Covid Vaccine

FDA approves new COVID-19 vaccines that target circulating variants

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Covid-19 vaccine and syringe

On September 11, 2023,  the U.S. Food and Drug Administration (FDA) took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

What You Need to Know

  • Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months since the last dose of any 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 an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
  • 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.
  • The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.
  • Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.
  • The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
  • The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet tomorrow (Sept. 12), to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals.
  • Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.

FDA headquarters in Maryland

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., 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 safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

Data Supporting the Updated mRNA COVID-19 Vaccines (2023-2024 Formula)

The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component.

  • The updated mRNA vaccines are manufactured using a similar process as previous formulations. In studies that have been recently conducted, the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection. This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.
  • The benefit-risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood as these vaccines have been administered to hundreds of millions of people in the United States.

Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine. Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.

Additional Details on Today’s Actions

Specifically, today’s actions include:

  • Approval of Comirnaty (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, and a change to a single dose for individuals 12 years of age and older. Comirnaty was previously approved as a two-dose series for individuals 12 years of age and older.
  • Approval of Spikevax (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, a change to a single dose for individuals 18 years of age and older, and approval of a single dose for individuals 12 through 17 years of age. Spikevax was previously approved as a two-dose series for individuals 18 years of age and older.
  • Authorization of Moderna COVID-19 Vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula and lower the age eligibility for receipt of a single dose from 6 years to 5 years of age. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets.
  • Authorization of Pfizer-BioNTech COVID-19 Vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets.

The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2023-2024 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) was issued to Pfizer Inc.

The approval of Spikevax (COVID-19 Vaccine, mRNA) (2023-2024 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2023-2024 Formula) was issued to ModernaTX Inc.

When to Take an At-Home COVID-19 Test

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man taking COVID-19 Home Test

At-home COVID-19 testing is one of our best tools to prevent the spread of the virus-alongside getting vaccinated and boosted. COVID-19 vaccines are highly effective at preventing infection, hospitalization, and serious illness, but no vaccine prevents 100% of infections. As the virus continues to evolve and cases are projected to spike seasonally, at-home testing helps you to determine if you have COVID-19 so you can prevent spreading it to others. Here are key scenarios and considerations to help you determine when you should take an at-home COVID-19 test and what to do when you get your results.

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When to Take an At-Home Covid-19 Test

  • You have symptoms of COVID-19.
    Refer to the CDC site for more information on COVID-19 symptoms.
  • You had close contact with someone who has COVID-19.
    Wear a high-quality mask after you find out you’ve been exposed, and get tested 5 days after exposure.
  • You will be with someone who is immunocompromised or at high risk for severe COVID-19.
    Wear a high-quality mask as an additional precaution.
  • You plan to attend an event or gathering.
    Consider testing right before you go to an indoor gathering as a precautionary measure.

If Your At-Home Covid-19 Test is POSITIVE

You should stay home and isolate away from others for at least 5 days after testing positive.

When to end isolation:

  • After 5 days if you have been fever-free for 24 hours and you had mild or asymptomatic COVID-19.
  • After 10 days if you had moderate or severe illness and/or you are immunocompromised. Consult your healthcare provider for further guidance.
  • If you ended isolation but your COVID-19 symptoms recur or worsen, you should restart your isolation from day 0 and consider re-testing.
  • Consider taking an at-home COVID-19 test to ensure you’re no longer infected.

Continued precautions:

  • After you have ended isolation and no longer experience symptoms, wear a high-quality mask through day 10 when around others.

Treatment and care:

  • If you experience severe symptoms, such as difficulty breathing or chest pain, seek medical care immediately.
  • If you are at high risk for severe COVID-19, consult your health care provider right away to discuss whether you need antiviral medication.

If Your At-Home Covid-19 Test is NEGATIVE

Re-test 24-48 hours after your first test, especially if you are continuing to experience symptoms. A negative test doesn’t rule out infection.

Continued precautions:

  • If you were exposed to COVID-19, take precautions to protect yourself and others (i.e. retesting, wearing a high­-quality mask) for 10 days after exposure, even if you test negative. Follow the CDC guidelines on COVID-19 exposure.
  • Knowing your COVID-19 Community Level can help you decide if you should take additional precautions, especially if you tested as a precaution before attending a gathering or spending time with someone at high risk.

Treatment and care:

  • If you continue to receive negative test results but symptoms persist, contact your healthcare provider.

Recommendations are from the CDC and current as of February 2023. For the latest COVID-19 information and testing guidelines, visit CDC.gov/coronavirus

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