The U.S. Food and Drug Administration (FDA) on June 3 recommended updating the formulation of the COVID-19 vaccines because of studies that indicate their effectiveness is worse against circulating variants of SARS-CoV-2, the virus that causes COVID-19.
“In prior years there appears to have been an inverse relationship between the time since vaccination and vaccine effectiveness, such that COVID-19 vaccine effectiveness against SARS-CoV-2 sublineages appears to wane over time and that better matching of the vaccine to circulating strains is associated with improved neutralizing antibody titers,” FDA staffers wrote in a briefing document, citing two studies.
“Consistent with this observation, a decrease in effectiveness of COVID-19 vaccines (2023-2024 Formula) against COVID-19 caused by JN.1 lineage viruses has been reported,” they added, pointing to one paper that found the currently available vaccines provided just 26.4 percent protection against hospitalization from five to nine weeks and another that found the shots provided just 23 percent protection against COVID-19 infection within 16 weeks of vaccination.
“Available data,” the FDA staffers wrote, “suggest that updating the current formula of COVID-19 vaccines to more closely match currently circulating JN.1 lineage viruses is warranted for the anticipated 2024–2025 respiratory virus season in the U.S.”
Three COVID-19 vaccines are on the market in the United States, made by Pfizer-BioNTech, Moderna, and Novavax. The shots target the XBB.1.5 subvariant of SARS-CoV-2 and were cleared by regulators in the fall of 2023.
“While the majority of healthy, non-elderly adults may have minimal need for an updated vaccine, those who are elderly, immunocompromised, or have significant comorbidities clearly benefit from vaccination,” Dr. David Boulware, an infectious disease professor at the University of Minnesota’s Department of Medicine, told The Epoch Times via email. “A vaccine that most closely matches the currently circulating virus would be most protective.”
Dr. Boulware pointed to another recent study that found the XBB shots provided good protection against hospitalization or death initially, although that protection dropped below 50 percent after four months. The researchers who conducted the study also said a sub-analysis detected lower levels of effectiveness against JN.1 than against XBB sublineages.
U.S. officials have said the COVID-19 vaccines could be updated annually—or even more frequently—in a system similar to the model used for influenza vaccines. The system is aimed at keeping up with newer variants.
XBB.1.5 has virtually no presence in the United States any longer. The JN.1 strain and its sublineages comprised the bulk of cases as of April 27, according to genomic surveillance conducted by the U.S. Centers for Disease Control and Prevention (CDC). The agency estimates KP.2, a descendant of JN.1, became the dominant strain in May.
WHO, EMA Recommend Update
Due to changes in circulating variants, the World Health Organization’s Technical Advisory Group on COVID-19 Vaccine Composition recommended in April that countries introduce monovalent vaccines targeting the JN.1 lineage. The group said the XBB vaccines provide “some additional protection” within three months of vaccination against JN.1, but that studies showed “a slight reduction” in effectiveness against the strain.
The European Medicines Agency also advised updating the shots to target JN.1. “Adapting vaccines to target the JN.1 family of Omicron subvariants is adequate to ensure cross-reactivity against current dominant and emerging strains,” the agency said in a statement.
The FDA’s Vaccines and Related Biological Products Advisory Committee, a group of advisers, is set to meet on Wednesday to consider adopting the FDA’s recommendation.
Advisers will be presented with data from Pfizer, Moderna, and Novavax concerning how their vaccines are performing against JN.1 and KP.2, according to the FDA. The data were not included in the briefing document.
Jessica Adams, a former FDA officer, wrote on the social media platform X that in her opinion, “the FDA has neglected to require evidence of benefit-risk across all ages and prior-infected.”
She added, “Their approach of annual updates based entirely on strain surveillance and waning efficacy of the current version prematurely acts as if COVID vax for all is settled science when it isn’t.”
The FDA’s advisory committee has largely aligned with the agency during the COVID-19 pandemic, and its recommendations are typically taken up by the agency.
If the approval comes, the CDC would then weigh whether to say that certain populations, or virtually everybody, should get one of the updated vaccines. The agency has repeatedly recommended vaccinations during the pandemic, including among people with robust immunity from prior infection.
Low Uptake
Hundreds of millions of Americans took the original COVID-19 vaccines. Many of those people have not returned to receive any of the newer shots.
Just 22.5 percent of adults, and 14.4 percent of children, have received one of the currently available COVID-19 vaccines, according to CDC surveys.
Outside polls indicate reasons for not receiving one of the updated vaccines include concerns they’re not effective, and worries about side effects.
The vaccines have been confirmed to cause heart inflammation and other serious issues, with a small number of cases verified as leading to death.
The CDC currently recommends all Americans aged 6 months and older receive one of the vaccines, regardless of how many times a person has been infected and/or vaccinated in the past.
From The Epoch Times