The U.S. is approaching 1 million deaths due to COVID-19 since the pandemic began. Current CDC trend reports show new cases, hospitalizations, and deaths associated with COVID-19 infection continue to decline nationwide. Global surveillance remains on alert for any uptick in reported cases and any emergence of new variants of concern and importance. The presence of the Omicron subvariant BA.2 variant is steadily increasing, with recent signals indicating cases are rising in Europe. U.S. wastewater surveillance over the last 15-day period shows nearly 150 wastewater testing sites indicating a 100% or greater increase in the presence of COVID-19.   

The Omicron BA.2 subvariant is approximately 30% more transmissible compared to Omicron (BA.1) based on early trial data from Denmark. According to NEJM, BA.2 has 8 mutations not found on BA.1 that may contribute to its higher transmissibility . The highly contagious Omicron subvariant BA.2 has been gaining speed globally, leading to a resurgence of infections in Europe and China.

In the U.S., the stealth Omicron subvariant BA.2 is now the dominant strain, accounting for 72% of the newly diagnosed COVID-19 cases. It remains unclear if BA.2 will lead to another surge of infections across the U.S. Certain regions are showing an uptick, such as the Northeast. According to Dr. Rochelle Walensky, the CDC is closely monitoring the BA.2 subvariant, stating recent data from areas around the world experiencing various peaks of infection due to the BA.2 show no evidence that BA.2 results in more severe disease or is more likely to evade immune protection. 

COVID-19 vaccinations remain the best line of defense for BA.2. Outpatient antiviral treatments active against BA.2 are remdesivir (Veklury®), ritonavir-boosted nirmatrelvir (Paxlovid™), bebtelovimab and molnupiravir (Lagevrio™).  Sotrovimab remains active against BA.1.1. lineage but unlikely to be effective against the BA.2.

Currently, Congress has not approved additional funding needed to continue the COVID-19 response and minimize the pandemic’s impact on the Nation and the U.S. economy. The Biden Administration has emphasized that failure to fund these efforts will have significant consequences due to insufficient resources required to deal with any future surges including: additional boosters, variant-specific vaccines, testing capacity, and antiviral treatments. As of April 4, 2022 it was announced the Senate had reached an agreement of $10B, less than one-half of the $22.5B proposed by the administration. Votes in the Senate and House are still needed.  

The CDC’s recently released COVID-19 Quarantine and Isolation Calculator helps individuals determine the actions to be taken if they are either exposed to COVID-19 or develop an active infection, including how long to isolate, quarantine, and additional steps recommended to prevent the spread of COVID-19. This calculator is geared towards the general population and does not apply to certain groups and high-risk settings.

Recently the FDA authorized, and the CDC endorsed, a second booster of either Pfizer-BioNTech or Moderna COVID-19 vaccines in the following people:

These additional boosters should be administered at least 4 months after receipt of a first booster dose of any FDA-approved or authorized COVID-19 vaccine. Current evidence suggests some waning of protection against serious outcomes from COVID-19 in older and immunocompromised people over time. Based on emerging data, a second booster dose of either a Pfizer-BioNTech or Moderna COVID-19 vaccine could help boost protection levels in higher-risk people. Nearly 50% of people eligible for a booster have not received one. The CDC continues to recommend that any one 12 years and older should receive a first booster dose. The importance of a second booster dose of mRNA vaccine in younger, healthy people is not certain.

(1) The Clalit Health Services which showed that a fourth dose reduces both the risk of infection and severe illness in people 60 year of age and older. This study is not yet peer-reviewed and awaiting journal publication acceptance.

(2) An open-label, non-randomized trial assessing the efficacy of a fourth dose of mRNA vaccine administered to Israeli health care workers during a period of Omicron-variant predominance. Antibody levels to SARS-CoV-2 had waned 5 months after the third dose, the fourth dose boosted antibodies up to levels observed after third dose but not higher. Vaccine efficacy ranged between 31 – 43% against symptomatic infection. Therefore, those who are young, healthy, and without risk factors may not benefit much from a fourth dose. Older and more vulnerable populations were not assessed in this trial.  

Moderna is expected to submit full data and a request to the FDA for vaccine approval for kids 6 months to 6 years in the coming weeks. Pfizer is currently testing a 3^rd dose in kids under 5 years and expects to have data in April. The next FDA VRBPAC meeting is scheduled for April 6, 2022.

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. 

Pfizer recently announced the initiation of a phase 2/3 study, EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients), to evaluate the safety, pharmacokinetics, and efficacy of Paxlovid™ (nirmatrelvir/ritonavir) in non-hospitalized, symptomatic, pediatric participants (ages 6–17 years) with a confirmed diagnosis of COVID-19 and at risk of progression to severe disease. Additionally, Pfizer is developing an age-appropriate formulation for three additional planned cohorts of younger than 6 years of age and will enroll these younger age groups as trial data from cohort 1 and 2 and the new formulation becomes available.

Effectiveness of 2-Dose Pfizer BioNTech mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5 - 11 Years and Adolescents Aged 12 - 15 Years Children and adolescents aged 5 – 15 years were tested for SARS-CoV-2 weekly, regardless of symptoms (July 2021-February 2022).  Approximately 50% of Omicron infections in this population were asymptomatic. Two doses of Pfizer-BioNTech COVID-19 vaccine reduced the risk of Omicron infection 31% in 5-11 years and 59% in those 12-15 years.

Effectiveness of mRNA Vaccination in Preventing COVID-19-Associated Invasive Mechanical Ventilation and Death - United States, March 2021 - 2022: A COVID-19 mRNA vaccination series is highly effective at protecting against COVID-19 associated mechanical ventilation or death during the Omicron period. Risk reduction was the highest (94%) in adults who received a third dose.

Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following One Johnson & Johnson (J&J) Vaccine Dose against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults. 24% Viral efficacy (VE) against COVID-19-associated emergency department/urgent visits after one J&J dose, 54% after two J&J doses, and 79% after one J&J/one mRNA dose compared to 83% after three mRNA doses. VE against COVID-19-associated hospitalizations followed a similar pattern 31%, 67%, 78%, and 90%, respectively.

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