This story was updated with more information on Sept. 14 at 10:53 a.m.

By Marie Rosenthal, MS

The CDC made a universal recommendation for the updated COVID-19 vaccines this fall and winter to protect against serious outcomes of COVID-19.

The updated mRNA vaccines from Pfizer-BioNTech and Moderna and the protein-based vaccine from Novavax have been modified to address currently circulating omicron strains of SARS-CoV-2. The original Wuhan strain is no longer circulating, according to Isabella Eckerle, MD, DTMH, a clinical virologist, who spoke during a webinar hosted by the European Society of Clinical Microbiology and Infectious Diseases and the Infectious Diseases Society of America (IDSA) on Sept. 12.

The Pfizer-BioNTech monovalent XBB.1.5 BNT162b2 vaccine is equally immunogenic against XBB.1.5, EG.5.1 and BA.2.86 SARS-CoV-2 variants, according to Kayvon Modjarrad, MD, PhD, the executive director of Viral Vaccines, Vaccine Research and Development, at Pfizer. The variant-adapted vaccines improve the immune responses against antigenically matched and closely related strains, he told members of the CDC Advisory Committee on Immunization Practices (ACIP).

The Moderna 2023-2024 formulation of the XBB.1.5 COVID-19 vaccine provides robust neutralizing antibody titers against XBB.1.5, XBB.1.16, EG.5.1, FL.1.5.1 and BA.2.86 variants of SARS-CoV-2 measured in sera from people who received the modified vaccination. The safety profile of Moderna’s XBB.1.5 vaccine was consistent with previously authorized vaccines, according to Frances Priddy, MD, MPH, the executive director of Clinical Development at Moderna, at the same September ACIP meeting.

Moderna anticipates the vaccine will be effective against current SARS-CoV-2 variants, she said.

Nonclinical data also support the use of the Novavax XBB.1.5 vaccine, the only protein-based COVID-19 vaccine available in the United States, according to Filip Dubovsky, MD, the president of Research and Development at Novavax. It also induces a robust neutralizing response against the XBB subvariants, he said, and generates a polyfunctional Th1-based CD4+ cellular immune response against the variants. 

The CDC’s recommendation came after the ACIP decided in a 10-11 vote that the vaccine should be given to most people who are 6 months of age and older. The one person who voted against the recommendation, Pablo Sanchez, MD, did so because he thought young children should receive the vaccination after a discussion with a healthcare provider in what is called shared decision making.

“I just want to be clear that I am not against this vaccine,” said Dr. Sanchez, a pediatric infectious disease specialist at The Ohio State University-Nationwide Children’s Hospital, in Columbus. “The data do look great. … It has neutralized activity against the other variants and certainly the ones that are circulating now or expected to be circulating. 

“I am very much pro-vaccination and certainly in high-risk groups,” he continued, but added that data about its use in children and infants are limited, and caregivers should be made aware of the potential side effects, especially in young adult males, before deciding. 

“I think all that needs to be weighed. And so that’s why I hesitate to make it just a universal recommendation, even though I do support vaccination with the COVID vaccine.”

All the vaccines, including the updated ones, carry a risk for myocarditis/pericarditis, especially for adolescent and young adult males. Cases of Guillain-Barré syndrome and anaphylaxis have also been reported. However, these serious adverse events are rare, according to Nicola Klein, MD, PhD, the director of the Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California.

Sarah S. Long, MD, another pediatric infectious disease specialist at Drexel University College of Medicine, in Philadelphia, also expressed concern about a universal vaccine that included young children but ended up voting for the recommendation.
Vaccination remains the best protection against COVID-19–related hospitalizations and death. Vaccination also reduces one’s chance of suffering the effects of long COVID, which can develop during or after acute infection and last for an extended time, according to the CDC.

“I’m fully in favor of the universal recommendation,” said Oliver Brooks, MD, FAAP, the chief medical officer at Watts Healthcare Corporation in Los Angeles. “I think the long-COVID data for post-COVID conditions is compelling, and although we don’t have a lot of data in children in terms of a universal [recommendation], it’s likely it will be a benefit.

“This is the information we have. The virus is out there mutating,” he said. Dr. Brooks pointed to the data that found the vaccine was effective in stimulating the development of neutralizing antibodies to at least one of the XBB strains.

The country has seen an increase in hospitalization rates in all age groups since mid-July, according to Fiona P. Havers, MD, MHS, the team lead, RESP-NET Hospitalization Surveillance Team, Surveillance and Prevention Branch, Coronavirus and Other Respiratory Viruses Division, CDC. From Aug. 27 to Sept. 2, there were almost 19,000 people hospitalized for COVID-19—an 8.7% increase. 

Most were older adults or infants younger than 6 months of age. While most hospitalized adults have multiple underlying medical conditions, most hospitalized children who were younger than 5 years did not have an underlying medical condition.

Presentations at the ACIP meeting showed that a combination of changing variants and waning immunity from both vaccination and natural infection required the updated vaccination and precipitated the recommendation. “Receiving an updated COVID-19 vaccine can restore protection and provide enhanced protection against the variants currently responsible for most infections and hospitalizations in the United States,” the CDC said in a statement.

Last season, those who received a 2022-2023 COVID-19 vaccine saw greater protection against illness and hospitalization than those who did not receive a COVID vaccine. To date, hundreds of millions of people have safely received a COVID-19 vaccine under the most intense safety monitoring in U.S. history, the CDC said.

Most Americans can still get a COVID-19 vaccine for free. For people with health insurance, most plans will cover a COVID-19 vaccine at no cost. People who don’t have health insurance or with health plans that do not cover the cost can get a free vaccine from their local health centers; state, local, tribal or territorial health department; and pharmacies participating in the CDC’s Bridge Access Program. Children eligible for the Vaccines for Children program also may receive the vaccine from a provider enrolled in that program. 

“We have more tools than ever to prevent the worst outcomes from COVID-19,” said CDC Director Mandy Cohen, MD, MPH. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older.”

The Infectious Diseases Society of America (IDSA) said it endorsed the recommendation. 

“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. IDSA strongly urges these individuals to receive the new vaccine.

“COVID-19 vaccination has been shown to reduce the risk of severe COVID-19 disease and may help protect against long COVID for those who get infected. The best protection against COVID-19 and the possibility of serious illness remains staying up to date with vaccinations, including the latest vaccine. Having vaccines approved is not enough—getting vaccinated is necessary for protection,” said Carlos del Rio, MD, FIDSA, the president of the IDSA.