CMG COVID-19 Update 6.19.22

New or Updated This Week:
Vaccine Approval for Young Children; Logistics at CMG (new)
Vaccine Decision Making for Young Children: To Vaccinate or Not, and When (new)
Vaccine Decision Making for Young Children: Moderna vs Pfizer (new)
On the Importance of Clinical Research (new)
Moderna Vaccine Approved for Ages 6-17; Not Yet Available (new)
Viral Activity in the CMG Community (updated)
Group Virtual Visit Offerings – Catalogue of This Week's Sessions (updated)

Hello again everyone. This is the 111th in a series of COVID-19 updates from Capitol Medical Group. These notices are meant to provide an update on the pandemic, explain procedures we have put in place to best serve you, and provide guidance about protecting yourselves and your families. New and updated sections are so indicated.

Vaccine Approval for Young Children; Logistics at CMG (new)

At the time of this writing (Saturday), CDC approval of the Pfizer and Moderna vaccines for young children appears imminent. Both vaccines received Emergency Use Authorizations from the FDA this week. If as anticipated the CDC also endorses their use, vaccination will begin as soon as shipments arrive.

This day has been a long time coming. We are grateful to the hundreds of families in the CMG community and the thousands across the country who participated in the vaccine clinical trials. Your efforts and those of your children have made vaccination for all young children a possibility. Thank you.

CMG has ordered a large quantity of both the Pfizer and Moderna vaccines for young children (please see below for a discussion of the two vaccines). Unfortunately, we do not yet know how many doses we will receive and when the first shipments will arrive, so we cannot yet schedule appointments.

Please refrain from calling the office to schedule a vaccine appointment at this time. As soon as vaccine arrives (expected this week), we will open appointment slots for online booking. Please use this link to schedule an appointment.

Assuming vaccine arrives this week, we plan to conduct a vaccine clinic for as many children as we can in our pediatric suite this Saturday 6/25. Because this Saturday's clinic is speculative at this time, appointments do not yet appear in the system. Please check the link periodically this week for the presence of Saturday slots – we will add them as soon as we know we have vaccine to administer. This Saturday's clinic, if it occurs, will only be for children 6 months through age 5 inclusive. Each patient coming for vaccine will need their own appointment. If we receive both vaccines, both will be available. This information will be posted on our website as soon as we know what we will be able to offer. More on vaccine decision making below.

We respectfully ask for your patience as we try to vaccinate as many children as we can as quickly as we can. Many of our staff have volunteered to work extra hours and days to try to make this happen, knowing how important it is to our community. Please be kind to them. They have been working tirelessly under very difficult circumstances for a very long time now.

Vaccine Decision Making for Young Children: To Vaccinate or Not, and When (new)
At the FDA's advisory committee meeting this week, the CDC laid out the rationale for vaccinating young children in a slide presentation. We agree with their thinking. To summarize, the argument goes like this:

1. Covid is extremely prevalent. The expectation should be that all children will be exposed over time.

2. The rate of Covid-associated hospitalization in children age 6 months through age 4 has increased substantially since Omicron and its derivatives became dominant. This age group is now the most likely among children to require hospitalization due to Covid. As of April, roughly 1 in 800 children this age in the United States had been hospitalized with Covid. The rate of Covid-associated hospitalization in this age group was as high or higher this past winter than all prior flu seasons on record.

3. Vaccination has substantially decreased the likelihood of hospitalization in all older age groups. It should be expected to do the same for this age group.

4. Since Omicron became predominant, this age group has been the most likely among children to require ICU care and oxygen support when admitted.

5. Between January 2020 and mid-May 2022 there were 202 Covid-related deaths in this age group in the United States. This translates to 1.7% of all deaths in this age group during that time. This makes Covid the 5th leading cause of death in this age group.

6. Many more deaths per year are attributable to Covid in this age group than to other vaccine-preventable diseases.

7. There have been roughly 2,000 cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in this age group following Covid infection, including 9 deaths. Not cited in the CDC presentation was this study from Denmark indicating the risk of MIS-C was roughly 9 times greater among unvaccinated children as compared to vaccinated children during the Omicron wave.

8. Though long covid occurs less frequently in young children than older children and adults,

it occurs in some. The likelihood of long covid is reduced in older age groups by vaccination.
We agree with the CDC's assessment that the value of vaccination in young children substantially outweighs the risk, which is minimal. Typical shot-day reactions such as fever, fatigue, injection-site pain, and achiness are likely to occur in a decent percentage of children, while others will have minimal or no reaction. In the vaccine trials there have been no cases of myocarditis/pericarditis in this age group. This condition occurs in a very small percentage of adolescent males after vaccination. It has been vanishingly rare among the millions of children age 5-11 who received the Pfizer vaccine, and is expected to be even less likely in the younger children.

As a result of this risk/benefit analysis, CMG recommends vaccination for this age group, whether or not a child has previously contracted the disease. Many studies have shown that people who get vaccinated after having the illness receive a major boost to their immunity as a result. These are the people who have the most robust immunity and will be best equipped to deal with future iterations of the virus.

As for vaccine timing, there are some considerations. For children who have not yet had the disease or who had it in March of this year or before, we recommend vaccinating now. For children who had the illness in April of this year or later, vaccination can occur now or be delayed another month or two.

For those who are not sure about vaccinating their young children or who would like to hear more about this question, we will be conducting two virtual group sessions on this topic this week. Please see below.

Vaccine Decision Making for Young Children: Moderna vs Pfizer (new)

There are substantial differences between the two vaccines, though we expect both will protect against severe disease, MIS-C, and long covid. The basics:

Pfizer: Ages 6 months to 4 years. 3 micrograms per dose. Three doses as an initial series. 3 weeks or more between Doses 1 and 2; 8 weeks or more between Doses 2 and 3. A 4th dose will likely be needed as a booster.

Moderna: Ages 6 months to 5 years. 25 micrograms per dose. Two doses as an initial series. 4 weeks or more between Doses 1 and 2. A 3rd dose will likely be needed as a booster.
As with the adolescent/adult and grade-school age versions of the vaccines, the two companies took different approaches with regard to dosing for young children. For each of the age categories, Moderna selected a higher dose than Pfizer. Moderna's dose for age 12 and up is 100mcg, whereas Pfizer's is 30mcg. Moderna's dose for age 6-11 is 50mcg, whereas Pfizer's dose for age 5-11 is 10mcg. The difference is most exaggerated for the young children: 25mcg for Moderna vs 3mcg for Pfizer.

Pfizer's rationale for selecting the smaller dose was to decrease the likelihood of shot-day side effects and thus increase tolerability. This decision seems to have been successful for this specific purpose – Pfizer's vaccine in young children does appear less likely than Moderna's to cause fever and fatigue in young children in the day following injection. However, selecting the smaller dose also appears to have compromised Pfizer's initial potency. Pfizer had hoped a two-dose regimen at 3mcg per dose would be sufficient as a primary series, but this turns out not to be the case. In the young children a third Pfizer dose is needed to reliably generate an immune response comparable to that generated by a two-dose series in the older age groups.

By contrast, Moderna's larger dose appears to generate a sufficiently potent immune response after the two-dose primary series, comparable to that in older children and adults. Trial data suggests the Moderna vaccine does more commonly cause fever and fatigue in the day or so after vaccination, again likely due to its larger dose. The rate of fever and fatigue, however, is comparable to that generated by many other pediatric vaccines. Neither vaccine generated any serious side effects during the vaccine trials.
Both vaccine regimens are likely to require at least one booster dose at some point. Thus, in our view parents should consider the Pfizer vaccine to be a 4-dose series and Moderna a 3-dose series.

Because both vaccines were made to protect against the original version of the virus but were not tested in young children until Delta and Omicron were dominant, their efficacy statistics against infection are not overly impressive. Pfizer's vaccine in young children was roughly 28% effective at preventing disease after two doses initially, and efficacy dropped further thereafter. Pfizer has represented that efficacy increases to 80% after the 3rd dose, but this claim is misleading – that figure was generated after only 10 instances of disease in its study population and only a short time after the third dose. The number may not be accurate to begin with and will certainly decline over time. Moderna's vaccine after two doses was roughly 51% effective against infection in the 6 month to 23 month cohort, and 37% in the age 2 to age 5 cohort. These numbers also will drop with time. There is no data yet available for Moderna after a third dose – this is being tested now. Moderna's efficacy numbers will surely go up after a third dose, likely by a substantial margin, but will then also drift down over time.

Efficacy against infection, however, is no longer the main point of these vaccines. Until they are reformulated to better address the Omicron derivatives, the main purpose of the vaccines will be to prime the immune system in order to prevent severe disease during the acute phase and reduce the likelihood of post-acute syndromes such as MIS-C and long covid. We feel both vaccines are likely to accomplish these goals.

Overall, we have a slight preference for the Moderna vaccine for most children, though we feel either is acceptable and both are preferable to not vaccinating. We prefer Moderna's higher dose and (likely) smaller number of overall injections. Moderna will lead to "full" protection more quickly (2 weeks after shot 2, or 6 weeks total after shot 1), as compared to Pfizer (2 weeks after shot 3, or 13 weeks total after shot 1).

There is one subset of children for whom Pfizer may make more sense: those with a history of febrile seizures and/or a history of major adverse reactions to other vaccines. For these children the lesser chance of a shot-day reaction may make Pfizer the better choice.
Please do some thinking about vaccine choice before you come to the office on vaccine day. The nurses will not be able to provide medical guidance between the vaccines and will ask which you would like for your child. For those who would like a more in-depth discussion of the vaccine options, Dr. Finkelstein will be conducting two virtual group visit sessions on the topic this week. Please see below.

Moderna Vaccine Approved for Ages 6-17; Not Yet Available (new)

Moderna's vaccine formulations for ages 6-11 and 12-17 were approved this week. The 12-17 year olds dose is the same as the adult dose (100mcg); the 6-11 year old dose is 50mcg. These doses are higher than the respective Pfizer doses (30mcg age 12 and up, 10mcg age 5-11).

Children in these age groups have been eligible for vaccination and boosting for some time, so approval of the Moderna vaccine will have a relatively small impact. However, for children still in need of the primary series or a booster, this vaccine may well be useful. Multiple studies suggest there is a small benefit to the mix-and-match vaccine approach.
The Moderna vaccine for these age groups is not yet available for us to order. We will let you know here when we have it at CMG.

On the Importance of Clinical Research (new)

Though it feels as though it has taken forever to reach approval for vaccine in young children, it is actually quite remarkable that we have two vaccines developed and tested within two-plus years of the emergence of a new pathogen. That we have a vaccine at all is the result of the incredible work done at breakneck speed by scientists around the world. But it is also due to the willingness of families to participate in clinical research. Children in our community, throughout the United States and around the world can now be vaccinated because many families volunteered for the clinical trials necessary to test the vaccines. We feel privileged to have been able to participate in this effort at CMG and are indebted to the families who helped us along the way. You have our sincere gratitude.
We hope to participate in additional important clinical research projects in the future. We will let you know if future opportunities come our way.

Viral Activity in the CMG Community (updated)

18 of 351 tests performed at CMG this week were positive, or 5.1%. This is the first time in 9 weeks our test positivity has fallen below 8%, and represents a second consecutive week of decline. We are once again cautiously optimistic that viral activity in our community may be starting to decrease.

The true number of cases in the CMG community continues to be much higher than our numbers suggest, as CMG statistics do not include the many reports of positive home tests we continue to receive. CMG's testing numbers for the last 10 weeks are as follows:

6/12 – 6/18: 18 of 351 positive, 5.1%
6/5 – 6/11: 37 of 444 positive, 8.3%
5/29 – 6/4: 31 of 286 positive, 10.8%
5/22 – 5/28: 45 of 529 positive, 8.5%
5/15 – 5/21: 71 of 679 positive, 10.5%
5/8 – 5/14: 79 of 587 positive, 13.5%
5/1 – 5/7: 63 of 468 positive, 13.5%
4/24 – 4/30: 35 of 420 positive, 8.3%
4/17 – 4/23: 53 of 467 positive, 11.3%
4/10 – 4/16: 17 of 352 positive, 4.8%

Montgomery County is currently reporting 247 new cases per 100,000 population over the last 7 days, down from 263 last week and 320, 393 and 393 the three weeks prior. 247 cases per 100,000 population is above the CDC threshold for elevated transmission in a community (200), and does not include the many unreported positive home tests.

Given the high level of viral activity in our area, we continue to recommend masking in indoor spaces and vaccinating fully, including all eligible boosters.

Group Virtual Visit Offerings – Catalogue of This Week's Sessions (updated)

Please see below the schedule for our Virtual Group Visit offerings this week. All sessions will take place on Zoom. Sessions will be billable to insurance as would a normal visit with your provider.

If there is a session you would like to join, please email This email address is being protected from spambots. You need JavaScript enabled to view it. or call the office at 301-907-3960. Please include the name and date of birth of the patient, the session you would like to join, the provider who is leading it, the day and the time. We look forward to seeing you online!

Vaccine Considerations for Young Children – Dr. Dan Finkelstein, Monday and Tuesday 3:15-4

In these sessions we will review the rationale for vaccinating young children, discuss whether and when to vaccinate children who have already had Covid, and talk through how to decide which vaccine to use. We will also discuss specific situations, such as a child soon to turn 5 or soon to turn 6. We will leave a significant portion of the time for question and answer. Please select one session or the other – the content will be the same.