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FDA approves updated Covid-19 vaccines from Moderna and Pfizer/BioNTech

FDA approves updated Covid-19 vaccines from Moderna and Pfizer/BioNTech



CNN

As the U.S. continues to be hit by a summer wave of Covid-19, the U.S. Food and Drug Administration on Thursday approved updated Covid-19 vaccines from Moderna and Pfizer/BioNTech.

Moderna and Pfizer said updated mRNA vaccines will be available in pharmacies and clinics in the coming days.

“Vaccination remains the cornerstone of COVID-19 prevention,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “These updated vaccines meet the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. Given the waning population immunity from previous exposure to the virus and from previous vaccinations, we strongly recommend that everyone who is eligible get vaccinated with an updated COVID-19 vaccine to ensure greater protection against the variants currently circulating.”

A CVS representative said doses are expected to arrive at stores within a few days. “As soon as vaccine supply arrives at any of our pharmacies, walk-in visits will be accepted,” CVS’ Amy Thibault said. “Our digital appointment scheduler will also be updated with available vaccination appointments,” and customers can check on-site availability online.

A Walgreens spokesperson said its customers can schedule appointments to be vaccinated with the new vaccine within 24 hours, and these will be available starting September 6. However, once the vaccine arrives in the next few days, there will also be the option to schedule an appointment without an appointment.

According to CDC data, levels of the SARS-CoV-2 virus that causes Covid-19 measured in wastewater are at “very high” levels nationwide, causing the highest summer peak in the U.S. since July 2022. Monitoring levels of the virus in wastewater can provide a picture of how widespread the virus is as testing and other forms of surveillance have declined.

According to the CDC, rates of severe illness, including hospitalizations and deaths, are increasing, but are nowhere near the levels of previous years.

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The strain currently prevalent in the U.S. is KP.3.1.1, CDC data show, and it is estimated to have accounted for 37% of cases in the past two weeks, three times the level a month ago.

KP.3.1.1 and KP.2 – the strain included in the updated mRNA vaccines – are both offshoots of JN.1, which will be the target of an updated protein-based vaccine from Novavax. All are versions of the Omicron variant.

The U.S. Centers for Disease Control and Prevention recommended in June that everyone over 6 months of age should receive both a current Covid-19 vaccine and a flu shot this year.

The FDA said Thursday that people ages 5 and older are eligible to receive an updated Covid-19 vaccine from Pfizer or Moderna, provided it has been at least two months since their last dose.

Unvaccinated people ages 6 months to 4 years can receive three doses of the updated Pfizer vaccine or two doses of the updated Moderna vaccine. People in this age group who have already been vaccinated can receive one to two doses of the updated vaccines, depending on the timing and number of doses previously received. Certain people ages 6 months to 11 years with weakened immune systems may be eligible for additional doses.

CNN’s Katherine Dillinger contributed to this report.

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