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FDA Approves New mRNA COVID-19 Vaccines As US Sees Spike In Virus

Shots from Pfizer-BioNTech and Moderna have been updated to match more recent variants.

Laura Simmons headshot

Laura Simmons

Laura Simmons headshot

Laura Simmons

Editor and Staff Writer

Laura is an editor and staff writer at IFLScience. She obtained her Master's in Experimental Neuroscience from Imperial College London.

Editor and Staff Writer

EditedbyFrancesca Benson
Francesca Benson headshot

Francesca Benson

Copy Editor and Staff Writer

Francesca Benson is a Copy Editor and Staff Writer with a MSci in Biochemistry from the University of Birmingham.

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macro of rows of vaccine bottles, photographed from the top

Updated shots are winging their way to healthcare settings across the US.

Image credit: Gorodenkoff/Shutterstock.com

New COVID-19 vaccines could soon be on their way to a pharmacy near you, as the US Food and Drug Administration (FDA) has approved updated mRNA shots from manufacturers Pfizer-BioNTech and Moderna.

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The vaccines have been approved and granted emergency use authorization, according to a statement from the agency. Changes have been made to the formulae to target the KP.2 variant, one of the so-called FLiRT variants that came to dominate during spring 2024.

Back in June, the FDA recommended that KP.2 would be the best strain to target, based on observations of how the virus has been evolving and the increase in reported cases. KP.2 – as with all the FLiRT variants – is an offshoot of JN.1, which is part of the Omicron SARS-CoV-2 lineage.

Both the Pfizer-BioNTech and Moderna vaccines are approved for use in those aged 12 and over, with emergency use authorization granted for children aged 6 months to 11 years. Over 12s and 5- to 11-year-olds will be eligible to receive one dose of vaccine, provided it has been two months since their most recent dose. Younger children, aged 6 months to 4 years, can get three doses if they’ve not been vaccinated before, or one to two doses to top up previous protection.

Some immunocompromised individuals may be eligible for additional doses, so if you think this could apply to you or your child it’s best to check with a healthcare provider.

Both manufacturers say their products could become available in pharmacies, clinics, and hospitals across the US in a matter of days. The latest statistics from the Centers for Disease Control and Prevention (CDC) show that positive tests for COVID-19 are on the increase, as well as diagnoses in emergency departments. Hospitalizations and deaths from the virus have also increased in recent weeks, although not as sharply.

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SARS-CoV-2 detections in wastewater are currently at “Very High” levels across much of the US, particularly in the south and west, which is an indicator of high levels of COVID-19 in the community.

“Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.

Earlier this year, concerns were raised about the low uptake of COVID-19 shots, despite data showing that they continue to protect people against severe disease. Keeping up to date with COVID vaccinations has been found to give people broad protection against a range of variants, with some experts even speculating that this baseline immunity could help shield us against future coronaviruses that might emerge.

Lots of people have had their summer plans derailed this year by a bout of COVID, and people continue to experience serious, long-term, and even lethal complications from infection. As we head towards autumn, and all of the seasonal illnesses that come with it, getting an updated COVID vaccine is a great way to help protect your health.

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“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Marks. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.”


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  • tag
  • medicine,

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  • Covid Vaccine,

  • mRNA vaccines

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