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At Nature, Nicky Phillips, David Cyranoski and Smriti Mallapaty covered the announcement that a collaboration between researchers at AstraZeneca and the University of Oxford is pausing Phase 3 vaccine-candidate experiments due to a “suspected adverse event” in a study participant in the UK (9/9/20). The collaboration’s Phase 3 studies are being paused in the U.S., Brazil, South Africa and the UK, Nature reports. “The news highlights the importance of waiting for the results of large, properly designed trials [experiments] to assess safety before approving a vaccine for widespread use,” the story states. Investigators will start by trying to find out if the participant received the vaccine candidate or a placebo, the story states. And then if it was the vaccine, they will assess whether the participant’s reaction is related or unrelated to receiving it. “I have every confidence that this group [of investigators] will very quickly assess this adverse event and make the results of that investigation known,” said a McGill University bioethicist quoted in the story.
Presumably in response to reports of political pushing for approvals this fall, the chief executive officers (CEOs) of 9 pharmaceutical companies released a pledge (dated 9/8/20) to “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.” The CEOs — including those for AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, and Pfizer — assert they will “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as [the U.S. Food and Drug Administration].” In other words, they don’t plan to cut any corners in their research nor to yield to political pressure. For more contextualized commentary on what Ed Silverman describes as a “highly unusual turn of events,” see his column at STAT (9/7/20). Meanwhile, the U.S. Food and Drug Administration (FDA) has quickly taken measures to block any political influence over ongoing research to develop vaccines to protect us from SARS-CoV-2, report Anna Edney, Drew Armstrong, and Robert Langreth for Bloomberg (9/8/20). One measure reportedly includes the FDA “sticking by” June guidance that the agency will only consider for approval vaccine candidates that are at least 50% effective. Lower down in the story, the reporters write, “There is no guarantee the vaccines furthest along in development will be the most effective, or be safe.” And it could take “months more” for Phase 3 findings to be conclusive, the story suggests. Still, the story ends with estimates by drug makers for how soon they might complete their Phase 3 studies (efficacy and safety experiments in thousands of study subjects) of SARS-CoV-2 vaccine candidates. Moderna reportedly says as soon as Thanksgiving, and Pfizer reportedly has been saying next month. I remain reasonably skeptical.
On Twitter, I came across a searchable web site called “Dear Pandemic,” which bills itself as an “interdisciplinary all-female team of researchers and clinicians with expertise including nursing, mental health, demography, health policy/economics, and epidemiology.” Posts date back to July but the site appears to have officially launched 9/10/20. Their mission is to “educate and empower individuals to successfully navigate the COVID-19 information overwhelm.” About two-thirds of the way down the home page, there’s a “submit a question” link. And below that, previous posts are indexed by topic and dates.
The risk of catching SARS-CoV-2 on an airplane is “relatively low” if travelers are screened for sickness, wear masks, and are spaced out among seats, according to experts interviewed by Noah Y. Kim for Kaiser Health News (9/10/20). The air exchange rate and use of HEPA (high-efficiency particulate air) filters on planes also significantly reduce the risk of catching the virus from travelers who are several rows away, according to the story. There is still a risk from an infected person seated nearby, the story states. And air filtration alone is insufficient to prevent transmission even when travelers are distanced in the plane, Kim writes. Delta, Hawaiian, Southwest and JetBlue currently keep middle seats open, the story states. Security checks and waiting at gates also pose some transmission risk. The U.S. Centers for Disease Control has not confirmed any SARS-CoV-2 transmission aboard a U.S. flight, an airline industry source says in the story, but that might reflect the difficulty of determining where people in the U.S. contract the virus, Kim writes. “Even though flying is a relatively low-risk activity,” the story states, “traveling should still be avoided unless absolutely necessary.”
An undated, recently published ESPN interactive, bylined by Kyle Bonagura, illustrates its analysis and mapping of anonymized cellphone tracking data for three 2019 U.S. college football games. The maps provide a sense of where fans travel to and disperse to after games and thus the regional concentration of potential SARS-CoV-2 (and other infectious disease) spread resulting from the mixing of people before, during and after big match-ups. The piece includes updates on some of the football conferences’ plans and protocols for the 2020 season. The Big Ten and Pac-12 have postponed their seasons, whereas the SEC (Southeastern Conference) seems to be allowing each school to set its own attendance guidelines. I can’t pretend to follow NCAA (National Collegiate Athletic Association) football designations but some or all of the NCAA teams drew “more than 47.5 million” attendees last season, the piece states. “Even with fewer teams in action and limited-capacity crowds, the prospect that college football could play a role in spreading the coronavirus is too obvious to ignore,” the story states. Thanks to a reader for alerting me to this piece.
Check out “To build emotional strength, expand your brain,” by Kerry Hannon at The New York Times (9/2/20). It basically asserts that learning new material, such as a language or craft, that expands your horizons helps you deal with change and crisis, such as the coronavirus pandemic. Near the end, the piece lists some free or low-cost online class sites and some programs that allow nontraditional students to audit classes or work on projects with enrolled graduate and undergraduate students.
You might enjoy “Looks like I wasn’t muted during our Zoom meeting,” by Susie Aquilina, for McSweeney’s (9/10/20).