March 3, 2022
New COVID cases in the U.S. have decreased over 90% since the peak of January 2022. Global new cases also continue to trend downward; however, the CDC continues to advise against travel to over 130 destinations worldwide considered to have very high levels of COVID-19 currently. If travel to these regions is necessary, ensure you are fully vaccinated before travel.
The National Wastewater Surveillance System is the latest public health tool to provide critical information on COVID-19 trends in the community and this data is now available on the CDC COVID-19 Data Tracker. More recent discussions have turned towards transitioning from a period of crisis mode with the virus being “upon us” to a time where living with the virus that we can protect against and treat. New variant surveillance, impacts and recovery of long COVID, and protecting the most vulnerable should continue to be a priority as we move towards a path of normalcy.
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Key Highlights for This Update |
- Additional COVID-19 At-Home Testing Kits Available for Free
- FDA Delays Action on Pfizer Vaccine for Kids Under 5
- FDA updates on monoclonal antibody treatments for COVID-19
- CDC changes booster intervals for immunocompromised
- CDC updated interim guidance for considerations for an 8-week interval between 1st and 2nd doses of a primary mRNA vaccine schedule
- COVID vaccinations in Cancer patients
- New MMWR releases summarized
- CDC’s New Framework for Monitoring COVID-19 in Communities & Masking Recommendations
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Additional COVID-19 At-Home Testing Kits Available for Free
FDA Delays Action on Pfizer Vaccine for Kids Under 5
The FDA VRBPAC meeting scheduled to discuss the potential authorization of Pfizer’s COVID-19 vaccine for children 6 months to 4 years of age has been postponed. This will allow the FDA more time to further evaluate additional data regarding a third dose from the ongoing trial that should be considered as part of the FDA-decision making for potential authorization in this patient population. The data results from the 3rd dose are expected in early April 2022.
FDA Updates on Monoclonal Antibody Treatments for COVID-19
Two key monoclonal antibodies (mAbs) are not performing as well against Omicron’s subvariants compared to the original Omicron. As a result, the FDA has modified the EUAs for both Evusheld and Sotrovimab. The FDA has authorized an increase in the initial dose of Evusheld and has placed a new restriction on Sotrovimab, recommending it not be utilized for COVID-19 treatment in geographical areas where new SARS-CoV-2 variants are showing resistance to the COVID-19 antibody.
Bebtelovimab received FDA authorization as a new mAb that retains activity against Omicron to treat COVID-19 infection. Bebtelovimab is given as a single intravenous injection over 30 seconds for the treatment of mild to moderate COVID-19 in patients at least 12 years of age with: (1) with a positive COVID-19 test and (2) a high risk of progression to severe disease that is not hospitalized or require oxygen therapy due to COVID, and (3) where alternative FDA approved, or authorized treatments are inaccessible or clinically inappropriate. This authorization comes at a crucial time of increasing need for readily available COVID-19 treatments with activity against Omicron.
CDC Update to Interim Clinical Considerations for the use of COVID-19 mRNA Vaccines
CDC Shortens Booster Interval for Immunocompromised
Pfizer and Moderna mRNA COVID-19 vaccines are preferred for both the primary series and booster vaccination in the immunocompromised. The CDC updated guidance recommends a booster be given 3 months after the third dose of an mRNA vaccine, for a total of four doses in immunocompromised individuals. This interval is shorter than the previous interval of 5 months and provides the ability to give earlier booster protection.
CDC Recommends 8-week interval between first and second doses of a primary series of mRNA vaccines for some age groups
The CDC added considerations for an 8-week interval between the first and second doses of a primary mRNA vaccine schedule which may be optimal for some people ages 12 years and older, especially males ages 12 to 39 years of age. Studies support that longer intervals lower rare side effects (myocarditis/pericarditis) while improving vaccine effectiveness. A shorter interval (3 weeks for Pfizer-BioNTech; 4. Weeks for Moderna) between the 1st and 2nd doses remains the interval for: people who are moderately to severely immunocompromised; adults ages 65 years and older; and others who need rapid protection due to increased concern about community transmission or severe risk of disease.
Please check the Ventegra COVID-19 Vaccine Grid for recent revisions regarding COVID-19 boosters, including eligible population and dosing. This quick-reference resource is updated regularly as additional information becomes available. The CDC also provides COVID-19 prevaccination checklist for healthcare professionals.
COVID-19 Vaccination in Cancer Patients
Patients with cancer are at increased risk of contracting SARS-CoV-2 and becoming seriously ill if infected. This patient group may have unique challenges when considering COVID-19 vaccination and was generally not included in pilot investigations nor analyzed as a group in follow-up trials. The Journal of the National Comprehensive Cancer Network (JNCCN) recently published a large study evaluating the short-term adverse events of COVID-19 vaccination in patients with cancer and the potential impact of cancer treatment on such effects. As in previous studies, the most frequently reported adverse event was pain at the injection site. Systemic adverse events were more frequent after a second dose of vaccine. Few differences were noted when comparing cancer patients to those without cancer, and active cancer treatment had little impact on the adverse event profile. In summary, any group differences in reported symptoms did not occur at a rate or degree that would warrant special precautions in administering COViD-19 vaccinations to cancer patients.
Summaries of Recent MMWR Releases
Safety Monitoring of booster doses in adults: All individuals 12 years of age and older should receive a COViD-19 booster dose and receive education that local and systemic reactions are expected after a homologous mRNA booster dose, but these reactions occur less often than those following the 2nd primary series dose.
Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines: During Omicron predominance, vaccine effectiveness against COVID-19 associated emergency department/urgent care (ED/UC) visits and hospitalization was 87% and 91% respectively, during the 2 months after a third dose and decreased to 66% and 78% by the fourth month after a third dose. Protection against hospitalization was greater than against ED/UC visits. Encourage individuals to stay up to date with their COVID-19 vaccination status.
Pfizer-BioNTech mRNA Vaccine Effectiveness (VE) in Children 5 -17 years: Two doses protect against COVID-19 emergency department and urgent care visits in non-immunocompromised children 5 – 17 years of age. However, VE was lower and decreased over time since vaccination during Omicron predominance; a booster dose restored VE to 81% among adolescents aged 16-17 years. Overall (pre-Delta, Delta, and Omicron periods), 2-dose VE against COVID-19 hospitalization was 73 – 94% among those 5 – 17 years of age.
CDC’s New Framework for Monitoring COVID-19 in Communities & Masking Recommendations
Last Friday the CDC announced a new framework for monitoring and reporting levels of COVID-19 in communities. Rather than looking at cases and test positivity alone, community levels of low, medium, and high are now determined by looking at 3 key metrics: hospital beds being used, hospital admissions, and the total number of new COVID-19 cases in an area. Below is a table summarizing the CDC's updated recommendations regarding masking based on your COVID-19 community level.
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Regardless of the community level, the CDC continues to recommend that people stay up to date on vaccines, get tested if showing symptoms, and people should always mask if they are showing symptoms, have tested positive, or have been exposed to someone with COVID-19.
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For questions, please contact:
Ventegra, Inc.
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