The Health 202: The hopeful news about Moderna’s coronavirus vaccine is extremely preliminary

Washington Post

with Paulina Firozi

An early-stage trial of a coronavirus vaccine appears promising — but it’s not time to pop out the champagne quite yet.

The announcement from biotech company Moderna amounted to a status update on how the first phase of its clinical trials are going. Some participants in the small, initial trial developed virus-fighting antibodies similar to those found in patients who have recovered from covid-19, suggesting the vaccine triggers a level of immunity. That’s good news, certainly, but far from the large-scale trial needed before a vaccine can be approved.

But medical professionals are under increasing pressure to produce results from President Trump, who yesterday announced he is taking the anti-malarial drug hydroxycholoroquine  – which has not proven to help prevent or treat the novel coronavirus – after two people inside the White House recently tested positive for covid-19. Trump last week announced a goal of “hundreds of millions” of vaccines against coronavirus for Americans by the end of 2020, which conflicts with the 12 to 18 month timeline offered by public health officials.

The stock market jumped for joy yesterday after Moderna’s announcement. Shares in the Massachusetts company surged nearly 20 percent at its news. That news, combined with positive comments from Federal Reserve Chair Jerome H. Powell and the loosening of state shutdowns, delivered a “triple whammy” for Wall Street investors after two weeks of market volatility, my colleague Taylor Telford reports.

Cambridge, Mass.-based Moderna. (Bill Sikes/AP)

Forty-five people received Moderna’s vaccine, but the company has reported results on only eight participants so far.

In a normal course of vaccine development, researchers would typically wait until all of the results are in before drawing conclusions. But because of heavy pressure to produce a vaccine in months instead of years during this pandemic, the company is moving forward more quickly than usual because it believes the initial results look sufficiently promising.

Laurie Garrett, former senior fellow at the Council on Foreign Relations:

Stock markets are grabbing at every hint of hope. This is only 8 cases tested, people. Eight ppl given the vax, blood found to have antibodies that kill #SARSCoV2 in petri dishes. We are still a lo-o-o-o-ng way from proving the mRNA vaccine is safe & effective at scale. https://t.co/yP4Sk3YfbT

— Laurie Garrett (@Laurie_Garrett) May 18, 2020

Tech-focused broker Gopal Kavalireddi:

The drug trial sample size seems to be as big as 2 #Uber full of people.#Moderna stock was up 25% in early trade. It was hanging at $19 levels from Dec 2018 – Mar 2020 & suddenly is up 291% in 2 mths🤷‍♂️

I hope the vaccine also supports Immortality.#moderna #COVID19 #investors pic.twitter.com/4Ppw34y5uk

— Gopal Kavalireddi (@gvkreddi) May 18, 2020

In the study, which began in March, 45 participants ages 18 to 55 were given three different dose levels of the vaccine. It’s typical for phase one clinical trials, which are intended to test the safety of a vaccine before it’s given to more people, to include fewer than 100 participants. Researchers are still collecting data about how the other 37 participants fared and will likely report that information once it’s assembled. 

Yesterday’s announcement was a chance for Moderna to trumpet its early successes but far from a guarantee that a vaccine will be ready by the end of the year.

“We are very, very happy because first the vaccine was generally safe,” Stephane Bancel, chief executive of Moderna, told my colleague Carolyn Y. Johnson. “The piece that was really exciting and was the big question, of course, was can you find antibodies in people in enough quantities” to prevent disease.

The Food and Drug Administration has given Moderna permission to begin a 600-person, phase two clinical trial next month. And in July, the company hopes to take on its biggest hurdle: a much larger, phase three trial that will determine whether regulators rule the vaccine is safe and effective for the public.

The consequences of moving so quickly is this: Scientists won’t be able to study a vaccine’s long-term effectiveness.

The vaccine Moderna is working on is one of 14 promising candidates identified by the National Institutes of Health, working in conjunction with biopharmaceutical companies. The vaccines are being put through the usual phases of clinical trials, with typical numbers of participants in each. 

The difference under the accelerated timeframe is researchers won’t have time to study the length of time over which the vaccines are effective that is, whether they protect people from the coronavirus for one year, three years or more.

“What is being cut out here is the time to study the long-term effects of the vaccine on those individuals,” said Esther Krofah, executive director of FasterCures, a center of the Santa Barbara, Calif.-based Milken Institute.

Vaccine trials and the government approval process can take a decade or more from start to finish. Phase one trials for the shingles vaccine Shingrix started in 2005. The FDA didn’t approve the drug until 2017. That gave researchers much more time to build a broad base of knowledge about how it works.

“You will typically have the long enough time frame to be able to answer those questions with clarity, and that’s what we’re losing the midst of all of this,” Krofah told me.

The celebratory reaction to the Moderna news shows how desperate Americans are for a return to their pre-pandemic lives.

People want to know the virus — whose death toll in the United States is approaching 90,000 — can be defeated sometime in the near future. Even as states reopen their economies, there’s a broad consensus life won’t return to normal until there’s a way to protect people through a vaccine, a process that typically takes years.

Trump has fueled such hopes for breakneck vaccine development, promising his Operation Warp Speed initiative will produce results by the end of the year — even as infectious-diseases chief Anthony S. Fauci has suggested such a short timeline is unrealistic.

President Trump meets with restaurant industry executives at the White House on Monday. (Evan Vucci/AP)

“Vaccine experts have said that these accelerated development timelines are theoretically possible, but extremely optimistic — and depend on everything going right,” Carolyn writes. “They stress that it will be crucial to gather convincing data the vaccines are safe and effective before using them broadly — and the new data are promising but preliminary, from the earliest phase one trials that test safety in healthy people.”

“I would certainly take this as good news, and it’s certainly worth moving forward” into later stage trials, Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, told her. “There’s just historically, if you look at vaccine development, lots of vaccines that look good out of phase one that don’t turn out to be good products.”

Welcome to The Health 202, our must-read newsletter on health policy.

Ahh, oof and ouch AHH: The Trump administration has released guidelines for a slow path to reopening the nation’s nursing homes. 

The Centers for Medicare and Medicaid Services, which issued the guidance, recommended the facilities ease restrictions more slowly than communities around them, Amy Goldstein, Debbie Cenziper and Maria Sacchetti report. 

A person is taken to an ambulance at the Life Care Center in Kirkland, Wash., on March 12. (Ted S. Warren/AP)

“The guidelines urge state and local officials to refrain from allowing virtually all visitors into nursing homes or other senior care facilities until several conditions are met. They include making sure a nursing home has no new cases of covid-19, the disease caused by the coronavirus, for four weeks,” they write. 

“In addition, such facilities must ensure that they have enough protective gear and access to coronavirus tests, and that nearby hospitals have sufficient space in intensive care units and other wards in the event cases spike again.” 

Long-term care facilities are among the hardest-hit settings for covid-19. One in four nursing homes nationwide have reported at least one case, according to a Post analysis of publicly available data for more than 15,000 skilled nursing facilities certified by Medicare and Medicaid. The Kaiser Family Foundation has estimated assisted-living facilities account for 41 percent of covid-19 deaths in the U.S.

The federal government is also gathering data on covid-19 deaths in such facilities. Maria reported.

In Canada, 81 percent of coronavirus deaths have occurred in nursing homes. 

That’s true even as officials say there are signs the virus’s spread is slowing in many parts of the country, Amanda Coletta reports. 

“But its ruthless whip through long-term care facilities continues — prompting calls for public inquiries, the deployment of military troops to hard-hit homes in Ontario and Quebec, and an admission from Prime Minister Justin Trudeau that Canada is ‘failing’ its elderly,” Amanda writes. “ … Several factors — a frail and elderly resident population, old buildings with little space for separating the sick from the healthy, cramped living quarters, and frequent contact between residents and caregivers — make long-term care facilities petri dishes.” 

A courier retrieves samples from a Toronto nursing home to be analyzed for the coronavirus at a testing facility. (Cole Burston/Bloomberg News)

The problem reaches far beyond Canada. 

“The World Health Organization said half of Europe’s covid-19 deaths occurred in such facilities,” she adds. “Nearly 40 percent of all U.S. deaths have occurred in nursing homes, according to the Kaiser Family Foundation. At least 1 in 10 U.S. nursing homes have reported outbreaks, according to a Washington Post analysis.”

 

AHH: Trump said he’s been taking the drug hydroxychloroquine as protection against the coronavirus.

The president said he’s been taking the controversial drug, despite the dearth of evidence it prevents people from contracting the illness. Whether it is effective for treating covid-19 is unproven, and doctors have warned the drug can have deadly side effects.

“The president said he began taking the anti-malaria drug about 10 days ago after he told the White House physician he would like to start taking hydroxychloroquine,” Anne Gearan, Laurie McGinley, Lenny Bernstein and Ariana Eunjung Cha report. “That timing would put the start of Trump’s drug regimen at roughly the same time as news broke that two White House staffers had tested positive for the virus, and the White House later released a letter from Trump’s in-house doctor that linked his drug regimen to one of those cases.” 

Here’s the letter from Trump’s doctor pic.twitter.com/dCNHZgklb9

— Anita Kumar (@anitakumar01) May 19, 2020

“I think it’s good. I’ve heard a lot of good stories. And if it’s not good, I’ll tell you right. I’m not going to get hurt by it,” Trump said. “It’s been around for 40 years — for malaria, for lupus, for other things. I take it. Front-line workers take it. A lot of doctors take it.”

Trump’s support for the drug has “perhaps been the area where he has most clearly rejected the advice of the health profession, including his own officials, while making clear he believes more in the anecdotal reports he has received from friends and supporters,” our colleagues write.

“Clinical trials, academic research and scientific analysis indicate that the danger of the drug is a significantly increased risk of death for certain patients, particularly those with heart problems,” they write. “The Food and Drug Administration, in a safety alert issued April 24, warned that it had received reports that hydroxychloroquine and chloroquine could have serious side effects and that the drug should be taken under the close supervision of a doctor in a hospital setting or a clinical trial.”

House Speaker Nancy Pelosi (D-Calif.) last night called the president “morbidly obese” and said she’d “rather he not be taking something that has not been approved by scientists.”

“I would rather he not be taking something that has not been approved by the scientists, especially in his age group, and in his, shall we say, weight group: ‘Morbidly obese,’ they say,” says House Speaker Nancy Pelosi on Pres. Trump’s revelation he is taking hydroxychloroquine. pic.twitter.com/0ImjpEjg9q

— Anderson Cooper 360° (@AC360) May 19, 2020 OUCH: The Veterans Affairs Department says more than 1,000 veterans have died from the coronavirus. But the actual toll is much higher. 

The official death toll reported on VA’s tracking site doesn’t include veterans who have died in state-run veterans’ homes, Alex Horton reports. 

A U.S. Marine stands near the flag-draped coffin of a veteran who contracted the coronavirus. (Brian Snyder/Reuters)

“That death count is at least 550, according to Vietnam Veterans of America, an advocacy group collecting nationwide data for a forthcoming report,” he writes. “And even then, 28 states are not reporting veteran deaths, making the cumulative total unknown, said Linda Schwartz, a special adviser to the group and a former VA assistant secretary for policy and planning.”

“Not only are veterans generally at greater risk of contracting and having complications from coronavirus due to age and underlying conditions but the pandemic is quickly worsening an already troubling veteran homelessness, mental health and unemployment crisis,” Jeremy Butler, the chief executive of Iraq and Afghanistan Veterans of America, told Alex.

Coronavirus latest The Trump administration will today announce a contract with a Richmond-based company to manufacture more treatments for covid-19 patients.

The administration has signed a $354 million, four-year contract with Phlow Corp. to make generic medicines and pharmaceutical ingredients that are currently produced overseas in India and China, the New York Times reports.

“The contract, awarded to Phlow Corp. by the Biomedical Advanced Research and Development Authority, meshes President Trump’s ‘America First’ economic promises with concerns that coronavirus treatments be manufactured in the United States,” Sheryl Gay Stolberg and Katie Thomas report. “It may be extended for a total of $812 million over 10 years, making it one of the largest awards in the authority’s history.”

“This is an historic turning point in America’s efforts to onshore its pharmaceutical production and supply chains,” Peter Navarro, Trump’s trade adviser, told The Times. The project, he said, “will not only help bring our essential medicines home but actually do so in a way that is cost competitive with the sweatshops and pollution havens of the world.”

White House trade adviser Peter Navarro. (AP Photo/Alex Brandon)

Here are a few more stories to catch up on this morning.

There are still shortages of protective equipment:  There’s no federal strategy to supply the nation with enough personal protective equipment. That means front-line workers without critical gear and a chaotic international marketplace for supplies that’s riddled with price gouging and fraud, Desmond Butler, Juliet Eilperin and Tom Hamburger report. The Trump administration’s response:  Trump and Treasury Secretary Steven Mnuchin suggested they’d be open to more flexibility in how companies are able to use emergency small-business loans, Politico’s Zachary Warmbrodt writes. The Treasury Department has spent little of the $500 billion fund created by the $2 trillion coronavirus stimulus Congress passed in March that’s meant to help businesses and local governments, according to a report from the Congressional Oversight Commission, Erica Werner reports. Around the world:  Brazil is now the fastest-growing coronavirus hotspot in the world. “For health professionals and long-time Brazil watchers, the brushfire spread of the deadly respiratory illness is aggravating in its predictability,” Bloomberg News’s Jessica Brice reports. “The emerging market is home to 210 million people and its public health system was already underfunded and under strain well before the pandemic raced around the globe.” At least 116 nurses have died of covid-19 in Brazil, where the health-care system was ill-prepared to handle the pandemic, the Wall Street Journal’s Luciana Magalhaes, Ryan Dube and Jeffrey T. Lewis report. “That is more than the 107 nurses who have died in the U.S., where the total death count of people succumbing to the pandemic is about six times more than in Brazil. In Italy, which has about twice as many total deaths as Brazil, 39 nurses have died, according to Italy’s National Federation of Nurses, or Fnopi.” The hardest hit:  The coronavirus could take a toll, long term, on regions across the country with particularly high rates of chronic health conditions, including diabetes, obesity and high blood pressure, the New York Times’s Nadja Popovich, Anjali Singhvi and Matthew Conlen report. In the Washington area: The number of daily coronavirus deaths in the District has been relatively flat or declining. If that continues, Mayor Muriel E. Bowser (D) could announce a date for reopening parts of the economy later this week. “The city does not publicly release its calculation of ‘community spread,’ but Bowser said Monday that it has been on the decline and the city needs six more days of that decline for it to reopen,” Erin Cox, Fenit Nirappil and Laura Vozzella report.
  Sugar rush


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