The US Food and Drug Administration (FDA) is planning to amend clearances as soon as Thursday for Moderna and Pfizer to allow extra doses of Covid-19 vaccines for people with compromised immune system.
The clearance for a third shot is likely to protect certain people with weakened immune systems as the Delta variant is spreading rapidly in the United States.
The federal health agency will expand the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow them to be administered as booster shots, reported NBC News.
3 Percent of All Americans Immuno-Compromised
The decision to expand the emergency use of both the Pfizer-BioNTech and Moderna vaccines is meant to help those patients with immune deficiencies who are considered most likely to benefit from an additional shot, according to The New York Times. It covers people who have had solid organ transplants and others whose immune systems are similarly compromised.
The development will give physicians the authority to recommend additional shots for those patients. At least 3 percent of all Americans have weakened immune systems for a variety of reasons, from a history of cancer to the use of certain medications such as steroids, reported the Times.
Covid-19 Immunity More Crucial for Immuno-Compromised People
In the past few months, several studies have suggested that immuno-compromised people don't have as much protection after being fully vaccinated as healthy people. A study, from Johns Hopkins University, says a third dose increased the antibody level of such people.
A study in May found that all cancer patients developed fewer antibodies after being vaccinated compared to healthy participants and 10 percent barely developed antibodies at all, reported the Daily Mail.
Another study in June looked at 30 organ transplant recipients and found that 24 developed negative antibody levels - meaning they did not have any immune-fighting cells - after two doses of the Pfizer-BioNTech or Moderna vaccines.
The findings are worrying because immuno-compromised people are already at an increased risk of hospitalization or death from the virus, according to the Daily mail.
Anthony Fauci, US's top infectious-disease doctor, said Covid-19 vaccine booster shots should be given "reasonably soon" to people with weakened immune systems. A panel of advisers to the CDC had also met in July and urged action on extra doses for immuno-compromised adults.
FDA's Nod Awaited
The CDC advisory group is scheduled to meet on Friday, when it may vote on whether to officially recommend a third shot for immuno-compromised people. The panel's go-ahead is needed before doctors can start prescribing extra doses.
Such a vote is only done after the FDA takes regulatory action, such as the expected amendment to the emergency use authorization, reported NBC News.