Tag: patients

The Food and Drug Administration is accelerating efforts to approve additional doses of the coronavirus vaccines for Americans with compromised immune systems, a change that reflects growing concern within the Biden government about these at-risk patients as the contagious Delta variant rises nationwide.

The regulatory move would mean that people with an impaired immune response who need additional vaccination, such as certain cancer patients, could receive legal vaccination. It’s a safer alternative than having patients looking for syringes on their own, as many are doing now, several experts said.

“The data is clear that they did not get a good response initially” and require additional doses, said Dr. Anthony S. Fauci, White House senior medical advisor on the pandemic, in an interview Friday.

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

The benefits of vaccinating these patients can extend well beyond this group. Persistent infection with the coronavirus in immunocompromised people can lead to more communicable or virulent variants, according to the latest research. Protecting these patients can help prevent variants from occurring.

Officials from the Centers for Disease Control and Prevention and the FDA had been reviewing special programs to give immunocompromised patients additional vaccinations. Now, if scientific data from the CDC supports such a move, the FDA intends to possibly change the emergency approval of the vaccine, manufactured by Moderna, as early as next week, according to two people who are aware of the discussions.

The CDC could then recommend extra injections to certain patients with poor immune responses if their advisory committee suggests, officials said. The government’s change in strategy was first reported by the Washington Post.

The FDA is also considering changing the emergency clearances for the vaccines manufactured by Johnson & Johnson and Pfizer-BioNTech, according to those familiar with the discussions. Johnson & Johnson has not yet applied for full approval of its vaccine and a change in its approval is considered unlikely.

And if the FDA grants full approval to the Pfizer BioNTech vaccine soon as expected, a change to the emergency approval may be unnecessary. Doctors are then free to simply prescribe an additional injection for immunocompromised patients.

“If you tell me that full approval is expected by February, I would say that it is a long time for immunocompromised people,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University. “But the next month will bring us a lot of data.”

Dr. At the beginning of the week, Fauci made a distinction between booster shots for people who are fully vaccinated but may have declining immunity – for which the scientific justification is not yet clear – and extra vaccinations for people with weakened immune systems. Research shows that at least some of the latter group require additional doses.

The World Health Organization (WHO) on Wednesday condemned the move towards booster vaccinations for fully vaccinated people in rich countries, saying that poor countries urgently need the extra doses. But officials went out of their way to add that this criticism did not apply to additional doses for people with compromised immune systems who may not have been fully protected to begin with.

France has been offering additional doses of vaccine to certain people with weak immune responses since April, and Germany and Hungary have recently followed suit. In many European countries, however, the strategy is not limited to these patients, but also includes, for example, older adults or those who have received vaccines from AstraZeneca or Johnson & Johnson.

In the United States, at least 3 percent of the population is immunocompromised due to medical reasons such as some cancers, organ transplants, chronic liver disease, kidney failure and dialysis, or from commonly prescribed drugs such as rituxan, steroids, and methotrexate.

Updated

Aug. 6, 2021, 7:54 p.m. ET

With the rise of the Delta variant, some of these patients and their doctors have asked federal agencies to open a regulatory pathway for additional doses. Although CDC advisors had long appeared to have endorsed the idea, the FDA had not yet done so.

Older adults and people with certain conditions that suppress the immune system are routinely given extra doses of the influenza and hepatitis B vaccines. This experience provides a good justification for offering extra doses to some older adults and people whose immune responses are subdued, said Dr Balazs Halmos, oncologist at Montefiore Medical Center in the Bronx.

“It makes sense for me to be very proactive,” said Dr. Halmos. “I would like the FDA to take a swift position and possibly pursue these countries on their proactive approach.”

However, other experts are more prudent. Scientists are not yet sure which groups of immunocompromised people will benefit from an additional dose.

“I think you can justify both positions,” said Dr. Helen Boucher, an infectious disease doctor at Tufts Medical Center. “Germany is justified, but I also have the feeling that we are entitled to hold back because the information is far from perfect.”

Dr. Boucher says she has empathy for immunocompromised patients. But “the bottom line is we need more information,” she added.

Understand the state of vaccine mandates in the United States

This information has trickled in far 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 have been ideal if a doctor would prescribe an additional dose if needed.

She is now alone, so Ms. Rogow plans to have a third dose of the Moderna vaccine at a pharmacy in Santa Barbara, California next week. The Moderna vaccine is still a long way from full approval, she noted, but she didn’t want a Pfizer BioNTech dose without more data on mixing the two vaccines.

“I would have definitely appreciated if I could have told my doctor that it was,” she said. “But it’s a little late.”

Extra doses may help some people with weak immune systems, but others may show little improvement and still others may not need extra doses at all. In a study of organ transplant recipients, only a third of patients who received a third dose showed any benefit.

“I wish we had a more rational process of identifying people within these categories who actually need it or not,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns about boosting immunity in patients whose responses are suppressed for a reason. One patient in the transplant study experienced mild rejection of her transplanted heart and recovered after receiving a third dose, said Dr. Segev, who led the research. People with autoimmune diseases can have flare-ups if their immunity is boosted.

“You walk this fine line between wanting to suppress the immune system and having the immune system activated in order to get a good vaccine response,” said Dr. Segev.

There is also not much long-term data on people who have received additional doses, he noted: “I don’t think there’s strong evidence that a third dose is still safe – there is encouraging evidence.”

In the meantime, he suggests that people with weak immune systems are safest to get an extra dose of vaccine if they participate in research studies where they can be closely monitored.

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

Some variants that are now floating around could have originated this way, researchers said, and leaving people with compromised immune systems unprotected could open the door to more dangerous variants.