Pediatric COVID-19 Updates

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

Pediatric Meet and Greet Update During Coronavirus Pandemic

If you would like to meet Dr. Thompson and her team prior to your upcoming delivery, we would be happy to schedule a meet and greet in person or via virtual visit! Meet and greets are held every 3rd Tuesday of the month at 5:30 pm. Please call our office to indicate that you are interested so we can coordinate a visit for your family with our team.