FDA aims to speed up additional vaccine doses for immunocompromised patients

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

The regulatory move would mean that people with impaired immune responses who need an additional injection, such as some cancer patients, could get one legally. It’s a safer alternative to patients seeking to get the vaccine themselves, as many are doing now, several experts have said.

“The data is unequivocal that they did not get a good response to begin with” and need additional doses, said Dr. Anthony S. Fauci, White House senior medical adviser on the pandemic on Friday.

Compared to other Americans, “there are many, many more compelling reasons to do this sooner rather than later,” he said.

The benefit of vaccinating these patients may extend far beyond this group. Persistent infection with the coronavirus in immunocompromised people can lead to more transmissible or virulent variants, according to recent research. Protecting these patients can help prevent the emergence of variants.

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

The move, expected this month, was first reported by the Washington Post.

Full approval of the Pfizer-BioNTech vaccine is expected in early September, possibly even earlier. “If you told me that full approval is expected by February, I would say it’s a long time to wait for people who are immunosuppressed,” said Dr. Dorry Segev, transplant surgeon at Johns Hopkins University. “But next month will bring us a lot of data. “

Earlier in the week, Dr Fauci distinguished between booster injections for people who are fully vaccinated but who may experience a decline in their immunity, for which the scientific rationale is not yet clear, and additional injections for people whose immune system is weakened. Research indicates that at least some of the latter group need extra doses.

The World Health Organization on Thursday denounced the move towards booster shots for fully vaccinated people in rich countries, saying poor countries urgently need additional doses. But officials were careful to add that this review did not refer to additional doses for people with weakened immune systems, who may not have been fully protected initially.

Since April, France has offered third doses to some people with weak immune responses, and recently Germany and Hungary have followed suit. But in many European countries, the strategy is not limited to these patients, but includes the elderly, for example, or those who have received the AstraZeneca or Johnson & Johnson vaccines.

In the United States, at least 3% of the population is immunocompromised for medical reasons like certain cancers, organ transplants, chronic liver disease, kidney failure and dialysis, or because of widely prescribed drugs like Rituxan, steroids and methotrexate.

With the Delta variant soaring, some of these patients and their doctors have begged federal agencies to open a regulatory path for third doses. While CDC advisers have long seemed supportive of the idea, the FDA has yet to do so.

The elderly and people with certain conditions that weaken the immune system routinely receive extra doses of influenza and hepatitis B vaccines. This experience provides a strong rationale for offering extra doses to some elderly people and those with immune responses are attenuated, said Dr. Balazs Halmos, an oncologist at Montefiore Medical Center in the Bronx.

“Being very proactive makes sense to me,” said Dr Halmos. “I would like to see the FDA take that position quickly and maybe follow these countries in terms of a proactive approach.”

But other experts are more circumspect. Scientists still do not know which groups of immunocompromised people will benefit from a third dose.

“I think you can justify both positions,” said Dr. Helen Boucher, infectious disease physician at Tufts Medical Center. “Germany is justified in what it does, but I also feel that we have the right to be left behind because the information is far from perfect.”

Dr. Boucher says she sympathizes with immunocompromised patients. But “at the end of the day, we need more information,” she added.

This information has come far too slowly for some Americans.

Deborah Rogow, 70, suffers from multiple myeloma and is worried about the spread of the contagious Delta variant. Ms Rogow said a doctor would prescribe a third dose if needed would have been ideal.

At the moment, she is alone, so Ms. Rogow plans to receive a third dose of the Moderna vaccine next week at a pharmacy in Santa Barbara, California. The Moderna vaccine is still a long way from being fully approved, she noted, but she didn’t want to get a Pfizer-BioNTech dose without more data on mixing the two vaccines.

“I would certainly have appreciated if I had been able to ask my doctor to do it,” she said. “But it’s coming a little too 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 additional doses at all. In a study of organ recipients, only a third of patients who received a third dose showed benefit.

“I wish we had a more streamlined process for identifying people in these categories who really need it versus those who don’t,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns regarding improving immunity in patients whose responses are suppressed for a reason. A patient in the transplant study rejected her heart after receiving a third dose, said Dr Segev, who led the research. Patients with autoimmune diseases may experience flare-ups when their immunity is strengthened.

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

There is also not a lot of long-term data from people who received third doses, he noted: “I don’t think there is strong evidence that a third dose is. still sure – there is encouraging evidence. “

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

The coronavirus persists much longer than usual in some immunocompromised people and has the potential to make big evolutionary leaps, according to a study published Thursday in the New England Journal of Medicine.

Some variants currently in circulation may have arisen this way, researchers said, and leaving people with weakened immune systems unprotected can open the door to more dangerous variants.