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Coronavirus Vaccine Makers Are Not Mass-Slaughtering Sharks

Several companies in the race for a coronavirus vaccine have stumbled upon a new and unexpected hurdle: activists protesting the use of a substance that comes from sharks in their products.

The oily compound, called squalene, is churned out by shark livers and has immunity-boosting powers, which has led several companies to use it as an ingredient in vaccines. A group called Shark Allies has mounted a campaign calling on the Food and Drug Administration and other regulatory bodies to halt the sourcing of the compound from sharks, warning that mass distribution of a coronavirus vaccine could require harvesting tissue from more than 500,000 sharks.

The call to action made headlines around the globe. But the story on shark squalene isn’t as clear-cut as it might at first seem.

Companies commonly use squalene as a moisturizing additive in cosmetics and sunscreens. But the substance has also been occasionally used in vaccines as an adjuvant — a chemical that kick-starts the immune system into action, driving stronger, longer-lasting protection against disease.

Although adjuvants aren’t necessary for all vaccines, they can make or break certain recipes. By boosting products’ immunity-priming powers, they can also increase the immunization’s efficiency, giving the vaccine’s ingredients more bang for their buck and freeing up supplies for more doses.

Shark livers are considered among the best sources of the compound. Between 63 million and 273 million sharks die at the hands of humans each year, and liver oil is harvested from at least a couple million of them, according to Catherine Macdonald, a shark biologist in Florida.

Two of the companies under the scrutiny of Shark Allies are GlaxoSmithKline and Seqirus, which each manufacture adjuvants that contain about 10 milligrams of squalene per dose. Those ingredients are found in a number of coronavirus vaccines currently being tested in humans, including products from Sanofi, Medicago and Clover Biopharmaceuticals, which have all partnered with GSK.

According to one estimate, between 2,500 and 3,000 sharks are needed per metric ton of squalene. Shark Allies extrapolated from these statistics to arrive at their widely quoted numbers tabulating the potential ecological toll on sharks.

Such estimates are difficult to make.

Dr. Macdonald pointed out that sharks — of which there are more than 500 species worldwide — vary in size, weight and liver squalene content. The number of sharks required to yield enough squalene-adjuvanted vaccine doses to treat everyone on Earth is thus likely to be a “huge range,” she said. Her own calculations for this statistic stretch between tens of thousands and more than a million, depending on how many doses are needed per person.

It’s also the case that of the dozens of vaccine candidates in clinical trials in people, most don’t include squalene. To only rely on vaccines that use shark-based squalene, “a ton of other promising candidates would have to fail — they would have to be the last vaccines standing,” said Saad

Shenzhen-listed traditional medicine makers ride high on endorsement by public face of China’s fight against coronavirus

a man cutting a cake: A traditional Chinese medicine pharmacy in Weinan City, in China’s northwest Shaanxi Province. The overall industry has stalled, with only 17 out of 68 TCM makers recording year-on-year growth in revenue in the first half of 2020. Photo: Xinhua

A traditional Chinese medicine pharmacy in Weinan City, in China’s northwest Shaanxi Province. The overall industry has stalled, with only 17 out of 68 TCM makers recording year-on-year growth in revenue in the first half of 2020. Photo: Xinhua

Two Shenzhen-listed makers of traditional Chinese medicine (TCM), Shijiazhuang Yiling Pharmaceutical and Tianjin Chase Sun Pharmaceutical, have reaped stunning gains this year, riding on endorsements by the public face of China’s successful fight against the coronavirus pandemic.

Yiling reported a 57 per cent jump in net profit to 714 million yuan (US$106 million) for the first half of 2020, while its stock price surged by as much as 245 per cent between January and mid April, hitting its highest level since it went public in 2011. Chase Sun recorded 2.8 billion yuan in revenue for the first half, a 22 per cent increase compared with the same period last year.

Their fortunes came even as growth in the overall TCM industry stalled, with only 17 out of 68 TCM makers listed in China recording year-on-year growth in revenue in the first half of 2020, according to companies’ earnings reports.

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Behind Yiling and Chase Sun’s success is their close association with Zhong Nanshan, a top mainland Chinese medical expert famous for leading the country’s coronavirus containment efforts. A pulmonologist who has also studied in the UK, Zhong is a supporter of TCM and has frequently recommended the use of traditional remedies for treating coronavirus patients.

Yiling was founded in 1992 by TCM practitioner Wu Yiling, who is famous for developing a concoction of leech, whole scorpion, centipede, soil beetle and cicada slough used to treat cardiovascular diseases.

Zhong Nanshan wearing a suit and tie: A pulmonologist who has also studied in the UK, Zhong Nanshan is a supporter of TCM. Photo: Handout

© Provided by South China Morning Post
A pulmonologist who has also studied in the UK, Zhong Nanshan is a supporter of TCM. Photo: Handout

Both Wu and Zhong are academicians at the Chinese Academy of Engineering, the highest academic title conferred by Beijing to engineers and scientists, and have collaborated since at least 2015, when Wu invited Zhong to join a 460 million yuan research lab set up for academicians by his company. In 2016, they co-founded a research centre to tackle lung diseases using TCM in the southern city of Guangzhou.

While his collaboration with Yiling is focused on research, Zhong’s association with Chase Sun has more to do with business. In April 2012, a Guangzhou-based medical foundation led by Zhong invested 3.5 million yuan in a pharmaceutical company along with Chase Sun, which invested 5 million, according to Tianyancha, a public database of business records.

Zhong has since sat on the board of the company along with Yao Xiaoqing, Chase Sun’s chairman. Founded in 1996, Chase Sun transferred a controlling stake in 2019 to the State-owned Assets Supervision and Administration Commission of Chengdu, and has become a state-owned company affiliated with the city in Southwest China.

Zhong, Yiling and Chase Sun did not reply

U.S. Government Asks Vaccine Makers To Hold Filing for Authorization Until They Have Enough Doses to Distribute

President Trump Makes Statement On Vaccine Development
President Trump Makes Statement On Vaccine Development

Moncef Slaoui, head of the White House’s “Operation Warp Speed” project to develop a coronavirus vaccine, listens to U.S. President Donald Trump deliversremarks about vaccine development in the Rose Garden of the White House on May 15, 2020 in Washington, DC. Credit – Drew Angerer—Getty Images

As the COVID-19 pandemic enters its 10th month, the pressure to develop an effective vaccine, or vaccines, continues to mount. Speaking at the Johns Hopkins University and University of Washington Vaccine Symposium online, Dr. Moncef Slaoui, scientific head of Operation Warp Speed—the government organization funding and supporting development and distribution of COVID-19 vaccines—provided the latest updates on when a vaccine (and how many doses) might be available in coming months.

Perhaps most strikingly, Slaoui said that the government has told vaccine manufacturers not to seek authorization of their drugs from the Food and Drug Administration (FDA) until they have enough doses to provide to a desperate public. “We have recommended to companies that if they achieve efficacy demonstration while no vaccine doses are available at industrial scale of several million doses to at least immunize a relevant fraction of the population, then they should refrain or consider refraining from filing an emergency use authorization, because the populations would have a major disappointment [over] expectation of the availability of the vaccine,” he said.

Emergency use authorization (EUA) is an accelerated review and authorization process by the FDA that would allow vaccine makers to distribute vaccines that are safe and effective but not fully approved by the agency.

Slaoui also supported the FDA in its recent conflict with the White House over stringent guidelines proposed by the agency for evaluating data from vaccine studies, which include a recommendation that all vaccine trial volunteers be followed for two months for any potential side effects. Vaccine makers supported the guidelines, but after initially rejecting them, arguing they would delay availability of the vaccines, the White House has accepted them.

At this point, meeting demand would not be a problem if an EUA were given to the two vaccines, made by Moderna and Pfizer, that are currently furthest along in testing. The companies began late-stage testing for these vaccine candidates in the summer, and Slaoui said the manufacturers have been manufacturing doses at large scale in parallel to testing. The government began stockpiling doses of these unapproved but promising vaccines “in the single digit millions” in September, and will continue to do so in October, he said, and both Moderna and Pfizer will likely have 20 to 30 million doses produced by November and December this year.

Two of the other most promising vaccines in development are from AztraZeneca and J&J, both of which are quickly enrolling participants in late stage studies outside of the U.S., and may deliver first hints of safety and effectiveness by late October or early November. However, even if those results prove positive, these companies would likely have to consider waiting until their manufacturing capabilities

Gov’t Bows to Vax Makers’ Demands? 2nd Wave Hits Europe; FDA Wants Makena Pulled

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The White House is blocking new FDA guidelines that would stiffen requirements for authorizing COVID-19 vaccines, after manufacturers reportedly objected to the guidance. (New York Times, Politico)

White House Press Secretary Kayleigh McEnany and Pastor Greg Laurie of the Harvest Christian Fellowship megachurch were the latest attendees at a recent White House event to report a positive coronavirus test. MedPage Today has a running list here.

Perhaps the most at risk White House staffers, however, are the 100 members of the White House’s residence staff. (The Atlantic)

Finally: the CDC acknowledges the potential for airborne SARS-CoV-2 transmission.

As of 8:00 a.m. ET Tuesday, the estimated U.S. COVID-19 toll reached 7,459,102 cases and 210,196 deaths — up 40,364 and 462, respectively, since the same time Monday.

The Northeast and Midwest are experiencing surges, and new cases have risen for at least two weeks in a row in 21 states. (Reuters)

Lockdown measures make a comeback in Europe. (The Guardian)

WHO official said roughly 1 in 10 people worldwide have been infected with COVID-19 and that we are now heading into a “difficult period.” (Reuters)

Three doctors met with HHS Secretary Alex Azar and Trump advisor Scott Atlas, MD, to push the herd immunity hypothesis. (The Hill)

European drug regulators are investigating reports of acute kidney injury in some COVID-19 patients who were on remdesivir. (Becker’s Hospital Review)

Moderna failed to enroll enough people of color in its vaccine trial and slowed enrollment to ensure more minority volunteers were recruited. (Reuters)

Trump issued an executive order establishing a Coronavirus Mental Health Working Group to respond to “mental-health conditions induced or exacerbated by the pandemic, including issues related to suicide prevention.”

Texas universities have plenty of tests, but participation rates are far lower than expected, prompting one school to offer prizes to students volunteering to be tested. (Texas Tribune)

PBS is airing a segment tonight on the nationwide scramble for personal protective equipment in the first wave of the pandemic.

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    Elizabeth Hlavinka covers clinical news, features, and investigative pieces for MedPage Today. She also produces episodes for the Anamnesis podcast. Follow

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