December 20, 2021
The United States started vaccinating against COVID-19 a year ago symbolizing a turning point in the fight against the virus and fostering hope for a light at the end of the tunnel with the on-going pandemic. Much progress has been made; however, it remains important to stay vigilant in using our scientific knowledge and tools to combat the emergence of the newest variant of concern – Omicron. Recent data indicates the Omicron variant of concern is beginning to chip away at Delta’s dominance worldwide, including here in the United States. Vaccines remain the best public health measure to protect people from COVID-19, slow transmission, and reduce the likelihood of new variants emerging. The CDC recommends everyone 5 years and older protect themselves by getting fully vaccinated.
It remains Ventegra’s deep commitment to our clients to provide the most updated and relevant one-stop-shop resource on COVID-19.
Key highlights for this update:
- The Delta variant continues to account for the majority of the sequenced COVID-19, however Omicron is quickly gaining traction
- COVID-19 vaccination rates by age group
- FDA expansion of booster eligibility and CDC recommendation for those 16 – 17 years of age
- FDA expansion of monoclonal antibodies for pediatric patients
- FDA authorization granted for AstraZeneca’s long-acting monoclonal antibody for pre-exposure prevention
- President Biden’s at-home testing reimbursement plan
- Pfizer oral antiviral Paxlovid
- Highlights from the Advisory Committee on Immunization Practices (ACIP) meeting on December 16, 2021
COVID-19 VARIANTS
The Delta variant no longer accounts for almost 100% of the sequenced COVID-cases, with the Omicron now accounting for 3% of cases and 45 states within the U.S. having at least one case (as of December 19, 2021). There is significant concern Omicron’s rapid spread could quickly lead to a wave of infection.
A recently released CDC Morbidity and Mortality Weekly Report (MMWR) summarizes current knowledge regarding the initial cases COVID-19 infections with the Omicron variant and provides prevention strategies to slow the spread. On an international scale, the World Health Organization [WHO] Blueprint Research and development recently organized a global consultation regarding the Omicron variant where experts reviewed the available evidence.
COVID-19 Vaccination Trends by Age Group
Individuals who receive one dose of a single-dose vaccine or two doses of mRNA series are considered fully vaccinated. Currently, 61% of the U.S. population is fully vaccinated against COVID-19. The below chart breaks down the number of individuals within each age group who have received at least one dose of the COVID-19 vaccine in the U.S. The newest age group of 5 to 11 year olds able to receive a COVID-19 vaccine is almost 6 million individuals. Other age groups have had 15 million to over 163 million individuals receiving at least one dose. In total, there over 241 million individuals who have received at least one dose of COVID-19 vaccine.
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FDA Expands Booster Eligibility for 16 – 17 Years of Age with CDC Support
December 9, 2021, the FDA recently amended EUA for the Pfizer/BioNTech COVID-19 vaccine allowing the use of a single booster dose for administration to individuals 16 and 17 years of age at least 6 months after completion of primary vaccination with Pfizer/BioNTech COVID-19 vaccine. The CDC has again strengthened its previous recommendations for booster doses for individuals 16 years of age and older, in part due to the emergence of the Omicron variant.
For updated information regarding COVID-19 vaccine boosters, including eligible population and dosing, please view the Ventegra COVID-19 Vaccine Grid for recent revisions. This quick-reference resource is updated regularly as additional information become available.
FDA Expansion of Two Monoclonal Antibodies for Pediatric Patients
December 3 , 2021 the FDA additionally authorized bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are high risk for progression to severe COVID-19, hospitalization or death. The FDA revision also authorized the combination for post-exposure prophylaxis to prevent COVID-19 in all pediatric patients, at high risk of progression to severe COVID-19, hospitalizations, or death.
FDA EUA for AstraZeneca’s New Long-Acting Monoclonal Antibodies
The FDA recently issued EUA for AstraZeneca’s SARS-CoV-2 spike protein-directed inhibitor Evusheld (tixagevimab copackaged with cilgavimab). Evusheld is for the prevention of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [approx. 88 pounds]) who are not currently infected, do not have a known recent exposure, and are moderately to severely immunocompromised or have a history of a severe adverse reaction to a COVID-19 vaccine. Evusheld is administered as two separate consecutive intramuscular injections of tixagevimab 150 mg and cilgavimab 150 mg.
Authorized monoclonal antibodies utilized in the treatment of COVID-19 are being assessed regarding their ability to retain activity against the Omicron variant. Authorized REGEN-COV (Regeneron) remains active against Delta but has shown diminished potency against Omicron. Both authorized sotrovimab (GSK) and Evusheld (AstraZeneca) retain neutralizing activity against Omicron. Next generation monoclonal antibodies in development indicate activity against all known variants of concern, including Omicron and Delta and are pending regulatory discussions.
President Biden’s At-Home COVID-19 Testing Reimbursement Plan
We are awaiting additional details and policy on President Biden’s early December announcement on an initiative that would require private health insurers to reimburse the cost of at-home COVID-19 diagnostic tests for covered individuals. This initiative is part of a broader 9-step plan to combat COVID-19 and the new Omicron variant. The U.S. Department of Health and Human Services, U.S. Department of Labor and U.S. Department of Treasury are expected to release joint guidance by January 15, 2022. Expect more detailed information on at-home COVID-19 testing reimbursement in the coming weeks.
Pfizer announces Additional Phase 2/3 Study Results of COVID-19 Oral antiviral Paxlovid (nirmatrelvir plus ritonavir)
Paxlovid is an oral combination of nirmatrelvir, an investigational SARS-CoV-2 protease inhibitor combined with low dose ritonavir, to slow the metabolism of nirmatrelvir and enhance its effect. Nirmatrelvir final EPIC-HR study data confirmed prior interim analysis results showing Paxlovid reduced risk of hospitalization or death by 89% (within 3 days of symptom onset) and 88% (within 5 days of symptom onset) compared to placebo in high-risk patients. There we no deaths with Paxlovid compared to placebo in the non-hospitalized. Pfizer has shared the data with the FDA as part of the ongoing rolling submission for EUA. A separate, interim analysis of a second study in standard-risk adults (EPIC-SR) showed a 70% reduction in hospitalization and no deaths in treated patients compared to placebo however, the secondary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met compared to placebo. Both trials indicate robust activity against SARS-CoV2 by showing a 10-fold viral load decrease at day five compared to placebo.
ACIP December 16, 2021 Meeting Highlights
ACIP completed a recent benefit-risk analysis of the Johnson & Johnson (J&J) COVID-19 vaccine and concluded the J&J vaccine prevents fewer COVID-19 hospitalizations, ICU admissions and deaths compared to the Pfizer/BioNTech and Moderna mRNA COVID-19 vaccines. The J&J vaccine was found to have more severe health impacts from thrombosis with thrombocytopenia syndrome (TTS) and Guillain Barre Syndrome (GBS) compared to impacts from myocarditis after mRNA vaccines.
As a result, ACIP unanimously recommended and the CDC has endorsed the clinical preference of the Pfizer/BioNTech and Moderna mRNA COVID-19 vaccines over the Johnson & Johnson COVID-19 vaccine among individuals 18 years of age and older. The Johnson & Johnson (J&J) COVID-19 vaccine may be offered to the following populations: (1) Persons with a contraindication to mRNA COVID-19 vaccines (2) Persons who would otherwise remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines (3) Persons who would prefer the Janssen COVID-19 vaccine despite safety concerns identified.
ACIP provided an update on adverse events among children ages 5–11 years after COVID-19 vaccination from v-safe (smartphone monitoring system) and the Vaccine Adverse Event Reporting System (VAERS). No major safety signals were identified with the most common side effects similar to clinical trials. The CDC will continue to monitor this age group and others.
The ACIP update on the Omicron variant indicates this variant is likely to be more transmissible than the original SARS-CoV2. How easily Omicron spreads compared to Delta is still unknown. More data is required to determine if Omicron causes more severe disease or death compared to other variants. The scientific community is still determining how well current COVID-19 treatments work against Omicron. COVID-19 vaccines are expected to continue to protect against severe illness, hospitalization and death.
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For questions, please contact:
Ventegra, Inc.
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