The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 in favor of recommending updated, monovalent, XBB-targeting COVID-19 shots for everyone age 6 months and up.
Specifically, the language in the recommendation supports the “2023-2024” vaccines as authorized or approved by the FDA — in order to cover the recently green-lighted mRNA shots, as well as the Novavax protein subunit vaccine should that be okayed by the agency.
Demetre Daskalakis, MD, MPH, acting director of CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said that the voting language was made to be “inclusive” for vaccines authorized in the coming months, so that ACIP won’t have to reconvene.
ACIP Chair Grace Lee, MD, MPH, of Stanford University in Palo Alto, California, said the risk-benefit balance was greatest for infants and people above 65, but was concerned that making a nuanced recommendation would likely add to existing inequities.
“I’m astonished at the number of people who have not been vaccinated, so we need to make the recommendation as clear as possible,” said ACIP member Camille Kotton, MD, of Massachusetts General Hospital in Boston. “Shared clinical decision-making will result in major problems with equity.”
Pablo Sanchez, MD, of Nationwide Children’s Hospital in Columbus, Ohio, cast the lone dissenting vote, mainly because of a lack of data supporting use of the updated vaccine in children.
“I would recommend it for the elderly, and for certain risk groups, including the immune-compromised, and during pregnancy. But I think we need to let the public know the data on children are not there,” Sanchez said, raising particular concerns about myocarditis risk, which was highest for boys ages 12 to 17, according to data presented at the meeting.
“I want to be clear, I am not against this vaccine,” he added. “The limited data that are available do look great,” he said. “I hesitate to make a universal recommendation even though I support vaccination.”
Vaccine makers noted that existing data using the same underlying platforms in children show safety and efficacy for their vaccines in pediatric populations. Moderna, for instance, said it has data on 16,000 kids in its earlier clinical trials, and that it would expect the safety and efficacy of this latest version to be similar.
In terms of specific recommendations, ACIP recommended that everyone age 5 and up receive one dose of a 2023-2024 mRNA COVID vaccine. Children ages 6 months to 4 years should complete an initial series (two doses of Moderna or three doses of Pfizer/BioNTech) with at least least one dose of the 2023-2024 COVID vaccine.
In addition, people who are moderately or severely immunocompromised should complete a three-dose initial series with at least one dose of the 2023-2024 COVID vaccine, and may receive one or more additional doses, per discussions with their clinicians.
The committee also noted that bivalent mRNA COVID vaccines are no longer recommended in the U.S.
During the meeting, Moderna, Pfizer, and Novavax presented the latest data on their 2023-2024 formulations of their COVID vaccines, targeting XBB lineages.
Moderna conducted a randomized controlled trial of 101 people, showing that safety was consistent with previously authorized vaccines, and that the vaccine induced robust neutralizing antibody titers against XBB.1.5, EG.5.1, and BA.2.86 variants along with other XBB variants.
Pfizer presented data from mouse studies showing robust neutralizing immune responses against XBB.1.5, EG.5.1, and BA.2.86 with their updated vaccine. Novavax presented primate data showing robust neutralizing immune responses against XBB lineages and EG.5.1, but didn’t study BA.2.86.
Earlier in the day, NCIRD officials presented detailed reviews of the COVID-19 literature. Among them were Natalie Thornburg, PhD, who noted that nearly all variants (more than 90%) currently circulating are XBB lineages, making the updated vaccines a good match for this season.
Thornburg noted that BA.2.86 is a descendant of BA.2, which was circulating in spring 2022, but data show that a reduction in virus neutralization is not as severe as might be expected — even though this variant has more than 30 amino acid substitutions in its spike protein.
Fiona Havers, MD, reported on hospitalizations using CDC’s COVID-NET network, showing that the highest hospitalization rates have occurred in people older than 65 and younger than 6 months. Most kids hospitalized with COVID didn’t have underlying medical conditions, she said, but this varied with age — from 75% for those under 6 months, to 23% for those ages 5 to 11.
Sharon Saydah, PhD, reported that there’s accumulating evidence that vaccination reduces long COVID among children and adults.
In addition, Nicola Klein, MD, PhD, of the Kaiser Permanente Vaccine Study Center, presented updated data from CDC’s Vaccine Safety Datalink totaling 12.5 million people. Klein reported that myocarditis rates remained highest in boys ages 12 to 17, and that an earlier signal of ischemic stroke with the Pfizer-BioNTech vaccine has attenuated over time. It also appeared to be associated with concurrent receipt of the adjuvanted or high-dose influenza vaccine and the COVID shot.
CDC’s Megan Wallace, DrPH, MPH, presented the committee’s rationale for making the recommendations, which not only took into account the latest evidence reviews, but also public perceptions about the vaccine, and modeling studies of hospitalizations and deaths based on a universal, risk-based, or no vaccine recommendation.
And Georgina Peacock, MD, of the CDC, explained that the agency aims to ensure no-cost, timely vaccine access for all Americans. Private insurance plans are expected to cover the vaccine at no cost to patients, as are Medicare and Medicaid. The Vaccines for Children program will cover all kids who are uninsured, and the Bridge Access Program will cover the 25 million to 30 million adults who do not have insurance, she said.
This will be the first time a COVID vaccine will be directly available from manufacturers as part of the commercial market rather than through the U.S. government, Peacock noted.
During the meeting, drugmakers revealed the price per dose for their shots: Moderna will have a list price of $129 per dose; Pfizer will cost $120 per dose; and if authorized or approved, Novavax will cost $130 per dose.
On Monday, the FDA approved and authorized the updated mRNA vaccines for use in adults and children ages 6 months and up. The XBB-targeting monovalent dose is approved for people age 12 years and up, and is under emergency use authorization for kids ages 6 months to 11 years.
Source link : https://www.medpagetoday.com/infectiousdisease/covid19vaccine/106308
Publish date : 2023-09-12 17:38:56
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