#17,414
Although the uptake of the bivalent COVID booster shot - introduced last September - has been a disappointing 17% across all age groups, it has gained far more favor (42.6% uptake) among those over the age of 65 who are most likely to experience severe or life-threatening SAR-CoV-2 infection.
Some of this tepid response is likely due to general vaccine fatigue, a belief that the worst of the pandemic is behind us, and to some early high-profile media reports suggesting these reformulated vaccines provided only limited protection against the newer Omicron variants.
But over time, we've see data come in confirming the vaccine's added value, including:
MMWR: 2 Early Estimates Of Effectiveness Of Bivalent COVID Booster In Preventing Medical Encounters
And an NIH Research Matters report from last February called Bivalent boosters provide better protection against severe COVID-19, which found:
- Bivalent booster vaccines against SARS-CoV-2 were 37% more effective than older booster shots at reducing the risk of severe COVID-19.
- The increased protection against hospitalization or death was seen regardless of age or whether people had previously received a different booster
With waning community immunity and the loss of our armamentarium of monoclonal antibody treatments for COVID, many have called for a spring COVID booster campaign, particularly for those at greatest risk of severe illness.
Yesterday the FDA announced their authorization of a second bivalent booster shot for specific age groups (primarily > 65), and a streamlining of the booster process for practically everyone else.
Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
For Immediate Release:April 18, 2023
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Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
What You Need to Know:
- Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.
- Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. The FDA intends to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.
- Individuals 65 years of age and older who have received a single dose of a bivalent vaccine may receive one additional dose at least four months following their initial bivalent dose.
- Most individuals with certain kinds of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months following a dose of a bivalent COVID-19 vaccine, and additional doses may be administered at the discretion of, and at intervals determined by, their healthcare provider. However, for immunocompromised individuals 6 months through 4 years of age, eligibility for additional doses will depend on the vaccine previously received.
- Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
- Children 6 months through 5 years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine (6 months through 5 years of age) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years of age). Children who are 5 years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
- Children 6 months through 5 years of age who have received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses that they receive will depend on the vaccine and their vaccination history.
“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”
(Continue . . .)
Later today (April 19th) the CDC's ACIP will meet to discuss the COVID booster, and make their recommendations. Later this summer the FDA will meet to discuss potential changes to the vaccine for the expected fall campaign.
Although many people have apparently decided that the threat from COVID has diminished, we continue to see evidence that the cumulative long-term impacts of repeat infections can be substantial. A few (of many) studies include:
Nature: Acute and Postacute Sequelae Associated with SARS-CoV-2 Reinfection
EID Journal: Postacute Sequelae of SARS-CoV-2 in University Setting
JAMA: Persistent COVID-19 Symptoms at 6 Months After Onset and the Role of Vaccination Before or After SARS-CoV-2 Infection
Nature: Long-term Cardiovascular Outcomes of COVID-19
BMJ: Elevated Risk Of Blood Clots Up To 6 Months After COVID Infection
While we have hopefully seen COVID's last hurrah as a pandemic threat, as community immunity wanes and new variants emerge, another wave is always possible. Should that happen over the summer, I'll be grateful for any extra protection the booster may provide.
