The Observatory and Fast Facts

April 22, 2020

FDA provides guidance to address the need for blood donations

The Food and Drug Administration (FDA) issued new policies to address the need for blood and blood components.

“The COVID-19 pandemic has caused unprecedented challenges to the U.S. blood supply. Donor centers have experienced a dramatic reduction in donations due to the implementation of social distancing and the cancellation of blood drives,” the FDA said in a news release.

Based on recently completed studies and epidemiologic data, the FDA said it has concluded that “current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply.”

As a result, the FDA is revising recommendations in three guidance documents about blood donor eligibility. The FDA said it expects the changes, which are effective immediately, to remain in place after the COVID-19 pandemic ends.

Among others, the FDA said it is making the following changes, for immediate implementation, to the December 2015 guidance, “Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products”:

  • For male donors who would have been deferred for having sex with another man, the agency is changing the recommended deferral period from 12 months to three months.
  • For female donors who would have been deferred for having sex with a man who had sex with another man, the agency is changing the recommended deferral period from 12 months to three months.
  • For those with recent tattoos and piercings, the agency is changing the recommended deferral period from 12 months to three months.

The FDA also is making changes to the 2013 guidance, “Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria.” For those who have traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the agency is changing the recommended deferral period for blood donations from 12 months to three months. In addition, the guidance provides a notice of an alternate procedure that permits the collection of blood and blood components from such donors without a deferral period provided that the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The FDA also said it is finalizing the January 2020 draft guidance, “Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components.” The final guidance includes a policy change for travelers and military personnel returning from Europe. Specifically, the FDA said that for people who spent time in certain European countries or on military bases in Europe who were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease, the agency is eliminating the recommended deferrals and is recommending allowing reentry of these donors.

FDA updates recommendations for human cell or tissue-based products

The Food and Drug Administration (FDA) does not recommend testing asymptomatic donors of human cells, tissues or other cellular or tissue-based product (HCT/P) for COVID-19, the agency said in a press release.

Noting that routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors, the agency said that SARS-CoV-2 has only been detected in blood samples of a small percentage of severely ill patients.

The agency also said it is aware that some HCT/P establishments in the United States are considering additional donor screening and testing measures in response to the COVID-19 outbreak.

The FDA said an HCT/P establishment should evaluate whether a donor in the 28 days prior to the HCT/P procedure:

  • Cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
  • Been diagnosed with or suspected of having a COVID-19 infection.

“While respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps), the potential for transmission of COVID-19 by HCT/Ps is unknown at this time. There have been no reported cases of transmission of COVID-19 via these products,” the FDA said.

Hospitals to report COVID-19 test data daily to the federal government

The Centers for Medicare & Medicaid Services (CMS) sent a letter to the nation’s hospitals, detailing how they should report data on tests they are performing to detect COVID-19, the agency said in a press release. The letter was sent on behalf of Vice President Mike Pence.

Specifically, the federal government wants hospitals to report daily data on COVID-19 test results conducted at in-house labs to both the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network. CMS said the data should not include personal identifying information to protect patients’ privacy.

“The nation’s nearly 4,700 hospitals have access to testing data that’s updated daily. This data will help us better support hospitals to address their supply and capacity needs, as well as strengthen our surveillance efforts across the country,” said CMS Administrator Seema Verma.

CMS said the White House Coronavirus Task Force is collecting data from public health labs and private laboratory companies.

NIH clinical trial of vaccine for COVID-19 begins

A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium.

The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately six weeks. The first participant received the investigational vaccine on March 16.

The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine.

The vaccine is called mRNA-1273 and was developed by NIAID scientists and their collaborators at the biotechnology company Moderna, based in Cambridge, MA. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial.

The investigational vaccine was developed using a genetic platform called mRNA (messenger RNA). The investigational vaccine directs the body’s cells to express a virus protein that researchers hope will elicit a robust immune response. The mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans.

Study participants will receive two doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be assigned to receive a 25-microgram (mcg), 100-mcg or 250-mcg dose at both vaccinations, with 15 people in each dose cohort. The first four participants will receive one injection with the low dose, and the next four participants will receive the 100-mcg dose. Investigators will review safety data before vaccinating the remaining participants in the 25- and 100-mcg dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250-mcg cohort.

Modeling study suggests 18 months of COVID-19 social distancing

A new modeling study on likely United States and United Kingdom outcomes during the COVID-19 pandemic, published by a team of epidemiologists at the Imperial College of London, which used pandemic data gathered in China, Italy and South Korea, has been lauded by epidemiologists around the world as the most comprehensive prediction of what the U.S. could be facing in the coming months. But it also paints some bleak pictures, including millions of deaths if little is done.

The model analyzes the two approaches to managing the virus. One is mitigation, or “flattening the curve,” which sees the novel coronavirus continue to spread, but at a slow rate so as not to overwhelm hospital systems.

The other approach is suppression, which tries to reverse the pandemic through extreme social distancing measures and home quarantines of cases and their families, achieving an R0—or reproduction number—of less than 1.

But suppression requires social distancing measures far longer than the 14 to 30 days Americans have been told to prepare for. Instead, they would need to be in place for 18 months, or until a vaccine is made available.

To understand how mitigation or suppression would play out, the Imperial College team, led by Neil Ferguson, OBE, ran a model based on three scenarios. In the first, U.S. officials do nothing to mitigate the spread of COVID-19, schools and businesses are kept open, and the virus is allowed to move through the population.

This would result in 81 percent of the U.S. population, about 264 million people, contracting the disease. Of those, 2.2 million would die, including 4-8 percent of Americans over age 70. More important, by the second week in April, the demand for critical care beds would be 30 times greater than supply.

If mitigation practices are put in place, including a combination of case isolation, home quarantine and social distancing of those most at risk (over age 70), the peak critical care demand would reduce by 60 percent, and there would be half the number of deaths. But this scenario still produces an eightfold demand on critical care beds above surge capacity.

In order to suppress the pandemic to an R0 of below 1, a country would need to combine case isolation, social distancing of the entire population, and either household quarantine or school and university closure, the authors found. These measures “are assumed to be in place for a five-month duration,” they wrote.

In addition, the authors said, these measures may have to be put back into place if restrictions are lifted and cases surge again.