May 10, 2022
Fueled by the Omicron subvariant BA.2, cases of COVID-19 appear to be on the rise in the U.S. The 7-day average of new cases indicates a 21.4% increase compared to the previous week. Forty seven states are showing an upward trend, including New York which recently increased its risk level from green (low-risk) to yellow (medium risk) indicating community spread and higher hospitalization rates.
The national rise in COVID-19 coincides with the general loosening of mask mandates, vaccination rates, and Omicron subvariants. There is a concern that COVID variants are not slowing down, and it is uncertain what the next chapter of COVID-19 may look like. South Africa's new surge fueled by subvariants B4 and B5, and the newly identified subvariant BA.2.12 in the U.S. may provide insights and are being closely monitored.
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 |
- OTC COVID-19 tests for Medicare Part B beneficiaries
- CDC Health Alert Network (HAN): availability and outpatient treatments
- Upcoming FDA advisory committee meeting on COVID-19 vaccines
- ACIP next steps on future COVID-19 vaccines
- MMWR weekly update on four recent MMWR reports on COVID-19
- CDC Clinical Outreach & Communication Activity (COCA) on post-COVID condition – Cognitive Symptoms
- FDA limits EUA of Janssen COVID-19 vaccine to certain individuals
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COVID-19 Variants
Accounting for more than 50% of cases in the U.S., the stealth Omicron subvariant BA.2 continues to be the dominant strain. However, the newest Omicron subvariant member, BA.2.12.1, is spreading quickly in the northeast and represents over 36% of cases. According to Dr. Rochelle Walensky, BA.2.12.1 is estimated to be 25% more transmissible than BA.2. Additional evaluation is being conducted to understand the impact of BA.2.12.1 on vaccine effectiveness and the CDC emphasizes those vaccinated and boosted continue to have strong protection against severe disease – even from BA.2.12.1.
OTC COVID-19 Tests for Medicare Part B Beneficiaries
Medicare part B beneficiaries, including those enrolled in a Medicare Advantage (MA) plan, may now receive up to eight OTC COVID-19 tests per calendar month at no cost from participating pharmacies and health care providers while the country remains in the COVID public health emergency. This is the first time Medicare has covered an OTC self-administered test at no cost to the Medicare beneficiaries. There is no new or special enrollment and CMS has provided a web link for frequently asked questions and a participating providers list.
CDC Health Alert Network (HAN) Advisory April 25, 2022
The CDC released updated information on the availability and use of recommended therapies for COVID and to advise against unproven treatments with known potential harms for outpatients with mild-moderate COVID at increased risk of severe outcomes of COVID. CDC/Infectious Disease Society of America (IDSA) has identified the increasing use of systemic corticosteroids and antibiotics to treat outpatients with COVID-19. The NIH COVID Treatments Guidelines (updated April 2022) note these agents can cause harm and provide no demonstrated benefit in patients with COVID-19 who do not have a supplemental oxygen requirement or bacterial coinfection. Antivirals are now widely available and accessible with a provider prescription at pharmacies nationwide and at Test-to-Treat locations. The CDC continues to stress the importance of keeping up-to-date with COVID vaccination in preventing serious outcomes of COVID-19.
Upcoming FDA advisory committee meeting on COVID-19 vaccines
In anticipation of completed EUA requests, the FDA announced a tentative meeting schedule for its Vaccine and Related Biologic Products Advisory Committee (VRBPAC):
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June 7 – Novavax EUA request for COVID-19 vaccine to prevent COVID-19 in those 18 years of age and older.
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June 8, 21 & 22 –Moderna and Pfizer-BioNTech EUAs vaccines in younger populations.
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June 28 – SARS-CoV-2 strain composition of COVID-19 vaccines: discuss the need for modification/fall 2022.
ACIP Next Steps regarding future doses of COVID-19 vaccines
- Continued partnership between FDA and CDC.
- Continued review of additional data: (1) COVID-19 epidemiology, genomic surveillance, and vaccine effectiveness, and (2) Safety, immunogenicity, and variant-specific vaccine efficacy data from manufacturers.
- Evaluation of future COVID-19 vaccine doses will be based on feasibility, implementation requirements and benefits vs. the risk by age group and population.
An important question for ACIP to address is what is the primary goal for future doses of COVID-19 vaccines? For example, is the primary goal to prevent infection or prevent serious illness, such as hospitalization and deaths.
PAXLOVID Update
Paxlovid is quickly becoming a part of the country’s pandemic approach and is now a widely available treatment for COVID. Health care providers should be aware of some recent reports regarding viral relapse with Paxlovid. Pfizer’s final-stage trial of Paxlovid indicated a small number of patients experienced rebound after treatment. According to WebMD the FDA previously stated it was “evaluating the reports of viral load rebound after Paxlovid treatment and will share recommendations if appropriate,” and Clifford Lane at NIH indicated examining potential relapses after 5 days of therapy is a priority for NIH.”
Paxlovid for post-exposure prophylaxis trial (Phase 2/3 EPIC-PEP) failed to show statistical significance in reducing the risk of confirmed and symptomatic COVID-19 infection in adults exposed to COVID through household contact. Compared to placebo, risk reductions of 32% and 37% were observed in adults who received Paxlovid for 5 – 10 days, respectively, to prevent infection, but did not reach statistical significance.
Summaries of Recent MMWR Releases
Hospitalizations of Children Aged 5-11 Years with Laboratory-Confirmed COVID-19. COVID-19 associated hospitalization rates in children ages 5-11 were 2 times higher in the unvaccinated vs vaccinated during the Omicron predominance period (Dec. 2021 – Feb. 2022). Thirty percent of children hospitalized had no underlying conditions and 19% were admitted to intensive care. Severe COVID-19 was more likely in those with diabetes and obesity. Increased vaccination in children aged 5-11 years can prevent COVID severe outcomes.
Seroprevalence of Infection-Induced SARS-CoV-2 Antibodies – United States, September 2021-Februaryy 2022. Three out of every 5 people in the U.S. now have antibodies from a previous COVID-19 infection. The proportion is even higher among children, demonstrating widespread infection during the Omicron surge. The study did not measure where prior infections had high enough antibody levels to protect against reinfection and severe illness, and therefore seropositivity for anti-N antibodies should not be interpreted as protection from future infection. Vaccination remains the safest strategy in preventing serious outcomes from SARS-CoV-2 infection, including hospitalization among children and adults.
Clinician Outreach and Communication Activity (COCA) webinar on Post COVID Conditions (PCC) - Cognitive Symptoms
The American Academy of Physical Medicine and Rehabilitation (AAPM&R) recently published a Multi-Disciplinary Collaborative Consensus Guideline Statement on the assessment and Treatment of Cognitive Symptoms in PCC. The consensus statement provides guidance in evaluating and treating cognitive symptoms consistent with PCC. The CDC hosted a COCA webinar addressing PCC – Cognitive Symptoms, on May 5, 2022. The webinar provided important information on terminology, the cognitive symptoms and risk factors of PCC.
FDA Limits EUA of Janssen COVID-19 Vaccine to Certain Individuals
After additional analysis and review, the FDA determined the risk of thrombosis with thrombocytopenia syndrome (TTS), one to two weeks post-administration of the Janssen COVID-19 vaccine, warrants limiting the use of the vaccine. The FDA concluded the known benefits of the Janssen COVID-19 outweigh the known and potential risks for individuals 18 years of age and older where other authorized/FDA-approved COVID-19 vaccines are not accessible or clinically appropriate, and for those 18 years of age and older who elect to receive the Janssen vaccine because they otherwise would not receive a COVID-19 vaccine.
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Ventegra, Inc.
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