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AVAC's weekly COVID News Brief provides a curated perspective on what COVID news is worth your time.
“While we continue to receive encouraging news about COVID-19 vaccines and remain cautiously optimistic about the potential for new tools to start to arrive in the coming months, right now, we’re extremely concerned by the surge in cases we’re seeing in some countries, particularly in Europe and the Americas.”
-- WHO Director-General Tedros Adhanom Ghebreyesus
quoted in Health Policy Watch ([link removed])


** Latest Global Stats
------------------------------------------------------------
November 24, 2020
Confirmed Cases
59,539,267 Recovered
38,070,672 Deaths
1,403,513
Source: Center for Systems Science and Engineering, Johns Hopkins University ([link removed])


** Table of Contents
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* Vaccines Now Speeding to Regulatory Review (#vaccines)
* Vaccine Deployment (#deployment)
* Vaccine Access (#access)
* Additional Vaccine Data Coming Soon (#soon)
* Researchers Concerned About EUA Impact on Trials (#trials)
* Long Term Immunity? (#long)

* More Good News for Antibodies (#more)
* Antibody Access Is Limited (#antibody)
* WHO Says No to Remdesivir, US Body Still Says Yes (#who)
* Disparities (#disparities)
* The Dolly Factor (#dolly)

Even as we celebrate the data coming from three vaccine trials—extremely high efficacy for the first two —more than most experts had dared hoped for—and high efficacy and other benefits from the third, the world is seeing new spikes in cases and the virus threatens to overwhelm healthcare facilities around the world. Cities in the US and elsewhere are seeing refrigerated trucks used for temporary morgues once again, even as logistics experts try to determine how to ship and store vaccines that require extremely cold temperatures (the Pfizer vaccine must be kept “colder than Antarctica” ([link removed]) ).

The warnings that the northern hemisphere winter could see a resurgence are coming true, and as we head into a holiday season, infection rates in many places are growing at unprecedented levels. US healthcare workers are bracing for a Thanksgiving-induced spike on top of the current extremely high daily rates of infections, hospitalizations and deaths.

Health Policy Watch ([link removed]) quotes WHO’s Tedros: “While we continue to receive encouraging news about COVID-19 vaccines and remain cautiously optimistic about the potential for new tools to start to arrive in the coming months, right now, we’re extremely concerned by the surge in cases we’re seeing in some countries, particularly in Europe and the Americas.”



** Vaccines Now Speeding to Regulatory Review
------------------------------------------------------------
CNN ([link removed]) reports “Pfizer and BioNTech on Friday submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate…. The vaccine, known as BNT162b2, could potentially be available for use in high-risk populations in the United States by the middle to end of December, Pfizer and BioNTech said in a statement…. The vaccine requires two doses a few weeks apart, and protection is achieved 28 days after the first shot.” The vaccine is scheduled to be reviewed in a public hearing on December 10.

FiercePharma ([link removed]) reports, “Moderna will file for an emergency nod for its mRNA-based vaccine candidate before the month is out, Moncef Slaoui, Ph.D., head of ‘Warp Speed’ and former vaccine chief at GlaxoSmithKline, said ([link removed]) during an interview on ABC News' ‘This Week with George Stephanopoulos.’ That submission will segue straight into a Dec. 17 data review, with the aim to ship vaccines to distributors within 24 hours of approval and potentially start vaccinations two days after the advisory panel makes its call, Slaoui said.”

Reuters ([link removed]) reports the US FDA said, “it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted to COVID-19 drugs and vaccines.” FDA Commissioner Steven Hahn is quoted: “We will also continue to follow the science and ensure that science remains the driver of the agency’s regulatory decision-making in our fight against COVID-19 and beyond on behalf of public health.” The FDA said in a statement ([link removed]) that materials would be made available to the public at least 2 days before the meeting and that the meeting would be livestreamed.

European Pharmaceutical Review ([link removed]) reports, “The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP ([link removed]) ) has initiated a rolling review of Moderna’s COVID-19 vaccine candidate, mRNA-1273. According to the EMA, the review was triggered by the release of preliminary results from non-clinical studies and early clinical studies in adults… The rolling review will continue until enough evidence is available to support a formal marketing authorisation application. The CHMP has already begun rolling reviews for the COVID-19 vaccines being developed by AstraZeneca and Pfizer and BioNTech.”



** Vaccine Deployment
------------------------------------------------------------

FiercePharma ([link removed]) reports that in the US “high-priority populations such as healthcare workers and nursing home residents could obtain COVID-19 vaccines in December, Department of Health and Human Services Secretary Alex Azar said ([link removed]) in a press conference. Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, predicted ([link removed]) in a meeting with USA Today’s editorial board that everyday Americans could
be vaccinated as early as April.”

Quartz Africa ([link removed]) reports on experiences in Sierra Leone and the Democratic Republic of Congo with an Ebola vaccine that required ultra-cold temperature. “This success was made possible mainly by a piece of technology called the Arktek introduced in 2014 during the Ebola outbreak in Sierra Leone
([link removed]
Tu-EVcmRC8pb_8X) . The Arktek…is a high-tech insulated and reusable container that can keep a vaccine at -80 ^oC for up to a week in the field even if the container is opened several times a day…. The Arktek cylinders which can carry up to 500 doses and be transported on motorbikes were used to move the vaccines to rural, remote, and hardly accessible communities.”

Jon Cohen reports in Science ([link removed]) on two of the advantages of the AstraZeneca vaccine. AstraZeneca “says the vaccine, which only requires standard refrigeration, may cost about $3 to $4 per dose. Moderna, in contrast, may charge $25 or more per dose, according to statements from its CEO. Its vaccine and the one from Pfizer/BioNTech both require freezers for storage and transport to prevent the RNA and the lipid particle that holds it from degrading.”



** Vaccine Access
------------------------------------------------------------

Business journalist Charlotte Kilpatrick writes in Salon ([link removed]) , “If you live in the United States, there may be cause to believe that the dark days of COVID will soon be over. But if you live in Burkina Faso, this pandemic is not ending anytime soon…. As a business journalist who covers the pharmaceutical industry, I have an up-close look over the past year at how Big Pharma has responded to the pandemic. At the start of the crisis, my cynicism was replaced with cautious optimism as I watched the industry quickly respond to the all-hands-on-deck call to find a vaccine. Now, as these vaccines inch closer to the finish line, I am once again fearful that how we choose to ramp up manufacturing—and who we decide should be first in line to receive the vaccine—is revealing a darker side of humanity…. human rights groups have reported that 82 percent of Pfizer's vaccine supply has
already been purchased by a handful of rich countries representing 14 percent of the global population; for Moderna, 78 percent of the doses have been pre-purchased for 12 percent of the population.”

The Human Vaccines Project ([link removed]) quotes GAVI’s Seth Berkley on the news: “The AstraZeneca/Oxford vaccine is… the first vaccine that can be stored within the normal cold chain, making it easier to use within the existing immunization infrastructure in developing countries. The fact that large numbers of sites are producing it all bodes well for global supply.”

The Guardian ([link removed]) reports the AstraZeneca vaccine “will be available on a non-profit basis ‘in perpetuity’ to low- and middle-income countries in the developing world…. However, vaccine hopes for poorer nations were tempered by the head of the World Health ([link removed]) Organization, Dr Tedros Adhanom Ghebreyesus, who said there was a risk the world’s poor could be trampled in a ‘stampede for vaccines’, adding that $4.3bn (£3.2bn) was still needed in order to share vaccines fairly.”

An Al Jazeera ([link removed]) Long Read looks at the COVAX facility and the checkered history of GAVI’s advance market commitments that may indicate how COVID vaccine access may work for low and middle income countries. South African research Shabir Madhi is quote: “The reality is that the majority of countries where 87 percent of the world’s population live, are going to have a very limited supply of vaccines, at least for 2021. It won’t work in every country’s favour, but from a global perspective, the COVAX facility is the one [option] that will ensure timely and reasonably equitable access to and distribution of vaccines. Outside of the COVAX, all that will end up happening is that we won’t get vaccines in sub-Saharan Africa until the pandemic is past. We have to accept that.”

The New York Times ([link removed]) reports, “In the current plan for a global vaccine deal, poor countries would receive only enough doses to inoculate 20 percent of their populations by the end of next year. Some models show that there will not be enough vaccines to cover the entire world until 2024.”

Al Jazeera ([link removed]) reports on the G20 communique: “Leaders of the world’s 20 biggest economies have said they would ensure an affordable and fair distribution of COVID-19 vaccines, drugs and tests around the world so that poorer countries were not left out, according to a final summit communique which, however, gave few specifics.”



** Additional Vaccine Data Coming Soon
------------------------------------------------------------

There are several other vaccines still in efficacy trials and data is expected from these studies in the coming months. (Check out AVAC’s COVID-19 Vaccine Cheat Sheet ([link removed]) for more on the frontrunner candidates.) Bill Gates is betting on more good efficacy news. CNET ([link removed]) reports he told CNN's Fareed Zakaria in an interview on Sunday, "Almost all the vaccines will work and with very high efficacy levels. I'm optimistic that by February it's very likely that they'll all prove very efficacious and safe."



** Researchers Concerned About EUA Impact on Trials
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Nature ([link removed]) reports “scientists are concerned that this kind of early deployment could compromise the ongoing clinical trials that seek to show conclusively how well the vaccines work…. Once a vaccine is granted emergency approval, there is pressure on developers to offer the immunization to trial participants who received a placebo. But if too many people cross over to the vaccine group, the companies might not have enough data to establish long-term outcomes, such as safety, how long vaccine protection lasts and whether the jab prevents infection or just the disease…. There’s also the risk of people in trials other than the Pfizer/BioNTech and Moderna ones dropping out to get vaccinated under emergency-use provisions, says Larry Corey, a vaccinologist at the Fred Hutchinson Research Center in Seattle, Washington State.”



** Long Term Immunity?
------------------------------------------------------------

Apoorva Mandavilla reports in the New York Times ([link removed]) that a preprint study suggests immunity could last “years, maybe even decades, according to a new study—the most hopeful answer yet to a question that has shadowed plans for widespread vaccination. Eight months after infection, most people who have recovered still have enough immune cells to fend off the virus and prevent illness ([link removed]) , the new data show. A slow rate of decline in the short term suggests, happily, that these cells may persist in the body for a very, very long time to come.”



** More Good News for Antibodies
------------------------------------------------------------

A second antibody treatment received an FDA EUA. Most of the headlines refer to the Regenron antibody cocktail as the drug Trump received. Fierce Pharma ([link removed]) reports, “The emergency use authorization ([link removed]) (EUA) for REGN-COV2, a combination of monoclonal antibodies casirivimab and imdevimab, marks the second for an antibody therapy. The first one went to Eli Lilly’s bamlanivimab ([link removed]) , which was given an EUA a few days ago.” The EUAs are for patients at high risk and Fierce Pharma reports “An FDA fact sheet ([link removed]) details the criteria for determining ‘high-risk’ patients. These
include obese people with a body mass index of more than 35, older patients at or over 65 years of age, or people with underlying conditions such as chronic kidney disease, diabetes, cardiovascular disease or respiratory conditions, among others.”



** Antibody Access Is Limited
------------------------------------------------------------

The Guardian ([link removed]) reports, “’We expect to distribute about 30,000 doses of the Regeneron product tomorrow with more to come in the ensuing weeks,’ said the US health and human services secretary Alex Azar. The federal government’s contract with Regeneron currently covers 300,000 doses, which will be distributed to states based on the number of people who test positive and are hospitalized for Covid-19. At such extremely limited quantities, demand will far outstrip supply.”



** WHO Says No to Remdesivir, US Body Still Says Yes
------------------------------------------------------------

STAT ([link removed]) reports “a World Health Organization panel is now recommending against the use of the antiviral remdesivir in hospitalized COVID-19 patients, saying there is no evidence that the drug—which US regulators have approved for the treatment of the coronavirus—improves mortality…. the WHO’s Guideline Development Group said that it now has a ‘weak or conditional recommendation against’ using remdesivir in hospitalized patients because of clinical trial data that showed the drug did not increase survival. The group’s review also found the drug had no meaningful effect on whether patients would need to be put on ventilators.”

Healio ([link removed]) reports The Infectious Diseases Society of America said it will continue to recommend remdesivir for patients with severe COVID-19 despite a guideline from WHO ([link removed]) last week that recommended against its use in any hospitalized patients…. Rajesh T. Gandhi, MD, a member of the IDSA’s expert panel on COVID-19 treatment and management guidelines and an ID physician at Massachusetts General Hospital, said the reason for maintaining the recommendation for remdesivir was that results from the ACCT-1 trial ([link removed]) showed an improved time to recovery in hospitalized patients.”



** Disparities
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Reuters ([link removed]) reports, “Many European countries avoid breaking down data along racial or ethnic lines out of concern over privacy or discrimination, but COVID-19's outsized impact on Black and Asian people has exposed flaws in the approach, some scientists and activists said. They want more comprehensive data collection across the continent to improve understanding about how and why COVID-19 affects different communities, and thereby help countries tailor testing and care to better protect them.”

A Stanford University press release ([link removed]) reports, “More than half of all in-hospital deaths due to COVID-19 during the first six months of 2020 were among Black and Hispanic patients, according to a new study ([link removed]) led by researchers at the Stanford University School of Medicine and Duke University School of Medicine. The researchers did not find any racial or ethnic differences in mortality rates among people hospitalized with the disease. Yet a disproportionate number of Black and Hispanic people became sick enough to require hospitalization, and they made up 53 percent of inpatient deaths.”

South Florida Gay News ([link removed]) reports “A new global study ([link removed]) has found the coronavirus pandemic has had a disproportionate impact on transgender people’s mental health and economic stability. The study by a team of seven researchers from the Johns Hopkins Bloomberg School of Public Health and the University Center for Public Health and Human Rights found 77 percent of respondents expected a decrease in income. And more than half of them reported losing gender-affirming resources; including surgery delays, inability to purchase beauty products and other factors.”



** The Dolly Factor
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The internet was thrilled with the news that the Moderna vaccine was funded in part by Dolly Parton. The Washington Post ([link removed]) reports on the friendship between Parton and a physician that led to her early critical investment in COVID research. Parton’s name trended on twitter and one professor recorded a parody of Parton’s famous “Jolene” changed to “Vaccine.” Catch it here ([link removed]) or read the revised lyrics in this tweet thread ([link removed]) from their author.

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