This measure, taken within the next 48 hours, would be the first authorization of an additional dose in the North American country.
The U.S. Food and Drug Administration (FDA) is close to amending the emergency use authorizations for the Pfizer and Moderna vaccines to allow immunosuppressed individuals to receive a third dose of the anti-drug formulas. COVID-19, according to two sources, advanced to the NBC network.
An advisory panel from the Centers for Disease Control and Prevention (CDC) met in July. It urged action to protect people with suppressed immune systems with additional doses, as health experts agree that they are among the population most vulnerable to the virus, Especially given the variety of delta in the United States, which is much more contagious than others.
This move would be part of a change that reflects growing concern from the administration of President Joe Biden about these people. It would mean that people with impaired immune responses with, for example, certain types of cancer could get a third booster dose. Legally. Experts explain that it would be a safer alternative to finding an amount on their own.
The CDC advisory group is scheduled to meet on Friday. It would vote on whether to officially recommend the third vaccine for immunosuppressed people, as panel approval is needed before doctors can begin prescribing additional doses. The vote only occurs after the FDA takes regulatory action, such as the expected amendment to the emergency use authorization.
The emergency use authorization does not include fully vaccinated, otherwise healthy individuals.
Anthony Fauci, the White House's chief medical adviser on the pandemic, said Friday: "The data is unequivocal that (these patients) have not received a good response to start with and need additional doses ." "There are many compelling arguments why you have to do this, sooner rather than later," he warned.
The United States is working to offer COVID-19 booster shots to Americans with compromised immune systems as soon as possible, as cases of the corona virus continue to rise." the nation's leading infectious disease expert had specified on Thursday. And director of the National Institute of Allergy and Infectious Diseases (NIAID).
According to a recent study published in The New England Journal of Medicine (NEJM), the benefit of having this population fully vaccinated - and with three doses - extends well beyond the group of immunosuppressed patients, since this protection also helps to prevent the appearance of new variants.
"Immunosuppressed patients are at risk of prolonged infection with SARS-CoV-2, as in several case reports, investigators have indicated that multinational variants of SARS-CoV-2 may emerge during such persistent cases of SARS-CoV-2.
The disease, he warned in a scientific paper led by medical doctors Lawrence Corey, Chris Beyrer, Myron Cohen, Nelson Michael, Trevor Bedford, and Morgane Roland.
The coronavirus persists more extended than usual in some immune people. According to NEJM research, there are opportunities for major evolutionary leaps. According to experts, circulating variables can now be created in this way, the researchers said, and allow vulnerable people with weakened immune systems to open the doors to more dangerous types.
The FDA and CDC were already exploring special programs to administer additional vaccines to these groups of patients. The FDA now intends to amend the emergency license for at least two vaccines.
At the same time, local authorities in the U.S. await full approval of the Pfizer-BioNTech vaccine by early September or even earlier.
If this immunization strategy is approved, the United States will join Germany, France, Hungary, and Israel in giving booster injections, ignoring a request from the World Health Organization (WHO) to wait until more people worldwide can receive. Your first vaccination.
The WHO condemned booster shots for fully vaccinated people in rich countries, saying developing nations urgently need the extra doses.
But officials added that the criticism does not refer to different amounts for people with weakened immune systems, who were not initially fully protected.
Regulators in the country must approve the COVID-19 vaccine or amend its emergency use options before authorities can recommend additional injections.
Still, the CDC is working to make third doses available sooner in certain circumstances, they said. Officials at a meeting in July.
"We need to move forward to promote these people, and now we're working on that," Fauci told reporters in a call.
Adding that their existing vaccines may not protect immunosuppressed people against COVID-19.
In the United States, at least 3% of the population is immunosuppressed due to medical reasons such as some cancers, organ transplants, chronic liver disease, kidney failure, and dialysis, or Due to widely prescribed medications such as rituxan, steroids, and methotrexate.