FDA Targets Vaccine Booster Rate for Patients with Immunodeficiency


The Food and Drug Administration is stepping up efforts to allow extra doses of coronavirus vaccines for Americans with weakened immune systems; This is a change that reflects growing concern about these vulnerable patients within the Biden administration as the contagious Delta variant increases nationwide.

The regulatory move means people with compromised immune responses who need an extra shot, such as certain cancer patients, can legally get one. A few experts said this is a safer alternative to patients seeking shots on their own, as many do.

The White House’s medical advisor on the epidemic, Dr. “The data clearly shows that they are not getting a good response to start with and need additional doses,” Anthony S. Fauci said in an interview Friday.

Compared to other Americans, he said, “There are many, many more compelling reasons to do this sooner or later.”

The benefit of vaccinating these patients may go far beyond this group. Persistent infection with coronavirus in immunocompromised persons can lead to more infectious or lethal variants, according to recent research. Protecting these patients can help prevent variants from appearing.

Centers for Disease Control and Prevention and FDA officials were investigating special programs to get immunocompromised patients to receive additional vaccines. Now the FDA is aiming to change the emergency permits for at least two of the vaccines if data from the CDC supports such a move, according to two people familiar with the discussions.

The move, which is expected to happen this month, was first reported by The Washington Post.

Full approval of the Pfizer-BioNTech vaccine Expected early September, maybe even sooner. Organ transplant surgeon at Johns Hopkins University, Dr. “If you tell me that full approval is expected by February, I’d say it’s a long time for immunocompromised people to wait,” said Dorry Segev. “But next month will bring us a lot of data.”

Dr. Earlier in the week, Fauci distinguished between booster vaccines for people who were fully vaccinated but could see reduced immunity, the scientific rationale for which is not yet clear, and supplemental vaccines for people with compromised immune systems. Studies show that at least some of the latter group need extra doses.

The World Health Organization on Thursday denounced the move towards booster vaccines for fully vaccinated people in rich countries and said poor nations urgently needed extra doses. But officials were careful to add that this criticism does not refer to extra doses for people with weakened immune systems who may not have been fully protected to begin with.

Since April, France has offered third doses to some people with weakened immune responses, and recently Germany and Hungary have done the same. However, in many European countries the strategy not only limited to these patients however include, for example, older adults or those who have received AstraZeneca or Johnson & Johnson vaccines.

In the United States, at least 3 percent of the population is immunocompromised for medical reasons such as: a little cancers, organ transplants, chronic liver disease, kidney failure and dialysisor due to commonly prescribed drugs such as Rituxan, steroids and methotrexate.

With the delta variant on the rise, some of these patients and their doctors are begging federal agencies to make a regulatory pathway to third doses. While CDC advisors have long seemed to support this idea, the FDA has yet to do so.

Older adults and people with certain immunosuppressive conditions are routinely given extra flu and hepatitis B vaccines. This experience provides solid justification for recommending additional doses to some older adults and people with compromised immune responses, said Dr. Balazs Halmos, MD, an oncologist at Montefiore Medical Center in the Bronx.

Dr. “It makes sense to me to be very proactive,” Halmos said. “I would love for the FDA to do this quickly and perhaps follow up with these countries in terms of their proactive approach.”

But other experts are more cautious. Scientists are still unsure which groups of immunocompromised people would benefit from a third dose.

An infectious disease physician at Tufts Medical Center, Dr. “I think you can justify both positions,” said Helen Boucher. “Germany is right in what they do, but I also think we are right to stay behind because the information is far from perfect.”

Dr. Boucher says he empathizes with immunocompromised patients. But “as a result, we need more information,” he added.

This information is leaking too slowly for some Americans.

Deborah Rogow, 70, has multiple myeloma and is concerned about the spread of the contagious Delta variant. Ms Rogow said it would be ideal for a doctor to prescribe a third dose if needed.

She’s on her own right now, and so Ms. Rogow plans to receive a third dose of the Moderna vaccine next week at a pharmacy in Santa Barbara, California. he didn’t want.

“I would definitely be glad if I could tell my doctor to do that,” she said. “But he’s coming a little late.”

Additional doses may help some people with weakened immune systems, but others may show little improvement even after a third dose and still others may not need the extra doses at all. In examination of organ transplant recipients, only one-third of patients who received the third dose showed a benefit.

“I wish we had a more rational process for identifying individuals within these categories who really need and don’t,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns about boosting immunity in patients whose responses are suppressed for some reason. The researcher led by Dr. In one patient in the transplant study, after receiving a third dose, his transplanted heart was mildly rejected and healed, Segev said. Patients with autoimmune conditions may experience flare-ups when their immunity is strengthened.

Dr. “You walk this fine line between wanting to have the immune system suppressed but also needing the immune system to be activated to get a good vaccine response,” Segev said.

“I don’t think there is strong evidence yet that the third dose is safe – there is encouraging evidence,” he said, noting that there isn’t a lot of long-term data on people taking the third dose.

In the meantime, she suggests the safest way for people with weakened immune systems to get a third dose is to enroll in research studies where they can be watched closely.

According to a study published Thursday in the New England Journal of Medicine, coronavirus persists for much longer than normal in some immunocompromised people and has opportunities to make huge evolutionary leaps.

Some currently circulating variants may have emerged this way, and leaving people with compromised immune systems unprotected could open the door to more dangerous variants, the researchers said.


Source link

Leave a Reply

Your email address will not be published. Required fields are marked *