The Federal Drug Administration (FDA) has authorized bivalent COVID boosters for adults and children ages 5-11, but the Centers for Disease Control and Prevention (CDC) has reported that only 31.4 million people—or 10.1% of those eligible—have received the new vaccine, compared to 68% who completed the primary series.
The booster is designed to bolster protection against the original strain and better combat Omicron variants BA.4 and BA.5, which are currently responsible for most cases of COVID-19 in the U.S. Public health officials are expecting a spike in COVID cases throughout the fall and winter and say the booster will help reduce the spread and severity of the virus in the colder months.
“[The updated COVID-19 boosters] can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants,” CDC director Dr. Rochelle Walensky said in a Sept. 1 press release.
Though COVID-19 cases have fallen since the summer surge, they are beginning to increase once more, with the U.S. seeing around 330 deaths and 3,400 hospitalizations from the virus each day. The average daily case count is around 41,000. New Omicron subvariants emerging in Europe are expected to soon gain steam in the U.S. Widespread use of the bivalent booster will be critical to mitigating the effects of the new strains.
Eligibility for a bivalent booster depends on age and completion of the primary COVID-19 vaccine series. The Moderna version is authorized for individuals 6 years of age and older while the Pfizer version is authorized for individuals 5 years of age and older. The vaccine also must be taken at least two months after completing the primary COVID-19 vaccine series or most recent booster. In addition, the CDC advises that patients with a recent COVID-19 infection wait at least three months to get the updated booster.
The bivalent boosters increase the number of antibodies that can protect the body from the Omicron variant. A new study from the Commonwealth Fund found that if 80% of eligible Americans receive the new booster, the country could avert as many as 90,000 deaths, 936,000 hospitalizations, and 25,900,000 infections.
The original series of vaccines and monovalent booster available last fall were designed to protect against the original variant of COVID-19, not the more recent, contagious strains of Delta and Omicron. The new booster—designed specifically to attack the Omicron variant—provides a fresh dose of immunity against the most prevalent form of the virus.
“If you compare the effect of the vaccine and the boosters against original variants, against Delta, and against Omicron, you can see that the effectiveness becomes less and less,” said Dr. Danyu Lin, a professor of biostatistics at the University of North Carolina Gillings School of Global Public Health. “So for people who have been vaccinated for the same amount of time, the effectiveness against this newer variant is just lower.”
Researchers are still trying to figure out the extent of the vaccine’s efficacy, as the vaccine was rolled out without human clinical trials. However, the vaccine generated positive antibody responses in animals, and a similarly designed vaccine targeted at the original Omicron strain (BA.1) showed strong results on human test subjects. Because the bivalent booster and BA.1 vaccines are so similar, the bivalent vaccine is deemed to be safe even though it did not go through human testing. The FDA has extensive experience safely rolling out vaccines for different strains of influenza in the same manner.
Getting the bivalent booster does not guarantee avoiding the infection, said Dr. Lin, but it will significantly reduce one’s chances of hospitalization or death.
“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness, and manufacturing quality standards for emergency use authorization,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 31 press release.
Bivalent vaccines may cause side effects similar to those of the previous COVID-19 vaccines, including fatigue, chills, fever, and muscle aches. The CDC recommends relieving symptoms by drinking fluids, resting, and taking over-the-counter painkillers after vaccination. The CDC does not recommend taking painkillers before vaccination as the impact of OTC medication on vaccine efficacy is still unknown.
As influenza cases skyrocket across the country, it is worth getting a flu shot as well, and it is perfectly safe to receive both the bivalent booster and the influenza vaccine at the same time. With the holidays arriving, the chances of getting both flu and COVID-19 increase, and getting vaccinated can provide some peace of mind. It is also fine to mix and match the Moderna and Pfizer vaccines.
Because the immune system takes a couple of weeks to fully benefit from the shot, Dr. Ashish Jha, White House COVID-19 response coordinator, has recommended people try to get vaccinated as soon as possible to help ensure safer social gatherings during Thanksgiving. However, he emphasized that any time is a good time to get the shot.
“Don’t wait,” said Jha. “Get your new flu shot and get your new COVID shot today. If Americans did that, we could save hundreds of lives each day this winter.”
BIPOC have suffered a disproportionate number of cases and deaths from COVID-19. Black people also report the lowest rates of vaccination with both the primary series and first booster. Several communities are partnering with local BIPOC-centered organizations to host vaccine events and answer questions.
If you’re looking to get a bivalent booster, visit vaccines.gov to find vaccine sites in your location and make an appointment online. Boosters are being carried in major drug stores such as CVS, Rite Aid, and Walgreens, as well as health care facilities and mass vaccination events. Vaccines are currently free of cost, but patients may have to provide health insurance information if they are insured.