Health Highlights: Feb. 23, 2021
Vaccine Makers Grilled on Shortages at Capitol Hill Hearing
COVID-19 vaccine shortages in the United States dominated the questioning of executives of major vaccine makers by members of Congress on Tuesday.
State health officials say demand for vaccinations is much higher than the limited weekly shipments from the federal government, the Associated Press reported.
Officials from the five companies with contracts to supply COVID-19 vaccines to the U.S. -- Pfizer, Moderna, Johnson & Johnson, AstraZeneca and Novavax -- began testimony Tuesday before an Energy and Commerce Committee panel.
"The most pressing challenge now is the lack of supply of vaccine doses," Rep. Diana DeGette, a Colorado Democrat, said as she opened the hearing, the AP reported. "Some of the companies here today are still short of the number of doses they promised to initially deliver when they last testified before this subcommittee in July."
DeGette, who chairs the investigative subcommittee that convened Tuesday's hearing called for "a straightforward assessment of where the manufacturing process stands."
It's expected that lawmakers will ask the vaccine makers' executives if shortages of raw materials, manpower or funding are holding back production, and if further use of the Defense Production Act could help speed vaccine manufacturing, the AP reported.
Transplant Recipient Dies After Receiving COVID-19-Infected Lungs
A Michigan woman died of COVID-19 after receiving a double-lung transplant from a donor infected with the new coronavirus, a newly published case study says.
It may be the first confirmed time in the United States that the virus was transmitted via an organ transplant, according to University of Michigan Medical School officials, Kaiser Health News reported.
A surgeon who handled the donor lungs also became infected and fell ill but recovered, according to the study published in the American Journal of Transplantation.
The recipient of the lungs died last fall, two months after receiving the new lungs from a woman who died from a severe brain injury suffered in a car crash.
Nose and throat samples from both the donor and the recipient -- who had chronic obstructive lung disease and was a patient at University Hospital in Ann Arbor -- were negative for the new coronavirus, and the donor had no COVID-19 symptoms or exposure to anyone with the disease, Kaiser Health News reported.
"We would absolutely not have used the lungs if we'd had a positive COVID test," said study co-author Dr. Daniel Kaul, director of Michigan Medicine's transplant infectious disease service. "All the screening that we normally do and are able to do, we did."
Three days after the transplant, the recipient spiked a fever, her blood pressure dropped, her breathing became difficult, and imaging showed signs of a lung infection. She later developed septic shock and heart problems. Tests of samples from her new lungs were positive for COVID-19, Kaiser Health News reported.
The doctors then ordered tests on a sample of fluid washed from deep within the donor's lungs, and the fluid was positive for the coronavirus.
This is the only confirmed case of its type among nearly 40,000 transplants in 2020, but has led to calls for more thorough testing of lung transplant donors, Kaul said.
Trial of Gene Therapy for Sickle Cell Disease Halted
A clinical trial of a new gene therapy for sickle cell disease that's shown promise has been halted after two participants were diagnosed with cancer.
Therapy developer Bluebird Bio said a patient who was treated five years ago developed myelodysplastic syndrome, a form of cancer that's often a precursor to leukemia, while another developed acute myeloid leukemia, The New York Times reported.
Though it isn't yet clear what caused the cancers, one possibility is that the disabled virus used to deliver the gene therapy damaged crucial DNA in blood-forming cells in the patients' bone marrows. That would be the worst-case scenario, said Dr. John Tisdale, head of the cellular and molecular therapeutics branch at the National Heart, Lung and Blood Institute.
But there is also the likelihood that both cancers were caused by a powerful drug, busulfan, which is used to clear bone marrow to make space for new cells modified by gene therapy. Busulfan is known to raise blood cancer risk, Tisdale noted.
Muddying the issue even further is the fact that people with sickle cell disease are known to have an increased risk of leukemia, even without treatment. Still, no one would expect two patients in a small trial to get the disease, the Times said.
The news is a disappointment for those who hoped a cure for sickle cell disease -- which mainly affects Black Americans -- was on the way.
"It feels like the sickle cell disease community just can never get a break," Dr. Melissa J. Frei-Jones, a researcher at the University of Texas School of Medicine in San Antonio, told theTimes.
"My other concern is that the Black community will lose faith or trust in research studies again after it has taken the medical community so long to even regain some degree of trust," she added.
COVID-19 Vaccines Adapted to Fight Variants Won't Require Long Clinical Trials: FDA
Long clinical trials won't be needed to prove the effectiveness of approved COVID-19 vaccines that have been adapted to protect against variants of the new coronavirus, the U.S. Food and Drug Administration said Monday.
Instead, vaccine developers will be asked to conduct small clinical trials such as those required for annual flu vaccines, The New York Times reported.
The recommendation was among a number of new documents released Monday by the FDA, including how antibody treatments and diagnostic tests might need to be altered to respond to coronavirus variants.
Experts are growing increasingly concerned about how the variants may hinder or reverse progress against the pandemic, the Times reported.
"The emergence of the virus variants raises new concerns about the performance of these products," acting FDA Commissioner Dr. Janet Woodcock said in a statement. "We want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts."
Most makers of approved COVID-19 vaccines or candidate vaccines in late-stage trials have said they plan to adapt their vaccines to tackle variants, the Times reported. The Moderna and Pfizer vaccines use mRNA technology that the companies have said can be used to alter the existing vaccines within six weeks, although testing and manufacturing would take longer.
Moderna has begun developing a new version of its vaccine that could be used as a booster shot against a virus variant that originated in South Africa, known as B.1.351, which seems to weaken the effectiveness of the existing vaccines.