As we ring in the new year, Ventegra remains steadfast in keeping our clients informed regarding the COVID-19 pandemic. We are now entering the third year of the pandemic and have experienced several waves of infection. There are some early signs that Omicron has peaked in certain regions, such as South Africa, that were among the first to be hit hard by this strain associated with higher transmissibility, but lower overall hospitalization rates. With Omicron now surging in the U.S., this information gives us cautious optimism. However, additional data is needed to know if the U.S. will follow a similar trajectory as other regions. The World Health Organization’s (WHO) strategy to reduce the global impact of COVID-19 emphasizes vaccinating 70% of the population in all countries by mid-2022. 

The Omicron variant has surpassed the previously dominant Delta variant and represents 95.4% of the sequenced COVID-19 cases. The rapid growth rate in Omicron infections is believed to result from a combination of higher transmissibility and its ability to evade immunity provided by past infection or vaccination. 

The CDC has modeled various scenarios of the epidemic trajectory based on what is currently known about the Omicron variant. The daily trend in the number of US COVID cases has recently hit a record high – the previous peak came almost a year ago in January 2021. 

FDA has given EUA for two different oral antivirals, Paxlovid and Molnupiravir, for the treatment of mild-to-moderate COVID-19. These new antivirals are available by prescription only and are not authorized for pre or post-exposure prevention or the initiation of therapy in severe or critical COVID-19 hospitalized patients. Paxlovid's and molnupiravir’s availability will be limited and the eligibility criteria differs between the agents. For more information, please refer to the Oral Antiviral COVID-19 Treatment grid.

Interim manufacturer communication for these agents is that the U.S. Department of Health and Human Services (HHS) is overseeing a fair and equitable distribution of these treatments. Individuals should visit their healthcare provider to determine eligibility for treatment. Healthcare providers and healthcare facilities should contact their state health department to determine how to access these products. NIH has provided guidance on the preference of outpatient antiviral treatments and individual prioritization for logistical or supply constraints.

Molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test. An FDA dedicated page provides information regarding the impact of viral mutations (including Omicron), recommendations for clinical laboratory staff and health care providers, and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations.  Please visit this page for up-to-date information on which tests are expected to fail to detect the Omicron variant and those tests with detection patterns that may be associated with the Omicron variant.

Based on currently available data on the Omicron variant, the CDC updated guidelines shortening the isolation period for those with a positive COVID-19 infection. Additionally, the CDC updated the quarantine period for individuals exposed to someone with COVID. Ventegra has created a flow chart to summarize the updated CDC guidelines for isolation and quarantine.

The FDA recently amended EUA for the Pfizer/BioNTech vaccine expands uses to include the following:

ACIP endorsed these EUA amendments at their meeting on January 5, 2022. 

On January 7th the FDA amended the EUA for the Moderna vaccine to shorten the time between the completion of a primary series and a Moderna booster dose to 5 months. This now aligns with the recommendations for the Pfizer/BioNTech vaccine booster.

For a summary of vaccine eligibility and guidance view Ventegra’s COVID-19 vaccine grid.

CDC COVID-19 Vaccine Study Shows No Link to Pre-Term Births

Many pregnant women remain unvaccinated – many out of concern the COVID-19 vaccine is not safe. In a recently released CDC retrospective study of > 40,000 pregnant women, COVID-19 vaccination during pregnancy was NOT associated with preterm birth or small-for-gestational age at birth compared with unvaccinated pregnant women. This new data supports the safety of COVID-19 vaccination during pregnancy. The CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant, trying to become pregnant now, or may become pregnant in the future.

We will continue to update the Ventegra COVID-19 Resource Center as new information becomes available and encourage you to check back frequently.

Mark Shinmoto, Pharm.D., V.P. Chief Pharmacy Officer