Trump Administration announces framework and leadership for ‘Operation Warp Speed’

‘Operation Warp Speed [the administration's national program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (medical countermeasures)] is a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of HHS, including CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH's ACTIV partnership for vaccine and therapeutic development, NIH's RADx initiative for diagnostic development, and work by BARDA.’

Read here (HHS, US Department of Health & Human Services, May 15, 2020)

How swamped preprint servers are blocking bad coronavirus research

‘Howard Bauchner, the editor-in-chief of JAMA, notes that low-quality submissions are rising. Journals in the JAMA Network have received 53% more submissions in the first quarter of this year than in the same period in 2019. “Many of these are related to COVID-19, but most are of low quality,” Bauchner says.

‘To address the need for rapid review, a group of publishers and scholarly-communication organizations announced an initiative last month to accelerate the publication of COVID-19 papers using measures such as asking people with relevant expertise to join a list of rapid reviewers. The initiative’s members include Outbreak Science Rapid PREreview, a platform where researchers can request or provide swift reviews of outbreak-related preprints.’

Read here (Nature, May 7, 2020)

The problem with stories about dangerous coronavirus mutations

‘There’s no clear evidence that the pandemic virus has evolved into significantly different forms—and there probably won’t be for months...

‘As if the pandemic weren’t bad enough, on April 30, a team led by scientists at Los Alamos National Laboratory released a paper that purportedly described “the emergence of a more transmissible form” of the new coronavirus, SARS-CoV-2. This new form, the team wrote, “began spreading in Europe in early February.” Whenever it appeared in a new place, including the U.S., it rapidly rose to dominance. Its success, the team suggested, is likely due to a single mutation, which is now “of urgent concern.”

‘The paper has not yet been formally published or reviewed by other scientists. But on May 5, the Los Angeles Times wrote about it, claiming that “a now-dominant strain of the coronavirus could be more contagious than [the] original.” That story quickly went … well … viral.

‘But “the conclusions are overblown,” says Lisa Gralinski of the University of North Carolina, who is one of the few scientists in the world who specializes in coronaviruses. “To say that you’ve revealed the emergence of a more transmissible form of SARS-CoV-2 without ever actually testing it isn’t the type of thing that makes me feel comfortable as a scientist.” She and other virologists I’ve spoken with who were not involved in the Los Alamos research agree that the paper’s claims are plausible, but not justified by the evidence it presents. More important, they’re not convinced different strains of the coronavirus exist at all.’

Read here (The Atlantic, May 6, 2020)

Cook County searching for overlooked COVID-19 deaths as far back as November just ‘to cover our bases’

‘The Cook County Medical Examiner’s Office is planning to review a “handful” of cases dating as far back as November to determine whether some earlier coronavirus deaths were overlooked. “We don’t anticipate having [coronavirus] cases from November, but if we found that we had cases in November, we might want to look even earlier,” Derevyanny said. “Again, we don’t anticipate that, we just want to cover our bases and make sure that we have the most complete data we can for COVID-19.”

Read here (Chicago Sun Times, May 5, 2020)

FDA steps up scrutiny of coronavirus antibody tests to ensure accuracy

‘The action was the latest about-face in the administration’s coronavirus response as it seeks to fix a flawed testing response that has been criticized as either too restrictive or too lenient. Earlier this year, the FDA agency was hammered for moving too slowly in allowing academic medical centers and others to develop diagnostic tests for the virus that might have made them more widely available. Then, critics say, it swung too far in the other direction in allowing the antibody tests to go unvetted.

‘The result, they complained, was a flood of products of dubious quality that confused hospitals, doctors and consumers — “a wild, wild West” environment, said Scott Becker, chief executive officer of the Association of Public Health Laboratories, which represents state and local public laboratories.’

Read here (Washington Post, May 4, 2020)

The pieces of the puzzle of covid-19’s origin are coming to light

‘Many scientists think that with so many biologists actively hunting for bat viruses, and gain-of-function work becoming more common, the world is at increasing risk of a laboratory-derived pandemic at some point. “One of my biggest hopes out of this pandemic is that we address this issue—it really worries me,” says Dr Pilch. Today there are around 70 bsl-4 sites in 30 countries. More such facilities are planned...

‘The question of whether they really are [unrecognised zoonoses], and how those threats may stack up, needs attention. That attention needs laboratories. It also needs a degree of open co-operation that America is now degrading with accusations and reductions in funding, and that China has taken steps to suppress at source. That suppression has done nothing to help the country; indeed, by supporting speculation, it may yet harm it.’

Read here (The Economist, May 2, 2020)

Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial

‘Government clinical trial investigators changed the primary metric for measuring the success of Gilead’s experimental drug remdesivir as a coronavirus treatment two weeks before Anthony S. Fauci’s announcement that the drug would be the new “standard of care.”

‘Instead of counting how many people taking the drug were kept alive on ventilators or died, among other measures, the National Institute of Allergy and Infectious Diseases said it would judge the drug primarily on a different outcome: how long it took surviving patients to recover.’

Read here (The Washington Post, May 1, 2020)

Coronavirus vaccine: Where profit and public health collide

‘When it comes to developing medicines available for all populations in the world, the image of Big Pharma has long been tarnished. Supply bottlenecks for some specific drugs are often the result of the pricing policies pursued by major drugmakers, says Wasem [Jürgen Wasem, a professor for healthcare management at the University of Duisburg-Essen in Germany] — a claim, which is nonetheless "difficult to prove in most cases," he says. Sometimes, companies strive to keep supply artificially low, he says, to achieve higher market prices. Moreover, certain treatments are often never developed because there isn't a "commercial incentive" to undertake the effort, he adds.’

Read here (DW, May 1, 2020)

Stanford study finds presence of Covid-19 may be 50 to 85 times higher than official figures

‘The study [not peer reviewed yet] has been interpreted by some to mean we are closer to herd immunity – the concept that if enough people in a population have developed antibodies to a disease that population becomes immune – than expected. This would allow some to more quickly get back to work, a strategy currently being deployed in Sweden. But researchers behind the study said not to jump to conclusions or make policy choices until more research has been done.

‘The study confirms the widely-held belief that far more people than originally thought have been infected with the coronavirus, said Arthur Reingold, an epidemiology professor at UC Berkeley who was not involved in the study, but it doesn’t mean the shelter-in-place order will be lifted any time soon.’

Read here (The Guardian, April 17, 2020)

Characteristics of health care personnel with Covid-19: A US CDC profile from Feb 12 to Apr 9, 2020

What is added by this report? ‘Of 9,282 US Covid-19 cases reported among HCP, median age was 42 years, and 73% were female, reflecting these distributions among the HCP workforce. HCP patients reported contact with COVID-19 patients in health care, household, and community settings. Most HCP patients were not hospitalised; however, severe outcomes, including death, were reported among all age groups.

What are the implications for public health practice? ‘It is critical to ensure the health and safety of HCP, both at work and in the community. Improving surveillance through routine reporting of occupation and industry not only benefits HCP, but all workers during the COVID-19 pandemic.’

Read here (US CDC, April 17, 2020)

Finding effective treatments for COVID-19: Scientific integrity and public confidence in a time of crisis

‘Everyone wants new treatments and vaccines to address the devastation of coronavirus disease 2019 (COVID-19). But, currently, under intense pressure and based on hope and limited data from poorly conducted clinical trials and observational data, many clinicians are embarking on ill-advised and uncontrolled human experimentation with unproven treatments.’

This paper calls for three important considerations:

1. ‘First, the regulatory and research communities owe it to patients, families, and clinicians to quickly learn what treatments are effective... 
2. ‘Second, it is important to optimise treatments that already exist, including supportive critical care. As learned from the Ebola outbreak, mortality can be reduced through identifying best practices...
3. ‘Third, and most important, it is critical to protect the integrity of and resulting public trust in the scientific and regulatory agencies and their advice and decisions. That trust will be needed once vaccines against COVID-19 become available and in future public health emergencies.’

Read here (JamaNetwork, April 16, 2020)

Medical researchers have been studying everything we know about Covid-19. What have they learned – and is it enough to halt the pandemic?

‘Due to the unprecedented and ongoing nature of the coronavirus outbreak, this article is being regularly updated to ensure that it reflects the current situation as best as possible. Any significant corrections made to this or previous versions of the article will continue to be footnoted in line with Guardian editorial policy.’

Read here (The Guardian, April 15, 2020)

Clinical trials on repurposing two vaccines, BCG and polio: Both statements start with "There is no evidence..."

On polio: ’There is no evidence that oral poliovirus vaccine (OPV) protects people against infection with COVID-19 virus. A clinical trial addressing this question is planned in the USA, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend OPV vaccination for the prevention of COVID-19.’

Download here (Polio Eradication Initiative, March 2020)

On BCG: ‘There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against infection with COVID-19 virus. Two clinical trials addressing this question are underway, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of COVID-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis.’

Read here (WHO, April 12, 2020)