Pediatric COVID-19 Updates

COVID Update (11/3/21) - Vaccine Approval for Patients Ages 5-11

We are sure most of you have seen the news on the approval of the Pfizer COVID-19 vaccine for the 5-11 year age group. Below is a summary of that approval yesterday as well as some answers to frequently asked questions and information on where to find the vaccine for your children.

During the Tuesday meeting of the CDC's Advisory Committee on Immunization Practices, panel members reviewed and discussed the science behind the FDA's Friday authorization of the vaccine in all children 5 to 11 years old. That authorization was based mostly on a Pfizer-BioNTech study of 4,600 children worldwide, of whom approximately 3,100 got the low-dose vaccine and about 1,500 got a placebo. These studies showed that the vaccine is about 91% effective against COVID-19. The immune system response to the vaccine, as measured by antibodies, was comparable to the response seen in 16- to 25-year-olds. The advisers spent considerable time weighing the public health need of a children's vaccine for a disease that is not as often severe or deadly as it is in adults. In the end, the prevalence of COVID-19 across the U.S. and the number of severe cases and deaths led them to recommend universal use of the vaccine in the 5-11 age group. The most recent CDC data from September 2021 show that 38% of children in the 5-11 age group have antibodies to the virus that causes COVID-19, indicating that they've been infected. Dr. Jefferson Jones, a medical officer with the CDC, said that young children are at least as likely to be infected as adults. More than 1.9 million cases have been reported in 5- to 11-year-olds. Overall, there have been more than 8,300 children ages 5 to 11 hospitalized with COVID-19. More than 2,300 children in this age group have gotten a related illness called MIS-C, a severe condition that affects multiple organs and can be fatal. The 5-11 age group had the highest number of cases of MIS-C among children. Hospitalization rates and severity of hospitalized cases for COVID-19 in this age group have been similar to what has been seen in past years for influenza.

Frequently Asked Questions:

Do you recommend the COVID-19 vaccine for 5-11-year-old children?

• Yes! The Thompson, Lye, and Campbell children will all receive their vaccines in the upcoming weeks.

Will Premier Pediatrics require COVID-19 vaccines for their patients?

• No. Similar to flu vaccines, we recommend these vaccines but do not require them.

What is the dose and schedule for this age group?

• It is a 10 mcg dose (⅓ of the adolescent and adult dose) given 3 weeks apart. Younger children mount a more robust immune response to vaccines so this dose minimizes side effects while still producing strong immunity. NOTE - this difference in immune response depends on AGE, not WEIGHT. So if you have a big 10-year-old or a tiny 12-year-old, you don’t have to worry that they should be dosed differently.

My child recently had a COVID-19 infection. Do I need to wait a certain amount of time before scheduling the vaccine?

• No, you can give the vaccine at any time following infection. It will basically act as a booster dose to their natural antibodies. The original recommendation to wait 3 months following infection was to give unprotected patients the chance to get a vaccine first when availability was limited.

We just got our flu shots. Do we need to wait a certain amount of time before scheduling the COVID vaccine?

• No, flu and COVID vaccines can be given on the same day or at any interval between vaccines. Go for it! (This is the same for any other routine immunization as well).

Where can I find the vaccine for my child?

• Unfortunately, we do not have immediate plans to carry the COVID-19 vaccine in our office. Below are trusted local providers who will be accepting appointments.

Texas Children’s Specialty Care - Their appointments were quickly filled through January as soon as released. They anticipate cancellations and also plan to add additional appointment slots. They are encouraging you to continue checking the link for availability.

Tarrytown Pharmacy

Dripping Springs Pharmacy (Martin’s Wellness pharmacy) - by appointment only, they have only received one shipment at this time but are anticipating more.

HEB pharmacy (all locations) - Expected shipment 11/8. Once they receive it, they will open online scheduling for the 5-11 age group on their website. Appointment times will be after school and on weekends.

Walgreens - Expected shipment 11/6. They are currently scheduling appointments online at multiple locations with appointments as soon as next week.

Once immunization is complete, you can send a copy of your child’s immunization card to the portal or bring it to your next visit so we can enter it into their vaccine record.

Please feel free to reach out with specific questions unique to your child or family. We are always happy to help.

Take care!

Carly Thompson, Cara Lye, and Kristin Campbell

COVID Update - Delta Variant, Vaccine Updates, and Back to School

Delta Variant - What Do We Know?

The Delta variant is more contagious, has a faster onset of symptoms, and may shed longer from infected people. We are still learning whether people actually get sicker or not, but this is being reported. I received an email from Dell today stating: ALERT! We are now seeing a spike in hospitalizations for COVID at Dell Children’s Hospital. Unlike in previous spikes when children were seldom hospitalized, we are seeing a sharp increase in hospital and ICU admissions among children and adolescents in our own community.

The most important thing that we do know is that 95% of people in the hospital are UNVACCINATED. The vaccine works! Yes, there are breakthrough infections which means that vaccinated people are getting sick but they aren’t landing in the hospital. That is all that really matters!

What are we seeing every day in our office and hearing from our colleagues at the children’s hospital?

We are seeing cases of COVID every day. Presentations can vary from no symptoms to mild allergy symptoms to headache alone to vomiting/diarrhea to flu-like symptoms to pink eye - you name it! Our tests are reliable and we are thankful for them! No two kiddos look exactly alike. While we have seen children of all ages test positive, the majority continue to be school-age children and teens.

Dell Children’s Hospital has also seen an increase in cases, however, most children who are currently hospitalized with COVID-19 have underlying risk factors. Risk factors for hospitalization include infants less than 1 year of age, medical complexity, obesity, chronic heart or lung disease, and neurological/developmental conditions. Complications vary by race and ethnicity, with African American and Hispanic children accounting for a disproportionately high number of severe cases.

Vaccine Updates

• Myocarditis Concerns - Thousands of 12 to 17-year-old vaccine recipients have now been observed for many months as part of research trials. One important notable side effect has been monitored - myocarditis, or inflammation of the heart muscle. It occurs more commonly in boys. Symptoms (typically chest pain) develop a few days following the vaccine dose. Cases have been mild and self-limited. Incidence is 1 in 50,000 - this is rare! Keep in mind that cardiac involvement from acute COVID-19 infection or MIS-C is more common. A recent study published in JAMA found that 15% of athletes, who had been ill with COVID, had some evidence of myocarditis, even after a mild illness. Myocarditis following COVID -19 infection is typically more severe and can be longer-lasting.
• Other side effects - As with other vaccines, COVID-19 vaccines have been known to cause side effects consistent with normal immune responses from any vaccine - sore arm, fever, body aches, fatigue. These are quick to appear and quick to resolve, usually within 24 hours. What about long-term side effects? An important point here is that vaccine side effects are seen within 4-8 weeks of administration. There has never been a side effect discovered more than 6 months beyond initial vaccine trials in the history of vaccines. Millions of Americans have been vaccinated over the last 7 months and trial participants over a year ago and we are more reassured with its safety every day. We should be more concerned about the long-term effects of COVID infection itself than the COVID vaccine.
• Fertility, Pregnancy and Nursing Moms - COVID-19 vaccination does not impact fertility for either gender. This is an anti-vax hoax and is not biologically plausible. It does not cause miscarriage. Outcome data on completed pregnancies for women who were vaccinated while pregnant has been very reassuring. COVID infection is more dangerous during pregnancy. I highly recommend vaccination for both pregnant and nursing mothers, as both moms and babies can benefit from it. The mRNA does not cross the placenta. It stays in the deltoid muscle where it is injected until it is destroyed a few days later, then the antibodies that are created circulate through the body and cross the placenta. Antibodies have been detected in cord blood as early as 2 weeks after the FIRST dose! This protects your baby and is SO cool! If you are currently pregnant and are considering the vaccine, we encourage you to talk more with your OB.
• Vaccines for children - Pfizer will complete their trial for ages 5-11 years in September. The study includes 3000 children in each study group, gives a smaller dose (10 mcg as compared to 30 mcg in the 12+ group), and is required to have 4-6 months of safety data. That is all reassuring and the results from that trial should be trusted. The vaccine should be available for that group under EUA shortly after it is reviewed. Ages 6 months to 5 years will follow, likely late 2021 to early 2022. Similarly, Moderna should have approval for children under 18 sometime this winter.

School 2021-2022 and Masks

If there is any topic related to COVID that I am passionate about, it is that all children should return to school. I could go on and on about the benefits of going to school in person. So what about the K-6th graders who are too young to be vaccinated? As parents of children in this age group ourselves, we understand your struggle between keeping your children safe and sending them to school. There is no one size fits all answer. This is where last year’s mask policies and other mitigation strategies are really going to be helpful. What we did last year worked. Not only was there very little COVID transmission in schools there was essentially no cold and flu season. Masks work, but they work best when everyone wears them. If you want to see the science on that, here is a good article.

Given the prevalence of the delta variant currently in our area, opening schools without mitigation strategies in place is going to ensure that COVID continues to spread rapidly. For adolescents (12-18), you are really making a choice between getting vaccinated or getting COVID. It’s just that contagious.

What About Preschool/Daycare?

We continue to see more RSV, croup, and other routine pediatric illnesses than COVID in this age group, however, there have been COVID outbreaks in local preschools in recent weeks. Thankfully children in this age group are more likely to have a milder course than older children and adults, though that is not a guarantee. This is a difficult question and every family has to evaluate their own level of risk and benefit. I do think it is reasonable to ask if teachers are vaccinated and will be wearing masks, as adults are still more likely to be the transmitters in their classrooms.

What Am I Doing With My Own Children?

Aside from my eldest child with mild asthma, my children have zero risk factors for severe illness from an acute COVID infection. They are all under 12 years, so not vaccinated. They will be going to school in person and participating in all of their usual activities. We are avoiding indoor crowds during this current surge. They will be wearing masks even though their school is mask optional. I don’t want them sick, I don’t want them out of school and sports for an extended time, I don’t want to be home from work for 10 days times 4 kids. And some of their classmates and teachers are in a higher risk group than they are. So it’s just the right thing to do. They will receive the vaccine when it is available. The science is clear - the vaccine is safe and effective.

Feel free to reach out to us with any questions regarding your personal situation. I have this conversation all day long and it goes a little bit different with every family. I know there is doubt and misinformation in every direction. I know there are very passionate people on both sides of this argument. The more that time goes on, I think the facts are easier and easier to see - the vaccinated are still standing (and healthy and having healthy babies) and the hospitals are full of young, unvaccinated people in critical condition. 96% of physicians are vaccinated, so if your personal doctor is telling you something different they are not following the standard of care or the recommendation of all governing bodies of medicine in the US.

We hope your children have a wonderful school year despite this very stressful start. They are so resilient! You know how to reach us should you need us - we are weary but the kiddos make us laugh and keep us going!

- Dr. Carly Thompson (with the help of Dr. Cara Lye and Kristin Campbell, CPNP!)

COVID-19 Vaccine Considerations for Childern and Adolescents

What is the current status of the research?

Pfizer-BioNTech has completed their study in 12-15-year-old patients and it has been granted EUA approval by the FDA and recommendation by the ACIP as of 5/12/2021. In a clinical trial, Pfizer and BioNTech enrolled 2,260 participants ages 12 to 15 and gave them either two doses of the vaccine or a placebo three weeks apart. The researchers recorded 18 cases of symptomatic coronavirus infection in the placebo group, and none among the children who received the vaccine, indicating that it was highly effective at preventing symptomatic illness. The company is still gathering information on potential asymptomatic infections by continuing to test the trial participants for the coronavirus every two weeks and checking them for antibodies produced in response to a natural infection.

Is the vaccine safe?

The side effects following the Pfizer vaccine have been similar to other routine vaccines- sore arm, redness, fatigue, fever, chills, headache, body aches. The side effects are temporary and mostly mild or moderate. Side effects may be worse after the second dose in some individuals. Fevers were slightly more common among 12 to 15-year-olds - about 20% compared with 17% in the older age group. Anaphylaxis has been observed following receipt of COVID-19 mRNA vaccines, but this has been incredibly rare. History of immediate severe allergic reactions to polyethylene glycol or polysorbate is a contraindication to receiving an mRNA COVID-19 vaccine. Patients with a history of severe anaphylaxis due to any cause should be monitored for 30 minutes after administration of the vaccine.

What about long-term safety data? Is my child participating in an experiment?

The safety follow-up for COVID-19 vaccines is essentially the same that it is for all vaccine trials. The expectation for the adult phase 3 trials is 2 years of safety follow-up - longer than for most vaccines during development. It is impossible to know the very long-term safety profile of vaccines that have only been in humans for about 6 months. That said, no vaccines licensed have been found to have an unexpected long-term safety problem, that was found only years or decades after introduction. Remember that the vast majority of vaccine side effects occur within 6 weeks of administration. The Janssen blood clots identified should actually give us great comfort in the robust reporting system in place and the speed at which these reports are identified and researched. Within 8 weeks of giving the J&J vaccine, a 1 in a million (literally) vaccine side effect was identified and the vaccine administration was paused and investigated.

Could MIS-C occur following COVID-19 vaccination?

MIS-C is a rare but dangerous inflammatory reaction occurring 3-6 weeks after COVID-19 infection. One of the reasons to perform vaccine trials in children is to make sure that they do not have any side effects that are pediatric-specific. Since there are also cases of MIS-A in young adults, if MIS were to be a problem, we may see it in the larger adult trials. We have not, to date. MIS-C typically develops 3-6 weeks following natural COVID infection, however has not been observed in vaccine recipients during that same time period. We hope that protection from COVID-19 by vaccination will also protect against its sequelae, including MIS-C.

If COVID-19 infection is unlikely to be dangerous for children, why would I bother with the vaccine?

The risk of your child catching Covid and getting really sick is low, but it’s not zero. And the risk of them getting sick or hospitalized or worse with Covid or with the post-Covid MIS-C is higher than the risk of an adverse reaction from this vaccine. And further, the opportunity for a normal life is in our very near future if we can reach high levels of immunity in our nation. If you struggle with vaccine hesitancy, look at the current situation in India - with new highly contagious variants spreading like wildfire and lack of available vaccine, death rates are soaring and lockdowns continue. Variants develop as the virus spreads. We are in a race between vaccination and virus mutation. We are incredibly fortunate to have safe, effective, available vaccines in the US. Vaccinating children is crucial to building up population levels of immunity and curtailing the spread of the coronavirus. Though children spread the virus less efficiently than adults do, they make up about 23 percent of the population. Experts have said that the country is unlikely to reach the “herd immunity” threshold — the point at which virus transmission essentially stalls — but vaccinating children will be important for getting as close as possible.

All children have been affected by the pandemic and its consequences during the last year. The amount of mental illness that we are seeing in our own patients is tremendous. Anxiety, depression, suicidal thoughts, eating disorders, substance use… just to name a few. I strongly believe that all children and adolescents desperately need to resume normal life - in-person schooling, socializing with friends, team sports, scouts, summer camps, travel, etc. This vaccine may be the ticket to get us there.

What’s next?

Pfizer and BioNTech began testing the vaccine in children ages 5 to 11 in March, and last month extended the trial to even younger children, ages 2 to 5. The company's next plan to test children who are 6 months to 2 years old. Assuming trial results are encouraging, the companies expect to apply to the FDA in September for emergency authorization to administer the vaccine to children ages 2 to 11. Results from trials of Moderna’s vaccine in 12- to 17-year-olds are expected in the next few weeks. Findings from another trial of the company’s vaccine in children 6 months to 12 years old should be available in the second half of this year. AstraZeneca is testing its vaccine in children 6 months and older. Johnson & Johnson plans to wait for results from trials in participants older than 12 before testing its vaccine in younger children.

Will our office carry the Pfizer vaccine for adolescents?

At this point, we are unable to get our hands on the vaccine. We are registered and would happily administer the vaccine to our patients once individual physician offices are allocated doses. At this point, you can register with Austin Public Health, UT Austin Health or call your local pharmacy to inquire about availability. Texas Children’s Specialty Center will be administering the vaccine on May 27th if you prefer a pediatric facility. You can call their main number 737-220-8200 and dial 0 to be put on a waiting list.

Final Thoughts

Can I be 100% sure that this vaccine is safe long term? No. The early and limited data so far confirms that this vaccine is safe and effective. But it is just that - early and limited. I trust vaccine technology and I trust the science of studying and following vaccine recipients. Does COVID-19 infection potentially have unknown long-term consequences as well? Absolutely. Only time will give us these answers. I do believe strongly that children and adolescents desperately need to resume their lives. I understand a watch-and-wait approach for the next few months as thousands of teens are being immunized daily. But I do feel confident that adverse reactions will come up in weeks to months if they are going to come up at all. I would highly recommend immunization for ages 12-15 years prior to the onset of school this fall and then we should let these kids be kids!

COVID Update - Testing, New Variants, Vaccine Update And When Will The Masks End?

Testing

Please let us take care of your family’s COVID testing! Depending on your needs, we offer both in-office rapid testing and send-out PCR testing. Our current turnaround time for the send-out PCR test is 24 hours or less. We are familiar with our local school districts and their return to school/play policies and are happy to write your school notes. We will bill your health insurance for your visit and test so no need to be paying high cash prices for these tests.

Vaccine Update

All of our providers and staff have received our two doses of Moderna’s COVID vaccine! Below are some brief thoughts on vaccine safety and efficacy.

• The two available vaccines at this point are mRNA vaccines - mRNA is basically an instruction given to a cell to make a protein. Your own cells then make that protein and stimulate a natural immune response (creating antibodies). Many vaccines inject a protein which starts that same process, mRNA technology is basically just injecting the recipe to create the protein yourself.
• mRNA technology has been researched since 1990 so it is really not new!
• mRNA CANNOT change your DNA
• While the vaccine was developed at warp speed (many vaccines take decades from idea to administration), the most important part of any vaccine development is the Phase 3 Trial. This is when tens of thousands of people receive placebo vs vaccine to see if it works and if it has side effects. This phase was NOT shortened with the COVID 19 vaccine.
• Infertility is a MYTH.
• Do we believe that the benefits outweigh the risks at this point? Yes. There is no risk-free choice, but the cost of not vaccinating comes with 3000 deaths in the US each day at this point. Most vaccine side effects occur within 6 weeks of administration. We are far past that with thousands of American’s and we are not seeing any concerning side effects. ALL recipients can report adverse events following their vaccine through VAERS and all of these are investigated to see if they are occurring at higher rates than the general population.

Variants

New COVID variants are emerging across the world and are making their way into the United States. Genetic mutations in these variants cause some potential consequences.

• The virus becomes more contagious (spreads more quickly)
• The virus causes more mild or more severe disease
• The virus becomes less susceptible to therapeutic treatments
• The virus develops the ability to evade natural or vaccine-induced immunity - both natural infection and vaccination produce a “polyclonal” response which means several parts of the spike protein are targeted. The virus would likely need to accumulate multiple mutations in the spike protein to evade immunity entirely, which at this point is thought to be unlikely.
• Research is ongoing to look at each of these questions as new variants arise.

Masks/Distancing

We know that the vaccine reduces severe disease in the person who received the vaccine. We do not know if it eliminates the spread of mild or asymptomatic infection in the community. We also have to vaccinate the majority of the population to achieve herd immunity - we certainly aren’t there yet. And we have these smart new strains to learn more about. I would guess that there is not an end to masks/social distancing anytime soon. I know we are all becoming weary. I am hoping spring brings some beautiful Austin weather so we can all get out and enjoy it!

Best,
- Carly Thompson, MD