FDA approves new COVID-19 booster targeting new variant

The Moderna and Pfizer boosters have been approved by the agency

The latest COVID-19 variant has been spreading rapidly across the country, and now the U.S. Food and Drug Administration (FDA) has approved two new boosters to help protect consumers as we enter the start of cold and flu season. 

These updated mRNA vaccines, which are coming from Moderna and Pfizer, have been specifically designed to target this new variant, XBB.1.5 – a variant of the Omicron strain of COVID. 

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for effectiveness, safety, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

What to expect with the updated vaccine

For consumers who have received an earlier version of a COVID-19 vaccine, the FDA says that this updated version should come with similar side effects. The fact sheets for both vaccines show that the most common side effects are: injection site pain/tenderness, fatigue, headache, muscle pain, joint pain, chills, and fever, among several others. 

Based on the testing done prior to approval, both the Moderna 2023-2024 and Pfizer 2023-2024 formulas of the vaccine have shown safety and efficacy at fighting off the latest strain of COVID-19. 

The FDA also explained that much like the flu vaccine that is updated yearly to combat the latest strains of the virus, consumers can expect COVID-19 vaccines to likely follow a similar pattern.  

Age requirements for the new vaccine

With the updated vaccine, the FDA has also released updated regulations and guidance about who should receive the vaccine and how many doses are necessary for optimal protection. 

Currently, the updated versions of the Moderna and Pfizer vaccines are approved for consumers aged 12 and older; however, for those between the ages of six months and 11 years, the vaccines can be used in emergency situations. 

Children who are five years or older can receive one dose of the updated vaccines – as long as they wait at least two months since their last COVID-19 vaccination. 

For children under the age of five, prior vaccination status plays a role in whether or not to get the updated vaccine. Children six months through four years old who have previously been vaccinated for COVID-19 can receive one to two doses of the new vaccine, though the number of doses and the timing of vaccination is dependent on the date of the child’s most recent COVID-19 vaccine. 

On the other hand, children in that age group who haven’t been vaccinated for COVID-19 are eligible for either two doses of the updated Moderna vaccine or three doses of the updated Pfizer vaccine. 

Vaccines will be available in the coming days

Now that the FDA has approved the updated vaccine formulas, the Centers for Disease Control and Prevention (CDC) will meet to draft specific guidelines and recommendations for who should get the updated vaccines. 

Pharmacies across the country are likely to start getting shipments of the updated vaccine formulas in the next few days, with full inventory happening within the next week. 

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