Should US consider risk-based recommendations for COVID-19 vaccines?
Click Here to Manage Email Alerts
CDC advisors this year introduced the idea of transitioning the United States from a universal recommendation for COVID-19 vaccination to a recommendation based on individual risk factors.
The U.S. is one of only a few remaining countries with universal COVID-19 vaccine recommendations, according to the COVID-19 vaccines work group that analyzes and prepares information for the CDC’s Advisory Committee on Immunization Practices. Other countries have recommendations that are based on risk factors or age.
Matthew F. Daley, MD, who chairs the work group, told the ACIP in a June meeting that the group had discussed risk-based vs. universal recommendations for the 2024-2025 vaccines and reviewed the policies of countries that have risk-based strategies.
According to Daley, they considered the pros and cons of implementing a risk-based strategy but decided not to go any further.
“Based on an extensive and deliberative conversation, the work group consensus was to proceed with deliberations for a universal recommendation for everyone aged 6 months and older,” Daley said during the meeting.
After hearing from the work group, the ACIP voted unanimously to stick with a universal recommendation that says all people aged 6 months or older should get a COVID-19 vaccine. The updated shots, which were manufactured to better target circulating SARS-CoV-2 viruses, became available in late August.
“Our top recommendation for protecting yourself and your loved ones from respiratory illness is to get vaccinated,” CDC Director Mandy Cohen, MD, MPH, said in a statement, signing off on the ACIP’s recommendation.
Given that the work group considered moving the U.S. from a universal to a risk-based recommendation, we asked experts about the pros and cons of each strategy, and whether the U.S. should rethink how it approaches COVID-19 vaccination.
Contrasting recommendations
Unlike the CDC, WHO does not recommend routine revaccination for healthy adults or children who have previously been vaccinated against COVID-19. Even children and adolescents who have never received one of the vaccines are not included in WHO’s recommendations unless they have a comorbidity.
Among other countries with targeted guidance, Canada recommends COVID-19 revaccination only for certain risk groups, including adults aged 65 years or older, nursing home residents and pregnant women. For all other previously vaccinated or unvaccinated people, the country says only that they “may be vaccinated” — a recommendation akin to the CDC’s shared decision-making, which puts the decision largely in the hands of patients and providers.
Whereas risk-based policies like Canada’s are clearly meant to target people who are most likely to experience severe complications from COVID-19, the objectives of the U.S. plan remain unclear, according to Amesh A. Adalja, MD, FIDSA, FACP, FACEP, senior scholar at the Johns Hopkins Center for Health Security.
“If the goal is to reduce severe disease, targeting vaccination to [those at highest risk] is the best policy — as is practiced in many countries,” Adalja told Healio. “If the goal is to prevent infection, it is a very difficult task, with protection being very fleeting with current vaccine technologies, although the current updated vaccine is the best match we’ve seen with updated vaccines."
Universal recommendation avoids confusion
ACIP voting member Jamie Loehr, MD, FAACP, owner of Cayuga Family Medicine in Ithaca, New York, said during the June meeting that he had been in favor of a risk-based approach to COVID-19 vaccination in the U.S. but changed his mind after reviewing public comments.
Although he did not read all 3,000 comments, Loehr estimated that 95% of the ones he did read were in support of a broad recommendation for vaccination.
“It seems that at least the public who are commenting are very [much] in favor of a universal recommendation and want the opportunity to get their vaccine,” Loehr said.
Another reason to stick with a universal recommendation is that it could result in higher uptake of the vaccines, experts said.
“We have seen COVID-19 vaccine uptake wither away due to pandemic fatigue, politicization of the pandemic and of vaccines, and poor public messaging,” Zyad Al-Aly, MD, director of the Clinical Epidemiology Center and chief of research and education service at the Veterans Affairs St. Louis Health Care System, told Healio.
Indeed, in the nearly 4 years since the first COVID-19 vaccines became available, uptake in the U.S. has decreased significantly, with just 13.3% of pregnant women, 14.4% of eligible children and 22.5% of all adults having received a dose of one of the 2023-2024 vaccines as of May 11, according to the CDC. Vaccine uptake in adults increased with age but was still only 41.5% among those aged 75 years or older, the CDC noted.
“We know that more people tend to get the vaccines who need it most when vaccine recommendations are universal vs. when a risk-based recommendation is given,” said Healio | Infectious Disease News Editorial Board Member Peter Chin-Hong, MD, professor of medicine and founding director of the transplant infectious disease program at the University of California, San Francisco.
Risk-based recommendations can be confusing for patients and providers and may reduce the overall number of people who get vaccinated, Chin-Hong said, adding that some people at the highest risk may not perceive themselves that way. A universal recommendation, on the other hand, can increase vaccine equity by reaching all populations, he said.
“Patients are notoriously bad for assessing personal risk, and the ensuing confusion may provide barriers for all communities, and especially communities of color,” he said.
In another vote in June, the ACIP changed its recommendations for respiratory syncytial virus vaccination in older adults, scrapping a shared clinical decision-making recommendation in favor of a universal recommendation, but only for patients aged 75 years or older. The committee implemented a risk-based recommendation for people aged 60 to 74 years.
Some physicians cited the original shared clinical decision-making recommendation as one of the reasons uptake of the RSV vaccines was low in their first year, but experts have said that a risk-based approach is just as difficult for vaccine providers to parse as shared clinical-decision making.
“It introduces uncertainty and can limit uptake in this way,” Chin-Hong said.
‘We cannot have our cake and eat it, too’
Vaccination does not just lower the risk for death and hospitalization from acute COVID-19. It also lowers the risk for longer term complications from SARS-CoV-2 infection that could become more prevalent if the U.S. abandons its universal recommendation, experts said.
“COVID-19 vaccination isn’t just about prevention of the most severe disease. There are other reported benefits,” Kizzmekia Corbett-Helaire, PhD, an assistant professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health who helped develop technology used in several COVID-19 vaccines, told Healio.
For instance, there is a possibility that a risk-based COVID-19 vaccine strategy could lead to higher rates of long COVID, including among younger people who might not be included in targeted recommendations but are also at risk for long COVID, according to Al-Aly.
“We know the risk of long COVID has declined considerably over the course of the pandemic, and we know that much of the decline — around 70% — was attributable to vaccination,” Al-Aly said, citing a study he co-authored that was published in July in The New England Journal of Medicine.
“We worry that abandoning vaccination will cause long COVID rates to go up,” he said. “We cannot have our cake and eat it, too. We cannot say that long COVID has declined because of vaccines and then abandon vaccination that led to that decline. This could very possibly lead to a rebound increase in long COVID.”
Corbett-Helaire noted that vaccines can also lower the risk for multisystem inflammatory syndrome in children, a serious pediatric complication of SARS-CoV-2 infection.
Two inflammatory conditions in the heart — myocarditis and pericarditis — have occurred in people after receiving a COVID-19 messenger RNA vaccine, but the outcome remains rare, according to the CDC, and studies have shown that natural SARS-CoV-2 infection poses a much higher risk for myocarditis than COVID-19 vaccination.
Additionally, a study published in JAMA in August showed that patients with myocarditis related to COVID-19 vaccination experienced fewer hospital readmissions and adverse cardiovascular events compared with patients who had conventional myocarditis, which was not the case with patients who had myocarditis after getting COVID-19.
According to another study published in Nature Communications in July, the incidence of heart attack and stroke is lower among people who have received a COVID-19 vaccine compared with those who have not. The study showed that an initial vaccine dose lowered the risk by around 10%, and that second and third doses nearly tripled that protection.
“It’s critically important to vaccinate and ensure boosts for the highest risk groups due to age or underlying risk factors, but we are also learning about the benefits of vaccination on lower risk groups in terms of protecting their heart health, avoiding thromboembolic events, and that vaccination reduces the risk of long COVID,” Peter J. Hotez, MD, PhD, FASTMH, FAAP, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Center for Vaccine Development at Texas Children's Hospital in Houston, told Healio.
“The more we learn, the more I'm concerned about the impact of COVID on heart health and long COVID, and therefore [I’m reluctant] to pivot away from universal vaccinations,” Hotez added.
‘Everyone is at some risk’
The ACIP work group noted other potential complications of changing the U.S. strategy.
According to a summary of the group’s considerations that was presented at the June meeting by CDC physician Lakshmi Panagiotakopoulos, MD, MPH, members said a risk-based recommendation might need to be changed if the strategy led to an unexpected surge in cases.
A targeted strategy also would prevent people who are not in a defined risk group from getting a vaccine if they want one, the group argued, according to Panagiotakopoulos.
Not that there are many people who fit that description. According to the work group, most people in the U.S. have a risk factor for severe illness.
“Although it is true that there are high-risk groups, everyone is at some risk of being hospitalized, even if the risk is very low,” Paul Offit, MD, director of the Vaccine Education Center at The Children’s Hospital of Philadelphia, told Healio, adding that “anybody who wants to get a vaccine should get a vaccine.”
“Anybody who’s upset about the possibility of getting this virus, even if it’s a mild, moderate infection, should get vaccinated,” he said.
‘We should continue to lead’
Research is lacking comparing targeted vs. universal recommendations for COVID-19 vaccination in terms of making sure that people who are at high risk understand that they should get vaccinated, according to Offit.
“It would be nice to have a study that answers that question,” he said. “If it's true that a universal recommendation is better at making sure those groups get vaccinated, that [supports] the recommendation. If that's not true, do you really want to vaccinate a healthy 16-year-old who has had three doses of vaccine and has been naturally infected?”
One non-U.S. study published in BMJ Paediatrics Open assessed the impact of universal and risk-based recommendations on vaccine uptake in Japan and South Korea, which have similar health care systems but different strategies for COVID-19 vaccination, according to the researchers.
In Japan, which universally recommends vaccination for children, coverage rates were between 19% and 72%, the study showed. In South Korea, where the recommendation targets high-risk children, coverage rates were between 2% and 55%, and the COVID-19 death rate among children was higher than in Japan, according to the study.
“The U.S. has led in this area, and we should continue to lead and provide protection to our population,” Al-Aly said. “Vaccines reduce risk of hospitalization and death in the acute phase and reduce the risk of long COVID. They are not a perfect shield but certainly the best available tool to reduce the risk in our population.”
References:
- CDC. Myocarditis and pericarditis after mRNA COVID-19 vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html. Updated Nov. 3, 2023. Accessed Aug. 28, 2024.
- CDC recommends updated 2024-2025 COVID-19 and flu vaccines for fall/winter virus season. https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html. Published June 27, 2024. Accessed Aug. 27, 2024.
- CDC. Weekly COVID-19 vaccination dashboard. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/vaccination-dashboard.html. Last reviewed July 11, 2024. Accessed Aug. 27, 2024.
- Choe S-A, et al. BMJ Paediatr Open. 2024; doi:10.1136/bmjpo-2023-002391.
- Government of Canada. COVID-19 vaccines: Guidance on the use of COVID-19 vaccines during the fall of 2024. https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-covid-19-vaccines-fall-2024.html#a12. Accessed Aug. 27, 2024.
- Ip S, et al. Nat Commun. 2024;doi:10.1038/s41467-024-49634-x.
- Patone M, et al. Circulation. 2022;doi:10.1161/CIRCULATIONAHA.122.059970.
- Semenzato L, et al. JAMA. 2024;doi:10.1001/jama.2024.16380.
- WHO. COVID-19 advice for the public: Getting vaccinated. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice. Last updated Dec. 5, 2023. Accessed Aug. 27, 2024.
- Xie Y, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2403211.
For more information:
Amesh A. Adalja, MD, FIDSA, FACP, FACEP, can be reached at https://www.centerforhealthsecurity.org.
Zyad Al-Aly, MD, can be reached at ziyad.al-aly@va.gov.
Peter Chin-Hong, MD, can be reached at peter.chin-hong@ucsf.edu.
Kizzmekia Corbett-Helaire, PhD, can be reached at ldempsey@burness.com.
Peter J. Hotez, MD, PhD, FASTMH, FAAP, can be reached at https://www.peterhotez.org.
Paul Offit, MD, can be reached at offit@chop.edu.
Collapse
Healio Coverage
Click Here to Manage Email Alerts