Tagged Vaccines

Must-Reads Of The Week

The news this week did seem dominated a bit by President Donald Trump. And most of it was trivial: Do we believe he is really taking hydroxychloroquine? (Who knows?) How obese is he? (Not as obese as Nancy Pelosi said he was.) Would he wear a mask at the Ford plant he was touring? (He did when he wasn’t in public view.)

It should not go unnoticed that Jacinda Ardern, who has led New Zealand through the coronavirus pandemic with but a few deaths (21, per the tally by Johns Hopkins University researchers), is that country’s most popular prime minister in 100 years.

I’m Damon Darlin, your guest writer for this edition of the Friday Breeze. We will have a rotating cast of writers for a few weeks to give you a breezy rundown of the week’s health care news.

You know, there were other things happening this week that mattered a bit more. People are still dying of COVID-19. The toll is approaching 100,000 deaths in the United States. Many of the deceased aren’t being counted among the COVID-19 casualties, according to a number of analyses.

The New York Times reported, in one of the most attention-getting pieces this week, that 36,000 fewer people in the United States would have died if only the country had locked down just one week earlier. If the U.S. had done it two weeks earlier, on March 1, “the vast majority of the nation’s deaths — about 83 percent — would have been avoided,” it reported.

Science magazine looked at the so-called superspreaders of the coronavirus. They examined a number of studies done across the globe in an attempt to understand how, if most people don’t transmit the virus, it spreads so much. It’s those circumstances in which it spreads massively that most intrigue the scientists.

The race for a vaccine to prevent further infections accelerated. So far, the results were mostly seen in the stock market. Moderna, a little-known drug company, announced preliminary results of its vaccine testing and its stock price soared. The federal government’s Biomedical Advanced Research and Development Authority (BARDA), the agency overseeing the rapid production of a vaccine, gave Moderna $438 million. (One of its board members, Moncef Slaoui, was appointed the nation’s new “vaccine czar,” and his financial ties to the industry are being questioned. The New York Times called them “vast.”)

Such publicity over vaccine development has raised the question of “science by press release.” KHN’s Jay Hancock took a look at how the pharmaceutical companies are trying to use publicity about their search for a vaccine to improve their damaged reputations.

The Centers for Disease Control and Prevention, which has faced withering criticism throughout this epidemic, came under fire again this week. This time, it was for messing up a pretty basic rule of epidemiology, supposedly its specialty. The federal agency was combining the results of two different kinds of tests for the coronavirus, viral and antibody, which would mess up crucial metrics needed to determine if it is safe to reopen a state. Virginia was doing this same thing. The Atlantic said Georgia, Texas and Pennsylvania were also misreporting data.

By the way, the head of the CDC, Robert Redfield, said he wasn’t being muzzled by the White House.

In other fiddling-with-the-data news, a data analyst working for the Florida state government said she was fired because, the South Florida Sun-Sentinel reported, “her bosses told her to remove the raw data from the website, meaning that users could no longer download it for analysis.”

Meanwhile, an assistant professor at the University of North Carolina in Wilmington said on Twitter that that state isn’t manipulating the data, just the graphic representation of it, so the results looked better.

We aren’t done yet with the data category. An article that broke late last Friday night said that the Stanford University study you undoubtedly read about suggesting the coronavirus was not as deadly as was thought was sponsored by David Neeleman, the JetBlue Airways founder who has been saying the pandemic isn’t deadly enough to justify lockdowns. Stanford didn’t disclose the financial ties, according to BuzzFeed, or that scientists were concerned about the accuracy of the antibody tests the study was based on.

This report from NBC was intriguing. It casts strong doubts on the much-touted technology for washing and reusing face masks that health care workers use. The federal government contracted with an Ohio research company to be the nation’s laundromat. NBC said the potential cost to taxpayers is $413 million.

Finally, because it’s a national holiday on Monday — no, really, check your calendar, it’s Memorial Day — I leave you with a host of things to worry about as the country struggles to reopen.

Enjoy your long weekend. The ultraviolet light in sunshine is useful.

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KHN’s ‘What The Health?’: When It Comes To COVID-19, States Are On Their Own

Can’t see the audio player? Click here to listen on SoundCloud.

At least so far, states that reopened their economies are not seeing a major spike in cases of COVID-19. But it remains unclear if that is because the coronavirus is not spreading, because the data is lagging or because the data is being manipulated.

Meanwhile, President Donald Trump said he’s taking the controversial antimalarial drug hydroxychloroquine as a preventive measure after he was exposed to a White House valet who tested positive for the coronavirus. Despite the fact that there is no data to suggest the drug works to prevent infection, the president’s endorsement has apparently led to new shortages for patients who take the medication for approved purposes.

This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Margot Sanger-Katz of The New York Times and Kimberly Leonard of Business Insider.

Among the takeaways from this week’s podcast:

  • As federal and state officials push to reopen the economy, there have been questions about the coronavirus data they are using. Sometimes they combine the number of diagnostic tests — which show if someone is currently infected with the virus — with the number of antibody tests — which show if a person once had the virus.
  • The Centers for Disease Control and Prevention, which has been the lead federal agency in other serious disease outbreaks, is relegated to a backup role on the coronavirus. That points to the difference in trust levels between the public and the White House, which has emphasized the reopening of the economy rather than public health.
  • So much attention is focused on the race to get a successful vaccine. But even if researchers are able to produce one, distribution to millions of Americans will be a logistical problem.
  • Public health officials are pushing hard for Americans to wear face coverings in public, but certain groups are resisting. Polling finds that most Americans don’t object to wearing a mask, but it is a significant change in the U.S. culture and also a key change in public health recommendations. That shift has added to the confusion and may have led to some of the resistance.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: Kaiser Health News’ and The Guardian’s “Lost on the Frontline,” by the staffs of KHN and The Guardian

Kimberly Leonard: Business Insider’s “How Coronavirus Will Permanently Change Healthcare, According to 26 Top Industry Leaders,” by Lydia Ramsey, Kimberly Leonard and Blake Dodge

Margot Sanger-Katz: The Atlantic’s “Why the Coronavirus Is So Confusing,” by Ed Yong

Alice Miranda Ollstein: Politico’s “Politics Could Dictate Who Gets a Coronavirus Vaccine,” by Sarah Owermohle

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Analysis: Get Ready For The Vaccine — They’re Never Simple

If there is a silver lining to the flawed U.S. response to the coronavirus pandemic, it is this: The relatively high number of new cases being diagnosed daily — upward of 20,000 — will make it easier to test new vaccines.

To determine whether a vaccine prevents disease, the study’s subjects need to be exposed to the pathogen as it circulates in the population. Reopening the economy will likely result in the faster spread of the coronavirus and therefore more opportunities to test a vaccine’s efficacy in trial subjects.

Under a proposal under discussion by a committee set up by the National Institutes of Health, each of four or five experimental vaccines would be tested on about 20,000 trial participants with a placebo group of 10,000 for each vaccine. Some 50 U.S. medical centers — and perhaps an equal number overseas — would participate in these trials.

On Monday, Moderna, the biotech company, reported promising results in the first eight of 45 people enrolled in an initial test of the safety and immune responses to its vaccine. Analysts attributed a 900-point jump in the Dow that day at least partly to this very preliminary data, so eager are investors for any signs of progress in efforts to control the pandemic.

Moderna is running animal and human studies simultaneously and plans to invest hundreds of millions of dollars to build laboratories where the vaccine will be produced even before it’s approved. The Food and Drug Administration on May 12 promised an accelerated review of Moderna’s vaccine, which works by injecting pieces of synthetic viral RNA into the body to stimulate an immune response to the virus.

The speed in developing vaccines for widespread testing this summer is impressive, certainly compared with the nation’s inadequate, delayed response to providing coronavirus testing and personal protective equipment to health care providers.

Still, many scientists have expressed skepticism at the breakneck timetable put forward by some Trump administration officials, who say that 100 million doses of a vaccine could be available by November. Even the normally sober Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told a Senate committee on May 12 that a vaccine could have proven safety and efficacy by then.

Running a trial of the size and speed contemplated by the NIH will be an immense undertaking. Just setting up trial locations and getting common consent and data-entry forms into shape usually take months. Enrolling 30,000 people for a single vaccine trial is a big challenge.

In addition, defining success in a vaccine against COVID-19 will be no simple matter. As scientists design vaccine trials, they first have to set the “endpoints” that determine success or failure. Death? Length of illness? Hospitalization? Number of days in which a subject is infectious?

If there is little virus circulating where a trial is being run, even a vast study won’t prove anything. On the other hand, if a vaccine trial had started in early April in New York City, where roughly 10,000 cases a day were reported for weeks, 30,000 participants would have been plenty to show whether the vaccine protected against the disease.

In all likelihood, the big NIH trials will focus on rates of infection as well as clinical symptoms such as fever and cough. To discover whether the vaccine prevents severe disease, which is relatively rare, is harder. COVID-19, according to one account, kills about 0.6% of those it infects, while perhaps six times that many require hospitalization.

People who take part in a trial will be given clear instructions to protect themselves against infection through social distancing, face masks, frequent hand-washing and so on. That will lower the number of people infected during the study.

“You’d have to ask all the people enrolled in a trial to practice good hygiene,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “You don’t want them to get infected — but you do.”

When Jonas Salk announced the successful trial of his polio vaccine in 1955, the nation celebrated a vaccine that could virtually eliminate a deadly infectious disease overnight. A new coronavirus vaccine may not provide that kind of overnight success. Instead, it may be more akin to the flu vaccine, which reduces the risk or severity of the illness but requires a new shot each year.

Vaccinating 20,000 people in a trial can reveal whether a vaccine is clearly dangerous to a general population. But when 200 million receive the same vaccine, less common side effects could still affect thousands. Botched batches of polio vaccines released after Salk’s trial permanently paralyzed 200 people and killed 10. Early vaccines against measles caused tens of thousands of cases of grave illness in the 1960s.

Maurice Hilleman, the vaccine pioneer who developed successful vaccines against measles, mumps, hepatitis A and B and other diseases, once said he never breathed a sigh of relief “until the first 3 million doses” had been delivered.

Unexpected problems naturally bedevil quick rollouts, as this one will almost certainly be as the nation searches for a way to check a pandemic that is killing tens of thousands of Americans and paralyzing the economy. But as Gregory Poland, the leader of Mayo Clinic’s vaccine research, told me, “There is an irresolvable tension of speed versus safety.”

Allen is the San Francisco editor for California Healthline, produced by Kaiser Health News, and the author of “Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver.”

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