F.D.A. Panel Meets on Moderna Boosters – The New York Times

A key advisory committee to the Food and Drug Administration voted unanimously on Thursday to recommend a booster shot of the Moderna coronavirus vaccine for many of the vaccine’s recipients, at least six months after a second dose.

The panel endorsed a half-dose as a third injection for people 65 and older as well as younger adults at high risk because of their medical conditions or jobs, the same groups of people who became eligible for a Pfizer-BioNTech booster last month. While regulators are not obligated to follow the panel’s recommendations, they typically do.

Although committee members decried the lack of more robust data justifying a booster shot, several emphasized that F.D.A. had already set a precedent by authorizing additional shots on an emergency basis for many recipients of the Pfizer-BioNTech vaccine.

“From a pragmatic point of view,” said Dr. Stanley Perlman of the University of Iowa, “because we’ve already approved it for Pfizer, I don’t see how we can possibly not approve it for Moderna.”

The panel voted after hearing from Moderna officials, agency scientists and a top public health official from Israel, which began offering boosters to Pfizer recipients two and a half months ago.

Dr. Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T. H. Chan School of Public Health, questioned whether Moderna has enough data showing whether a booster shot will create adverse side effects.

Like Pfizer, “Moderna is presenting the results of a relatively small trial,” he said. But “Pfizer had all those real-world data from Israel” on its booster campaign, showing results from “millions of people who received the vaccine,” he said.

Johnson & Johnson has asked the Food and Drug Administration to issue emergency use authorization for a booster for recipients of their vaccines, and the panel will vote Friday on the company’s request. They will also hear then about the initial results of an ongoing federal study that found Johnson & Johnson recipients may benefit more from a booster of Moderna’s or Pfizer’s vaccineLater Thursday, the committee will discuss, but not vote on, whether to consider broader eligibility for boosters of both Pfizer and Moderna’s vaccines, allowing people younger than 65 but not at especially high risk to get them.

The new frontier: Israeli hospitals contend with ‘long COVID’ in children – Israel News – Haaretz.com

At the “long COVID” clinic at Schneider Children’s Medical Center in Petah Tikva, about 150 children are being treated, but several hundred more are on a waiting list. “Demand is high and the wait is more than half a year, because we monitor and test everything for each patient,” says Dr. Liat Ashkenazi-Hoffnung, an infectious-disease specialist.

The clinic began operating in November, several months after similar clinics were opened for adults. The symptoms the doctors see are varied, from shortness of breath (the most common complaint), muscle pain, headaches, fatigue, disordered sleep, chest pain, hair loss, and digestive disorders, to the loss of taste and smell, weight loss, difficulty concentrating, memory loss and the exacerbation of tics in children who suffered from them previously. About 60 percent report reduced daily functioning because of the symptoms.

Source: The new frontier: Israeli hospitals contend with ‘long COVID’ in children – Israel News – Haaretz.com

Deaths involving COVID-19 by self-reported disability status during the first two waves of the COVID-19 pandemic in England: a retrospective, population-based cohort study – The Lancet Public Health (United Kingdom)

105 213 people died from causes involving COVID-19 in England, 61 416 (58%) of whom were disabled. Age-adjusted analyses showed higher mortality involving COVID-19 among disabled people who were limited a lot (HR 3·05 [95% CI 2·98–3·11] for men; 3·48 [3·41–3·56] for women) and disabled people who were limited a little (HR 1·88 [1·84–1·92] for men; 2·03 [1·98–2·08] for women) than among non-disabled people. Source: Deaths involving COVID-19 by self-reported disability status during the first two waves of the COVID-19 pandemic in England: a retrospective, population-based cohort study – The Lancet Public Health

The climate disaster is here – this is what the future looks like | Environment | The Guardian

Until now, human civilization has operated within a narrow, stable band of temperature. Through the burning of fossil fuels, we have now unmoored ourselves from our past, as if we have transplanted ourselves onto another planet. The last time it was hotter than now was at least 125,000 years ago, while the atmosphere has more heat-trapping carbon dioxide in it than any time in the past two million years, perhaps more.

Since 1970, the Earth’s temperature has raced upwards faster than in any comparable period. The oceans have heated up at a rate not seen in at least 11,000 years. “We are conducting an unprecedented experiment with our planet,” said Hayhoe. “The temperature has only moved a few tenths of a degree for us until now, just small wiggles in the road. But now we are hitting a curve we’ve never seen before.”

No one is entirely sure how this horrifying experiment will end but humans like defined goals and so, in the 2015 Paris climate agreement, nearly 200 countries agreed to limit the global temperature rise to “well below” 2C, with an aspirational goal to keep it to 1.5C. The latter target was fought for by smaller, poorer nations, aware that an existential threat of unlivable heatwaves, floods and drought hinged upon this ostensibly small increment. “The difference between 1.5C and 2C is a death sentence for the Maldives,” said Ibrahim Mohamed Solih, president of the country, to world leaders at the United Nations in September.

There is no huge chasm after a 1.49C rise, we are tumbling down a painful, worsening rocky slope rather than about to suddenly hit a sheer cliff edge – but by most standards the world’s governments are currently failing to avert a grim fate. “We are on a catastrophic path,” said António Guterres, secretary general of the UN. “We can either save our world or condemn humanity to a hellish future.”

Source: The climate disaster is here – this is what the future looks like | Environment | The Guardian

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