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AVAC's weekly COVID News Brief provides a curated perspective on what COVID news is worth your time.
"The COVID-19 pandemic is a turning point within each of our lifetimes and must serve as a moment of transition for humanity. To protect human health and all of life on Earth, we will need to, and can, effect urgent, deep, structural changes in how we live. This great transition demands a rapid shift in how we produce and consume food, energy, and manufactured goods; requires rethinking the way we design and live in the world's cities; and insists we heal our relationship with nature and to each other. Such a paradigm shift requires participation of every sector, every community, and every individual."
— The São Paulo Declaration on Planetary Health in Lancet ([link removed](21)02181-4/fulltext)


** Share of Population Fully Vaccinated Against COVID-19
------------------------------------------------------------
October 7, 2021
Source: Our World in Data ([link removed])


** Table of Contents
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* If You Are in a Hurry (#hurry)
* Vaccine and Medicines Access and TRIPS (#vaccines)
* WHO and UN Set Global COVID Vaccine Targets (#who)
* Vaccine Hesitancy (#hesitancy)
* Merck’s COVID Pill (#merck)
* Self-testing and Rapid Testing Seen as Key Strategies (#self)
* The Researcher Who Helped Us Get Ready to Fight COVID (#research)
* Companies Seek FDA Approval for Boosters and Vaccinating Children (#companies)
* Study to Vaccinate a Whole Brazilian Town (#study)
* Global Syringe Shortage (#global)


* Nordic Countries Limit Use of Moderna Vaccine (#nordic)
* Assessing the US FDA’s Emergency Use Authorizations (#assess)
* The São Paulo Declaration on Planetary Health (#sao)
* Some Travel Restrictions Easing (#some)
* Transplants Dependent on Vaccine Status (#trans)
* Medical Waste Piles Up (#med)
* Vaccine Mandates Must be Anti-colonial (#vax)
* False Science and Fraud Propped Up Ivermectin (#false)
* South African Study Gives Clues to What Causes Long-COVID (#south)

We’ve long known that the US has the largest number of confirmed COVID deaths in the world, recently passing 700,000. This week we learned what those and other pandemic-related deaths have meant for children in the US. The Washington Post ([link removed]) (US) reports, “A new study published Thursday in the journal Pediatrics ([link removed]) [estimates] that roughly 140,000 children under 18 may have lost parents or caregivers from March 2020 to June 2021 due to covid or other causes classified as pandemic-related. Those numbers take into account both official covid deaths and deaths from other causes, such as homicides and drug overdoses, beyond those expected in a typical year before the pandemic. The consequences are life-changing: Losing a parent or other primary caregiver is one of the most stressful things that can happen in a child’s life—putting them at risk of a
trajectory of depression and post-traumatic stress, as well as physical manifestations of grief, such as heart problems…. The data also reveal vast disparities by race and ethnicity—even more skewed toward an overrepresentation of minority communities than covid deaths. In the United States as a whole, 1 out of 500 children lost at least one parent/caregiver. But for American Indian children, it’s 1 out of 168; for Black children, 1 out of 310; for Hispanic children, 1 out of 412, for Asian children, 1 out of 612; and for White children, 1 out of 753. The highest burden of death has occurred along the US-Mexico border, in the South and in tribal areas.”



** If You Are in a Hurry
------------------------------------------------------------
* Read The São Paulo Declaration on Planetary Health – a global call to action in Lancet ([link removed](21)02181-4/fulltext) .
* Read Devex ([link removed]) on where things stand a year after the proposal to temporarily waive intellectual property for vaccines, medicines and tests for COVID-19.
* Read a perspective in NEJM ([link removed]) about how to address vaccine hesitancy among BIPOC.
* Read Vanity Fair ([link removed]) on how a shortage of syringes could derail access to donated vaccines.
* Read a BBC ([link removed]) on an investigation into clinical trials of ivermectin.
* Read Bloomberg ([link removed]) on a study that found clues to help explain long COVID.
* Read a Washington Post ([link removed]) profile of Barney Graham who led a “visionary group of researchers” in developing tools to fight the pandemic.
* Read Reuters ([link removed]) on a new plan from WHO to vaccinate the world.




** Vaccine and Medicines Access and TRIPS
------------------------------------------------------------

Devex ([link removed]) (US) reports, “It has been a year since the South African and Indian delegations to the World Trade Organization tabled their proposal to temporarily waive intellectual property protections governing COVID-19 vaccines, diagnostics, and therapeutics…. It is impossible to determine how many lives, if any, would have been saved by the quick adoption of India and South Africa’s proposal… At the very least, ‘if we had taken that step a year ago and started that process a year ago, a lot of countries would be in a better spot. We would be facing a different global landscape,’ said Rachel Thrasher, a researcher at Boston University’s Global Development Policy Center…. Vaccine access is not all that is at stake. The waiver also covers diagnostics and therapeutics, including Merck’s promising antiviral and similar advances, which could soon be central to efforts to combat the virus…. The p
rocess of manufacturing those treatments is less complicated than for vaccines and more broadly established. That means an IP waiver, even without technology transfers, could speed their production and availability.”

Devex ([link removed]) (US) reports, “Biotechnology company Moderna says it plans to build a messenger RNA therapeutics and vaccine manufacturing facility ‘in Africa’—but has yet to decide on a country. The plant is expected to produce up to 500 million vaccine doses annually, including for COVID-19 and other conditions…. ’Vaccine manufacturing is very, very much welcome news. It is news or efforts that will address our medium term to long term needs. It doesn’t necessarily solve our problem today,’ said Dr. John Nkengasong, director of the Africa Centres for Disease Control and Prevention, during a press briefing on Thursday. ‘The problems we have to solve today is access—quick access to vaccines.’”



** WHO and UN Set Global COVID Vaccine Targets
------------------------------------------------------------

Reuters ([link removed]) (UK) reports, “UN Secretary-General Antonio Guterres appealed on Thursday for $8 billion to help equitably vaccinate 40 percent of people in all countries by the end of the year, as the World Health Organization (WHO) launched a plan that aims to inoculate 70 percent of the world by mid-2022…. The WHO plan calls for countries with high vaccine coverage to allow expected deliveries of additional doses to first go to the COVAX global sharing program and the African Vaccine Acquisition Trust (AVAT) for distribution to where they are more urgently needed. It also wants the richer nations to fulfill and accelerate vaccine dose-sharing and donation commitments to COVAX, and make new pledges.” Guterres said at a press conference, “Not to have equitable distribution of vaccines is not only a question of being immoral, it is also a question of being stupid.’…
Tedros also questioned why countries had been unable to agree on a temporary waiver of intellectual property rights on COVID-19 vaccines and therapies at the World Trade Organization. ‘If we cannot use it now during this unprecedented situation, when do we use the TRIPS waiver?’ Tedros said. ‘Why do we even, in the first place, have these IP waivers ... if we're not going to use it in such conditions?’"

CNBC ([link removed]) (US) reports, “A World Health Organization official said Tuesday that unvaccinated people are ‘dying unnecessarily’ from COVID-19, citing global vaccine inequities as one of the main obstacles to immunizing more people against the virus. Some 56 countries fell short of the WHO’s goal of getting 10 percent of their populations immunized against the virus by the end of September, officials said…. Maria Van Kerkhove, the WHO’s technical lead for COVID-19 [said] ‘Not meeting that target is heartbreaking; it’s more than heartbreaking, it’s more than frustrating. It’s beyond words, I have to say, because if we had used the more than 6 billion vaccines that have been administered today differently, we would be in a very, very different situation right now.’”

Read the WHO plan here ([link removed]) .



** Vaccine Hesitancy
------------------------------------------------------------

A perspective in NEJM ([link removed]) (US) looks at overcoming vaccine hesitancy among Black, Indigenous, and People of Color (BIPOC). The authors argue, “For BIPOC communities, such hesitancy is rooted in both the historical and contemporary contexts of systemic racism, marginalization, and neglect that shape daily life today…. Although BIPOC communities have important reasons to be hesitant, increasing reports of disparities in vaccine access throughout the country point to broader systemic challenges.... It is essential to remember that hesitancy doesn’t mean refusal, and in fact, skepticism can be protective for BIPOC communities. However, we believe it’s time to shift the focus from a sole emphasis on changing hearts and minds among members of BIPOC communities to ensuring that institutions are trustworthy, transparent, and engaged with communities during the vaccine rollout. [This] will require listening to community voices, preparing public health
and health care organizations to respectfully engage with BIPOC communities, and becoming more client-centered, including viewing hesitancy and barriers to vaccine uptake through the eyes of members of the BIPOC community.”

The Star ([link removed]) (Kenya) reports, “Uptake of the COVID-19 vaccine is disturbingly low in densely populated counties in Western [Kenya]…. The Health ministry has urged county leaders to be more proactive, promoting the vaccine and activating grassroots information campaigns. They need to aggressively push the vaccine and dispel myths that prevent people from getting the jab. For instance, in Kakamega, just 20,787 people were fully vaccinated by Sunday. The county has a target population of 982,838, the Health ministry said.”



** Merck’s COVID Pill
------------------------------------------------------------

Since Merck’s announcement of the efficacy of its new COVID pill last week, countries are rushing to buy it. Al Jazeera ([link removed]) (Qatar) reports, “Australia has said it will buy 300,000 courses of Merck’s promising antiviral drug…. Molnupiravir, which would be the first oral antiviral medication for COVID-19 if it gets regulatory approval, could halve the chances of people most at risk of severe COVID-19 dying or being hospitalised from the disease, according to experts.” The New York Times ([link removed]) (US) reports, “Countries in the Asia-Pacific region this week became some of the first after the United States to secure supplies of molnupiravir…. Merck said in June that the United States had agreed to buy enough pills for 1.7 million treatments, at a cost of $1.2 billion. This week, Australia, Malaysia, Singapore and
South Korea said that they had reached agreements with the drug maker to buy the pills, even though their regulatory agencies have yet to approve the drug. Thailand and Taiwan are also in talks with Merck to buy them….”

The Intercept ([link removed]) (US) reports, “A five-day course of molnupiravir, the new medicine being hailed as a ‘huge advance’ in the treatment of COVID-19, costs $17.74 to produce, according to a report issued last week by drug pricing experts…. Merck is charging the US government $712 for the same amount of medicine, or 40 times the price…. Like the vast majority of medicines on the market, molnupiravir…was developed using government funds…. Yet only Merck and Ridgeback will reap the profits from the new antiviral, which…could bring in as much as $7 billion by the end of this year.”

The Atlantic ([link removed]) (US) reports, “The drug is meant to be taken within the first five or so days of illness, ‘the earlier, the better,’ George Painter, a pharmacologist at Emory University and one of molnupiravir’s early developers, told me. That’s a punishingly tight window, especially in nations short on diagnostics to detect the virus—as well as access to health workers and infrastructure to prescribe and provide the drug.”



** Self-testing and Rapid Testing Seen as Key Strategies
------------------------------------------------------------

An opinion piece in the New York Times ([link removed]) (US) examines why rapid COVID tests are cheap and accessible in many other countries, but not in the US. “The problem is that rapid-test makers who want to sell in the United States need to comply with the Food and Drug Administration’s medical device authorization process, which requires rapid tests to meet the same standards as laboratory-based medical diagnostic tools…. But for public health purposes, we need fast, accessible tests that answer the question, ‘Am I infectious now?’ Rapid tests can help prevent spread to your child, spouse, friend, colleague, classmate or the stranger sitting next to you at dinner. If the primary beneficiaries of a test are other people, the test is not a medical tool, but a public health one.” The authors argue, “Using executive action, President Biden should redefine rapid COVID-19 tests as public health tools rather than medical devices. The
president has already declared these tests a public health priority, and an executive action making rapid tests official public health tools would be the natural next step.”

MedPage Today ([link removed]) (US) reports, “Police officers and firefighters were capable of self-administering COVID antibody tests at home, which had comparable sensitivity and specificity to tests administered by healthcare professionals, a British study found…. The authors said that since their data demonstrated that non-healthcare workers could self-administer these antibody tests, ‘this could then be extended to obtain prevalence estimates in the wider population at low cost, without the need for supervision by a healthcare practitioner’ and that self-testing could be used in occupational and community studies of SARS-CoV-2 seroprevalence.”

CNN ([link removed]) (US) reports, “On Wednesday, the Biden administration announced that it will spend an additional $1 billion to get more at-home tests into the market, but the shortages could continue for months and, experts say, the additional tests might not be enough to make this tool as effective as it could be to help end the pandemic…. The Biden administration has made testing a priority. It's $1 billion purchase agreement was inked to prompt manufacturers to ramp up production. This follows the $2 billion the administration promised in September that it said would ensure tests are available to those who need them.”



** The Researcher Who Helped Us Get Ready to Fight COVID
------------------------------------------------------------

A Washington Post ([link removed]) (US) profiles Barney Graham and how his longtime work on corona viruses helped pave the way for an mRNA vaccine. “Graham and a tightknit group of academic collaborators had been studying the nooks and crannies of spike-covered coronaviruses for nearly a decade. Every month or two, they met with the world’s coronavirus experts via conference call. He had forged a relationship with an up-and-coming biotechnology company, Moderna, that could design vaccines fast. His lifelong effort to increase diversity in science had culminated in a team of Black scientists who were ready to go. All the pieces were in place…. Thousands of individuals contributed to the coronavirus vaccines, which were possible because of scientific teamwork on a massive scale. But the sprint to a vaccine depended on the meticulous labor of a visionary group of researchers. They are the vaccine vanguard, the people who invented
the tools that will help wrestle the pandemic to the ground. Their insights and discoveries flew under the radar for years, until the world needed them the most.”



** Companies Seek FDA Approval for Boosters and Vaccinating Children
------------------------------------------------------------

NPR ([link removed]) (US) reports, “J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company's one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators…. The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It's the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.”

AP ([link removed]) (US) reports, “Parents tired of worrying about classroom outbreaks and sick of telling their elementary school-age children no to sleepovers and family gatherings felt a wave of relief Thursday when Pfizer asked the US government to authorize its COVID-19 vaccine for youngsters ages 5 to 11. If regulators give the go-ahead, reduced-dose kids’ shots could begin within a matter of weeks.”



** Study to Vaccinate a Whole Brazilian Town
------------------------------------------------------------

Reuters ([link removed]) (UK) reports, “Pfizer Inc will study the effectiveness of its vaccine against COVID-19 by inoculating the whole population over the age of 12 in a town in southern Brazil, the company said on Wednesday. The study will be conducted in Toledo, population 143,000, in the west of Parana state, together with Brazil's National Vaccination Program, local health authorities, a hospital and the federal university. Pfizer said the purpose was to study the behavior of COVID-19 in a ‘real life scenario’ after the population has been vaccinated.”



** Global Syringe Shortage
------------------------------------------------------------

Vanity Fair ([link removed]) (US) reports COVID vaccine access could be further derailed by a worldwide shortage of specialized syringes needed to inject the Pfizer vaccine. Biden’s announcement at the September COVID-19 Summit of additional Pfizer vaccines to be donated was met with praise, but “To advocates on the sidelines, this welcome news came with a major catch: It meant that the yawning shortfall of syringes would now become cavernous.” Updated projections presented to the White House, “warned of a shortfall of 226 million of the syringes needed to administer Pfizer doses by February 2022, and a shortage of 1.8 billion of those needed for all COVID-19 vaccines by the end of 2022…. Dr. Salim Abdool Karim, a member of the Africa Task Force for Novel Coronavirus, told Vanity Fair that Biden’s declaration at the summit was ‘really good’ but added, it ‘doesn’t acknowledge there is a need for a pla
n, and doesn’t support it because there is no plan.’”



** Nordic Countries Limit Use of Moderna Vaccine
------------------------------------------------------------

Reuters ([link removed]) (UK) reports, “Finland on Thursday paused the use of Moderna's (MRNA.O) COVID-19 vaccine for younger males due to reports of a rare cardiovascular side effect, joining Sweden and Denmark in limiting its use.” A Finnish health official said, “A Nordic study involving Finland, Sweden, Norway and Denmark found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis.”



** Assessing the US FDA’s Emergency Use Authorizations
------------------------------------------------------------

MedPage Today ([link removed]) (US) reports on an online panel discussion in which, “Physicians, academics, pharmaceutical industry experts, and one bioethicist examined the FDA's performance in issuing COVID-19-related emergency use authorizations (EUAs)….” One former FDA official said the agency did well with EUAs for tests and vaccines, but when it came to therapeutics, in particular the authorization of convalescent plasma, Borio was unimpressed. “’I felt very embarrassed for FDA, and I felt sorry for its scientific staff. Some reached out to me to say they were no longer proud to work at the agency,’ she said.” Aaron Kesselheim of Harvard and Brigham and Women's Hospital “recommended issuing guidelines that clearly state the kind of data that would be needed to support an EUA. This, he noted, would vary depending on whether the product was a new drug, a previously approved drug, or an extension of an indication. Any new guidance should
also specify the need for continued data collection and clarify what that should look like. ‘We need to understand how the EUA is going to integrate with clinical trials or collecting real-world data as they come in,’ he said. Kesselheim also stressed the need for a clear ‘communication plan’ to prevent the ‘harmful urging by public officials, like we saw...around hydroxychloroquine.’"



** The São Paulo Declaration on Planetary Health
------------------------------------------------------------

The São Paulo Declaration on Planetary Health published in Lancet ([link removed](21)02181-4/fulltext) (UK) “is a global call to action from the planetary health community charting a path forward to support a more equitable and resilient post-pandemic world…. The COVID-19 pandemic is a turning point within each of our lifetimes and must serve as a moment of transition for humanity. To protect human health and all of life on Earth, we will need to, and can, effect urgent, deep, structural changes in how we live. This great transition demands a rapid shift in how we produce and consume food, energy, and manufactured goods; requires rethinking the way we design and live in the world's cities; and insists we heal our relationship with nature and to each other. Such a paradigm shift requires participation of every sector, every community, and every individual.”



** Some Travel Restrictions Easing
------------------------------------------------------------

Al Jazeera ([link removed]) (Qatar) reports, “India will reopen to tourism from October 15, the government said, after more than a year of closure due to the coronavirus pandemic. Foreign nationals will be able to apply for a visa for the first time since March 2020, when Prime Minister Narendra Modi’s government imposed a strict lockdown in response to the pandemic…. Earlier this month, India announced fully vaccinated British nationals arriving in India will be subjected to a 10-day mandatory quarantine, in response to similar measures imposed by the UK on Indian nationals. The United Kingdom has not recognised the Indian version of the AstraZeneca vaccine, known as Covishield. India has called the decision “discriminatory” ([link removed]) and imposed restrictions on all British arrivals irrespective of their
vaccination status.”

BBC ([link removed]) (UK) reports the UK travel “red list” has been cut to just seven countries: Panama, Colombia, Venezuela, Peru, Ecuador, Haiti and the Dominican Republic…. South Africa, Brazil and Mexico come off the red list, which requires travellers to quarantine in an approved hotel at their cost for 10 full days…. Arrivals from 37 more destinations will have their vaccination status certificates recognised, meaning they can avoid more expensive post-arrival testing requirements.”



** Transplants Dependent on Vaccine Status
------------------------------------------------------------

The Washington Post ([link removed]) (US) reports on a controversial new policy by a Colorado health system that, “says it is denying organ transplants to patients not vaccinated against the coronavirus ([link removed]) in ‘almost all situations,’ citing studies that show these patients are much more likely to die if they get COVID-19…. The policy illustrates the growing costs of being unvaccinated and wades into deeply controversial territory—the use of immunization status to decide who gets limited medical care. The mere idea of prioritizing the vaccinated for rationed health resources has drawn intense backlash, as overwhelmingly unvaccinated COVID-19 patients push some hospitals to adopt ‘crisis standards of care,’ in which health systems can prioritize patients for scarce resources based largely on their likelihood of survival.”



** Medical Waste Piles Up
------------------------------------------------------------

Al Jazeera ([link removed]) (Qatar) reports on mounds of medical waste in Indonesia. “According to the United Nations Environment Program, the rate of medical waste disposal has risen by 500 percent in Jakarta and four other Asian capital cities.” In one hospital the amount of medical waste, “has quadrupled during the pandemic, rising to 10 tonnes each month.”



** Vaccine Mandates Must be Anti-colonial
------------------------------------------------------------

A commentary in New Humanitarian ([link removed]) (Switzerland) argues, “When people perceive they’re being accessed and treated not for their own good but because they’re a public health threat, it reeks of colonial-style ‘control-over-care’. If we can make vaccines free and compulsory, it’s natural to ask why can’t we make other forms of healthcare at least free…. Governments need to answer two questions before implementing a vaccine mandate: Does the vaccination requirement justify potential infringement on other rights? And does the vaccine mandate create an undue burden on any section of the population? In international law, the right to health includes an obligation to prevent and control epidemic disease, for which widespread vaccination is an important tool. And the right to health applies to everyone—whether vaccinated, clamouring for a vaccine, considering it, or facing
barriers to getting one. Vaccine mandates should be designed with deep attention to context—including the social, political, and economic barriers people might face.”



** False Science and Fraud Propped Up Ivermectin
------------------------------------------------------------

BBC ([link removed]) (UK) reports on an investigation of trials cited by supporters of the anti-parasite drug ivermectin as proof it fights COVID-19: “The BBC can reveal that more than a third of 26 major trials of the drug for use on COVID have serious errors or signs of potential fraud. None of the rest show convincing evidence of ivermectin's effectiveness. Dr. Kyle Sheldrick, one of the group investigating the studies, said they had not found ‘a single clinical trial’ claiming to show that ivermectin prevented COVID deaths that did not contain ‘either obvious signs of fabrication or errors so critical they invalidate the study.’”



** South African Study Gives Clues to What Causes Long-COVID
------------------------------------------------------------

Bloomberg ([link removed]) (US) reports on a peer reviewed study from Stellenbosch University: “Some of the symptoms of so-called long-COVID, the ailments that can persist for months after a COVID-19 infection, may be caused by inflammatory molecules trapped inside tiny blood clots....” A statement noted, “These ‘might be the cause of some of the lingering symptoms experienced by individuals with long-COVID. This ‘provides further evidence that COVID-19, and now long-COVID, have significant cardiovascular and clotting pathologies.’”
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