CVR - Coronavirus Vaccines R&D Roadmap

Latest evidence confirms protection against severe illness and death, finds no new safety concerns in comparative studies, and informs 2026-27 medical society recommendations.

FOR IMMEDIATE RELEASE

MINNEAPOLIS, Minn. — The Vaccine Integrity Project, in collaboration with the American Medical Association (AMA), today announced the completion of an independent, vaccine evidence review that assessed the safety and effectiveness of immunizations against influenza, SARS CoV-2 and respiratory syncytial virus (RSV). 

The latest high-quality scientific evidence found that these immunizations continue to provide meaningful protection against severe illness, hospitalization and death. Led by the Vaccine Integrity Project, the review also examined new safety data collected since summer 2025 and identified no new safety concerns in comparative studies with currently recommended immunizations.

Based on the most recent peer-reviewed data, the review gives the public the information they need to help inform their vaccination decisions about the three leading causes of serious respiratory virus-related Illness. 

JAMA published the evidence reviews for RSV, influenza and SARS CoV-2 today. An interactive tool on the Vaccine Integrity Project website lets clinicians, researchers and the public search the studies evaluated by virus or by population group, with links to each paper. 

The evidence review helped inform the 2026-27 respiratory virus immunization recommendations released today by the American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists (ACOG) and Infectious Diseases Society of America (IDSA). 

“Immunization continues to be one of our best tools for preventing severe illness from respiratory viruses,” Vaccine Integrity Project Executive Director Michael T. Osterholm, PhD, MPH, said. “This year’s review confirms that the newest evidence remains consistent with research showing these immunizations reduce the risk of hospitalization and death among the people most likely to experience serious disease.”

The AMA and the Vaccine Integrity Project collaborated on the 2026–2027 respiratory virus season evidence review process. The organizations worked with medical specialty societies and public health organizations to identify key policy questions, evaluate emerging evidence to inform immunization recommendations, and to communicate findings to clinicians and patients.

The AMA also launched a digital resource hub with immunization materials for clinicians and patients based on the evidence review and the medical societies’ recommendations. The resources reflect an AMA needs assessment of physicians, patients and parents of caregivers, public health professionals, and payers, which identified the tools needed to put this season’s vaccine recommendations to practice. These resources, along with the immunization evidence reviews and recommendations, can be found at SpreadTheFacts.org.

“The American public deserves clear, credible information – based on the best available scientific evidence – when making decisions about vaccination. The latest evidence reviews and recommendations are the result of our shared commitment across clinical medicine, science and public health to ensure vaccine recommendations are grounded in sound evidence and developed through a transparent process,” said AMA President-elect Sandra Adamson Fryhofer, MD. “We will continue to work together to make sure the public has evidence-based vaccine guidance to help them make informed decisions.” 

The Vaccine Integrity Project reviewed hundreds of peer-reviewed studies published since August 2025, building on its 2025-26 evidence review of vaccine effectiveness, safety and disease epidemiology data. Prior to 2025, CDC’s Advisory Committee on Immunization Practices (ACIP) routinely reviewed vaccine data to guide immunization recommendations. That process was disrupted last year when the U.S. Department of Health and Human Services abruptly dismissed ACIP’s members and appointed replacements. Despite a successful court challenge in March, an expert-led ACIP has yet to be restored.

###

Below are highlights from the Vaccine Integrity Project’s evidence reviews for influenza, COVID-19 and RSV immunizations:

Respiratory viruses continue to cause substantial illness

Although the burden of respiratory viruses has changed since the COVID-19 pandemic, influenza, COVID-19 and RSV continue to cause hundreds of thousands of hospitalizations in the United States each year.

Influenza remains one of the nation’s leading causes of vaccine-preventable respiratory illness. During the 2025-26 season alone, interim CDC estimates indicate there were at least 390,000 influenza-related hospitalizations and 24,000 deaths. 

COVID-19 has become substantially less severe than during the height of the pandemic, which is good news for the country. The peak weekly COVID-19 hospitalization rate during the 2025–26 respiratory season was 2.0 per 100,000 people. That’s less than half the previous season’s peak and about 80% below the 2022–23 peak. Still, it continues to cause significant illness, particularly among older adults, infants, pregnant women and people with compromised immune systems. During the 2025-26 respiratory virus season, COVID-19 was associated with an estimated 4.6 million to 12.9 million illnesses, 140,000 to 240,000 hospitalizations and 15,000 to 42,000 deaths in the United States. 

RSV continues to place infants and older adults at greatest risk for severe disease. During the 2025-26 season, RSV caused an estimated 2.8 million to 5.8 million outpatient visits, 170,000 to 340,000 hospitalizations and as many as 25,000 deaths. 

What the immunization evidence showed

The influenza review screened more than 5,800 studies and identified 69 newly published studies, including 21randomized control trials, and found that seasonal influenza vaccination continued to reduce hospitalization and mortality among those at greatest risk for severe disease. 

• Among adults over 65, the flu vaccine increased protection against hospitalization by 31%, according to an analysis of VISION Network data. 
• A case-cohort analysis of national surveillance data over eight seasons (2016-2020, 2021-2025) reported that vaccine effectiveness was 80% against laboratory-confirmed influenza-associated deaths among infants and children aged 6 months to 17 years.
• A study of data from 2011-2022 showed that vaccination during pregnancy improved protection by 44% against symptomatic disease in infants 0-6 months.
• For children 6 months-17 years with underlying health conditions, vaccine effectiveness was 48% against influenza-related hospitalization or emergency department visits. 

New evidence also demonstrated greater protection against hospitalization with high-dose influenza vaccines in older adults compared with standard-dose vaccines. 

No new safety concerns were identified, including among nearly 10 million people evaluated through post-marketing safety surveillance. 

Researchers screened more than 11,000 studies related to COVID-19 vaccine safety and effectiveness, identifying 155 that met the eligibility criteria for inclusion in the review. The data show that updated vaccines continue to provide meaningful protection against hospitalization, intensive care admission and death, particularly among older adults and other high-risk populations. 

• For adults over 65, vaccination cut the risk of COVID-related hospitalization by 53% in the 2025-26 respiratory virus season. 
• Maternal vaccination lowered the risk of emergency department and urgent care visits for pregnant women by 58% and extended protection to infants too, with fewer COVID-related hospital contacts in the first two months of life – a vaccine effectiveness range of 50-54.0% - regardless of which month of pregnancy the vaccine was received.
• Young children (9 months-4 years) saw a 76% reduction in COVID-related pediatric emergency department visits.
• For adults with immunocompromising conditions, vaccination cut the risk of intensive care admission or death by 32%-53%, depending on the condition and other factors. 

The review identified no new safety concerns in comparative studies. While investigators also reviewed post-marketing surveillance studies that reported adverse events following vaccination, they lacked appropriate comparison groups, which prevents a determination that those events occurred more frequently than would be expected in the absence of vaccination. 

The examination of RSV data identified 75 eligible studies for inclusion in the evidence review out of more than 2,000 assessed. Vaccination of older adults and pregnant women, along with infant immunization with nirsevimab, substantially reduced severe RSV illness and hospitalization. Newly published evidence continued to support the favorable safety profile of RSV immunizations, with no new safety concerns identified. 

• For adults over 60, multiple studies showed significant protection against hospitalization, with vaccine effectiveness ranging from 69%-83% within the same season as vaccination.
• Maternal vaccination helped to protect infants against hospitalization, with studies showing a risk reduction of 51%-70%.
• The infant monoclonal antibody immunization nirsevimab reduced the risk of RSV-related hospitalization by 63.6%-93.0% within the first RSV season, regardless of the timing of administration. 

One of the questions before researchers and clinicians is whether older Americans need an RSV vaccine booster. At this point, more data is needed. In one study examined by the Vaccine Integrity Project, estimates for RSV vaccine effectiveness against hospitalization and lab-confirmed RSV illness among older adults were higher during the first season after vaccination compared with 12-18 months of follow-up, however, another study showed no significant difference.  

None of the comparative studies included in the Vaccine Integrity Project’s evidence review found an association between RSV vaccination during pregnancy and preterm birth or other adverse pregnancy outcomes.

The evidence reviews were conducted using prospectively and publicly registered protocols and internationally recognized methods for systematic reviews. Researchers searched major scientific databases, independently screened studies at each stage and assessed study quality and risk of bias before synthesizing the findings. 

“Our objective is straightforward: Provide clinicians and medical societies with a transparent, rigorous assessment of the latest evidence so immunization recommendations remain grounded in the best available science,” Osterholm said.

###

Media Contacts:
Kevin Griffis
Director of Media Relations and Public Affairs
Center for Infectious Disease Research and Policy, University of Minnesota
kgriffis@umn.edu
202-412-8377

Kelly Jakubek
AMA Media & Editorial
Kelly.Jakubek@ama-assn.org
312-464-4443

About the Vaccine Integrity Project

Launched by CIDRAP in 2025, the Vaccine Integrity Project works to ensure vaccine recommendations remain grounded in the best available scientific evidence through transparent, independent evidence reviews and collaboration with medical societies and public health experts.

About the AMA
The American Medical Association is the physician’s powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crises, and driving the future of medicine to tackle the biggest challenges in health care. For more information, visit ama-assn.org.