dfgerg Antibody drugs could protect people with weak immune systems against Covid

Even as the Covid delta wave ebbs in the U.S., millions of people with compromised immune systems remain trapped in an anxious and sequestered limbo. A considerable portion of this population, research indicates, remains highly vulnerable to the coronavirus even after three or four vaccine shots.

Many immunocompromised Americans, including people with cancer, autoimmune disorders and transplanted organs, are impatiently awaiting what could be their ticket back to some semblance of normalcy: the ability to receive periodic injections of long-acting monoclonal antibodies. This, research suggests, could provide them the substantial protection against Covid-19 that in their cases vaccination may not.

The Food and Drug Administration could soon grant emergency authorization to monoclonal antibodies from drugmaker Regeneron for what is known as pre-exposure prophylaxis, or PrEP, against Covid-19. If cleared by the FDA, Regeneron’s therapy could be given as a set of injections every one to three months before potential exposure to the coronavirus.

But questions remain about how accessible such routine preventive therapy would be to any of the estimated 3 percent of Americans who have compromised immune systems.

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Inga Lennes, senior vice president of ambulatory care and patient experience at Massachusetts General Hospital in Boston, said that if particular antibodies were approved for competing uses of both PrEP and treatment of Covid-19, she would be “wary of potential supply issues.”

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On the upside, antibody-based PrEP would not need to be provided through time-consuming intravenous infusions, as is mostly required for such antibodies’ use as treatment. Instead, antibody PrEP could be injected into the muscle or under the skin.

This, according to Dr. Marshal Lyon, a professor of infectious diseases at Emory University School of Medicine in Atlanta, would make providing PrEP much less of a logistical headache for over-taxed health care systems.

We would find a way to give PrEP to our most vulnerable patients who greatly need it.

DR. MARSHAL LYON, EMORY UNIVERSITY SCHOOL OF MEDICINE

The nation is facing a labor shortage and, critically, a dearth of nurses, who help manage such injections. Also, the FDA could dictate that PrEP recipients undergo the hour of post-injection monitoring that is currently required after receipt of these antibodies.

“We would find a way to give PrEP to our most vulnerable patients who greatly need it,” Lyon said. “However, staffing is a huge issue right now.”

Infectious-disease experts stress that monoclonal antibodies should not be used as a vaccination alternative and that the therapies’ use as PrEP should be limited to those unable to mount a proper immune response to the vaccines.

Restrictions on use have eased
In mid-September, the Biden administration wrested control of distribution of the nation’s supply of monoclonal antibodies in the face of potential shortages. However, predictions of high-risk people being denied these antibody cocktails as a Covid treatment have largely not come to pass, representatives of numerous state health departments and major health care facilities nationwide told NBC News.

National distribution of monoclonal antibodies for Covid peaked from late September to early October, at nearly 200,000 doses per week. Multiple health care providers report that supply was indeed tight during that period, compelling them to prioritize antibodies for higher-risk patients.

But just as the national Covid-19 diagnosis rate has since declined, and along with it demand for antibodies, the most recent weekly shipment has dropped to 126,000 doses. Restrictions on their use have eased, but have not always been eliminated.

Lennes reported that the Massachusetts Department of Public Health has largely provided Mass General’s health care network with sufficient weekly supplies of monoclonal antibodies.

“I would hope that production would increase to match demand if this were approved,” Dr. Sarah Doernberg, an infectious disease physician at the University of California, San Francisco, said of the potential of the FDA granting Regeneron’s request for authorization of its antibody cocktail, REGEN-COV, as PrEP.

REGEN-COV, along with antibodies from Eli Lilly and GSK, is authorized for treatment of mild-to-moderate Covid-19 within 10 days of symptom onset. Such treatment greatly reduces the risk of hospitalization and death.

In September, the Biden administration purchased 1.4 million doses of REGEN-COV at $2,100 per dose, following a January order of 1.25 million doses. Regeneron is currently assessing future potential need of the therapy.

AstraZeneca has also applied for an FDA nod for a Covid-19 antibody cocktail, called AZD7442, as PrEP. The company may also pursue a therapeutic approval.

Regeneron’s cocktail received further FDA authorization in August for use as post-exposure prophylaxis. Unvaccinated or immunocompromised people who have been in close contact with someone with the coronavirus can substantially reduce their own Covid-19 risk by subsequently receiving the antibody cocktail, ideally within four days of exposure.

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