New COVID-19 Vaccine Approved by FDA

Photo Courtesy of the U.S. Food and Drug Administration

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The fall virus season is upon us, and the U.S. Food & Drug Administration just approved one of the newest tools to protect Americans from severe illness. 

The updated COVID-19 vaccine is expected to be available at pharmacies around the country in the coming weeks.

The mRNA vaccine is not a booster, says Doug Kasper, MD, an infectious disease specialist with OSF HealthCare. He says it’s recommended for a much broader portion of the population.

“The vaccine is now recommended for everybody 6 months and older as a one-time, once-a-year vaccine,” Dr. Kasper says. “The vaccine has been updated. For people who are at really high risk, those 65 and older or with respiratory conditions, they may get a second shot. This would be in a six-month interval in the springtime.” 

Does the vaccine prevent me from getting COVID-19?

The quick answer? No, much like you find with the annual influenza vaccine.

“The vaccine seeks to protect severe outcomes associated with COVID-19. It doesn’t protect you from getting COVID, it tries to decrease the severity of how sick you would get,” Dr. Kasper says. 

While there has been an uptick in COVID-19 cases recently, Dr. Kasper says there has not been an increase in COVID hospitalizations. He attributes this to robust natural immunity in the population and adding this COVID-19 vaccine is just another way to protect yourself from severe illness.

FDA’s “What to Know” sheet

The 2024-2025 formula has been updated to protect against the Omicron variant KP.2.

  • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated, authorized Moderna COVID-19 vaccine.
  • Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
  • Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least two months after the last dose of any COVID-19 vaccine.
  • Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty (manufactured by Pfizer BioNTech) or the updated, approved Spikevax (manufactured by Moderna); if previously vaccinated, the dose is administered at least two months since the last dose of any COVID-19 vaccine.
  • Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine fact sheets.

Commercial retailers are the way to go

As the vaccines from Pfizer and Moderna become available, the Centers for Disease Control & Prevention (CDC) will publish a pharmacy lookup website at https://www.vaccines.gov/en/vaccines.gov to help people find the nearest vaccine locations.

Dr. Kasper says the best bet at getting a vaccine appointment for COVID-19 or influenza, is through pharmacies at local commercial retailers like Target, Walgreens, CVS or Walmart.

Free COVID-19 home tests are coming back

“The U.S. government will make the at-home COVID testing available for free again this year. You can request up to four home tests that will be delivered to your address for free,” Dr. Kasper says. That gives people another option for testing if they think they’re developing signs of COVID even after receiving a vaccine, which can be another way to avoid wait lines at urgent cares, ERs or primary care clinics, and to keep themselves isolated until symptoms have resolved.”

The U.S. Department of Health & Human Services reports that COVIDTests.gov will be the website to order from once the website is active.

Status of the Novavax vaccine

A third manufacturer, Novavax, makes a protein-based vaccine similar to influenza vaccines. While it hasn’t been approved by the FDA, Dr. Kasper suspects it will be soon.

“It likely will be approved, and Novavax has been a prior manufacturer of COVID-19 vaccines. That is a third option that will be coming that isn’t mRNA based for people to consider if they had an adverse reaction with Pfizer or Moderna in the past,” Dr. Kasper says.

Can I get the COVID-19 and flu vaccine at the same time?

“There’s no issue with timing on getting the COVID and influenza vaccines. The RSV vaccine is recommended to be given separate,” Dr. Kasper says. “Most of that has to do with the fact they weren’t studied together, there’s not an adverse issue with it. For the population, COVID and influenza are recommended across almost all age groups. RSV is for our older population, so we recommend spacing that out by a week or two.”

For all vaccine questions, Dr. Kasper recommends speaking with your primary care team to go over options.

***Courtesy of OSF HealthCare, Photo Courtesy of the U.S. Food and Drug Administration***

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