The Food and Drug Administration has greenlit a new medicine to protect some of the people most at risk from Covid.
The agency granted emergency use authorization for Pemgarda, a monoclonal antibody infusion, in immunocompromised people ages 12 and older. The drug is intended to protect against Covid for people who are not likely to mount an adequate immune response after vaccination. This includes those who have received stem cell or organ transplants and cancer patients taking medications that suppress the immune system.
“It’s going to be for a very small section of Americans,” said Dr. Michael Mina, a former Harvard epidemiologist who is now the chief science officer for eMed, a telehealth company. But, he said, it’s a vital group to protect: the people who most feel left behind at this stage in the pandemic.
“For people who are immunocompromised and literally defenseless because their immune system doesn’t really work, this is really an important development,” said Dr. Ziyad Al-Aly, the chief of research and development at the Veterans Affairs St. Louis Healthcare System.
Pemgarda will become available within the next week or two, said David Hering, the chief executive of Invivyd, the company that makes it. The company is still evaluating what the drug will cost, Mr. Hering said; he expects that Medicare and private insurance plans will cover it.
The drug is given as an infusion in doctors’ offices and other health care settings; it takes about an hour to complete the infusion. The most common side effects in a clinical trial included reactions at the infusion site, cold and flulike illness, fatigue, headaches and nausea. Four out of 623 participants in the trial experienced anaphylaxis, a severe allergic reaction.