February 8, 2022
COVID cases in the U.S. are on a significant downward trend. The seven-day average of hospital admissions decreased about 18% over the previous week, while the daily deaths (~ 2,400 deaths per day) increased 1.6% over the previous week. The United States is now experiencing more deaths per capita than other wealthy countries: 270 deaths per 100k population compared to 233 (UK), 143 (Germany) and 15 (Japan), which may in part be due to our lagging vaccination rates and slow uptake of booster doses.
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During a COVID-19 briefing last Wednesday, it was stated, "with this mixed news, similar to other waves during the pandemic, our data continues to reinforce the critical importance of vaccination."
We have come a long way from the beginning of the pandemic with our expanded knowledge of SARS-CoV-2 and mitigation strategies, the wide availability of safe and effective vaccines and new emerging therapeutics. These trends and progress should not make us complacent; the potential of new variants, the effects of long COVID, and protecting our most vulnerable people should continue to be on our radar as we transition to a more "new normal."
It remains Ventegra’s deep commitment to our clients to provide the most updated and relevant one-stop-shop resource on COVID-19.
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Key Highlights for This Update |
COVID-19 variants
Omicron and boosters
Morbidity and Mortality Weekly Report (MMWR) on the unvaccinated, vs. fully-vaccinated vs. fully-vaccinated with booster
Update on vaccines
- Staying up-to-date with COVID-19 vaccination status
- Full FDA approval and ACIP support for Moderna's COVID-19 mRNA vaccine
- ACIP's February 4, 2022 meeting on interim clinical considerations
- Pfizer/BioNTech's FDA submission for kids under 5 (6 months through age 4)
Antiviral therapy update
- FDA revokes EUA for certain COVID-19 monoclonal antibody treatments
- Antiviral overview & guidance - Ventegra Resource Page updated with new links
CMS Medicare beneficiary coverage of free at-home OTC COVID-19 antigen tests
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COVID-19 Variants
The Omicron variant continues to be the dominant strain and represents 99.9% of the sequenced COVID-19 cases. The Omicron variant can spread more easily but appears to cause less severe disease than previous variants. Mitigation protocols and vaccinations remain the best strategies against Omicron.
An Omicron sub-variant, BA.2 (the original Omicron is BA.1), has been identified and is being closely monitored. Per the CDC Director on February 2, Dr. Rochelle Walensky noted surveillance shows BA.2 represents 1.5% of sequenced cases in the U.S. Early reports indicate that BA.2 has a modest transmission advantage over BA.1 but not at the level seen between Omicron and Delta. So far, there is no indication that BA.2 is more severe or has greater vaccine evasion than Omicron (BA.1), according to Dr. Walensky. Denmark has seen a higher number of the BA.2 sub-variant cases, but that is also in the background of relaxing mitigation strategies.
Omicron and Boosters
Studies continue to demonstrate the effectiveness of COVID-19 vaccinations against the Omicron variant. In particular, when comparing those unvaccinated, fully vaccinated, and those who are up-to-date with COVID vaccinations (see COVID-19 Vaccine Updates below for definition of up-to-date).
CDC MMWR -study concluded that all unvaccinated persons should start vaccination as soon as possible. All adults who have received mRNA vaccines during their primary COVID-19 vaccination series should receive a third dose when eligible, and eligible persons should stay up to date with COVID-19 vaccinations. This study was during both the Delta and Omicron predominant periods.
CDC MMWR -study concluded that COVID-19 vaccinations protected against SARS-CoV-2 infection, including the Omicron variant. All eligible persons should stay up to date with COVID-19 vaccination. Protection against infection and death were higher among fully vaccinated and boosted, esp. among people aged 50-64 years and >65 years.
The charts below show the differences in risk between unvaccinated (UV), fully vaccinated with no booster (FVNB), and fully vaccinated with booster (FVWB). The study showed the risk of a COVID-19 infection for UV were 4 and 14 times higher than FVNB and FVWB respectively. With COVID-19 deaths, the risk for UV were 13 and 53 times higher than FVNB and FVWB respectively.
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COVID-19 Vaccine Updates
Encourage individuals to stay current with their COVID-19 vaccination status. Individuals are up-to-date after receiving a primary vaccination series and one subsequent booster dose. For immunocompromised patients, a third mRNA vaccine dose is considered part of their primary series and they are eligible for a booster dose after the last dose of their mRNA COVID-19 vaccine primary series – see more below on February 4th, 2022 ACIP meeting.
The FDA grants full approval for Moderna's COVID-19 two-dose, primary series, mRNA vaccine (Spikevax) for the prevention of COVID-19 in individuals 18 years age and older with a unanimous recommendation from ACIP.
At the February 4, 2022 ACIP meeting – committee members supported the interim clinical considerations of COVID-19 vaccination for people who are moderately or severely immunocompromised, on passive antibody products and extended intervals for mRNA vaccines. These updates under the Emergency Use Instructions (EUI) will provide more flexibility on shared decision-making between the clinician and patient on weighing the risk and benefits of their clinical scenario. We expect to see more formal guidance in the coming weeks.
Pfizer/BioNTech initiated a rolling submission for their COVID-19 vaccine for EUA in children 6 months through 4 years of age. At the request of the FDA, Pfizer/BioNTech submitted available data on the safety and efficacy of two 3 mcg doses, part of a three-dose series for this age group, with plans to submit additional data on the third 3 mcg dose in the coming months. The VRBPAC will be meeting February 15, 2022 to review the EUA.
Anti-Viral Treatment Update
The FDA revised their EUA to limit the use of two monoclonal antibodies for COVID-19 due to their ineffectiveness in targeting Omicron, Regeneron's REGEN-COV (casirivimab plus imdervimab) and Lilly's bamalanivumab/etesevimab.
For current COVID-19 treatment resources available to healthcare professionals, please visit the Ventegra COVID-19 Resource Center and look for “COVID-19 Treatments” in the Resources for Healthcare Professionals section. Some helpful recent U.S. Department of Health and Human Services (DHHS) references include their Side-By-Side Overview of Outpatient COVID-19 Treatments, Outpatient Therapeutics Decision Guide, and Therapeutic Locator.
CMS Medicare Beneficiary Coverage of Free At-Home OTC COVID-19 Antigen Tests
CMS is developing an OTC COVID-19 test initiative to enable original Medicare and Medicare Advantage beneficiaries to access up to eight at-home OTC COVID-19 antigen tests per month for free directly at eligible pharmacies with no cost to beneficiaries at point-of-sale and without the need for reimbursement. Expect more detailed information before the roll-out of this initiative planned for early spring 2022.
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For questions, please contact:
Ventegra, Inc.
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