The Centers for Disease Control and Prevention urges all Americans ages 6 months and older to get updated COVID vaccines that more closely match current coronavirus variants.
On September 12, CDC's Advisory Committee on Immunization Practices voted 13-1 in favor of the universal recommendation, though some experts think it should have been limited to older individuals and others at higher risk for severe COVID. New CDC director Dr. Mandy Cohen signed off on the recommendation Tuesday afternoon.
"We have more tools than ever to prevent the worst outcomes from COVID-19," Cohen stated in a news release. "CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones."
The previous day, the federal Food and Drug Administration authorized updated mRNA vaccines from Moderna and Pfizer-BioNTech. The vaccines were granted full approval for people ages 12 and older and emergency use authorization for younger children. A more traditional vaccine from Novavax is still under review and did not get the FDA nod on Monday.
All three updated vaccines —which health officials are no longer calling boosters — target a SARS-CoV-2 omicron variant known as XBB.1.5, which was the most common variant for most of this year.
The vaccines temporarily boost antibody levels, but they also stimulate T-cell and memory B-cell responses that provide longer-lasting protection against severe illness. Some evidence suggests vaccines also reduce the risk of developing long COVID. They do not, however, reliably prevent infection or transmission.
COVID has been on the rise in recent weeks, but case numbers, hospitalizations, and deaths remain far below previous surges because most Americans already have some immunity due to prior vaccination or natural immunity after infection.
As the coronavirus evolves, it becomes better able to evade immunity. However, all three companies have reported that their new vaccines work against the newly dominant EG.5 variant, which is closely related to XBB.1.5. A potentially more evasive variant dubbed BA.2.86 has been detected in several countries, including the United States, but it does not appear to be spreading rapidly.
Studies have shown that the new vaccines are generally safe and well tolerated, but some people may develop flu-like side effects or soreness at the injection site. Although effectiveness data are limited, waiting for the results of larger clinical trials gives new variants time to take over.
"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," stated Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality."
One dose of the updated Moderna or Pfizer-BioNTech vaccine is recommended for most people ages 5 and older, regardless of their prior vaccination history. The vaccines can be administered two months after the last vaccine dose or infection, but some experts urge waiting a few more months to encourage a stronger immune response.
The new Moderna and Pfizer-BioNTech vaccines are expected to be available by the end of this week. The timing of the Novavax vaccine is uncertain, but the CDC's recommendation is written so that this vaccine can also be included once it receives FDA authorization, according to Dr. Demetre Daskalakis, a gay man who is acting director of the CDC's National Center for Immunization and Respiratory Diseases.
These are the first COVID vaccines that will not be provided for free by the federal government; the cost is up to $130 per dose. The vaccines will be covered by Medicare, Medicaid, and most health insurers plans, and the government's Bridge Access Program and Vaccines for Children program will provide them for uninsured individuals.
People can get the new COVID vaccine and the annual flu vaccine at the same time. In addition, a new vaccine to prevent respiratory syncytial virus, or RSV, is available for the first time this year for people ages 60 and older and others at risk.
Who needs the new vaccines?
Despite the lopsided CDC committee vote, all experts do not agree about who should get the new vaccines. Some argue that healthy young and middle-aged people do not need additional vaccines because they remain well protected by prior vaccination and past bouts of COVID.
For example, Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's vaccine advisory committee, who is 72 and healthy, told Science magazine that he plans to skip the new shot.
Experts agree that older adults, immunocompromised people, and those with comorbidities that raise the risk for COVID complications stand to benefit most from the new vaccines.
"It should be noted that the most important people to receive this new vaccine are individuals at increased risk for severe COVID-19 infection, including people 65 years of age and older and those with underlying medical conditions," Infectious Diseases Society of America President Dr. Carlos del Rio said in a statement. "IDSA strongly urges these individuals to receive the new vaccine."
The lone CDC committee dissenter, Dr. Pablo Sanchez, a pediatric specialist at Ohio State University, expressed concern about the lack of vaccine data for children. Children and young adults are already at low risk for severe COVID, and young men are at greatest risk for myocarditis, a type of heart inflammation that rarely occurs as a vaccine side effect.
But even some healthy young people develop severe COVID and long-term complications and could potentially benefit from vaccines, health officials say. What's more, recommending the new vaccines for everyone simplifies things for patients and providers, offers freedom of choice, facilitates insurance coverage, and promotes health equity.
The authorization of the new vaccines gives people one more tool to protect themselves, but as always, they should discuss their personal risk-benefit balance with their health care provider, officials said.
"The proven effectiveness of the COVID-19 vaccines is to prevent serious disease, hospitalization, and death," Dr. Jeffrey Klausner, a professor at the University of Southern California Keck School of Medicine and a former deputy health officer for the San Francisco Department of Health, told the Bay Area Reporter. "Not everyone is at the same risk for those outcomes. The risk in younger, healthy people is quite low.
"Now, because 99% of people have some immunity to prevent serious outcomes due to prior vaccination or recovery from infection, the benefit of boosters is going to be in those with increased risk of those bad outcomes due to having a weaker immune system," Klausner continued. "Public health messaging that does not take into consideration the balance of risks and benefits, including costs, does not engender trust with the community."
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