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

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COVID vaccine trials are on hold. Why experts say that’s reassuring.

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It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important.

Wochit

Recent pauses to two large-scale COVID-19 vaccine trials and a treatment study should reassure people — not frighten them — vaccine experts said, though it is a reminder of the messiness of science.

“This is an indication that the system is working as it was designed to work to protect human subjects in clinical trials,” Lawrence Gostin, a public health and legal expert at Georgetown and Johns Hopkins universities, said Tuesday. “It demonstrates that the ethical guard rails on vaccine trials are working.”

It’s not unusual for late-stage trials of drugs and vaccines to be stopped briefly to examine safety concerns, he and others said.

The discovery of an adverse event and a pause in the clinical trial is actually reassuring, said Dr. Bali Pulendran, a professor of immunology and vaccine design at Stanford University.

“Let’s say they got to the end of the clinical trial and there had not been one single report of any adverse event in the tens of thousands of people involved in the trial. That,” he said, “would worry me. That would be extraordinarily unusual.”

Eli Lilly announced Tuesday it was pausing a trial of an experimental drug similar to one President Donald Trump recently claimed cured him of COVID-19. On Monday, Johnson & Johnson halted a large-scale trial of a candidate COVID-19 vaccine. And, in September, British regulators put a hold on another trial of a candidate vaccine by AstraZeneca. They lifted the hold a week later, but it has continued in the American arm of the study.

COVID-19 vaccine trial on Aug. 5, 2020, in Detroit. (Photo: Henry Ford Health System/AFP via Getty Images)

These occurrences should serve as a reminder that scientific research can be unpredictable, disappointing and time-consuming, specialists said.

“After four decades in vaccines, I expect the unexpected,” said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine. “The nature of vaccine development is there are always surprises and the unexpected. Everybody’s looking for them, but time has to pass before you actually know.”

According to a new poll from Informa Pharma Intelligence, a business intelligence provider, and research firm YouGov, 35% of Americans don’t trust how quickly the COVID-19 vaccine clinical trials are moving and 23% don’t think pharmaceutical companies have consumers’ best interests in mind.

The public may have unrealistic expectations of avaccine that’s “100% effective and 150% safe,” said Alan Barrett, director of the Sealy Institute for Vaccine Sciences at The University of Texas Medical Branch at Galveston.

USA TODAY Editorial Board: Don’t inject politics into vaccine policy

But he thinks the companies have shown an impressive attention to safety, including the trial pauses. “We can’t afford to have a mistake,” Barrett said. “The public has to have confidence that any vaccine given to them is going to be safe and effective.”

Only about 31% of all vaccine candidates

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Experts foresee triumph and tragedy in COVID-19 vaccine quest

Panel on COVID-19 vaccine
GeekWire founders John Cook and Todd Bishop chat with a trio of experts involved in the quest to develop coronavirus vaccines on the first day of the 2020 GeekWire Summit. The annual event is being conducted virtually due to COVID-19 concerns. (GeekWire Photo)

The good news is that Operation Warp Speed, the multibillion-dollar effort to develop vaccines for COVID-19, is moving ahead at a pace that justifies its name.

The bad news is that despite all that effort, the coronavirus outbreak is still likely to be with us next year — and low- to medium-income countries such as India are likely to be hit particularly hard.

“We’re going to probably see a lot of deaths,” said Lynda Stuart, deputy director for vaccines and human immunobiology at the Bill & Melinda Gates Foundation. “It’s going to be a great inequity and tragedy that will unfold.”

Stuart and other experts involved in the vaccine quest laid out their assessment of the road ahead today during the first session of the 2020 GeekWire Summit.

The fact that the annual summit’s first session focused on the pandemic was apt, and not just because beating COVID-19 is the top issue facing the world today.

Safety concerns forced the GeekWire Summit to go totally virtual for the first time in its eight-year history — and you just knew there had to be a few technical glitches to overcome. (Any attendees who weren’t able to stream the panel live can access it on-demand in the event platform.)

Any technical challenges that cropped up during today’s panel would pale in comparison with the challenges being faced by Stuart and her two fellow panelists: Melanie Ivarsson, chief development officer for Moderna; and Deborah Fuller, a vaccinologist at the University of Washington.

COVID-19 vaccine panelists on Zoom
Participants in the GeekWire Summit panel on the search for COVID-19 vaccines include Moderna’s Melanie Ivarsson (top left), the University of Washington’s Deborah Fuller (top right) and the Gates Foundation’s Lynda Stuart. (GeekWire Photo)

“I’ve never worked this fast in my life, or this hard, and it’s as if everything’s moving super-fast,” Fuller said. “And yet, at the same time, it feels like it’s just one long, nine-month day.”

Fuller has been studying how the coronavirus behind COVID-19 spreads, and how next-generation vaccines can stop it. Ivarsson’s company, meanwhile, has been racing to test and distribute one of those next-gen, RNA-based vaccines. Moderna’s vaccine candidate went through its first clinical trial in Seattle, and the company is just about to finish enrolling 30,000 volunteers for the crucial Phase 3 trial.

“We are trying to save the world, and it’s a very exciting way to spend your day,” Ivarsson said.

The course of the COVID-19 vaccine race hasn’t always run smooth: One company, AstraZeneca, had to pause its Phase 3 trial last month when one of the participants suffered an unexplained illness. Johnson & Johnson paused its trial this week for similar reasons.

Ivarsson said Moderna’s vaccine development program has continued on track, but she stressed that safety is

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Pfizer to start testing its Covid-19 vaccine in kids as young as 12

It will be the first coronavirus vaccine trial to include children in the United States.

A team at Cincinnati Children’s Hospital will begin vaccinating teenagers aged 16 and 17 this week, and will move to enroll 12-to 15-year-olds later, said Dr. Robert Frenck, director of the Vaccine Research Center at the hospital.

The company confirmed on its website it has approval from the US Food and Drug Administration to enroll children as young as 12 in its trial.

“We really think a vaccine for adolescents and children is going to be critical for getting Covid under control,” Frenck told CNN in a telephone interview.

“I think one of the things that is important to remember is that although the death rate for children with Covid is lower than in older adults, it’s not zero,” he saId, noting that more than half a million children have been diagnosed with coronavirus in the US. “It is not a nonexistent infection in children.”

Children can develop serious illness and also die from coronavirus and there is no way to predict which ones will, he said. They also can spread it to other, more vulnerable people, including parents, grandparents, healthcare workers and others. And children can develop a rare but serious side-effect from coronavirus infection called multisystem inflammatory syndrome in children or MIS-C.
Kids struggle with Covid-19 and its months of aftermath

Frenck also believes more children have been infected with coronavirus than the official data show. “I think we are probably under detecting the number of kids that are infected because they are not getting sick enough to where a parent says they need to go to a doctor,” he said.

“Most of the time in kids, you have a young kid at home and they have a runny nose, they have a cough — you are not going to bring them to a doctor,” he added.

“And most of the time, what a coronavirus causes is a cold.”

Plus, the FDA has asked the companies working to make a coronavirus vaccine to test them in diverse groups — including in people usually missed in drug and vaccine trials, such as the elderly, Blacks, Hispanics and Native Americans.

New ads encourage minorities to roll up their sleeves and participate in coronavirus vaccine trials

Pfizer, one of four companies to have vaccines in advanced, Phase 3 clinical trials in the US, says it has enrolled close to 38,000 volunteers in its trial. More than 31,000 of them have received the second of two shots.

Frenck said more than 90 people have responded to an ad looking for volunteers to sign up teens for the trial.

Pfizer developed its two-dose coronavirus vaccine with Germany’s BioNtech. It uses pieces of viral genetic material to induce immunity to the coronavirus.

“If regulatory approval or authorization is obtained, the companies expect to manufacture globally up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021,” the company said on its website.

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Vaccine reluctance linked to belief in virus hoaxes: study

Up to a third of people in certain countries may believe coronavirus misinformation and in turn be less open to immunisation, scientists said Wednesday, warning that development of a vaccine “might not be enough”. 

Researchers in Britain and the Netherlands conducted surveys in the UK, United States, Ireland, Mexico and Spain and found that while most people rejected Covid-19 conspiracy theories, some of these false stories had taken root in “substantial sections” of the population. 

The World Health Organization has warned that the pandemic has been accompanied by a damaging “infodemic” that has made it hard for people to cut through the misinformation.  

The study found the conspiracy most believed by participants was the claim that the virus was deliberately engineered in a laboratory in the Chinese city of Wuhan, where the epidemic first emerged. 

Between 22-23 percent of respondents in the UK and US rated this assertion as “reliable”, rising to 33 percent and 37 percent Mexico and Spain respectively.

The hoax that Covid-19 symptoms are worsened by 5G phone networks was deemed reliable by 16 percent of respondents in Mexico and in Spain, 12 percent in Ireland, and 8 percent in both the UK and US.

The study, published in the journal Royal Society Open Science, found “a clear link” between believing coronavirus conspiracies and hesitancy around any future vaccine, said co-author Sander van der Linden, director of the Cambridge University Social Decision-Making Lab. 

“As well as flagging false claims, governments and technology companies should explore ways to increase digital media literacy in the population,” he said. 

“Otherwise, developing a working vaccine might not be enough.”

– Infodemic –

Researchers conducted two surveys in the UK in April and May with 1,050 and 1,150 participants respectively, while there were also 700 participants each in the US, Mexico, Spain and Ireland. 

They were also asked to rate the reliability of coronavirus claims on a scale of one to seven.

On average, the study found that an increase by one-seventh in someone’s perception that misinformation was reliable was associated with a drop of 23 percent in the likelihood they would agree to get vaccinated.  

By contrast, a one-seventh increase in trust in scientists was associated with a 73 percent increase in the likelihood of getting vaccinated. 

Jon Roozenbeek, the lead author and a postdoctoral fellow at Cambridge’s Department of Psychology, said people were dealing with “a deluge of statistics” in the pandemic. 

“The fostering of numerical skills for sifting through online information could well be vital for curbing the ‘infodemic’ and promoting good public health behaviour,” he said.  

Researchers found that high levels of trust in scientists and numeracy levels were “significantly and consistently” associated with imperviousness to misinformation across all countries studied.  

Trusting politicians’ ability to tackle the crisis predicted a higher likelihood of believing conspiracies in Mexico, Spain and the US, but not in the UK and Ireland, the study found. 

A study from Cornell University earlier in October found that US President Donald Trump was

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Pauses of coronavirus antibody and vaccine trials are routine, doctor says

Two setbacks have been reported in 24 hours in the fight against the coronavirus. On Tuesday, drugmaker Eli Lilly halted human testing of a COVID-19 treatment citing a potential safety concern. A person familiar with the trial told CBS News the pause will last approximately two weeks.

The treatment, which uses COVID-19 antibodies, is similar to a therapeutic given to President Donald Trump that he touted as a cure. “It was like unbelievable,” Mr. Trump said. “I felt good immediately.”

This comes as Johnson & Johnson said its vaccine trial, the largest to date, is also stopping temporarily while it investigates if an unexplained illness was caused by its vaccine.

CBS News medical contributor Dr. David Agus said these pauses are routine and reassuring.

“So this is not unusual,” Agus said. “I hope that Americans see news like this and have comfort that we are investigating every single issue with these drugs and with these vaccines to make sure they are safe for the American people.”

Thirty-seven states are seeing a rise in average new cases; only one state — South Carolina — is down. A key driver is gatherings. A recent CDC report found that a 13-year-old girl infected 11 people staying at the same house during a family vacation, without masks or social distancing.

With many Americans resisting guidelines, the death toll continues to grow. Leanna Richardson lost her mother — a third-grade teacher from North Carolina — in just 10 days.

“And if anything else, let her death be a reminder that COVID-19 doesn’t care,” Richardson said. “COVID-19 is serious. This is a pandemic. This is not a joke.”

School officials at her mother’s school said they do not believe she contracted the virus at work where she was teaching students in person. 

© 2020 CBS Interactive Inc. All Rights Reserved.

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Dustin Johnson; Johnson & Johnson vaccine trial

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Since the coronavirus pandemic started, the United States has recorded more than 7.6 million cases of COVID-19 and 213,000 deaths.

USA TODAY

A third of U.S. states are reporting higher coronavirus case counts than they’ve ever had before.

A USA TODAY analysis of Johns Hopkins data shows 16 states set records for new cases in a week. But nearly all states are surging: 41 states had worse weeks than they did a week earlier. And an analysis of COVID Tracking Project data shows that in 36 states, a higher rate of people were testing positive than in the week before.

While the data continues to show the virus’ reach is not letting up, the head of the World Health Organization said achieving herd immunity by allowing the virus to spread is “scientifically and ethically problematic.”

“Herd immunity is achieved by protecting people from a virus, not by exposing them to it,” WHO Director-General Tedros Ghebreyesus said Monday, adding that the strategy relies on vaccination.

The quest for a vaccine, however, ran into trouble on Monday when Johnson & Johnson paused its Phase 3 clinical trial because of a participant’s unexplained illness. It’s the second of four large-scale, final-stage vaccine trials to go on hold as President Donald Trump pushes for a vaccine by Election Day on Nov. 3. Eli Lilly paused an antibody trial on Tuesday because of safety concerns.

Some significant developments:

  • Golfer Dustin Johnson, the number one player in the world, has tested positive for the virus, the PGA Tour announced Tuesday. 
  • Soccer star Cristiano Ronaldo tested positive for COVID-19, the Portuguese soccer federation announced Tuesday.
  • An 89-year-old Dutch woman is believed to be the first person to have died from a reinfection of COVID-19. Researchers note that her case is similar to that of a healthy 25-year-old Nevada man, who is the first American to have confirmed to have caught COVID-19 twice. Both the man and woman had a worse sickness the second time. 
  • Slightly more than half of Americans in a recent poll say they already have or plan to stockpile food and other essentials over fears of another COVID-19 surge and potential unrest after the Nov. 3 election.
  • Based on their weight, more than 70% of Americans are at an increased risk of experiencing severe illness if they contract the coronavirus, according to new guidance posted by the CDC.

📈 Today’s numbers: The U.S. has reported more than 7.8 million cases and 215,000 deaths, according to Johns Hopkins data. There have been more than 37.8 million confirmed cases around the world and 1 million deaths.

🗺️ Mapping coronavirus: Track the U.S. outbreak, state by state.

This file will be updated throughout the day. For updates in your inbox, subscribe to The Daily Briefing newsletter.

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World’s top golfer Dustin Johnson has positive COVID-19 test

World No. 1 golfer Dustin Johnson withdrew Tuesday from an upcoming golf tournament in Las Vegas after testing positive for COVID-19.

According to

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