From AVAC <[email protected]>
Subject COVID News Brief: We're-going-to-need-more-vials edition
Date June 25, 2020 2:20 PM
  Links have been removed from this email. Learn more in the FAQ.
  Links have been removed from this email. Learn more in the FAQ.
View this email in your browser ([link removed])
“People are marching around the world. ‘I can't breathe.’ Brown people. Black people are dying. More than others. And it's not fair. It's not fair that the hospital on the hill has the beds and the food and the ambulances while the community waits at the edges, trapped in the flats with no way out…There are no heroes in community health centres. Just tired doctors and nurses waiting for help. And mountains of quiet paperwork, for the living and the dead.” News24 ([link removed]) (South Africa)


** Latest Global Stats
------------------------------------------------------------
June 25, 2020
Confirmed Cases
9,457,902 Recovered
4,767,027 Deaths
483,247
Source: Center for Systems Science and Engineering, Johns Hopkins University
AVAC's weekly COVID News Brief provides a curated perspective on what COVID news is worth your time. AVAC has been sharing similar information internally for years. Given the rapidly changing research landscape, we've decided to make them more widely available.


** Table of Contents
------------------------------------------------------------
* US Minorities Remain Undercounted and Underserved (#minorities)
* Ever Widening Effects of the Pandemic (#widening)
* Changing from VMMC to COVID-19 Testing (#VMMC)
* New in Vaccine Research (#VaxRx)
* The Politics of Vaccine Research (#VaxRx)
* New in Treatment (#treatment)
* The End of Hydroxychloroquine? (#hydroxy)
* Adapting Research in a Pandemic (#adapting)
* Pricing (#pricing)
* Another Call for Funding (#funding)
* Problems with Tests Continue (#problems)


* A Swab-less Test in UK (#swab)
* Confused About Testing? Here’s Help (#confused)
* Antibodies May Not Hang Around (#antibodies)
* COVID Impact on Other Research (#impact)
* COVID and Protests (#protests)
* WHO and US politics (#who)
* US Public Health Experts Threatened (#experts)
* COVID and Nationalism (#nationalism)
* COVID and HIV (#HIV)
* COVID and Breastfeeding (#breastfeeding)
* After Lockdown What? (#after)
* This Week in Mis/disinformation (#misinfo)
* A Day in the Life… (#day)
* Resource of the Week (#resource)

The world is on track to cross 500,000 COVID-19 deaths in the coming days as cases and deaths continue to rise in many countries. Last Friday, the WHO once again marked a record, with 150,000 new cases reported to WHO in a single day, the highest number so far. AFP ([link removed]) reports that WHO said the pandemic is in a "new and dangerous phase" and Dr. Tedros “urged nations and citizens to remain extremely vigilant….”

Several countries are marking high numbers of cases, hospitalizations and death. Washington Post ([link removed]) reports “For three months, Egypt seemed to escape the huge case numbers seen in many other nations, including those with far lower populations. But the number of reported cases in the country has steadily risen in recent weeks, with more than 1,500 infections per day since Friday, escalating pressure on a health-care system that was strained long before the pandemic. New York Times ([link removed]) reports, “Pakistanis stricken by the coronavirus are being turned away from hospitals that have simply closed their gates and put up signs reading ‘full house.’ Doctors and nurses are falling ill at alarming rates, and are also coming
under physical assault from desperate and angry families.”

Reuters ([link removed]) says, “Global infections surpassed 9 million on Monday, as Brazil and India grappled with a surge in cases and the United States, China and other hard-hit countries reported new outbreaks….”

Forbes Africa ([link removed]) reports, “The African continent has 309,710 cases of COVID-19, while the death toll stands at 8,156. The continent has made 149,039 recoveries.”



** US Minorities Remain Undercounted and Underserved
------------------------------------------------------------
Politico ([link removed]) reports, “Despite rising pressure on the Trump administration to fix the data deficits, 52 percent of reported coronavirus cases in the US are still missing information on race or ethnicity. Recent federal guidance on gathering more of that data through testing won’t start until August…. The gaping holes weaken efforts to contain the pandemic, and they disguise the full impact of the coronavirus on minority populations that have been disproportionately ravaged by the disease.”

STAT ([link removed]) reports, “Four months into a pandemic that has disproportionately devastated Black, Latino, and Native American communities, leading minority health experts within the Trump administration remain conspicuously quiet and have conducted minimal outreach to communities of color…. This lack of advocacy is especially apparent amid a broader national reckoning over police violence and other systemic forms of racism in the US, including in health care, critics said.”

Leana Wen writes in The Washington Post ([link removed]) , “A new Brookings Institution report ([link removed]) finds that in some age groups, death rates for African Americans and Hispanic Americans are as much as six times higher than for white people. Policymakers are rightly discussing the complexity of the overlapping crises of racism and COVID-19, but we don’t have time to wait.” She outlines 8 steps to address the disparity, including “target[ing] testing to minority communities” and “track[ing] demographic information to ensure equitable resource allocation.”


**
Ever Widening Effects of the Pandemic
------------------------------------------------------------
Medscape ([link removed]) reports on the intersection of the US epidemic of opioid addiction with COVID-19: “addiction medicine specialist…are working harder than ever to help patients who are caught up in the opioid crisis retain their access to treatment in the midst of the pandemic.”

A UNAIDS (applewebdata://318D0EB0-E24A-4F3D-8621-03F7A51718B4/unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2020/june/20200622_availability-and-cost-of-antiretroviral-medicines?utm_source=UN+News+-+Newsletter&utm_campaign=ed2f1fcae0-EMAIL_CAMPAIGN_2020_06_23_12_00&utm_medium=email&utm_term=0_fdbf1af606-ed2f1fcae0-107106709) statement reports on a “UNAIDS survey [that] discovered that the lockdowns and border closures imposed to stop COVID-19 are impacting both the production of medicines and their distribution, potentially leading to increases in their cost and to supply issues, including stock-outs over the next two months.” The full analysis of the survey is here ([link removed]) .


** Changing from VMMC to COVID-19 Testing
------------------------------------------------------------
Bhekisisa ([link removed]) reports, “…as South Africa went into its coronavirus lockdown in March, non-emergency procedures such as medical circumcisions were stopped. And CHAPS teams—like many organisations providing VMMC around the world—pivoted to begin supporting the fight against COVID-19, specifically South Africa’s massive COVID-19 screening and testing campaign.” The CHAPS team who switched from VMMC to COVID-19 brought many lessons from HIV to COVID-19, including “the biggest lesson South Africa could learn from COVID-19 is something we also saw with past efforts to increase the uptake of VMMC and antiretrovirals for HIV-positive clients: Don’t roll out a public health response without adequate knowledge, or information dissemination, to communities.”


**
New in Vaccine Research
------------------------------------------------------------
NEJM Journal Watch ([link removed]) reports on the “first published study on safety and immunogenicity of any COVID-19 vaccine in humans.” The study of the Phase I “recombinant adenovirus type-5 vectored COVID-19 vaccine” trialed in Wuhan, China was published in The Lancet ([link removed](20)31208-3.pdf) last week. NEJM warns, “The choice of Ad5 as a vector is concerning. When Ad5 was used as a vector for vaccination against HIV in humans, common pre-existing immunity to the vector was one factor associated with increased HIV acquisition. In addition, this vaccine demonstrates significant reactogenicity, albeit self-limited, and only modest immunogenicity. Despite these concerns, the investigators indicate that this vaccine entered phase 2 evaluations.”

Helio ([link removed]) interviews, Carol M. Kao, MD, assistant professor of pediatric infectious diseases at Emory, author of “a recent paper in Clinical Infectious Diseases, the ‘true burden’ of SARS-CoV-2 in children may be underrepresented ([link removed]) based on a number of factors that make them less likely than adults to be tested…. Kao and colleagues argued that to achieve herd immunity, COVID-19 vaccine trials should include children.” Kao says, “We advocate that planning for clinical trials in children should begin now and studies should be implemented as soon as preliminary data are available about safety in adults from phase 2 trials.”

In an op-ed in Wired ([link removed]) , Jerome Kim argues, “An effective vaccine(s) against COVID-19 holds great promise, but that promise will not be fully realized unless we think and prepare carefully for the future.... while vaccines are the most cost-effective weapons in the war against COVID-19, and our surest bridge ‘back to the future’ of normalcy, we must take particular care in planning the development, manufacturing and roll-out of safe and effective vaccines against COVID-19.”

ABC News ([link removed]) and other outlets are reporting on a potential shortage of glass vials that could lead to a “life-threatening bottleneck in the supply chain that could prevent the medicine from finding its way into the glass vials used to give patients shots.” One expert says, "It could take up to two years to produce enough vials for US vaccine needs, while some therapeutics will also require vials."


** The Politics of Vaccine Research
------------------------------------------------------------
The Guardian ([link removed]) warns, “Concerns that Donald Trump’s inner circle might pressure the Food and Drug Administration (FDA) to rush a coronavirus vaccine to market in time for the presidential election have risen after the White House attacked the agency for reversing itself on an experimental drug treatment…. But other outside experts said that regulatory approval for any vaccine would require a degree of data transparency that would prevent the process from being unduly rushed…. Wayne Koff, president of the Human Vaccines Project, said he did not think ‘there’s going to be political pressure’ to rush vaccine approval. ‘Because I think the data is going to be transparent, as all the data has been in this field,’ Koff said.”

Time ([link removed]) reports, “Seizing on a medical milestone that doesn’t exist, President Donald Trump said Tuesday he thinks the same scientific expertise that produced a vaccine for AIDS can deliver one soon for COVID-19, too. There is no vaccine for AIDS.”

Wall Street analysts told MarketWatch ([link removed]) , “A vaccine may be approved before the November election…. ‘We believe the FDA will likely approve at least one vaccine prior to the November election,” Jefferies health-care strategist Jared Holz ([link removed]) said in an interview. “Perhaps multiple vaccines could get the go-ahead at some point early in the fourth quarter and quell fears of a second wave of COVID-19.’…. President Trump has a penchant for timing policy decisions (such as China trade negotiation breakthroughs) to influence the markets and the electorate at key tactical turning points. So, it won’t be surprising if he exerts behind-the-scenes pressure to get vaccine approval to boost ratings and his odds against the Democrats, says Holz. Sounds Machiavellian. But welcome to
politics.”


**
New in Treatment
------------------------------------------------------------
Fierce Pharma ([link removed]) reports Gilead has received “FDA clearance to start a phase 1 trial of an inhaled version of remdesivir in healthy volunteers…. The company’s intention is very clear: reaching patients earlier, before their disease worsens and becomes harder to treat. ‘An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease,’ [Gilead CEO] O’Day said.”

Fierce Pharma ([link removed]) reports on two new Phase II trials of an “antiviral treatment, EIDD-2801: the first in hospitalized COVID-19 patients and the second in patients newly diagnosed with COVID-19 who are still at home. Both trials will pit a twice-daily dose of EIDD-2801 against placebo over five days to see whether the drug can clear the virus more quickly than placebo.”


**
The End of Hydroxychloroquine?
------------------------------------------------------------
Fierce Pharma ([link removed]) reports, “The road for hydroxychloroquine against COVID-19 is coming to an end. Three major clinical programs have been terminated after a UK trial found ‘no clinical benefit’ for the malaria drug championed by US President Donald Trump. In the past few days, the World Health Organization (WHO), generic hydroxychloroquine (HCQ) maker Novartis and the US National Institutes of Health (NIH) have all ended their HCQ COVID-19 studies in hospitalized patients in quick succession.

Science ([link removed]) reports on Brazilian researchers who “published a study showing chloroquine can increase mortality in COVID-19 patients. Since then, they have been accused of poisoning their patients with a high dose of chloroquine just to give the drug—praised by US President Donald Trump and his Brazilian counterpart Jair Bolsonaro—a bad name ([link removed]) . Social media attacks, defamatory articles, death threats, and even a legal inquiry into the group’s work have” followed.


** Adapting Research in a Pandemic
------------------------------------------------------------
The COVID-19 pandemic has changed much about how research is done in an emergency situation. Former Trump FDA head Scott Gottlieb and former Bush FDA head Mark McClellan write in a Wall Street Journal ([link removed]) op-ed that “public-health authorities in the US aren’t supporting the Recovery model, viewing it as insufficiently rigorous because it didn’t collect information on all of the variables that could influence outcomes. But complex studies are often impractical in the setting of an epidemic, where clinicians are hard pressed to carve out time from crisis medical care to track and record hundreds of required variables. The British approach makes it manageable to learn what works in many more hospitals…. The US appears consigned to high COVID-19 case levels and health-care systems that will continue to be under threat. We owe it to all of the patients who will be hospitalized to use this unfortunate reality to help
providers make the best treatment decisions possible.”



** Pricing
------------------------------------------------------------
STAT ([link removed]) reports, “Amid ongoing concern that COVID-19 therapies and vaccines may be unaffordable, a bipartisan group of lawmakers introduced a pair of bills Monday that would prohibit drug makers from price gouging and also require all taxpayer-funded COVID-19 research to be recorded in a federal database…. The move comes as access to COVID-19 medical products emerges as a hot-button issue in the US and elsewhere, with worries mounting over the extent to which a therapy or vaccine will be available in sufficient quantities at affordable prices.”



** Another Call for Funding
------------------------------------------------------------
Wellcome Trust director Jeremy Farrar makes a plea in an opinion ([link removed]) on the Trust’s website for business and philanthropy to fund COVID-19 treatments, diagnostics and vaccines. He argues, “Science is the exit strategy from every epidemic. It will be our exit strategy from the coronavirus pandemic too, but we need to fund it in a way that produces results much faster than ever before and on a global, equitable scale from the outset…. Our experience of the HIV/AIDS epidemic shows that while a coronavirus vaccine would be ideal, there are no guarantees that one will work. And if we do find a viable candidate, it may take a year or more to be ready at the global scale needed. Effective and proven coronavirus treatments are also a crucial part of the answer to this crisis. They could prevent infection, save lives, protect public health and help us get ahead of this pandemic while we
continue our search for a vaccine.” Farrar calls for contributions to a Wellcome Trust fund for COVID-19 research.



** Problems with Tests Continue
------------------------------------------------------------
Medscape ([link removed]) reports on concerns around the Abbott rapid COVID-19 test that “had received high praise from the White House because of its speed….” The test is now reported to miss out on 2 in 10 positives. “False negatives increase the risk that patients will not self-isolate or exercise other precautions—such as wearing a mask—and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn't likely to miss sicker patients.”



** A Swab-less Test in UK
------------------------------------------------------------
Fierce Pharma ([link removed]) reports, “The UK government will begin testing a new, swabless coronavirus test, designed to be completed at home on a weekly basis by spitting into a collection tube…. ‘Saliva testing could potentially make it even easier for people to take coronavirus tests at home, without having to use swabs,’ said ([link removed]) the UK’s Health and Social Care Secretary, Matt Hancock. ‘This trial will also help us learn if routine, at-home testing could pick up cases of the virus earlier.’"



** Confused About Testing? Here’s Help
------------------------------------------------------------
Scientific American ([link removed]) has a nice overview of antibody testing. “Antibody tests do have potential shortcomings: they may detect ineffective antibodies, they do not indicate if an infection is still active, and they fail to detect infection if administered before antibodies develop. A new test's accuracy can also be difficult to determine because of a lack of data.” It also has helpful illustrations.



** Antibodies May Not Hang Around
------------------------------------------------------------

Reuters ([link removed]) reports, “Levels of an antibody found in recovered COVID-19 patients fell sharply in 2-3 months after infection for both symptomatic and asymptomatic patients, according to a Chinese study, raising questions about the length of any immunity against the novel coronavirus…. The research, published in Nature Medicine on June 18, highlights the risks of using COVID-19 ‘immunity passports’ and supports the prolonged use of public health interventions such as social distancing and isolating high-risk groups, researchers said.” The New York Times ([link removed]) notes, “The conclusion does not necessarily mean that these people can be infected a second time, several experts cautioned. Even low levels of powerful neutralizing antibodies may still be protective, as are the immune system’s
T cells and B cells.”



** COVID Impact on Other Research
------------------------------------------------------------
“The US Food and Drug Administration (FDA) on Wednesday issued immediately effective guidance ([link removed]) offering statistical advice to clinical trial sponsors with the aim of maintaining trial integrity and mitigating the effects of coronavirus disease (COVID-19) public health emergency on clinical trials,” according to Regulatory Focus ([link removed]) . According to the FDA, “To help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty, this guidance addresses statistical considerations for proposed changes to trial conduct due to the COVID-19 pandemic that may impact the analysis and interpretation of the primary or key secondary endpoints in the trial.”

CNBC ([link removed]) reports, “The pandemic postponed the start of clinical trials for potentially life-changing new medicines and now may delay the time in which some of those drugs will reach the market as the Food and Drug Administration faces a potential surge in applications amid a pandemic.” Noting the stopping of many trials during the early days of the pandemic, the article reports, “While some drugmakers have since resumed their clinical trials, the full impact of the postponements for testing new drugs, treatments and vaccines for ailments besides COVID-19 may not be known for months, experts say. A near-term impact could be at the FDA, where the delays may create a backlog once drugmakers finish their clinical trials and submit their drugs for regulatory approval, analysts say.”


** COVID and Protests
------------------------------------------------------------
Medpage Today ([link removed]) reports “some cities are cautiously optimistic that these large outdoor gatherings didn't speed the spread of COVID-19. Loud talking, inconsistent masking, and lack of social distancing at demonstrations made public health experts wary, but many cities with large protests have continued to see a decline in cases.” Experts warned this does not necessarily mean the virus is not being transmitted during protests. “Ryan Demmer, PhD, MPH, an epidemiologist and community health expert at the University of Minnesota, cautioned that ‘since it takes time for spread and exponential growth, I think we still need more time…. If by the end of June, we don't see meaningful increases in hospitalizations/mortality. I think it would be fair to say that the protests didn't move the needle in a meaningful way.’"



** WHO and US politics
------------------------------------------------------------
A long commentary in Ethiopian Insight ([link removed]) examines Tedros’s relationship with the West and the Trump administration, concluding, “Apropos of any proposed investigation into WHO or Tedros, it should be made clear to western media that emphasising Tedros’ background or Ethiopia’s relations with China have nothing to do with his performance at the WHO. In the last resort, most of the attacks on Tedros, and indeed on WHO, are as Lawrence Gostin said ([link removed]) ‘utterly irresponsible’ during a ‘once-in-a-century’ public-health crisis. Moreover, they are part of the anti-China policy of President Trump and the US, and have little to do with the actual competence of either the WHO or of its Director-General.”

ProPublica ([link removed]) takes an in-depth look at the Trump move to exit WHO, reporting that “Despite Trump’s declared exit from the WHO, officials continued working toward reforms and to prevent withdrawal. This week, they were told they must justify any cooperation with the WHO on the grounds of national security and public health safety.” An HHS spokesperson says, “All US-WHO collaborations are being examined through an interagency exercise as part of the termination process to ensure the safety of the American people will be protected.”


** US Public Health Experts Threatened
------------------------------------------------------------
Washington Post ([link removed]) reports, “Public health workers, already underfunded and understaffed ([link removed]) , are confronting waves of protest at their homes and offices in addition to pressure from politicians who favor a faster reopening. Lori Tremmel Freeman, chief executive of the National Association of County and City Health Officials, said more than 20 health officials have resigned, retired or been fired in recent weeks ‘due to conditions related to having to enforce and stand up for strong public health tactics during this pandemic.’”

LA Times ([link removed]) reports, “For months, anti-vaccine activists have joined protests against coronavirus restrictions ([link removed]) aimed at preventing the spread of infection. Now this unusual alliance is taking direct aim at the county officials issuing these orders.” The Times reports numerous threats California public health officials who have issued mask orders.


** COVID and Nationalism
------------------------------------------------------------
An op-ed in The Daily Maverick ([link removed]) is headlined COVID-19 has been a boon to the world’s authoritarians, tyrants and bigots. It has given them what they crave most: Fear and the cover of darkness. The author quotes Gordon Brown saying, “You’ve got what people now call ‘vaccine nationalism’. You’ve got this idea that countries just take what they want in a race to the bottom in a global search for equipment. The only way to solve some of these problems is to cooperate to build up capacity, to search together for a vaccine and a cure, to stop a second and third round by protecting the poorest countries, from whom the disease would flow back into the West if we did nothing. When we talk about self-isolation, we’ve got to think that national self-isolation has become an issue, but we’ve got to fight it.”



** COVID and HIV
------------------------------------------------------------
A short report on JIAS ([link removed]) highlights “challenges of outpatient and inpatient HIV care in the setting of the COVID‐19 pandemic and present the largest detailed case series to date from the United States on HIV/SARS‐CoV‐2 coinfection, adding to limited global reports. The aggregated clinical findings suggest that the clinical presentation and outcomes of COVID‐19 appear consistent with those without HIV. Whether SARS‐CoV‐2 infection is more frequent among persons with HIV remains to be determined. More data are needed as we develop our understanding of how HIV and antiretroviral therapy are affected by or have an impact on this pandemic.”

Health-E ([link removed]) reports on concerns that access to the new 3-in-1 HIV treatment TLD is being affected by COVID-19 lockdowns in South Africa, reporting that “The Civil Society Forum, through its various collaborators, says it will double efforts to ensure that the current situation is reversed and that people living with HIV will be on the new TLD regimen. ‘We will go to the frontlines to educate HIV–positive patients to switch to TLD in a way that will ensure a smooth transition. This we will do by joining hands with the health facilities. We dare not fail,’ adds [SANAC chair Steve] Letsike.

According to SANAC, the current state of affairs has potentially set the country back from the goal of adding an additional two-million people living with HIV on ART by December 2020.”


** COVID and Breastfeeding
------------------------------------------------------------
Health-E ([link removed]) says, “Health experts agree it is safe for new mothers to breastfeed ([link removed]) their infants during the coronavirus outbreak, with the current evidence on hand. According to the World Health Organisation ([link removed]) (WHO) there is no scientific data yet that which indicates that the coronavirus can be transmitted through breastmilk. Research conducted by the health body indicates that breast–feeding is good for new-borns and helps to protect them throughout their infancy and childhood. But, ‘to date, the virus that causes COVID-19 has not been detected in breastmilk. However, as the disease is new, this evidence is based on limited studies,’ it says.”



** After Lockdown What?
------------------------------------------------------------
An op-ed in The Daily Maverick ([link removed]) argues, “As the lockdown is relaxed, South Africa’s focus should now be on how best to suppress the spread of the SARS-CoV-2 virus using other strategies. Policy should be informed by understanding the spread of the virus both in terms of the main mechanism of transmission (respiratory particles) as well as in terms of the connections that result in spread between communities. Crucially, not all spreaders are equal, and understanding this is important for policy.”



** This Week in Mis/disinformation
------------------------------------------------------------
A blog ([link removed]) from the Peace Research Institute Oslo looks at state spreading of disinformation around COVID-19, writing, “It is crucial to make a distinction here. A wide range of individuals peddle disinformation and conspiracy theories. However, state-supported use of information manipulation takes on a new dimension because it is more coordinated and frequently targeted towards a specific political goal. It is, therefore, using disinformation deliberately either to exploit social divisions abroad or to control public opinions at home. ([link removed]) ... COVID-19 has put a spotlight on many instances where governments have attempted to steer the narrative around the pandemic both internally and externally. It remains important not only to highlight obvious cases of disinformation and propaganda but also not to forget the
genuine damage governments can cause by using these tools.”



** A Day in the Life…
------------------------------------------------------------
In a commentary on News24 ([link removed]) a community health center worker in Cape Town outlines a difficult day caring for COVID-19 patients and sending those who need more care on to hospitals. “People are marching around the world. ‘I can't breathe.’ Brown people. Black people are dying. More than others. And it's not fair. It's not fair that the hospital on the hill has the beds and the food and the ambulances while the community waits at the edges, trapped in the flats with no way out. ‘I can't breathe.’…There are no heroes in community health centres. Just tired doctors and nurses waiting for help. And mountains of quiet paperwork, for the living and the dead.”



** Resource of the Week
------------------------------------------------------------
Check out Global Health Now’s COVID-19 Expert Reality Check ([link removed]) updated frequently with answers to key questions.



Got this from a friend? Subscribe here. ([link removed])

============================================================
Our mailing address is:
** [email protected] (mailto:[email protected])

** unsubscribe from this list ([link removed])
** update subscription preferences ([link removed])
Screenshot of the email generated on import

Message Analysis