These are the reasons doctors believe that some people might benefit from an extra dose.
FRIDAY, the US Centers for Disease Control and Prevention (CDC) approved a recommendation by its vaccine safety panel that moderately-to-severely immunocompromised persons receive an additional dose of the Pfizer BioNTech or Moderna COVID-19 vaccinations.
CDC Director Rochelle Walensky, MD, announced the agency’s decision on Friday, just hours after the Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the additional doses.
ACIP examined data regarding the safety and risk of additional doses of COVID-19 mRNA vaccinations for individuals with weak immune systems. The FDA stated that an extra amount was recommended for patients undergoing organ transplants and people with similarly immune-compromising conditions.
The CDC is updating the guidance it provides for health care professionals and the general public on implementing these additional doses in practice. How would you go about getting an extra amount? Do you need to have a doctor sign off on your request?
Amanda Cohn, MD of the CDC’s National Center for Immunization and Respiratory Disorders, stated that the intention allows providers some flexibility to evaluate their patients’ immunosuppression. But, it won’t be required that patients get a prescription from a doctor or a recommendation from a healthcare provider. Dr Cohn stated that it is likely that those seeking additional medication at the pharmacy will be asked to confirm that they are severely or moderately immune-compromised.
The CDC recommends that organ and stem-cell transplant recipients, patients with untreated HIV and people receiving cancer treatment be included in the recommendation. CDC’s website provides additional details on who needs another COVID-19 vaccine.
Not included are people with chronic medical conditions, such as diabetes or heart disease.
Following the FDA’s action, an additional Pfizer dose can be given to patients 12 years and older who are moderately or severely immunocompromised. A Moderna dose is for adults 18 years and older.
The new guidance does not apply to those who have received the Johnson & Johnson/Janssen vaccination. Panellists explained that the FDA’s expanded emergency authorizations didn’t include an additional dose for J&J patients due to a lack of data.
Dr Cohn said, “But, we understand that this issue needs to be addressed. We’re working towards that population.”
Another point: This is not a booster but an “additional dosage,” as CDC calls it. What is the difference? ACIP defines an additional dose as one given after a series of vaccines when the person’s initial immune reaction is unlikely to be sufficient. A booster shot is a dose given to a person after their immune response has likely declined over time.
The news comes as the very contagious Delta variant rips across the nation, straining hospitals in hot spots like Florida, Texas, Arkansas, and Louisiana.
According to the New York Times, about 3% of Americans suffer from weak immune systems due to a range of factors, including a history of cancer or use of steroids.
A third COVID-19 shot has been used for severely immunocompromised people in countries like Israel. This country has also offered an additional image with the Pfizer BioNTech vaccine to those over 60.
According to data from the CDC, nearly 59% of Americans over the age of 12 are vaccinated against COVID-19. This population is just 69%, with only one dose.
What does this mean for all people? Infectious disease experts break it down.
Who needs a third dose of COVID-19?
Research suggests that those with severe immunocompromised conditions, such as those who have had an organ transplant, may not be able to respond to the two recommended doses of the mRNA COVID-19 vaccinations.
Amesh A. Adalja is an infectious disease expert and senior scholar at Johns Hopkins Center for Health Security. He tells Health that immunocompromised means someone with the same immune system as someone with a standard immune system. “This suppression can also suppress an immune response to vaccines.”
This is not surprising, according to Stanley Weiss MD, Rutgers New Jersey Medical School professor of medicine and professor of biostatistics at the Rutgers School of Public Health. He says that historical data from other vaccines has shown that many people with immunocompromised and don’t respond to vaccines. “The expectation was that they would not respond to the COVID vaccine. The data that is emerging supports that assumption.
A May JAMA research letter noted that only 17% of solid-organ transplant recipients received a single dose of mRNA COVID-19 vaccine. a Moderna or Pfizer-BioNTech vaccine). Researchers analyzed 658 transplant recipients’ responses and found that 15% of them had “measurable” antibodies after two doses. Researchers also discovered that 301 (or 46%) had no antibody responses after doses one and two, while 259, which did not react to dose one, had an antibody response following dose two.
The researchers concluded that these data suggested that transplant recipients are still at risk of COVID-19 even after receiving two doses of the mRNA vaccine.
What is the value of a third shot?
It’s unclear, but it is likely to do something, William Schaffner MD, an infectious diseases specialist and professor at Vanderbilt University School of Medicine, tells Health. He says that there are many ways an individual can become immunocompromised. It is impossible to predict whether a third dose will help. It appears to be relatively safe, and some studies have shown that immunocompromised people respond better to the third dose.
For example, this week’s study published in The New England Journal of Medicine showed that organ transplant recipients who received the third dose of Moderna COVID-19 vaccine had a more robust immune response than those who did not receive the third shot.
Dr Schaffner explains that everyone has an immune response to the vaccine.
Is this something that will eventually spread to other people?
People who aren’t immune-compromised will not be affected by the FDA’s actions. Experts don’t anticipate that anyone will soon receive a third dose COVID-19 vaccine. “Despite these company presidents stating that we need third doses by December,” John Sellick, DO, an infectious diseases expert and professor at the University at Buffalo/SUNY, tells Health.
However, Dr Sellick believes that it could eventually reach a point when federal health officials add so many people to the “immunocompromised” group that things may change. Sellick states, “Once you add too many groups, it eventually gets down to the point that it’s easier to say, “Everyone gets a third dose.”
This story was accurate at press time. Some data may have changed as COVID-19’s situation continues to change. Health tries to keep its levels up-to-date, but we encourage readers to use the WHO, CDC and local public health departments as resources to keep informed about news and recommendations.