No evidence to back plasma treatment, expert panel says, despite FDA authorization

A National Institutes of Health panel says there’s no evidence backing the use of convalescent plasma to treat coronavirus patients and says doctors should not treat it as a standard of care until more study has been done. 

“Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19,” added the committee, which evaluates treatments for coronavirus.

“Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19. Members of the public and health care providers are encouraged to participate in these prospective clinical trials.”

Some background: Last week, the US Food and Drug Administration issued an emergency use authorization for convalescent plasma, and President Trump declared it a historic breakthrough at a news conference. 

The timing raised suspicions the White House had pressured FDA – something FDA Commissioner Dr. Stephen Hahn denied several times.

But Hahn had also made misleading comments about the data supporting the use of convalescent plasma – which is the antibody-rich serum taken from the blood of people who have recovered from an infection. The hope is infusing this plasma into new patients will kickstart their immune response. It’s a treatment that dates back more than 100 years and has never been used broadly.

The NIH panel, led by Dr. Clifford Lane, who heads research at the National Institute of Allergy and Infectious Diseases; Dr. Roy Gulick, chief of the Division of Infectious Diseases at Weill Medical College of Cornell University; and Dr. Henry Masur, chief of the Critical Care Medicine Department at NIH, said much more research is needed into whether the treatment works. Data published so far don’t really show whether it helps patients, they said.

“The long-term risks of treatment with COVID-19 convalescent plasma and whether its use attenuates the immune response to SARS-CoV-2, making patients more susceptible to reinfection, have not been evaluated,” the statement added.

Plus, different patients have differing levels of antibodies, so the treatment is highly variable.

After Cincinnati Police Chief Eliot Isaac wrote a letter to Ohio Gov. Mike DeWine saying there had been some unintended consequences from the state’s order closing bars early, including multiple shootings and assaults, DeWine said the state is consulting its lawyers to see if it is possible to carve Cincinnati out of the statewide order.

“Frankly, our lawyers’ initial read they gave us, was they were very skeptical if we legally could do that. But they’re going to research it and we’re going to see what they come up with,” DeWine said.

The governor said unlike Cincinnati’s police chief and Mayor John Cranley, the majority of mayors in the state believe the 10:00 p.m. liquor shutoff has been helpful rather than harmful as the state combats the Covid-19 pandemic.

New guidelines put in place by South Carolina’s Department of Health and Environmental Control will allow for limited, outdoor visitation at select long-term care facilities in the state.

The new guidelines were announced at a news conference Tuesday afternoon. 

Facilities must meet criteria, including staying below a certain disease transmission level, keeping adequate amounts of personal protective equipment and maintaining appropriate staffing.

Additionally, testing at the facility must be in accordance with federal requirements.

Visitors will be screened prior to their visit and the length of their visit will be contingent on whether they have had a Covid-19 virus or antibody test.

Any eventual coronavirus vaccine should go first to the people most at risk of catching it, and of spreading it to others, an independent committee said Tuesday.

The draft report from the National Academies of Sciences, Engineering and Medicine makes recommendations similar to those that have come from other groups, but it goes into detail to explain why health workers, for instance, should be among the first to get a vaccine.

The framework document weighs four different criteria.

“While major efforts are being made to have a significant supply of COVID-19 vaccine as soon as possible, the committee has been tasked with considering the tough choices that will need to be made for allocating the tightly constrained initial supplies,” committee co-chair Dr. Helene Gayle, the president and CEO of the Chicago Community Trust and a former HIV/AIDS expert at the Centers for Disease Control and Prevention, said in a statement.  

The 115-page draft is open for comment. The independent committee at the National Academies was set up at the request of the National Institutes of Health and the Centers for Disease Control and Prevention, which wanted an outside voice to advise on distributing vaccine.

CDC’s Advisory Committee on Immunization Practices will also weigh in on how to distribute vaccine.

More than 600 students and staff members in two Florida counties are in quarantine or isolation due to Covid-19. 

The Martin County School District tells CNN that 425 students and 31 employees have transitioned to quarantine and remote learning since August 11, the first day of school.  

Hillsborough County, which launched a Covid-19 dashboard yesterday, reports 159 students and employees have tested positive. The health department is helping contact trace, per the district.

CNN has reached out to the Florida Department of Health asking for a full list of Covid-19 cases in K-12 schools and has not heard back.

North Carolina Gov. Roy Cooper North Carolina Department of Public Safety

North Carolina Gov. Roy Cooper announced the state will move to phase 2.5 of reopening during the Covid-19 pandemic. 

The state will enter the new phase on Friday at 5 p.m. ET, Cooper said during a news briefing on Tuesday.

"We're encouraged to see North Carolina holding steady on most and decreasing on some of our key data metrics," Cooper said. 

What's changing: In this new phase, mass gathering limits will increase to 25 people indoors and 50 people outdoors from the current limit of 10 indoors and 25 outdoors. Large venues will remain subject to these limits. 

Playgrounds may open, while museums and aquariums may do so at 50% capacity. Gyms and indoor exercise facilities can open at 30% capacity. 

Bars, nightclubs, movie theaters, indoor entertainment facilities, amusement parks and dance halls will remain closed. 

New Hampshire Gov. Chris Sununu Pool

New Hampshire Gov. Chris Sununu announced the state is rolling out a Covid-19 Schools Dashboard, set to go live today, to track cases in real time.  

“You can find your schools, your school district, the number of cases, the clusters of illness, things of that nature, so you can see in real time what the true status is to your child or family’s school as it pertains to the Covid-19 pandemic,” the governor said during a press conference on Tuesday.

Sununu thanked parents, teachers, and school administrators in advance for doing the reporting it will require to keep the dashboard accurately updated. It will be run by the Department of Health and Human Service, Sununu said.

New Hampshire State Epidemiologist Dr. Benjamin Chan said at the press conference that they are expecting students to get sick with Covid-19 and it’s not a reason for alarm. 

“We expect students and staff to be diagnosed with Covid-19 and to have been in the school, right?” Chan said. “So this should not be a surprise or cause significant fear when people look on the data dashboard, for example, and see there is someone with Covid-19 in their school.”

Chan said the plan is for the DHHS to work with schools to identify who was in “close contact” with the infected student and make an appropriate plan depending on the individual circumstance.

Michigan athletic director Warde Manuel Kirthmon F. Dozier/Detroit Free Press/USA Today Network/magn Content Services

The University of Michigan athletics department has announced layoffs and salary cuts to staff as the school prepares for a $100 million shortfall.

This comes a few weeks after, the Big Ten, the conference Michigan competes in, announced the postponement of the conference’s fall sports season because of coronavirus concerns – including the football season.

Michigan athletic director Warde Manuel appeared on the Conqu’ring Heroes podcast and revealed the impact of the disposed football season has had on the department's budget.

In a Tuesday open letter, Manuel blamed the Covid-19 pandemic for the cuts to the athletic department including the elimination of 21 staff positions, salary reductions and a hiring freeze that will not fill 15 positions.

"I am genuinely sorry for the position we find ourselves and that I had to communicate in this manner. Please support each other and your impacted colleagues during this challenging time," Manual said.

Oregon Gov. Kate Brown has extended the Covid-19 state of emergency in Oregon until November 3, 2020, according to a press release from her office today.