CMG COVID-19 Update 5.22.22

New or Updated This Week:
Pfizer Boosters Approved for Age 5-11 (new)
Moderna Vaccine Trial at CMG Reopening Enrollment for Ages 6-23 Months (new)
Continued High Viral Activity in the CMG Community (updated)
First Real World Study of Paxlovid and Molnupiravir (new)
On Acute Hepatitis Cases in Children (new)
On the Monkeypox Outbreak (new)

Hello again everyone. This is the 107th 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.

Pfizer Boosters Approved for Age 5-11 (new)

The FDA and CDC this week approved a booster dose of Pfizer’s Covid vaccine for children age 5-11 who completed their primary series 5 or more months ago.

We recommend booster vaccines for everyone in this age group. For children who have not yet had the illness, we recommend a booster now. Those who have had two doses of vaccine plus the illness have existing immune protection, but a third dose will augment that protection and is encouraged. If your child had the illness during the winter wave or before, now is a good time to boost. If your child just had the illness during the current wave, there is no urgency to boost right now. For these children we feel it makes more sense to wait until summer or early fall to boost.

It is possible Moderna’s version of the vaccine for children in this age group will be approved next month, but there is no way to know for sure. Moderna’s vaccine for children age 6–11 contains 50 micrograms per dose, compared to Pfizer’s 10. Moderna’s vaccine for ages 6 months to 5 years (also not yet approved) contains 25 micrograms. The higher doses in the Moderna vaccines may cause some parents to wait to see whether Moderna’s vaccine is approved before boosting with Pfizer. Though this is an understandable impulse, we do not recommend waiting for the FDA and CDC’s decision given the current high rate of viral transmission locally. Especially for children who have not yet had the illness, we recommend going ahead with a Pfizer booster now. For these children in particular we would like to improve existing immune protection sooner rather than later given the likelihood of exposure at the moment.

Moderna Vaccine Trial at CMG Reopening Enrollment for Ages 6-23 Months (new)

We are thrilled to announce that Moderna has given CMG additional enrollment slots for its KidCOVE vaccine trial. These slots are for children age 6 to 23 months. Enrollment will begin in the next several weeks. We are not yet sure of the total number of slots available.

As a reminder, 75% of participants in this study receive two doses of vaccine while the other 25% receive two doses of placebo. This is a double-blind randomized trial, meaning the families and doctors/staff do not know which children receive vaccine and which receive placebo. If vaccine for this age group is approved by the FDA/CDC while the trial is ongoing, the trial will “unblind,” meaning participants will learn whether they received vaccine or placebo. If this happens, participants who received placebo will be offered vaccine through the trial.

If you are interested in enrolling your 6-23 month old child(ren) in the study, please fill out an Interest Form. Multiple children can be listed on the same form. Please note that enrollment will only be open to children in the 6-23 month age group.

We expect there will be more interest than available slots. We will make the trial available to as many CMG families as we possibly can, and ask for your understanding if we are not able to offer spaces to all who are interested.

Continued High Viral Activity in the CMG Community (updated)

The current viral wave has not yet crested locally. 71 of 679 tests performed at CMG this week were positive, or 10.5%. The true number of cases in the CMG community is much higher – we continue to receive many reports of positive home tests, which are not included in our statistics. Over the last 6 weeks there has been far more viral transmission locally than at any time in the pandemic other than the Omicron wave in December and January. Common symptoms continue to include dry or barky cough, sore throat, fever, nasal congestion/runny nose, aches, fatigue, chills, and stomach upset. The clinical presentation continues to vary greatly – some have few or no symptoms, while others are quite ill.

CMG’s testing numbers for the last 8 weeks are as follows:

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%

4/3 – 4/9:         27 of 533 positive, 5.1%

3/27 – 4/2:       15 of 336 positive, 4.5%

Montgomery County’s official numbers increased significantly again this week. As of Saturday the County was reporting 393 new cases per 100,000 population in the preceding 7 days, up from 300, 200, 179, 145, 118, 84, and 53 the seven weeks prior. 393 cases per 100,000 population is nearly double the CDC threshold for elevated transmission in a community. The County numbers do not include unreported positive home tests, which likely outnumber reported tests by a factor of 3 to 8.

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.

First Real World Study of Paxlovid and Molnupiravir (new)

A preprint study published Friday is the first to document real-world outcomes in patients with mild-to-moderate Covid-19 treated with the oral antivirals Paxlovid and Molnupiravir. This study was conducted in Hong Kong from late February to late April during its Omicron BA.2 wave. The authors evaluated over 40,000 hospitalized Covid patients who did not initially require oxygen support. Patients were monitored for “disease progression,” a composite of all-cause mortality, mechanical ventilation, and ICU admission, for an average of 41 days. Roughly 2,350 patients received Molnupirovir, and 1,000 received Paxlovid (nirmatrelvir/ritonavir). These patients’ outcomes were compared to one another and to those who did not receive oral antivirals.

The authors found that the likelihood of “disease progression” was reduced by roughly 67% among those receiving Paxlovid (Hazard Ratio 0.33) as compared to those not treated with an antiviral. Molnupiravir use was associated with a decrease in disease progression of roughly 50% (Hazard Ratio 0.53). Both antivirals resulted in a shorter time to achieving a low viral load. Compared head-to-head, Paxlovid use was associated with a lower mortality rate and shorter length of stay than Molnupiravir.

These results suggest both antivirals decrease the risk of ICU admission, mechanical ventilation, and death among patients who do not initially require oxygen. In this study Paxlovid was more effective than Molnupiravir, which mirrors results of the initial studies of these medications.

Given its ability to prevent disease progression, we recommend the use of Paxlovid in people 12 and over who have recently been diagnosed with Covid-19 and have risk of progression to severe disease. The medication is not without its drawbacks. It leaves a bitter metallic taste in the mouth that some find intolerable but can be minimized by taking the medication with a sweet-tasting sports drink. Paxlovid can affect the body’s metabolism of many other medications, so regular medications must be reviewed with a physician prior to initiating therapy. And there have been many reports of symptoms returning to some degree after discontinuing Paxlovid, especially if the medication is stopped sooner than its intended 5 day course. It may turn out that 7 or 10 days of therapy is more appropriate than 5 days; this is not yet clear and study is ongoing. Despite the drawbacks, we feel the potential life-saving ability of this medication warrants its use in those at risk.

On Acute Hepatitis Cases in Children (new)

An unusual number of cases of acute hepatitis (inflammation of the liver) in children have been identified in the US, the UK, and several other countries over the last 7 months. The total number thus far identified is just under 200 in the US and just over 200 in the UK. The majority of cases have been in children under age 6.

These cases are unusual in several respects. First, they appear to be occurring more frequently than normally expected in young children. Second, they are not due to the common Hepatitis A-E viruses. Third, a significant percentage of cases have been severe enough to require liver transplantation, and there have been a few deaths.

The etiology of these cases is not yet clear. A significant percentage of patients have tested positive for Adenovirus (68% of the UK patients and many patients in other countries), specifically Adenovirus 41F. Adenoviruses are not typically known for causing hepatitis. Roughly 15% of the UK patients tested positive for Covid. Because most cases have occurred in children too young to receive Covid vaccine, the vaccine itself is not a possible explanation. The UK Health Security Agency is actively investigating several hypotheses. Their most recent Technical Briefing on the issue, published Friday, can be found here. Cases in the UK appear to have peaked in April and have been declining since. The US does not have as comprehensive data to review.

These cases are rare enough that we do not feel parents should be overly concerned, but we do recommend being aware of common hepatitis symptoms. These can include jaundice (yellowing of the whites of the eyes and the skin), dark colored urine, pale/grey colored stool, itchy skin, muscle/joint pain, lethargy, fever, nausea/vomiting, loss of appetite, and abdominal pain.

On the Monkeypox Outbreak (new)

Cases of Monkeypox have been identified recently in Europe, Canada, and the United States. While this sounds concerning and individual cases can be quite severe, monkeypox is far less transmissible than many other viruses. It is spread by respiratory droplets and contact with bodily fluids or active pox lesions. Crucially, it is not very transmissible before symptoms appear, so there is little asymptomatic spread. The monkeypox lesions (raised, blistery “vesicles” on the skin) are quite distinctive, so isolation and containment are relatively easy to achieve.

There is no chance monkeypox will become a global scourge on par with Covid. We recommend putting monkeypox out of your mind unless local cases are identified.