CMG COVID-19 Weekly Update 10.17.21

New or Updated This Week:
Compelling Data On Short Term Efficacy of Pfizer Boosters (new)
On Moderna and J&J Boosters and the Mix-and-Match Vaccine Strategy (new)
Moderna/CMG Pediatric Vaccine Trial Moves to Younger Children (new)
CMG Flu Vaccine Information (updated)
Status of the Pandemic in the United States and the World (updated)
Status of the Pandemic in the Washington Area (updated)
Statistics – CMG Tests for Active Disease (updated)
Pandemic Themed Group Virtual Visit Offerings – Catalogue of Upcoming Sessions (updated)

Hello again everyone. This is the 79th 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.

Compelling Data On Short Term Efficacy of Pfizer Boosters (new)

Data from Israel presented at an FDA advisory committee meeting Thursday indicates that in the two months following administration of a third ("booster") dose of Pfizer vaccine, recipients are far less likely to contract Covid, develop a severe case, or die than are those who did not receive a booster. The data is consistent across all age groups and has implications for vaccine policy in the United States as we move toward the holiday travel period.

Israel began an aggressive Pfizer booster campaign on July 30th in the midst of a major Delta wave that for a time generated more cases per capita than any country in the world. It was Israel's worst wave of the pandemic in terms of overall caseload despite the fact that much of its population had been fully vaccinated. The booster campaign began with those over age 60 then moved to progressively younger age groups, ultimately including those age 16 and up. Each age cohort showed a marked reduction in the number of new cases and in severity of disease starting two weeks after administration of the booster. The older age groups also showed a marked reduction in the likelihood of death.

The reduction in caseload following booster administration can be seen clearly in Slide 5 of the presentation, which depicts the number of new cases in people over age 60 vs those under age 60 in the time period before, during, and after the booster rollout. During the 6 weeks prior to the campaign and for two weeks after it began, the number of new cases in those over 60 and under 60 were nearly identical and rising steadily. Starting two weeks after boosters began, however, the numbers in these two groups diverged dramatically. New cases in those over 60 dropped from roughly 700 a day on August 15th to 500 a day two weeks later, while new cases in those under age 60 (who were not yet eligible for boosters) continued to increase, from 500 a day to more than 1,300 a day.

These numbers translate to a 10-fold reduction in the risk of infection among those 60 and over who received a booster, meaning a 90% improvement in disease prevention as compared to those who had not received a booster. Similar risk reduction numbers were documented for the age 50-59, 40-49, and 30-39 cohorts when they started receiving boosters. The age 16-29 cohort receiving boosters showed the most marked improvement of all: a 16-fold reduction in the risk of disease as compared to those who did not receive a third dose.

Severe cases were also far less likely in those who received boosters. In the age 60+ and 40-59 cohorts respectively, severe cases were 18.7 and 22 times more likely in those who only received the standard two-dose course as compared to those given a third dose. The absolute numbers: in people 60 and above who had 2 doses of vaccine, there were 957 severe cases in 20.9 million person-days; in people with 3 doses, there were 150 severe cases in 39.6 million person-days. Among those age 40-59 who received 2 doses: 160 severe cases in 25.2 million person-days, as compared to 7 severe cases in 20.2 million person-days among those who received a third dose. And for the 16-39 year-olds: 23 severe cases in 36.9 million person-days for those with 2 doses; 1 severe case in 9.8 million person-days for those with 3 doses.

Third doses reduced the likelihood of death in the 60+ age group by a factor of 14.7 as compared to those with 2 doses (270 deaths in 16.4 million person-days for those with 2 doses; 23 deaths in 10.6 million person-days for those with 3 doses). Among those 40-59 who received 2 doses, there were 7 deaths in 11.9 million person-days; among those with 3 doses there were 0 deaths in 874,000 person days.

The safety data from the Israeli booster campaign is also encouraging. Whereas dose 2 is known to generate a larger side effect profile than dose 1, the dose 3 side effect profile more closely resembled that of dose 1. There were 20 cases of myocarditis or pericarditis out of 2.5 million vaccinees age 16-59, or 1 in 125,000, following dose 3. All recovered.

The data from Israel clearly indicates that those who receive a third dose of Pfizer vaccine are better protected, at least for a period of two-plus months post-vaccination. It is not clear, however, how long the enhanced protection will last. It is possible protection will once again wane after some number of months, though there are many vaccines that generate much more durable protection after a third or fourth dose. We will have to wait for an answer to this question.

Interestingly, the Isreali data also suggests the added protection generated by the third dose may not be limited to vaccinees themselves. After Israel's booster campaign was extended to the 16-39 year old cohort, the rate of illness among the unvaccinated population started to drop significantly. This suggests that amplifying the immunity of a large enough percentage of the previously vaccinated population can have the secondary benefit of decreasing transmission to the unvaccinated. This is not an unreasonable concept – it is in essence a representation of partial herd immunity, where a reduction in susceptibility among those with immune protection provides a measure of protection for those without.

This phenomenon has potential policy implications for countries like the United States in which a sizable percentage of the population is likely to remain unvaccinated. The period from mid-November to January in the United States routinely leads to increased viral transmission due to the onset of cold weather and the increase in travel and visitation over the holidays. There is likely to be significantly more travel and visitation this year as compared to last given the percentage of the population that is now vaccinated and more comfortable visiting with others. This means there is real risk of another rise in caseload over the next several months. An aggressive booster campaign in the United States similar to Israel's summer campaign might significantly decrease transmission among the vaccinated, and to a lesser degree among the unvaccinated.

On Moderna and J&J Boosters and the Mix-and-Match Vaccine Strategy (new)

After considering the presentation referenced above and reviewing data specific to Moderna and J&J, the FDA advisory committee recommended boosters for both this week. Moderna boosters were recommended for the same groups of people as Pfizer boosters: those age 65 and older, those 18-64 with risk factors for severity of disease, and those whose professions put them at high risk of contracting the disease. J&J boosters were recommended for everyone who received that vaccine, regardless of age or risk category. If the FDA itself agrees, an Emergency Use Authorization for Moderna and J&J boosters could be forthcoming at any time. If the CDC also agrees after hearing from its own group of advisors early this week, boosters would officially become available. Our guess is that this will happen this week.

The Moderna booster is likely to be a half dose rather than a full dose. A half dose appears sufficient to generate an enhanced immune response in those who have previously received two full doses. The J&J booster will almost certainly be a full dose.

There is a real question, however, as to whether people who received an initial J&J dose should boost with a second J&J dose or with a single dose of one of the mRNA vaccines. A preprint in medRxiv this week is the latest of several studies to suggest that the immune response is more robust when an mRNA vaccine is given as a second dose following a non-mRNA vaccine such as J&J. In this so called mix-and-match study, 154 people who had previously received a single dose of Pfizer, 154 who'd received a single dose of Moderna, and 150 who'd received a single dose of J&J were enrolled. Each vaccine group was then subdivided into three smaller groups and given a second dose of vaccine. One subgroup received a Pfizer booster dose, one a Moderna booster (full dose), and one a J&J booster. Neutralizing antibody levels were later measured to assess the effect of the various vaccine combinations on immune response. Those who entered the study having previously received one dose of J&J showed a 4-fold increase in neutralizing antibody titer after receiving a second dose of J&J. A 4-fold increase shows an effective immune response, but is not overly impressive. By comparison, those who received J&J as dose 1 and Pfizer as dose 2 showed a 35-fold increase in neutralizing antibody titer, and those who received J&J as dose 1 and Moderna as dose 2 showed a 76-fold increase in antibody titer. These responses are much more impressive.

The FDA advisory committee considering J&J boosters discussed mix-and-match vaccination briefly, but did not issue a recommendation with regard to using one of the mRNA vaccines to boost J&J. To us at CMG it seems clear that using Moderna or Pfizer to boost J&J is likely to generate a more robust immune response. Since there has been no suggestion of a safety issue in this or other mix-and-match studies, this would be our recommended course of action for those who received J&J.

Moderna/CMG Pediatric Vaccine Trial Moves to Younger Children (new)

The next stage of Moderna's KidCOVE vaccine trial in children will begin this week. This will involve the two youngest cohorts of the study: 6 months to less than age 2, and age 2 to age 5. We are happy to report that CMG has been awarded 50 additional slots (for a total of 75) in the 6 months to age 2 group and 90 slots in the age 2 to age 5 group. ¾ of the children who enroll will receive 2 doses of vaccine one month apart. The other ¼ will receive placebo. The vaccine dose for both age groups will be 25 micrograms, one-fourth the adult dose.

This is a double blind study, so neither the families nor the doctors will know which children receive vaccine and which receive placebo. If during the course of the study either Pfizer or Moderna receives an Emergency Use Authroization for their vaccine in these age groups, the study will become unblinded. In this event parents will be told whether their children received vaccine or placebo, and the placebo group will be offered vaccine (both doses) as part of the study. For those of you who have children age 6-11 already enrolled in the study, this same plan applies.

CMG's participation in this stage of the trial will commence this week. If you would like to indicate interest in enrolling your child(ren) and have not previously done so, please fill out an interest form. Only one interest form is needed per family – multiple children can be registered on the same form.

Details of the Planned Pfizer Vaccine Formulation for Children Age 5-11 (new)

Details are now available regarding the planned Pfizer vaccine formulation for children age 5-11. If approved, this version of Pfizer's vaccine will contain 10 micrograms as compared to the 30 microgram adolescent/adult dose. Unfortunately, it will not be possible to simply use the existing adult vaccine stock, draw up 1/3 the normal amount, and use this for the children. Doing so would result in an injection volume of 0.1mL, which is considered too small for an intramuscular injection and has not been tested.

Instead, there will be a new formulation of the vaccine for use in this age group specifically. The vaccine will come in 10-dose vials with an injection volume of 0.2mL. Initial doses will be allocated to the states, which will then direct them to individual practices and perhaps other locations. In Maryland, individual practices will be able to request doses, but are not guaranteed to receive the number they request. CMG will be requesting a large volume of vaccine; we hope to be able to offer it to as many pediatric patients as possible if it is approved.

A decision on Pfizer vaccine for this age group is likely to come in early November. The FDA's advisory panel is scheduled to discuss the issue October 26th, followed by the CDC's advisory panel November 2nd and 3rd. Maryland hopes to "pre-position" doses at injection sites as early as November 1st so vaccination can begin as quickly as possible if approval is granted.

If you have questions or concerns about vaccinating children in this age group, we will be conducting a virtual group session on this topic this week. Please see below.

CMG Flu Vaccine Information (updated)

We are happy to report CMG flu vaccine has arrived and clinics have begun for our patients and their families. We are using an online vaccine scheduling system this year. To book an appointment, please follow this link. Please note that although the link leads to a landing page that says "Capitol Medical Group Pediatrics," it can and should be used for both pediatric and adult patients and their families. There is not a separate scheduling modality for adults. Please also note that each person being vaccinated must have their own appointment – we will not be able to vaccinate those who arrive without an appointment. Appointments are currently available to be booked through Saturday, November 6th. There are still many slots available.

We are using a drive-up vaccine strategy this year, utilizing the building's parking lots. Flu clinics will occur Tuesdays through Fridays in the first of the two underground parking levels, and Saturdays in the second of the two underground levels. Signs on the street will indicate which garage to enter. Families will be directed where to park, have their appointments checked off, fill out a simple form, receive their vaccines at the car, and drive away. Administering flu vaccine will be the sole activity of these drive-up clinics. The nurses will not have other vaccines available to administer, nor will they be equipped to perform testing of any kind.

Patients who are coming into the office for an appointment with a provider, such as a well visit, will be able to receive flu vaccine at that time if they wish. The exception is during our early morning "Before Hours" walk-in hour for sick children – we do not have enough nursing staff during Before Hours to administer flu vaccine.

Status of the Pandemic in the United States and the World (updated)

The situation in the United States improved again this week. The 7-day average of new cases, number of hospitalizations, and deaths per day all decreased. Test positivity was unchanged.
The 7-day cumulative number of Covid-19 cases per 100,000 people in the United States currently stands at 175, down from 210 last week and 231, 259, 315, 308, and 343 the five weeks prior.
The 7-day average number of new cases per day in the United States is currently 84,000, down from 98,000 last week and 109,000, 123,000, 148,000, 145,000, and 164,000 the five weeks prior. The United States recorded roughly 590,000 total new cases in the last week. This represents 23.4% of all new cases worldwide. The United States has 4.25% of the world's population.

The national test positivity rate currently stands at 5.9%, unchanged from last week and down from 6.8%, 7.9%, 8.7%, 10.1%, and 10.5% the five weeks prior.

The number of people currently hospitalized with Covid stands at 62,000, down from 68,000 last week and 75,000, 85,000, 95,000 and 102,000 the four weeks prior.

An average of roughly 1,585 deaths per day were recorded in the United States this week, down from 1,770 last week and 1,880, 2,060 and 2,000 the three weeks prior. As of Saturday morning, the pandemic had killed roughly 724,000 people in the United States.

Only 5 states saw an increase in average caseload this week: Minnesota, Michigan, Colorado, New Hampshire, and Vermont. The current top 10 states (cumulative 7-day case rate per 100,000 population): Alaska 875, Montana 560, Wyoming 490, North Dakota 476, Idaho 469, West Virginia 427, Minnesota 350, Michigan 308, Kentucky 301, and Colorado 287. Again, the national number is currently 175 cases per week per 100,000 people.

The per capita numbers in our region improved again this week. Cumulative 7-day case rate per 100,000 population: Maryland 119 (down from 126 last week and 147, 140, and 147 the three weeks prior), DC 98 (down from 133 last week and 161, 189, and 266 the three weeks prior), and Virginia 175 (down from 224 last week and 231, 266, and 294 the three weeks prior). Virginia, Maryland and DC rank 33rd, 44th and 46th out of the 51 states plus DC on the list this week.

20 populous nations have higher per capita rates of disease than the United States at the moment. The top 10: Georgia (644 cases per 100,000 population this week), Latvia 637, Serbia 616, Lithuania 574, Estonia 560, Romania 511, UK 420, Mongolia 413, Singapore 371, and Moldova 294.

Status of the Pandemic in the Washington Area (updated)

New cases reported in DC averaged 101 per day this week, down from 134 last week and 161, 193, and 269 the three weeks prior. To this point DC has documented roughly 62,975 total cases and 1,183 deaths. New cases in Montgomery County averaged 92 per day this week, down from 106 last week and 122, 116, and 146 the three weeks prior. Montgomery County has now recorded roughly 81,120 total cases and approximately 1,641 deaths.

Statistics – CMG Tests for Active Disease (updated)

CMG conducted 502 tests for active disease this week, 7 of which were positive. This translates to a positivity rate of 1.4%, down from 1.5% last week and compared to 0.8%, 4.6%, 1.7%, 1.8%, and 2.5% the five weeks prior. CMG's average positivity rate for the duration of the pandemic is 2.0%.

Pandemic Themed Group Virtual Visit Offerings – Catalogue of Upcoming Sessions (updated)

Please see below the schedule for our Virtual Group Visit offerings this week. All sessions will take place on Zoom. We expect most sessions to have between 8 and 20 participants. The sessions are meant to be participatory, but if you prefer to keep your camera off and your microphone muted, you are welcome to do so. Questions can be posed directly by voice, or indirectly through the chat function. 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!

Covid Vaccine for Age 5-11: A Discussion In Advance of Likely Approval. Dr. Dan Finkelstein, Tuesday 10/19 2-2:45

In this session we will review the data on the Pfizer vaccine for younger children, discuss the rationale for vaccinating this age group, and address concerns about vaccination. A large portion of this session will be devoted to question and answer about the prospect of vaccines in young children. Parents of toddlers and infants welcome as well.

Boosters, Travel, and Advance Planning for the Holidays. Dr. Dan Finkelstein, Wednesday 10/20, 2-2:45

In this session we will discuss an approach to the next several months – whether it makes sense to seek a booster (whether or not you are in a high risk group), how to think about travel, and circumstances around visits with family/friends. Questions encouraged.