended multivitamins especially Vitamin C and D with small dose of Melatonin 1 mg and Zinc. I don’t recommend the optional meds like aspirin and hydroxychloroquine because of their danger. Doses mentioned are for adults, we don’t have much data for kids doses.

We were able to buy kn95 masks for kids ages 4-10 y/o. We will give them away for free to our high risk patients (ex asthmatics and diabetics). Pls PM us if your kids fit the criteria to get their free masks. We only have limited amount so we want to give it to the ones who need them most. Pls continue #social distancing and #proper hand hygiene. #covid-19 #staysafe

There is an ongoing need to protect healthcare workers and patients in outpatient clinics. Kern county health officer mandate as follows effective April 14. 1. Patient must be masked upon entering a healthcare facility. Patients and caregiver may wear cloth face coverings or be provided with surgical- type masks. 2. All staff in healthcare facilities must wear surgical face masks at all times 3. All staff must wear N95 respirators while caring for suspected or confirmed Covid-19 patients or when likely to engage in aerosol-generating procedures. This order is issued due to CDC reports of asymptomatic COVID-19 patients and presymptomatic COVID-19 infections.

Our very cute patients with their cute PPEs to keep them safe from COVID-19. . Good way to encourage kids and parents to wear masks in public. (Consent given to post)

As much as we want to follow the stay at home order, we as healthcare providers have to keep on working. Otherwise all the sick patients will have to go to the ER or urgent care and that might overwhelm the system. We also want to ensure refill of chronic medications are sent especially those patients suffering from asthma and diabetes. Pls. bear with us if we are not able to give you an appointment for non essential or non emergency problems since we are trying to limit and ...prevent overcrowding. We also would like to request you to stay in your car until you are ready to be called in the room if we already have 3 patients in the waiting room in order to keep the 6 ft minimum distance. We will be wearing masks in the clinic and if your kids are coughing pls make them wear a mask, we can provide them the masks if needed. Also practice hand hygiene as soon as you arrive. We provide hand sanitizers or you can also wash your hands in the room. Telemedicine is now allowed for BFMC patients for refills and follow up of labs instead of clinic visits and other doctor consultations that don’t need physical contact such as head lice, mental health questions etc. I’m sure other insurance will follow soon. For now we will try to schedule well child visit for vaccinations in the morning and sick visits in the afternoon. Pls stay home and let’s all fight the spread of this Covid-19 virus. See more

Due to the Coronavirus epidemic we are limiting the patients we are seeing to avoid crowding the waiting rooms. We request to only bring the patient and leave the other kids at home and only one parent or adult per patient. Below is a guideline on how to distinguish the viral infections.