HEALTH CARE BRIEFING: Moderna Vaccine Sparks Cautious Optimism

Moderna’s Covid-19 vaccine candidate produced antibodies in all patients tested in an initial safety trial, federal researchers said.

The neutralizing antibody levels produced were equivalent to the upper half of what’s seen in patients who get infected with the SARS-Cov-2 virus and recover, according to the results published in the New England Journal of Medicine. The Moderna vaccine is one of the farthest along for Covid-19.

While stimulating production of neutralizing antibodies doesn’t prove a vaccine will be effective, it’s viewed as a crucial early step in testing. Meanwhile, the side effects reported were not severe enough in the majority of patients to preclude further testing, according to the report by researchers at the National Institute of Allergy and Infectious Diseases published yesterday.

Over half of those who got the middle of three doses suffered mild to moderate fatigue, chills, headache and muscle pain. Also, 40% of those in the middle-dose group experienced a fever after the second vaccine. Three of 14 patients given the highest dose of the vaccine experienced severe side effects, but that dose is not being used in larger trials.

Still, “that is a lot of adverse events,” Tony Moody, a doctor and researcher at the Duke Human Vaccine Institute, said. He said it would be “unusual” for a vaccine to have this rate of side effects. On the plus side, he said that the antibody levels produced were “really encouraging.”

If researchers are measuring the right thing, the vaccine should work, he said, noting that this can only be proved in large trials.

Moderna’s initial results are from the first group of 45 patients who received the vaccine. It evaluated three doses of the vaccine that were given in a two-shot regimen. The middle dose from this initial trial will be used in a large final-stage trial of the Moderna vaccine, called mRNA-1273, that is slated to begin on July 27th.

The final stage trial will compare the vaccine to placebo shots in 30,000 healthy people at a high risk of coming down with Covid-19. Robert Langreth has more.

Covid Vaccine Front-Runner Is Months Ahead of Her Competition: In April, Sarah Gilbert’s three children, 21-year-old triplets all studying biochemistry, decided to take part in a trial for an experimental vaccine against Covid-19. It was their mother’s vaccine—she leads the University of Oxford team that developed it—but there wasn’t a big family talk. “We didn’t really discuss it as I wasn’t home much at the time,” Gilbert told me recently. She’d been working around the clock, as one does while trying to end a pandemic, and at any rate wasn’t worried for her kids. “We know the adverse event profile and we know the dose to use, because we’ve done this so many times before,” she says. “Obviously we’re doing safety testing, but we’re not concerned.”

Gilbert has been all over the British press, but she appears to regard public attention as a distraction. For more than two decades she worked anonymously, developing vaccines while also, of necessity, churning out endless grant applications. Her research was rarely discussed outside scientific circles. Now she’s leading one of the most high-profile and advanced vaccine candidates against Covid-19, with Phase III, or final-stage, trials under way involving thousands of people in Brazil, South Africa, the U.K., and, soon, the U.S. Money is no longer a struggle. Read more from Stephanie Baker.

Happening on the Hill

Energy and Commerce Markup: The House Energy and Commerce Committee is scheduled to virtually mark up 30 bills including: H.R. 3935, to provide for the continuing requirement of Medicaid coverage of nonemergency transportation to medically necessary services; H.R. 5619, to authorize a pilot program to expand and intensify surveillance of self-harm in partnership with state and local public health departments and establish a grant program to provide self-harm and suicide prevention services in hospital emergency departments; and H.R. 7574, to strengthen the Strategic National Stockpile.

Children in CBP Custody: The House Homeland Security Committee plans a virtual meeting today on children in Customs and Border Protection custody and related deaths, medical care and spending.

McConnell Says Stimulus Will Include Liability Shield: Senate Majority Leader Mitch McConnell (R-Ky.) said yesterday the new recovery package that he plans to unveil soon will be “guaranteed” to emerge from the Senate with a plan he’s written to protect everything from small businesses to schools from a new rash of lawsuits. McConnell said 1,100 lawsuits now have been filed seeking to “take advantage” of the crisis, which would prevent recovery except in extreme cases.

He also told hospital officials in Kentucky he expects there to be another infusion of funds to help health care providers but offered no details on its size, Nancy Ognanovich reports.

Research & Treatment Efforts

Giroir Rebuts Trump, Warns of Death Toll: Top U.S. health officials expect the rate of coronavirus deaths to rise with more hospitalizations, and states seeing intense outbreaks should close their bars and slash restaurant capacity, one of President Donald Trump’s senior coronavirus advisers said yesterday, rebutting the president’s downplaying of the pandemic. Brett Giroir, who serves as the country’s testing chief, acknowledged the gravity of the outbreak in an interview with NBC, while offering notes of optimism and urging the public to keep wearing masks. Read more from Josh Wingrove.

U.S. to Offer Covid Tests at Nursing Homes: The Trump administration plans to offer “point of care testing” at nursing homes across the U.S., Seema Verma, administrator of the Centers for Medicare and Medicaid Services, said during a press conference in Louisiana. The “rapid on the spot, 20 tests per hour” device will initially be given to 2,000 nursing homes, Giroir said separately. Meanwhile, Vice President Mike Pence said the increase in virus cases across the Sun Belt is “serious” but the U.S. is “substantially better” prepared to respond than it was a few months ago, Vivek Shankar reports.

Trump Reportedly Told Hospitals to Bypass CDC: The Trump administration has ordered hospitals to send data on Covid-19 patients to a central database and skip the CDC, a move some public health experts say will allow the data to be manipulated for political gain, The New York Times reports. The order is set to be effective today. It was posted on HHS’s website this week and came after an uneasy conference call between coronavirus response coordinator Deborah Birx and hospital officials, the Times reports.

White House Orders $16 Million in ICU Medicines: Fresenius Kabi and Baxter Healthcare will supply $16 million in vital intensive care unit medications to the national medical stockpile to bolster supplies for hospitals battling coronavirus. The Strategic National Stockpile, a repository of emergency medical supplies, is purchasing “critically needed ICU medications as part of the Covid-19 response” from Fresenius Kabi and Baxter Healthcare. Fresenius was awarded a contract worth $12.5 million, while Baxter’s is worth $3.6 million. Shira Stein has more.

Federal Virus Study Expands to All States: The administration is expanding a coronavirus antibody study in an effort to build the first large-scale estimate of just how many Americans have already had Covid-19. The survey would look at blood donors from 55 sites in all 50 states and Puerto Rico, the General Services Administration said. Vitalant Research Institute and three partner blood collection centers are conducting the study for the Centers for Disease Control and Prevention. Read more from Shira Stein.

Pharmacies Can Produce Promising Drug, FDA Says: Hospitals will have more options to buy a promising Covid-19 treatment that’s been in short supply for a month, thanks to relaxed production regulations the FDA announced yesterday. Pharmacies got the green light to produce intravenous dexamethasone and sell it to hospitals that can’t get it from regular suppliers. Drug production facilities are less regulated by the FDA than standard drug manufacturers, but still have to uphold certain industry production and reporting standards. Read more from Jacquie Lee.

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What Else to Know Today

Startups Pair Black Patients, Doctors: Black communities have faced racist medical treatment for centuries, stirring distrust in health care professionals. But it’s not easy for Black Americans to find Black doctors. Only about 5% of active physicians are Black, the latest available data show, and insurers have avoided using race filters on their online provider lists out of fears that they could open the door for discrimination. That’s led several Black entrepreneurs to create platforms aimed at making those connections amid the coronavirus pandemic, which is disproportionately impacting Black people. Read more from Ayanna Alexander.

Ross to Lead School Nutrition Association: The School Nutrition Association, a national nonprofit representing 55,000 school nutrition professionals announced Reginald Ross as its new president today for the 2020-2021 term, Megan Boyanton reports.

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To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com

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