The FDA’s decision applies only to the high-risk group. This is less than 3% of US. adults. This decision does not open the door to booster doses for all Americans.
US. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to protect them better as the delta variant continues to surge.
The Food and Drug Administration announced Thursday night that it would apply to millions of Americans who are particularly vulnerable due to organ transplants, certain types of cancers, or other conditions. Similar recommendations have been made by several other countries, such as France and Israel.
Immunotherapies are more difficult to boost an immune system that certain drugs and diseases have suppressed. Patients who have suffered from these conditions don’t get the same protection as others. Small studies suggest that an additional dose of vaccines may be an option.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a statement.
The FDA stated that transplant recipients or others with similar levels of compromised immunity might receive a third dose from Moderna and Pfizer within 28 days of receiving their second shot. The FDA did not mention immune-compromised patients who had received the single-dose Johnson & Johnson vaccine.
The announcement comes as the extra-contagious delta version of the coronavirus surges through much of the country, pushing new cases, hospitalizations, and deaths to heights not seen since last winter.
The FDA’s decision applies only to the high-risk group. This is less than 3% of U.S. adults. This decision does not open the door to booster doses for all Americans.
Instead, the extra dose is part of the initial prescription given to the immune-compromised. France, for example, has been encouraging such patients to receive the third dose of vaccines four weeks after the second. Germany and Israel have also started to recommend a third dose for two-dose vaccines.
Separately, US. officials continue to monitor whether or not average people’s immunity wanes enough to warrant boosters for everyone. However, for now, vaccines offer strong protection for the entire population.
After Friday’s meeting with its outside advisors, the Centers for Disease Control and Prevention will likely recommend extra shots for certain immuno-compromised patients.
Transplant recipients and people with suppressed immune systems know they are at greater risk than the average American. Some have sought extra doses even though it meant lying about their vaccination status. Experts caution that only high-risk individuals will now be able to get another shot.
“This will all be very personal,” warned Dr. Dorry Segev at Johns Hopkins University, a transplant surgeon who is leading a major National Institutes of Health research on extra shots for organ donors. A third dose may “increase their immune response” for some. However, it doesn’t seem to be for everyone. “We don’t know who the real person is.”
A recent study of over 650 transplant recipients revealed that just over half had virus-fighting antibodies following two doses of Pfizer or Moderna vaccines. However, this is generally lower than the number of healthy people who were vaccinated. A second study on rheumatoid and other autoimmune diseases revealed that only those who take particular medications had very poor vaccine responses.
It is unknown how a third dose of the drug works or if it poses any safety issues, such as increased organ rejection risk. Canadian researchers found that transplant recipients are more likely to develop antibodies after receiving a third dose of chemotherapy than those who received a dummy shot. Similar results have been reported in other small studies. Some transplant recipients are more responsive to the third dose than others.