That the use of plasma (shown effective in many other cases) isn’t being considered is another inefficiency by the (U.S. at least) governmental response to the coronavirus pandemic.
It might be the next best thing to a coronavirus vaccine.
Scientists have devised a way to use the antibody-rich blood plasma of COVID-19 survivors for an upper-arm injection that they say could inoculate people against the virus for months.
Using technology that’s been proven effective in preventing other diseases such as hepatitis A, the injections would be administered to high-risk healthcare workers, nursing home patients, or even at public drive-through sites — potentially protecting millions of lives, the doctors and other experts say.
The two scientists who spearheaded the proposal — an 83-year-old shingles researcher and his counterpart, an HIV gene therapy expert — have garnered widespread support from leading blood and immunology specialists, including those at the center of the nation’s COVID-19 plasma research.
But the idea exists only on paper. Federal officials have twice rejected requests to discuss the proposal, and pharmaceutical companies — even acknowledging the likely efficacy of the plan — have declined to design or manufacture the shots, according to a Times investigation. The lack of interest in launching development of immunity shots comes amid heightened scrutiny of the federal government’s sluggish pandemic response.
There is little disagreement that the idea holds promise; the dispute is over the timing. Federal health officials and industry groups say the development of plasma-based therapies should focus on treating people who are already sick, not on preventing infections in those who are still healthy.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said an upper-arm injection that would function like a vaccine “is a very attractive concept.”
However, he said, scientists should first demonstrate that the coronavirus antibodies that are currently delivered to patients intravenously in hospital wards across the country actually work. “Once you show the efficacy, then the obvious next step is to convert it into an intramuscular” shot.
But scientists who question the delay argue that the immunity shots are easy to scale up and should enter clinical trials immediately. They say that until there’s a vaccine, the shots offer the only plausible method for preventing potentially millions of infections at a critical moment in the pandemic.
“Beyond being a lost opportunity, this is a real head-scratcher,” said Dr. Michael Joyner, a Mayo Clinic researcher who leads a program sponsored by the Food and Drug Administration to capitalize on coronavirus antibodies from COVID-19 survivors. “It seems obvious.”
The use of so-called convalescent plasma has already become widespread. More than 28,000 patients have already received the IV treatment, and preliminary data suggest that the method is safe. Researchers are also looking at whether the IV drip products would prevent new infections from taking root.
The antibodies in plasma can be concentrated and delivered to patients through a type of drug called immune globulin, or IG, which can be given through either an IV drip or a shot. IG shots have for decades been used to prevent an array of diseases; the IG shot that prevents hepatitis A was first licensed in 1944. They are available to treat patients who have recently been exposed to hepatitis B, tetanus, varicella and rabies.
The proposal for an injection approach to coronavirus prevention came from an immunization researcher who drew his inspiration from history.
Dr. Michael Oxman knew that, even during the 1918 flu pandemic, the blood of recovered patients appeared to help treat others. Since then, convalescent plasma has been used to fight measles and severe acute respiratory syndrome, or SARS, among other diseases.
Like other doctors, Oxman surmised that, for a limited time, the blood coursing through the veins of coronavirus survivors probably contains immune-rich antibodies that could prevent — or help treat — an infection.
Throughout May, researchers and doctors at Yale, Harvard, Johns Hopkins, Duke and four University of California schools sent a barrage of letters to dozens of lawmakers. They held virtual meetings with health policy directors on Capitol Hill, but say they have heard no follow-up to date.
Dr. Arturo Casadevall, the chair of the National COVID-19 Convalescent Plasma Project, said he spoke to FDA officials who told him they do not instruct companies on what to produce. Casadevall told The Times that the leaders of the national project were “very supportive of the need to develop” an IG shot rapidly and that he believed it would be “very helpful in stemming the epidemic.”
Joyner, of the Mayo Clinic, said there are probably 10 million to 20 million people in the U.S. carrying coronavirus antibodies — and the number keeps climbing. If just 2% of them were to donate a standard 800 milliliters of plasma on three separate occasions, their plasma alone could generate millions of IG shots for high-risk Americans.
“At a hot-spot meatpacking plant, or at a mobile unit in the parking lot outside a mall — trust me, you can get the plasma,” Joyner said. “This is not a biological problem nor a technology problem. It’s a back-of-the-envelope intelligence problem.”
The antibody injections, for now, do not appear to be a high priority for the government or the industry.
Grifols, on April 28 — the same day that the U.S. topped 1 million confirmed coronavirus cases — made a major product announcement that would “expand its leadership in disease treatment with immunoglobulins.”
The product was a new vial for IG shots — to treat rabies.