As the country strives to get ahead of the Coronavirus by getting as many vaccinated as possible, booster shots may help extend protection. Get the latest developments in today’s blog!
COVID-19 is now reported to be the deadliest virus in the United States, with more than 700,000 deaths, surpassing the 1918 pandemic flu of 675,000.1,2 More than 395 million doses of the COVID-19 vaccine have been administered in the United States.2 Sixty-five percent of the total population have received at least one dose and over half are fully vaccinated.2 With the increased spread of the Delta variant, which is even more infectious than the earlier strains of COVID-19, the urgency for Americans to get fully vaccinated is stronger now than ever.
According to a recent study conducted by the CDC, unvaccinated individuals are 29 times at more risk of being hospitalized for COVID-19 compared to those who are fully vaccinated.3
Even though the Pfizer-BioNTech COVID-19 vaccine received full approval by the FDA in August, there has not been an overwhelming uptake in vaccinations. Over a third of the U.S. population remains unvaccinated.
Moderna and Johnson&Johnson Janssen (J&J/Janssen) have not yet received full FDA approval.
SUSTAINING PROTECTION WITH BOOSTER SHOTS
The COVID-19 vaccines provide highly effective protection against becoming seriously ill from the virus. However, studies show that protection may begin to wane after six months and is less able to provide protection against the Delta variant. The FDA recently approved additional doses of the vaccine for certain populations.
The CDC now recommends that the following groups SHOULD receive the Pfizer-BioNTech booster:
- Aged 65 years and older
- Adults residing in a long-term care setting
- Adults 50 – 64 years of age with certain underlying medical conditions increasing risk of severe illness
The CDC also recommends that the following groups MAY CONSIDER receiving the Pfizer-BioNTech booster, based upon an individual assessment of risks and benefits:
- Adults 18 – 49 years of age with certain underlying medical conditions increasing risk of severe illness
- Adults 18 – 64 years of age at increased risk for COVID-19 exposure and transmission based upon specific occupational or institutional exposures
The booster shot should be administered at least six months after their Pfizer-BioNTech primary series.4 So far, over six million people have received a booster shot.2
Moderna submitted data on additional shots to the FDA on September 1, stating that administering the third vaccination, at half of the original dosing amount, increased antibody levels more than 40 times against the Delta variant.
On October 5, J&J/Janssen asked the FDA to grant emergency-use authorization for its booster dose. Their clinical program found that "a booster of their COVID-19 vaccine increases levels of protection for those who have received their single-shot vaccine to 94 percent."
The requests from both Moderna and J&J/Janssen are set to be discussed and considered at the FDA's Vaccine and Related Biological Products Advisory Committee on October 14 and 15.
WHAT DOES THIS MEAN FOR NAVITUS CLIENTS?
With the authorization of third doses in immunocompromised patients for Moderna and Pfizer-BioNTech vaccines, and of booster doses of the Pfizer-BioNTech vaccines in certain populations, Navitus has made adjustments to ensure claims are paid without additional hurdles.
We continue to proactively test new potential situations, in accordance with national standards, so that when new recommendations occur, they can be updated in our system as soon as possible.
We continue to observe the major public clinical groups tasked with the review of vaccine safety and efficacy, including the FDA’s Vaccine and Related Biological Products Advisory Committee and the CDC’s Advisory Committee on Immunization Practices, to understand the recommendations and concerns that arise from those groups.
Ensure Vaccine Availability
Our goal is to continue making the vaccines available to as many of our members as possible and recommend the inclusion of the vaccines on clients’ formularies.
Monitor Fraud, Waste & Abuse
We recognize that with the nationwide rollout to vaccinate millions of Americans, there may be unscrupulous players looking to take advantage of the situation. Rest assured, Navitus has a robust fraud, waste and abuse team who closely monitor vaccination claims for suspicious activity.
We will continue to monitor vaccine activity and will provide timely updates as more information becomes available.
- Lovelace Jr., B. Covid is officially America’s deadliest pandemic as U.S. fatalities surpass 1918 flu estimates. CNBC.com. https://www.cnbc.com/2021/09/20/covid-is-americas-deadliest-pandemic-as-us-fatalities-near-1918-flu-estimates.html. Published September 20, 2021. Accessed September 22, 2021.
- COVID-19 Vaccinations in the United States. Center for Disease Control and Prevention. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Accessed October 6, 2021.
- Lovelace Jr., B. CDC study shows unvaccinated people are 29 times more likely to be hospitalized with Covid. CNBC.com. https://www.cnbc.com/2021/08/24/cdc-study-shows-unvaccinated-people-are-29-times-more-likely-to-be-hospitalized-with-covid.html. Published August 24, 2021. Accessed September 23, 2021.
- CDC Statement on ACIP Booster Recommendations. Center for Disease Control and Prevention. https://www.cdc.gov/media/releases/2021/p0924-booster-recommendations-.html. Published September 24, 2021. Accessed October 1, 2021.