Day: May 31, 2023

The U.S. Food and Drug Administration (FDA) on Wednesday approved Pfizer Inc.’s respiratory syncytial virus (RSV) vaccine for older adults, making it the second shot against the common respiratory disease that can be fatal for seniors.

The approval comes less than a month after the FDA approved a similar shot by rival GSK PLC. Pfizer’s vaccine was approved for people aged 60 and older, the company said, the same age group as GSK’s shot.

In a late-stage study, Pfizer’s vaccine, to be sold under the brand name Abrysvo, was 67% effective among those aged 60 and older with two or more symptoms of RSV, and 85.7% effective against severe illness defined by three or more symptoms.

Pfizer and GSK have said they expect a multibillion-dollar market for RSV vaccines.

Vaccine available in third quarter

The company expects to make the vaccine available during the third quarter, ahead of the next RSV season, once the U.S. Centers for Disease Control and Prevention (CDC) signs off on its use.

The CDC’s advisory committee is expected to meet in June to discuss the vaccines, including who should receive them and how often.

Pfizer did not disclose a price for the vaccine. It said the price would be value-based to support routine vaccination for the recommended age group for the shots.

If the vaccine is recommended by the CDC for routine use, it will be widely available at no out-of-pocket cost for most older Americans covered by the government Medicare health plan, the company said.

RSV usually causes mild cold-like symptoms but also can lead to serious illness and hospitalization. It is estimated to be responsible for 14,000 deaths in adults aged 65 and older in the United States annually, according to government data.

Seeking OK for pregnant women

Pfizer also is seeking FDA approval for its RSV vaccine to prevent the disease in infants by inoculating pregnant women. It could become the first RSV vaccine available to protect babies, who are among those at greatest risk for severe illness.

The shot received backing by the agency’s panel of outside experts earlier this month for use in pregnant women.

The company has said it is ready to launch its RSV vaccine for both older adults and pregnant women in the United States and Europe this year.

Moderna Inc. has said it expects to seek approval for its RSV vaccine this quarter for those aged 60 and older.

Sanofi and partner AstraZeneca PLC in November gained European marketing authorization for their antibody treatment nirsevimab for preventing RSV in newborns and infants. It is currently under FDA review.
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Canada will soon require that health warnings be printed on individual cigarettes and cigars in a further crackdown on smoking, the country’s addictions minister announced Wednesday.

The messaging, to be phased in starting August 1, will include lines such as “Poison in every puff,” “Tobacco smoke harms children” and “Cigarettes cause cancer.”

Addictions Minister Carolyn Bennett said tobacco use continues to kill 48,000 Canadians each year. The new labeling rule is a world first, she said, although Britain has flirted with a similar regulation.

“This bold step will make health warning messages virtually unavoidable and, together with updated graphic images displayed on the package, will provide a real and startling reminder of the health consequences of smoking,” Bennett said.

The Canadian government noted that some young people, who are particularly susceptible to the risk of tobacco dependence, start smoking after being given a single cigarette rather than a pack labeled with health warnings.

In 2000, Canada became the first country to order graphic warnings on packs of cigarettes — including grisly pictorials of diseased hearts and lungs — to raise awareness of the health hazards associated with tobacco use.

Smoking has been trending down over the past two decades.

Ottawa aims to further reduce the number of smokers in the country to 5% of the population, or about 2 million people, by 2035, from about 13% currently.

According to government data, almost half of the country’s health care costs are linked to substance use.
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Earth has pushed past seven out of eight scientifically established safety limits and into “the danger zone,” not just for an overheating planet that’s losing its natural areas, but for the well-being of people living on it, according to a new study.

The study looks not just at guardrails for the planetary ecosystem but for the first time it includes measures of “justice,” which is mostly about preventing harm for countries, ethnicities and genders.

The study by the international scientist group Earth Commission published Wednesday in the journal Nature looks at climate, air pollution, phosphorus and nitrogen contamination of water from fertilizer overuse, groundwater supplies, fresh surface water, the unbuilt natural environment and the overall natural and human-built environment. Only air pollution wasn’t quite at the danger point globally.

Air pollution is dangerous at local and regional levels, while climate was beyond the harmful levels for humans in groups but not quite past the safety guideline for the planet as a system, the study from the Swedish group said.

The study found “hot spots” of problem areas throughout Eastern Europe, South Asia, the Middle East, Southeast Asia, parts of Africa and much of Brazil, Mexico, China and some of the U.S. West — much of it from climate change. About two-thirds of Earth don’t meet the criteria for freshwater safety, scientists said as an example.

“We are in a danger zone for most of the Earth system boundaries,” said study co-author Kristie Ebi, a professor of climate and public health at the University of Washington.

If planet Earth just got an annual checkup, similar to a person’s physical, “our doctor would say that the Earth is really quite sick right now, and it is sick in terms of many different areas or systems, and this sickness is also affecting the people living on Earth,” Earth Commission co-chair Joyeeta Gupta, a professor of environment and development at the University of Amsterdam, said at a press conference.

It’s not a terminal diagnosis. The planet can recover if it changes, including its use of coal, oil and natural gas and the way it treats the land and water, the scientists said.

But “we are moving in the wrong direction on basically all of these,” said study lead Johan Rockstrom, director of the Potsdam Institute for Climate Impact Research in Germany.

“This is a compelling and provocative paper — scientifically sound in methodology and important for identifying the dimensions in which the planet is nearing the edge of boundaries that would launch us into irreversible states,” Indy Burke, dean of the Yale School of the Environment, said in an email. She wasn’t part of the study.

The team of about 40 scientists created quantifiable boundaries for each environmental category, both for what’s safe for the planet and for the point at which it becomes harmful for groups of people, which the researchers termed a justice issue.

Rockstrom said he thinks of those points as setting up “a safety fence,” outside of which the risks become higher, but not necessarily fatal.

Rockstrom and other scientists have attempted in the past this type of holistic measuring of Earth’s various interlocking ecosystems. The big difference in this attempt is that scientists also looked at local and regional levels, and they added the element of justice.

The justice part includes fairness between young and old generations, different nations and even different species. Frequently, it applies to conditions that harm people more than the planet.

An example of that is climate change.

The report uses the same boundary of 1.5 degree Celsius (2.7 degrees Fahrenheit) of warming since pre-industrial times that international leaders agreed upon in the 2015 Paris climate agreement. The world has so far warmed about 1.1 degrees Celsius (2 degrees Fahrenheit), so it hasn’t crossed that safety fence, Rockstrom and Gupta said, but that doesn’t mean people aren’t being hurt.

“What we are trying to show through our paper is that event at 1 degree Centigrade (1.8 degrees Fahrenheit) there is a huge amount of damage taking place,” Gupta said, pointing to tens of millions of people exposed to extreme hot temperatures.

The planetary safety guardrail of 1.5 degrees hasn’t been breached, but the “just” boundary where people are hurt of 1 degree has been.

“Sustainability and justice are inseparable,” said Stanford environmental studies chief Chris Field, who wasn’t part of the research. He said he would want even more stringent boundaries. “Unsafe conditions do not need to cover a large fraction of Earth’s area to be unacceptable, especially if the unsafe conditions are concentrated in and near poor and vulnerable communities.”

Another outside expert, Dr. Lynn Goldman, an environmental health professor and dean of The George Washington University’s public health school, said the study was “kind of bold,” but she wasn’t optimistic that it would result in much action.
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The director of the leading U.S. cybersecurity agency has a message for scientists and top technology company officials who are warning that artificial intelligence could lead to the end of humankind: Take action.

“If you actually think that these capabilities can lead to extinction of humanity, well, let’s come together and do something about it,” the Cybersecurity and Infrastructure Security Agency’s Jen Easterly told an audience Wednesday.

“While we’re trying to put a regulatory framework in place, think about self-regulation,” she told an Axios News Shapers event in Washington. “Think about what you can do to slow this down.”

The comments by the CISA director come just a day after more than 350 researchers and technology executives issued a one-sentence warning about the dangers of artificial intelligence, or AI.

“Mitigating the risk of extinction from AI should be a global priority alongside other societal-scale risks such as pandemics and nuclear war,” they said in a post on the website for the Center for AI Safety.

Those signing onto the warning included the co-founder and CEO of OpenAI, the company behind Chat GPT, Microsoft’s chief technology officer, the CEO of Google’s AI research lab and Geoffrey Hinton, sometimes called “the godfather of artificial intelligence.”

Hinton, notably, quit his job at Google earlier in May to focus on warning others of the dangers of AI.

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U.S. government officials, like CISA’s Easterly, have likewise been warning about the dangers posed by AI.

“AI will be the most powerful capability of our time,” Easterly told students at Vanderbilt University during a speech earlier this month.

“I believe it will also be the most powerful weapon of our time,” she added. “While one person will use this technology to plan a dinner party, another will use the capability to plan a cyberattack or a terrorist attack.”

Easterly has previously called for “smart regulation” of AI technology and products, warning that tech companies, as with other technologies, are too focused on getting AI products to market quickly and not paying enough attention to safety.

Earlier in May she said that CISA has held discussions with tech companies about a way forward for AI.

In April, CISA’s parent agency, the Department of Homeland Security, launched its own initiative to take on the dangers posed by artificial intelligence.

“We must address the many ways in which artificial intelligence will drastically alter the threat landscape and augment the arsenal of tools we possess to succeed in the face of these threats,” Homeland Security Secretary Alejandro Mayorkas said at the time.

 
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