FDA approves updated COVID vaccines for fall

Millions of updated COVID-19 vaccines will soon be ready for patients, following approval by the U.S. Food and Drug Administration announced Thursday.

The improved Pfizer and Moderna vaccines for people aged 6 months and older come amid a summer surge in COVID-19 cases across the U.S. Two major chains, Walgreens and CVS, previously told USA Today that vaccine shipments could arrive within days of FDA approval.

The new vaccines are designed to target the most current and dominant variants of the virus and protect against severe illness, so getting vaccinated now could help prevent an expected winter surge in infections and the spread of other respiratory illnesses as people gather indoors.

“Vaccination remains the cornerstone of COVID-19 prevention,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

A federal advisory committee said in June that any new vaccines against COVID-19 should target the JN.1 lineage, and the FDA has recommended that manufacturers also target the JN.1 subvariant KP.2.

Pfizer, Moderna and Novavax had previously told federal regulators that vaccines would be available in August, pending FDA approval. The Pfizer and Moderna vaccines use advanced messenger RNA technology to target the KP.2 variant.

The Novavax vaccine, which has not yet been approved this year, uses a traditional protein-based vaccine against the JN.1 lineage. Should trigger an immune response Against the sub-variants circulating.

in statementNovavax said it expects pre-filled syringes to be available “in time for the peak vaccination season.”

Dr. James Cutrell, an infectious disease specialist and associate professor of medicine at the University of Texas Southwestern Medical Center in Dallas, said people in high-risk groups, such as those over 65 and those with chronic diseases, organ transplants or cancer, should get vaccinated as soon as possible. These groups tend to be at higher risk of severe illness and death from COVID-19. They are eligible to be vaccinated every four months.

The protective effect of COVID-19 vaccines fades over time, even for people who were vaccinated last year, and experts say it’s important to get the latest shots because they target the latest variants.

“Every time you get the vaccine, it’s kind of a reminder to your immune system that, ‘Hey, this is still out there,'” Cutrell told USA Today. “If we find the virus, we need to be prepared to fight it.”

The KP.3.1.1 subvariant appears to be the predominant strain of the virus circulating in the United States in the latest estimates. SARS-CoV-2, like other viruses, is constantly changing its genetic makeup in order to survive. KP.3.1.1 is part of the JN.1 subvariant, so the updated vaccine should protect against the circulating variants. Like JN.1 and its subvariants, KP.3.1.1 is derived from the Omicron variant that caused a surge in cases and deaths in the second half of 2021.

Last year, an updated vaccine targeted another derivative of Omicron, XBB.1.5. Despite continued cases and deaths from COVID-19, the number of people vaccinated in the U.S. has dropped dramatically. As of May, only 14% of children ages 6 months to 17 had received the latest vaccine. Federal Commission The percentage of adults who had been vaccinated was 22.5%.

COVID-19 cases, hospitalizations and deaths are far from the levels recorded early in the pandemic, but infection remains a serious risk for many: More than 916,300 people were hospitalized with COVID-19 last season and 75,500 died, according to the Centers for Disease Control and Prevention.

Cleveland Public Health Commissioner Dr. David Margolius said questions remain about vaccine supply and recommendations for priority groups. Last year’s updated vaccine rollout was challenged by vaccine supply and insurance coverage after the public health emergency ends in 2023. Getting vaccinated this year won’t be as easy as it was earlier in the pandemic, he said.

“We’ve learned from last year’s mistakes about setting expectations and how quickly things can unfold,” he told USA Today. “There’s still a learning curve.”

As improved vaccines become available, they could limit a key route for people to get vaccinated for free. The $1.1 billion Bridge Access Program, launched last September, allowed uninsured and underinsured people in the U.S. to get COVID-19 vaccines for free. program It has offered vaccinations to 1.5 million people but will finish on August 31, several months earlier than planned.

Instead, the CDC will distribute $62 million in “unused vaccine contract money” to local and state health departments to provide the latest vaccines to uninsured and underinsured people, a CDC spokesperson said.

Until an alternative program is found, the Galveston County, Texas Health Department: News Release “There will be extremely limited opportunities for uninsured adults to receive the vaccine at no cost,” he said Thursday.

Galveston County Immunization Manager Constance Almendarez told USA Today that vaccine availability will likely be difficult because the virus is still spreading and mutating.

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