The US Centers for Disease Control and Prevention (CDC) is considering to incolate all “immunocompromised” people with additional doses of the Covid vaccines, amid surging infections from the Delta variant, the media reported.
Members of the Advisory Committee on Immunisation Practices, at a meeting on Thursday, spoke of the urgent need to give additional doses to people with fragile immune systems, as they are more vulnerable to severe Covid outcomes and may also spread the virus to others more frequently, the Washington Post reported.
Immunocompromised patients which include organ transplant recipients, people on cancer treatments, and those living with rheumatologic conditions, HIV and leukaemia, represent about 3 per cent of US adults.
“I think what you’re asking about is, you know, is there a way to offer a third dose to individuals a through a study, or through an investigational new drug format for this population? I will just say that we are actively looking into ways that could be done to potentially provide access earlier than any potential change in regulatory decisions,” Amanda Cohn, the CDC’s chief medical officer for vaccine policy, told panel members.
However, the adviosory panel cannot recommend until the US Food and Drug Administration (FDA) gives full approval, the report said. FDA has currently authorised a two-dose regimen of the Pfizer-BioNTech and Moderna vaccines, or a single dose of the Johnson & Johnson shot.
As a result, the CDC is exploring a programme that allows sick people to get unapproved drugs until FDA grants the permission, the report added.
The programme known as expanded access or, more commonly, compassionate use, can help patients with serious disease or condition get access to investigational new drug/product, that is not FDA-approved. The coronavirus vaccines are considered such products.
The process would require enrolling individuals in a clinical study where additional doses can be given, the Post said.
Earlier this month, the CDC and FDA released a joint statement on vaccine boosters, saying that people who are fully vaccinated are protected from severe illness and death, including from emerging variants such as the highly contagious Delta variant.
“FDA, CDC, and NIH (National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” said the statement.
However, studies have suggested that booster dose in immunocompromised people may enhance disease-fighting antibody responses and increase the proportion of those who respond to the vaccines, Sara Oliver, a CDC vaccine expert, told panel members.
At a Senate panel hearing this week, Anthony S. Fauci, the US top infectious disease expert, also agreed the need for an additional dose.
Immunosuppressed individuals “may actually need a boost as part of their initial regimen, in the sense of getting them up to the point where they are protected”, he said.
Meanwhile, Israel has rolled out a third dose of the Pfizer-BioNTech coronavirus vaccine to severely immunocompromised adults. Britain has also announced plans for a booster shot to immunosuppressed, people older than 70 and front-line health-care workers in September.