FDA

WASHINGTON, D.C. — The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine on August 12 to allow for the use of an additional dose in certain immunocompromised individuals.

Specifically, the FDA authorized a third COVID-19 dose for solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” said Acting FDA Commissioner Janet Woodcock in a statement. “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”

A day after the FDA authorized the third shot, an advisory committee within the Centers for Disease Control and Prevention voted to allow the third shot for those with weakened immune systems.

According to the FDA, people who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19. The FDA stated in a release that it evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines in these individuals and determined that the administration of third vaccine doses may increase protection in this population.

These patients should be counseled to maintain physical precautions to help prevent COVID-19, the department stated. In addition, close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection to their loved ones.

“This additional dose will offer valuable protection to those who need it, especially as we face a surge in COVID-19 cases due to the Delta variant,” said Elizabeth Tilson, NCDHHS State Health Director and chief medical officer, in a press release on Aug. 16. “I encourage those who are eligible to get this additional dose. In addition, if you are not fully vaccinated, please do so now to protect yourself and others – like those who are immunocompromised – from severe illness, hospitalization and death from COVID-19.”

An additional dose of the same brand of vaccine is recommended for moderately to severely immunocompromised people at least 28 days after they’ve completed their initial two-dose series to help increase the body’s immune response. The same vaccine brand should be used unless unavailable, in which case either Pfizer or Moderna vaccine can be used.

The Moderna vaccine is available to those 18 and older, while the Pfizer vaccine is available to those 12 and older.

Studies supporting this change were specific to people who are moderately to severely immunocompromised and the authorization and recommendation for the additional dose is limited to this population. Additional doses should only be provided to people who are moderately or severely immunocompromised. Patients may self-attest to their medical condition.

The Pfizer-BioNTech COVID-19 Vaccine is currently authorized for emergency use in individuals ages 12 and older, and the Moderna COVID-19 Vaccine is authorized for emergency use in individuals ages 18 and older. Both vaccines are administered as a series of two shots: the Pfizer-BioNTech COVID-19 Vaccine is administered three weeks apart, and the Moderna COVID-19 Vaccine is administered one month apart.

The authorizations for these vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine to individuals 18 years of age or older (ages 12 or older for Pfizer-BioNTech) who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Avery County Health Department (545 Schultz Circle, Newland) offers First Dose Vaccines Monday through Friday by appointment only at the department. Vaccines are available on Saturdays at the Baker Center for Primary Care at Sloop Medical Plaza. Individuals are asked to bring their insurance card and wear appropriate clothing for easy access to have the vaccination in the upper arm. Masks are required.

To schedule a vaccine appointment or for more information call (828) 733-8273.

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