Tag Archives: Coronavirus

J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel

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Kerry Dooley Young, Medscape Medical News: February 26, 2021

An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine.

The Food and Drug Administration (FDA) is expected to quickly provide an emergency use authorization (EUA) for the vaccine following the recommendation by the panel.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22-0 on this question: Based on the totality of scientific evidence available, do the benefits of the Johnson & Johnson COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?

The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already available in the United States. Janssen’s vaccine is intended to be given in a single dose. In December, the FDA granted EUAs for the Pfizer/BioNTech and Moderna COVID-19 vaccines, which are each two-dose regimens.

[….]

Weakened Standards?

Several researchers called on the FDA to maintain a critical attitude when assessing Johnson & Johnson’s application for the EUA, warning of a potential for a permanent erosion of agency rules due to hasty action on COVID vaccines.

They raised concerns about the FDA demanding too little in terms of follow-up studies on COVID vaccines and with persisting murkiness resulting in attempts to determine how well these treatments work beyond the initial study period.

“I worry about FDA lowering its approval standards,” said Peter Doshi, PhD, from The BMJ and a faculty member at the University of Maryland School of Medicine in Baltimore, during an open public hearing at the meeting.

“There’s a real urgency to stand back right now and look at the forest here, as well as the trees, and I urge the committee to consider the effects FDA decisions may have on the entire regulatory approval process,” Doshi said.

Doshi asked why Johnson & Johnson did not seek a standard full approval — a biologics license application (BLA) — instead of aiming for the lower bar of an EUA. The FDA already has allowed wide distribution of the Pfizer/BioNTech and Moderna vaccines through EUAs. That removes the sense of urgency that FDA faced last year in his view.

The FDA’s June 2020 guidance on the development of COVID vaccines had asked drug makers to plan on following participants in COVID vaccine trials for “ideally at least one to two years.” Yet people who got placebo in Moderna and Pfizer trials already are being vaccinated, Doshi said. And Johnson & Johnson said in its presentation to the FDA that if the Ad26.COV2.S vaccine were granted an EUA, the COV3001 study design would be amended to “facilitate cross-over of placebo participants in all participating countries to receive one dose of active study vaccine as fast as operationally feasible.”

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard” for a BLA instead of the more limited EUA, Doshi said.

Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, noted that the FDA’s subsequent guidance tailored for EUAs for COVID vaccines “drastically shortened” the follow-up time to a median of 2 months. Zuckerman said that a crossover design would be “a reasonable compromise, but only if the placebo group has at least 6 months of data.” Zuckerman opened her remarks in the open public hearing by saying she had inherited Johnson & Johnson stock, so was speaking at the meeting against her own financial interest.

“As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets that happen, that’s a huge loss for public health and a huge loss of information about how we can all stay safe,” Zuckerman said.

Read the entire article here. 

Four ways Trump has meddled in pandemic science — and why it matters

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Giuliana Viglione, Nature: November 3, 2020

As the United States votes today on who will be its next president, Donald Trump’s response to the COVID-19 pandemic looms large. One issue that resonates with the research community is the extent to which the current president and his administration have meddled with science and scientific advice during the pandemic — often with disastrous results.

Last month, a coronavirus-crisis sub-committee within the US House of Representatives released a report documenting 47 instances in which government scientists had been sidelined or their recommendations altered. And the report notes that the frequency of meddling has been increasing in the lead-up to the US election.

“It’s hard to express how unbelievably demoralizing this experience has been,” says Diana Zuckerman, president of the National Center for Health Research, a non-profit organization in Washington DC.

If Trump wins a second term, researchers fear what that could mean for public health and the scientific enterprise. If Democratic challenger and former vice-president Joe Biden wins, he’ll have his work cut out for him to restore the reputation of the US science agencies that Trump has damaged.

Nature chronicles some of the most significant cases of meddling so far, and assesses their impact.

Scientists sidelined, silenced and ignored

At a campaign rally this week, Trump suggested that if he were re-elected, he would fire much-revered and long-standing infectious-disease expert Anthony Fauci, who has led the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), since 1984. Fauci has earned international acclaim as an adviser on HIV/AIDS to six US presidents, and is one of the most-cited researchers in the world.

This display follows a pattern of Trump attempting to silence and discredit Fauci throughout the pandemic: in May, in an unprecedented move, the administration blocked Fauci from testifying about the US pandemic response in front of the Democrat-led House of Representatives’ appropriations committee. “Never in my 30-plus years here in Washington do I recall ever a White House refusing to let an NIH expert testify before Congress,” says Zuckerman. The White House did not respond to Nature’s request for comment.

From cruise ships to asymptomatic spread: expert advice ignored

[….]

 

But Trump’s treatment of Fauci is just one example of the administration’s willingness to sideline its world-famous experts and institutions. The Centers for Disease Control and Prevention (CDC) is a world-renowned health agency and typically plays a major role in tracking and responding to outbreaks. In previous crises, its scientists have issued advice and updates directly to the public through regular media briefings. But compared with previous global-health crises, experts at the CDC have been unusually quiet during the COVID-19 pandemic, according to an analysis by the Union of Concerned Scientists (UCS) that was issued in May.

The report found that during the current pandemic, the CDC has held a much smaller proportion of press events than usual. For instance, during the H1N1 pandemic in 2009, the CDC led all but 3 of the 35 press conferences in the first 13 weeks of the pandemic. In contrast, Trump led close to three-quarters of the 69 press events during the same period of the COVID-19 outbreak. CNN reported that the lack of press briefings by the CDC on the coronavirus was due to pressure from the White House. “It is concerning that the scientists that are doing this great work are unable to talk,” says Anita Desikan, a research analyst at the UCS’s Center for Science and Democracy. The CDC did not respond to Nature’s request for comment.

[….]

In August, now-removed guidance appeared on the CDC’s website that stated that asymptomatic people no longer needed to be tested for the virus, counter to the recommendations of public-health experts. A senior CDC official told CNN that this guidance was issued “from the top down”; it was eventually reversed after public outcry. Officials outside the CDC have allegedly inserted their own documents on the CDC website in a move that Samuel Groseclose, a retired epidemiologist who spent 27 years at the agency, calls “bizarre”.

Revered public-health report delayed

The Trump administration has also attempted to meddle with a mainstay of the American public-health community: a weekly, peer-reviewed report that’s meant to facilitate the rapid release of epidemiological data. In September, Politico reported that political appointees in the Department of Health and Human Services, which oversees the CDC, had attempted to delay or halt the release of and retroactively edit the CDC’s Morbidity and Mortality Weekly Report (MMWR). Officials also demanded oversight before some results were published. The MMWR is “revered in the public-health community”, says Liz Borkowski, a public-health researcher at George Washington University in Washington DC, adding that she was “utterly horrified” to hear of the attempted meddling.

[….]

COVID treatments prematurely approved

Convalescent plasma, antibody-laden blood plasma from someone who survived COVID-19, was a promising treatment early in the pandemic. In August, the Trump administration leaned heavily on Food and Drug Administration (FDA) commissioner Stephen Hahn to issue an Emergency Use Authorization (EUA) for the treatment despite a lack of solid evidence that it helps people, as reported by The New York Times and The Washington Post. The FDA issued the EUA, making plasma available to a wide swath of the US population. But evidence from a clinical trial in India1, posted in September, suggests that the treatment has no effect on patient outcomes. Earlier in the pandemic, the agency had to revoke its authorization of hydroxychloroquine, which Trump had touted as a “game changer” for COVID-19, because it, too, was subsequently shown to be ineffectual at treating the disease.

[….]

To many public-health experts, it is clear that the Trump administration’s persistent meddling is responsible for the disastrous way in which the pandemic has unfolded in the United States. “Some of it is probably real and some of it is probably supposition,” Georges Benjamin, the executive director of the American Public Health Association in Washington DC, says of the media reports about interference. “But at the end of the day, this has been one of the worst risk-communications processes that I’ve ever seen. And I think that’s tragic.”

doi: https://doi.org/10.1038/d41586-020-03035-4

References

  1. 1.

Agarwal, A. et al. Preprint at medRxiv https://doi.org/10.1101/2020.09.03.20187252 (2020).

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HEALTH CARE BRIEFING: FDA Vaccine Rules Challenged as Weak

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Brandon Lee and Alex Ruoff, Bloomberg Government: October 23, 2020

U.S. vaccine advisers questioned whether safety and efficacy standards set by Food and Drug Administration officials were high enough to warrant emergency authorization of a shot.

About two dozen outside advisers to the FDA with expertise in infectious diseases met yesterday to weigh in on agency standards that require a vaccine to work in at least 50% of people and for drugmakers to collect two months of safety data on at least half of clinical trial volunteers.

“They haven’t gone far enough” in terms of safety, said Hayley Altman-Gans, a panel member and pediatrics professor at Stanford University Medical Center.

Many panel members and outside researchers who commented during the hearing worried that if a vaccine is rushed out that later turns out to have safety problems or to be less effective than promised, it could backfire in a big way, undermining public confidence in Covid-19 vaccines for years to come.

Several panel members expressed concern that the two-month safety follow-up the FDA is calling for before a vaccine gets an emergency authorization is simply not enough. In addition to safety, it means that doctors won’t know whether a vaccine’s efficacy could fade after just a few months.

Diana Zuckerman of the National Center for Health Research told the committee the vaccine trials “have serious design flaws.”

The trials are too geared to preventing mild infections, and may not show whether they prevent severe infections and hospitalizations, she said. Longer follow up may be especially important because some of the first vaccines, including messenger RNA vaccines from Pfizer and Moderna, are based on new technologies that have never been used in an approved product. 

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FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine

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Noel King and Sydney Lupkin, NPR: October 22, 2020

NOEL KING, HOST:

There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It’s the FDA’s job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It’ll be making recommendations based not on politically motivated timetables, but on data.

Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.

SYDNEY LUPKIN, BYLINE: Good morning.

KING: So what is the deal with this FDA panel? Who’s on it? What are they going to be doing?

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today’s meeting of the committee that looks at vaccines is going to be a little different.

KING: How?

LUPKIN: Like everything else in this pandemic, it’s a bit unusual. The big difference is that the committee isn’t going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children’s Hospital of Philadelphia.

PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?

LUPKIN: They’ll be discussing FDA’s existing guidance to companies, which includes some of that information. They’ll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn’t have to.

KING: So since there’s no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It’s very clear that the FDA wants to make public that this is happening. Why do they want to do that?

LUPKIN: Well, I mean, it gives the American public a window into the process. There’s been so much discussion around whether the FDA will put politics ahead of science. So it’s important to see what’s going on. And the FDA has questions that it wants answers to. Here’s Dr. Miles Braun, a former FDA epidemiologist.

MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that’s a good thing. And if they find out they’ve missed some important things, they’ll address those.

LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.

DIANA ZUCKERMAN: We’ve seen the guidance of what they’re telling companies they’re supposed to be studying. Frankly, they’re not very stringent, so we are concerned about them.

LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.

[…]

Read or listen to the full article here. 

FDA Promises Strong Safety Standards for Covid-19 Vaccines as It Convenes Advisory Panel

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Thomas M. Burton, Wall Street Journal: October 23, 2020

SILVER SPRING, Md.—Food and Drug Administration officials gave fresh assurances Thursday that Covid-19 vaccines will undergo rigorous testing before being made widely available—a message they underscored in a meeting with outside medical experts aimed at bolstering the agency’s credibility.

“Only those vaccines that are demonstrated to be safe and effective” will be licensed by the FDA, said Marion F. Gruber, director of the FDA’s Office of Vaccines Research and Review. But some speakers and panel members raised concerns about whether the FDA’s vaccine guidelines for Covid-19 clinical trials are sufficiently rigorous.

These comments came at the first meeting of a 25-member panel of medical experts, including specialists in fields like virology, infectious diseases and biostatistics. The group, which met remotely via video-conferencing, was  established to make recommendations to the FDA on how best to assess the safety and effectiveness of vaccines.

“The FDA frequently convenes outside panels of medical experts for their advice on products,” said Peter Marks, director of the FDA’s center for biological products. “But normally panels about vaccines are watched by dozens of people. In this case, it’s watched by many thousands.”

[….]

President Trump has pushed to get a vaccine approved quickly, which has drawn concern from some public health experts and political opponents that the FDA would be under pressure to bypass usual precautions to rush a vaccine to market quickly.

FDA officials have vowed not to do so. In addition to convening the advisory panel, they have issued a set of guidelines to govern how vaccine clinical trials will be conducted and evaluated.

They also formulated a set of rigorous standards for the FDA to employ before granting what is known as an emergency-use authorization (EUA) for a vaccine. The EUA is the faster equivalent during the Covid-19 pandemic of a conventional approval by the agency.

[….]

Various speakers questioned whether the shorter EUA test period was sufficient.

“The vaccine trials have serious design flaws,” said Diana Zuckerman, president of the National Center for Health Research in Washington. In addition to the two-month period, she said FDA guidelines focus on measuring milder cases of the disease, and not the most serious cases.  

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MLB’s return plan mirrors the Bundesliga’s. The key difference? It’s in the U.S., not Germany.

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Jesse Dougherty: The Washington Post, June 3, 2020

One season is ending, another is beginning, and the intersection of the two — Major League Baseball and Bundesliga soccer — shows how risky it is to restart sports in the United States right now.

On Saturday, Bayern Munich and Bayer Leverkusen will meet in the German Cup final in Berlin, capping a successful six-week schedule. Across the Atlantic Ocean and all over North America, MLB will begin summer camp during the novel coronavirus pandemic. The models for the two are similar in that, unlike the NBA, they are operating outside of a bubble, traveling between cities and having players, coaches and staff live at home.

But here’s a key difference: Germany’s response to the pandemic was much more successful — and much more proactive — than the United States’. It enabled the Bundesliga, the country’s top-tier soccer league, to resume in mid-May and handle sporadic coronavirus cases. Baseball, on the other hand, is about to make a similar attempt in a much different environment.

The United States topped 50,000 new daily cases for the first time Wednesday. That was more than a fourth of Germany’s total cases to date. Germany has had around 9,000 coronavirus deaths, and by mid-May, when soccer returned, it had almost completely flattened the curve.

“Germany was able to pull it off, but we are not Germany. Many of the markets that MLB wants to play in do not look like Germany,” said Zachary Binney, an epidemiologist at Oxford College of Emory University. “The baseline risk is much higher. So unfortunately, because of our response to covid-19, sports leagues need stricter return plans, and I don’t know that MLB has really wrestled with that yet.”

Both plans hinge on players, coaches, staff and their families being cautious and smart away from team facilities. That’s the reality of not playing inside a bubble, which the NBA will use in Florida to negate travel and limit exposure to the outside world. But MLB and the Bundesliga took near-opposite approaches for regulating off-site behavior.

MLB’s 113-page operations manual dedicated one paragraph to it, writing individuals “must exercise care,” adding that they should avoid restaurants, bars and other crowded areas. MLB left each team to craft and enforce its own policy. Four players, who spoke on the condition of anonymity to freely discuss a sensitive topic, said this is MLB’s way of avoiding responsibility should an outbreak occur.

[….]

Here is where baseball picks up this weekend, starting with testing. Before training begins, all players, coaches and staff have to take a coronavirus test and self-quarantine while awaiting results. After that, they will be tested every other day. A lab in suburban Salt Lake City will be tasked with fielding thousands of tests and turning around results in “approximately 24 hours,” according to MLB’s operations manual. There is, however, already skepticism within the sport that results will come that quickly.

Before training began in Germany, players, coaches and staff did a week-long quarantine at a hotel. They ate meals separately and, each morning, completed a questionnaire to check for possible symptoms. Testing was frequent during that period, then slowed to around twice a week during the season. The Bundesliga contracted five labs to process results and, according to news accounts, was comfortable doing so because the country wasn’t stretched for resources.

Since the Bundesliga was the first league to return, it provided a template for how to play outside of a bubble. But environmental influences serve as the trickiest element there. Baseball’s plan, while similar, is less detailed in critical areas, according to public health experts, and set to unfold where the virus is still rampant.

“The biggest risk for baseball is location,” said Diana Zuckerman, president of the nonprofit think tank National Center for Health Research. “The greatest weakness of the plan is sending teams and having teams in states where the governor is unwilling to have strict rules.”

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DOT Wants to Weaken Its Own Power to Penalize Airlines Over Consumer Complaints

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Amy Marten: Fair Warning June 1, 2020

With enforcement against airlines for consumer violations already falling sharply, the Department of Transportation is pushing for a rule change that consumer groups and some lawmakers say would serve no other purpose than further protecting airlines from civil fines.

The proposed change, announced in February, would require the DOT to use a more rigid definition of “unfair and deceptive practices” when investigating consumer complaints against airlines. The rule would also allow airlines to call for additional hearings when defending complaints or when facing future regulations.

Under Transportation Secretary Elaine Chao, the agency already is taking a more hands-off approach to complaints by air travelers, with enforcement actions on a sharp downward trend. In 2019, the DOT’s Aviation Consumer Protection Division issued eight enforcement orders against airlines, a record low and half as many as it issued the previous year, an agency database shows. The previous record low was nine enforcement orders, set in 2000, according to The Washington Post.

This year has also seen few cases, with three civil penalties imposed on airlines so far in 2020 totalling $850,000.

The DOT acknowledges in its proposal that it could be “performing fewer enforcement and rulemaking actions” under the rule. The agency credits Airlines for America, the lobbying organization that represents the nation’s major airlines, for suggesting the change. The industry group had complained that it had been subject to aggressive regulatory activity over the years, even for “minor infractions, inadvertent errors, or isolated incidents,” according to the DOT’s summary of the request.

“The value of this proposal is that DOT will need to explain…the reasons why it believes a practice is ‘unfair’ or ‘deceptive,’” Airlines for America said in a statement to FairWarning.

Few outside the industry would argue that airlines are being burdened by excessive regulations, especially with the free-for-all that has characterized air travel during the Covid-19 crisis.

In a June 10 letter to Chao blasting the proposal, Senators Edward Markey, Maria Cantwell, Tammy Baldwin and Richard Blumenthal, all Democrats, cited the recent decline in enforcement and thousands of consumer complaints since the onset of the coronavirus pandemic, many about airlines’ refusal to pay refunds.

[…]

Even as infection rates are on the rise in the U.S., some carriers are starting to abandon voluntary measures to prevent the spread of disease, such as leaving the middle seat open to allow for social distancing. This week, American Airlines announced that it would resume selling planes at full capacity. The airline justified the plan by saying it would require enhanced cleaning and face coverings. “With all of these layers of protection, we are comfortable removing the load factor cap,” American Airlines said in an email to FairWarning.

But the airline refused to say whether the Centers for Disease Control and Prevention had vetted its plan to allow full planes. Instead, American Airlines said that its safety plan is accredited by ISSA, a trade group for corporations that sell cleaning products, such as 3M and Procter & Gamble.

“Having a certification from an industry group is not the same thing as having met the standards of the CDC or the NIH [National Institutes of Health] or any other objective agency,” Dr. Diana Zuckerman, president of the nonprofit National Center for Health Research, said in an interview. 

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CRS: Congress Can Rein In FDA’s Flexible COVID-19 Vaccine Trial Policies

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Beth Wang, Inside Health Policy: June 03, 2020

The Congressional Research Service says Congress could rein in FDA’s broad discretionary authority over vaccine clinical trial policies by legislating how the agency and Institutional Review Boards approach clinical trial designs and reviews for the current COVID-19 pandemic, as well as for future emergencies. In a Tuesday (June 2) report, CRS suggests Congress could provide more specific direction to FDA and IRBs on how to approach clinical trials in emergency situations, and also could appoint a neutral scientific body to consider ethical and scientific issues as well as general guidelines for trials. Congress also could fund global collaboration among regulators, and provide additional funding and resources to facilitate clinical trials, the report suggests, echoing recent calls from lawmakers who have said the United States should get involved with global efforts to fund and develop COVID-19 vaccines and treatments.

Diana Zuckerman, president of the National Center for Health Research, applauded CRS for explaining the vaccine approval process to Congress and for telling lawmakers what their options are so Congress can, in Zuckerman’s words, “ensure a better outcome than we’ve seen with the disastrous coronavirus testing situation (in terms of accuracy, transparency, and availability).” The document, she told Inside Health Policy, does a good job of explaining that FDA has authority to lower approval standards for any drug or vaccine unless Congress steps in. “[B]ased on FDA’s actions of the last 3 months, it seems likely that they will do so in ways that could create the free-for-all that currently exists for coronavirus testing,” Zuckerman wrote in an email. “So the CRS is telling Congress that legislation is the option they have if they want to ensure a better outcome.”

Existing law, CRS says, requires FDA and IRBs to weigh considerations about safety and effectiveness against the desire to bring products to market quickly when evaluating proposed clinical trial designs for vaccines.

[…]

Congress previously told FDA what to do in the drug trial and approval space through passage of the 21st Century Cures Act, but FDA was given leeway in how to interpret the law, Zuckerman explained. “It pushed FDA in a particular direction but still gave the FDA the authority to rely on the agency’s subjective judgment,” she said. If Congress were to step in and tell FDA what it should do, it would be a radical departure, Zuckerman added. “[But it’s] probably necessary given FDA’s response to the pandemic so far, and the Administration’s track record of ignoring Congress when it suits them,” she said.

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Hahn Defends Using Less ‘Robust’ Data During COVID, But Critics Contend It Has Gone Too Far

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Sarah Karlin-Smith, Informa Pharma Intelligence: June 04, 2020

[…]

Anecdotes Are Not Data Sets

The regulatory flexibility touted by Hahn was embraced to some degree by even some of the agency’s most notable critics, who agreed that the nature of the COVID-19 pandemic should allow for a different pace of decision making than under normal circumstances. However, they said they were concerned that FDA is misusing such flexibility, particularly when it came to the emergency use authorization (EUA) for hydroxychloroquine and chloroquine.

“I agree with Dr. Hahn that in emergency situations it makes sense to move quickly and change course quickly if the evidence is different from what was hoped for. But the only justification for making [hydroxychloroquine] immediately widely available was that President Trump had ‘a good feeling about it,” said Diana Zuckerman, president of the National Center for Health Research.

The EUA was granted based on laboratory data and anecdotal clinical reports. (Also see “FDA’s Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments” – Pink Sheet, 30 Mar, 2020.)

Zuckerman described this not as datasets but as anecdotal evidence. “Scientists don’t call anecdotal evidence datasets. As any scientist can tell you, the plural of anecdote is ‘anecdotes’ not ‘data,”” Zuckerman said.

In an emergency situation “making decisions on the fly and using the best data that you have is inevitable,” but the agency should follow certain principles when it does this, said Aaron Kesselheim, the director of the Program on Regulation, Therapeutics and Law at Harvard Medical School and Brigham and Women’s Hospital.

Kesselheim’s third principle was that the FDA should revisit or revise these decisions just as quickly as they made them when new information emerges. He said the FDA has done a good job in some circumstances of adhering to these principles and done less well in others.

As Hahn mentioned in his speech, the agency has reversed some of its early EUAs for COVID-19 tests. (Also see “FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block” – Medtech Insight, 22 May, 2020.)

[…]

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How MLB is navigating the coronavirus pandemic to play ball

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ESPN staff, ESPN: May 19, 2020

MAJOR LEAGUE BASEBALL’S plan to start the season by July 4 relies on a dizzying array of moving parts, including the cooperation of 27 U.S. cities and a foreign country, the availability of more than 200,000 reliable coronavirus tests and a promise not to interfere with the nationwide fight to contain the pandemic.

ESPN examined the challenges facing MLB as it struggles to get back on the field. What emerges is like nothing that has been attempted in the history of American sport, less a baseball season than a military-style operation in which any number of variables could derail the plan, or, worse, contribute to the spread of the deadly disease.

[…]

WHEN MLB ABANDONED the idea to play the season under a bubble-like quarantine, it eased the restrictions that players would face but also created a riskier and more complicated scenario, according to health experts.

Even if teams are limited to regions — reducing travel, as the plan anticipates — players and other personnel will still travel between cities where people are living under different health orders and the virus may be spreading at different rates. Some states have reopened more than others and are projected to see a spike in cases, while others remain all but closed. Georgia, for example, partially ended its stay-at-home order on April 24, lifting restrictions on gyms, bowling alleys, hair salons and other businesses. In Cobb County, where the Braves play, new cases have been averaging about 50 a day. Some models and experts predict Georgia will soon see an increase in deaths because of the reopening.

“I wouldn’t want to put players in Atlanta’s ballpark,” said Beth Blauer, the executive director of the Johns Hopkins Center for Civic Impact, which specializes in the use of data to advise governments and nonprofits on best practices. “You have to determine where to play based on that modeling. You can’t bring players into hot spots. … You’ll know between mid-May and June how devastating the decisions are and where the new hot spots are, potentially.”

Alex Fairly, CEO of Fairly Group, an Amarillo, Texas-based risk management firm whose clients include MLB and the NFL, served as chairman of Lt. Gov. Dan Patrick’s Back to Work Task Force on Sports and Entertainment, which included representatives of the Astros and Houston Texans. The challenge of figuring how sports will be staged safely “fried my brain,” said Fairly, adding that the process caused him to lose sleep. “There are 8,000 issues. No one knows exactly what to do because this has never happened. It’s a true black swan moment.”

Baseball’s plan designates about 100 essential employees per team — players and other on-field personnel and “a limited number of essential staff who come in close proximity to the players.” These “Tier 1” and “Tier 2” individuals will be tested multiple times per week, though the plan doesn’t specify how many times that would be. The plan says nothing about regular testing for 150 “Tier 3” individuals who are involved in “essential event services” but will be separated from the others. If those people come into contact with someone who has the virus, they will be tested.

Beyond their families, teammates, managers and other baseball personnel, players still will be exposed to a broad range of people — from hotel staff to security personnel; from bus drivers to flight attendants. All will be traveling in their own circles when not working; MLB’s plan does not say anything about testing those workers. That creates added potential for an outbreak, experts said.

“One of the things I try to explain to people is that whatever other people are doing who live anywhere near you, is gonna affect you,” said Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., a nonprofit independent think tank. “Just because you’re not going to get a tattoo when you’re in Georgia when your team is playing the Braves, if the person serving you at the restaurant is married to a person who got a tattoo or married to the person who is the tattoo artist, then you as a customer at that restaurant or even picking up carryout has the potential for being contaminated by those people who are doing those things.”

Keeping stadiums and other areas sterile will be a perpetual ordeal. It will involve perimeter security to keep fans away, both at the ballpark and hotels, where autograph seekers often congregate.

[…]

IN INTERVIEWS WITH dozens of health care experts — doctors, epidemiologists, immunologists, policy specialists, government authorities — there was consensus that the main component to keeping baseball safe will be diagnostic testing. That’s the same issue that has bedeviled the national effort to combat the coronavirus.

The goal of testing is to weed out and isolate those who test positive and prevent outbreaks. The risks of insufficient testing are incalculable. Clusters of the coronavirus have erupted in group and travel environments. In early March, more than 100 people became infected at a Boston leadership conference of Biogen, turning the drug company into an unwitting spreader of the disease to other states.

With that nightmare scenario for baseball in mind, and players and staff traveling in and out of their communities, it’s imperative for MLB to ferret out positive cases before they spread, the experts said. MLB’s plan calls for testing players and personnel “multiple times” per week, but not daily, as some experts suggest.

“If you were doing daily testing, you’d have the ability to pick up very low numbers on the virus, pick it up as soon as somebody has the ability to transmit,” said Dr. Melissa Nolan, an infectious disease expert at the University of South Carolina.

Nolan described MLB’s testing plan as a B-minus — compared to an A-plus if you were testing daily — but said she believed it could be effective, particularly if players are diligent about social distancing and limit their exposure away from the ballpark.

Trout told ESPN: “I don’t see us playing without testing every day.”

Dr. Howard Forman, a Yale professor of health policy who has offered guidance to some sports leagues and teams, said he believes baseball’s plan should work. He noted that data suggest the prevalence of the virus among top-level athletes is likely to be extremely low, plus it will be easier to limit exposure without fans and other workers at the ballparks. Forman wouldn’t say which leagues he had spoken with.

Under MLB’s plan, only the person who tests positive will be quarantined. That policy conflicts with current Centers for Disease Control and Prevention guidelines, which call for anyone who has had close contact with a confirmed case to quarantine for 14 days. “Our experts are advising us that we don’t need a 14-day quarantine [in such cases],” Manfred told CNN. The plan says baseball is following rules established by “health care institutions and governmental entities” but does not specify which entities.

Baseball is in a difficult position: Quarantining players who come in contact with infected individuals could force MLB to shut down entire teams.

Most health experts interviewed by ESPN said they believe MLB would be increasing the risk of an outbreak by not quarantining more extensively, if only for a few days.

“CDC guidelines are pretty clear that anybody who makes substantial contact with somebody who has the virus needs to be quarantined,” Dr. Ashish Jha, director of the Harvard Health Institute, told ESPN. “I think baseball has to ask themselves on what basis are they going against the CDC guidelines. How confident are they gonna be that another player on another team didn’t have substantial contact with that player? It just strikes me as risky. My feeling is it just depends on how lucky you feel.”

Zuckerman, who runs the nonprofit think tank in D.C., said, “I could understand not quarantining for 14 days, because potentially you’d end up never being able to play. But not quarantining at all seems dangerous.” But Humble, the former Arizona health director, said MLB developed “a reasonable plan. The idea of the CDC guidance is to minimize risk, so if you find another way, that’s OK. Guidance shouldn’t be one-size-fits-all. This may even be better, because of the frequency of testing, which is robust.”

After a positive test, clubs are required to work with local health officials to trace those who came in contact with the infected individual. Those people will receive an expedited test and, if negative, will be allowed to remain active — raising the possibility that people exposed to the virus could return to baseball within minutes. Baseball’s plan calls for additional testing of those individuals every day for one week, with results returned within 24 hours. “That’s time someone could be infecting other players, staff, their families,” one union source said.

Experts told ESPN that it can take several days for someone to test positive after contracting the virus.

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Read the full article here.