On August 12, 2021, the Food and Drug Administration (FDA) authorized a third dose of the mRNA vaccines against the coronavirus for those who are immunocompromised. The Emergency Use Authorization (EUA) for both the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines has been amended to allow for the administration of additional doses for certain immunocompromised people — specifically, solid organ transplantation recipients or those with health conditions that have an equal 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," stated acting FDA Commissioner Janet Woodcock, MD.
The following day, the Centers for Disease Control and Prevention (CDC) released updated information regarding vaccines and immunocompromised individuals, which aligned with that of the FDA.
"Today, I signed CDC's Advisory Committee on Immunization Practices' (ACIP) recommendation that endorsed the use of an additional dose of COVID-19 vaccine for people with moderately to severely compromised immune systems after an initial two-dose vaccine series," stated CDC Director Rochelle Walensky, MD, MPH.
Immune response and COVID-19
In the United States, those who are immunocompromised account for approximately 3% of the adult population, yet studies show that fully vaccinated immunocompromised people make up a large portion of hospitalized breakthrough COVID cases: 40-44%.
Those who are immunocompromised have weakened immune systems and have a much slower immune response when it comes to fighting off foreign invaders. Because of this, they are at greater risk of contracting and spreading COVID-19 and developing severe COVID-19-related outcomes.
Although vaccines increase protection against COVID-19 tremendously, many who are immunocompromised and fully vaccinated do not have the same level of protection as someone who is fully vaccinated and not immunocompromised, due to a weaker antibody response. A third dose of the vaccine helps increase the antibody response, which in turn, increases the recipient's level of protection. It is also important to note that immunocompromised protection rates may vary based on health condition.
Who is eligible?
According to the CDC, immunocompromised people who are eligible to receive a third dose of the vaccine include those who:
People living with chronic health conditions, such as heart disease, asthma, and diabetes — which puts them at greater risk for serious related outcomes from COVID-19 — are not eligible to receive a third dose at this time. The CDC suggests that they speak with their healthcare providers about their medical conditions in order to determine whether a third dose of the vaccine would be beneficial.
What you need to know about getting your third dose
It's important to note that the Pfizer vaccine is authorized for use in those aged 12 and up, while the Moderna vaccine is authorized for those aged 18 and up. A third dose for those who are immunocompromised and fit the criteria should be given at minimum 28 days following the second dose, according to the FDA.
Reactions to the third dose are similar to those from the first two doses and range from mild to moderate, with the most commonly reported symptoms being fatigue and pain at the injection site.
In addition, people should stick with the same mRNA they've been going with: those fully vaccinated with Pfizer should receive a third dose of the Pfizer vaccine, and those fully vaccinated with Moderna should receive a third dose of the Moderna vaccine.
Johnson & Johnson on stand-by
The FDA and the CDC are working on the best course of action for immunocompromised Americans who received the single-dose Johnson & Johnson vaccine. According to the CDC, "There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson's Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine."
Due to the lack of data, the EUA of the Johnson & Johnson vaccine has yet to be amended, and those that received it who are immunocompromised must wait.
Additional recommendations from health officials
A focus of the CDC and FDA is on making sure immunocompromised Americans have enough protection against the coronavirus. It is recommended that those who are immunocompromised follow all safety precaution measures, including wearing a mask, maintaining six feet of distance from others outside of one's household, and avoiding large crowds and poorly ventilated areas.
Those who are in close contact with immunocompromised people should also get fully vaccinated, if they are not already.
On August 13, 2021, 24 deaths were reported in Washington state, which has been seeing on average 3,000 cases per day — a high since the winter surge.
Undoubtedly, the coronavirus continues to spread in Washington, which is why the Department of Health recommends that everyone — including those who are not immunocompromised — continue to follow all preventive measures, such as mask wearing, frequent handwashing, keeping gatherings small and outdoors, and staying home if symptomatic or exposed.
"We need to use all the tools we have to reduce the ongoing spread of this virus in our community and to keep ourselves and our loved ones safe," stated the Secretary of Health Umair A. Shah, MD.