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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

Pfizer to enroll kids as young as 12 in COVID-19 vaccine study

(Reuters) – Pfizer Inc will enroll participants as young as 12 in its large, late-stage COVID-19 vaccine trial to understand how it works in a wider age group.

While severe COVID-19 symptoms are extremely rare in infected children, they can pass on the virus to high-risk groups such as the elderly.

That makes determining the effectiveness of a potential vaccine in children crucial, as vaccines work differently in kids and adults, the FDA said in its guidelines https://www.fda.gov/media/139638/download in June.

The U.S. Food and Drug Administration (FDA) granted permission to the drugmaker and German partner BioNTech SE to enroll younger participants this month, according to an update on the U.S. company’s website https://www.pfizer.com/science/coronavirus/vaccine on Monday.

Last month, Pfizer scaled up its trial to about 44,000 participants, from up to 30,000, to enroll people as young as 16 and those with chronic, stable HIV, hepatitis C and hepatitis B.

The company said on Tuesday it would enroll children in its study based on satisfactory safety data in older adolescents and young adults, but did not specify a timeline.

Pfizer is racing to develop a safe and effective vaccine for the new coronavirus with rivals such as Moderna Inc, AstraZeneca Plc and Johnson & Johnson.

Late-stage vaccine trials initiated by Moderna, J&J and Novavax Inc are testing their respective candidates only in adults.

AstraZeneca’s U.K. vaccine trial, targeting more than 12,000 volunteers, will have one out of 11 subgroups with children 5 to 12 years of age. Chief Executive Officer Pascal Soriot said last month that tests on children had not yet started.

(Reporting by Manojna Maddipatla in Bengaluru and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Shinjini Ganguli)

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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

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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Johnson & Johnson Paused Trials on Its COVID-19 Vaccine Due to Subject’s “Unexplained Illness”

Update, Oct. 13: Johnson & Johnson announced that it has paused all of its COVID-19 vaccine candidate clinical trials, including a large-scale Phase 3 human trial called “Ensemble” that began in September and aimed to enroll up to 60,000 people across three continents. One of the participants in that trial had an “unexplained illness,” the company said.

The Phase 3 clinical trial was in the process of comparing the efficacy of a single-dose vaccine versus a placebo. A company statement explained that the participant’s illness is currently being reviewed, and no other information has been released about the participant’s condition out of privacy. “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies,” the company wrote. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

This pause, Johnson & Johnson explained, is different than a regulatory hold put in place by a health authority such as the FDA. “As noted in the ENSEMBLE study protocol, Johnson & Johnson has robust mechanisms in place to protect the safety of participants in its clinical trials. While the Company informs all study investigators, we typically do not communicate study pauses publicly,” the company’s statement reads (it does, however, normally disclose information about regulatory holds). Stat News was the first outlet to report on this trial pause on Oct. 12.

Original post: Pharmaceutical brand Johnson & Johnson has been working on a coronavirus vaccine since January 2020, as soon as the virus’s genetic sequence became available. On March 30, the company announced plans to begin human testing of the vaccine in September, working towards an anticipated emergency use date in early 2021.

It’s a “substantially accelerated timeline,” the company noted in a press release; typical vaccine development can take five to seven years before a viable candidate is considered for approval, it said. The company’s manufacturing sector is ramping up production as well, with the goal of eventually providing over one billion doses of the vaccine globally.

“The world is facing an urgent public health crisis,” said Alex Gorsky, the chairman and CEO of Johnson & Johnson, in the press release. “We are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible.” He noted that the company’s research, operational, and financial capabilities put it in a favorable position to quickly develop and distribute a vaccine.

Related: If You Have COVID-19 Symptoms, This Is How You Can Take Care of Yourself at Home

Johnson & Johnson has also partnered with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, to commit $1 billion in funding towards vaccine research, development, and testing, the company said.

It’s hopeful news, especially considering that Johnson & Johnson is just one of multiple pharmaceutical companies rapidly working towards a COVID-19 vaccine; Moderna’s vaccine began its

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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J&J says review of illness that led to pause of coronavirus vaccine trial could take days

(Reuters) – Johnson & Johnson said on Tuesday it would take a few days at least to hear from a safety monitoring panel about its review of the company’s late-stage COVID-19 vaccine trial after announcing that the large study had been paused due to an unexplained illness in one participant.

The pause comes around a month after AstraZeneca Plc also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill. That trial remains on pause.

U.S.-based J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as its own clinical and safety team. The data board is then required to submit its findings to the U.S. Food and Drug administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo.

J&J said such pauses are normal in big trials, which can include tens of thousands of people. The company said the trial is still on track to continue adding patients over the coming months.

It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.

Former FDA chief said on Twitter the trial said that the oversight of safety boards for the COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Experts and officials have voiced concerns that U.S. President Donald Trump could put pressure on vaccine makers to rush an unsafe or ineffective vaccine to market.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines both use modified, harmless versions of adenoviruses to deliver genetic instructions to human cells in order to spur an immune response to the target virus, in this case the novel coronavirus.

FILE PHOTO: The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid/File Photo

They are both also

Johnson & Johnson moves to buoy investors over paused Covid vaccine trial

US pharmaceutical giant Johnson & Johnson sought Tuesday to reassure investors after its stock slumped on an announcement that it was pausing a Covid-19 vaccine trial over a sick participant.

The company is one of several working on a vaccine, but on Monday it announced the unexplained illness, closing enrollment for the 60,000-patient trial while an independent patient safety committee is convened.

The announcement sent shares tumbling 2.3 percent at the close of trading Tuesday, even as the company reported healthy third-quarter results, with sales growing 1.7 percent to $21.08 billion.

In a conference call earlier in the day, J&J’s global research head Mathai Mammen said “our plan is to continue the study” following “a temporary pause” caused by the illness.

“It’s not at all unusual for unexpected illnesses (to occur) in large studies over their duration. In some cases, serious adverse events… may have something or nothing to do with the drug or vaccine being investigated,” he said.

The Phase 3 trial had started recruiting participants in late September, with a goal of enrolling volunteers across more than 200 US and international locations, the company and the US National Institutes for Health (NIH), which is providing funding, said.

The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

The company’s chief financial officer Joe Wolk said it was unclear whether the participant who became ill was receiving the trial vaccine or the placebo.

“We are waiting for the independent drug safety monitoring board to do their analysis,” he said.

J&J is one of 11 organizations globally to begin a Phase 3 trial on a Covid-19 vaccine.

Washington has given the multinational about $1.45 billion in funding under Operation Warp Speed.

The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

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Vaccine development process is safe, claims of the contrary are baseless

All of our lives have been drastically impacted by the ongoing coronavirus pandemic — and we know all of us are eager to return to the way things were before the pandemic began. However, that simply won’t be possible without a safe, effective vaccine. Fortunately, due to the strength of American innovation and unprecedented public-private partnerships, a COVID-19 vaccine is on the horizon. We, as the top Republican on the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee and a physician on the Energy and Commerce Health Subcommittee, have been closely following our nation’s progress — and we are confident that we will have a safe, effective vaccine soon.

On July 21, 2020, the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee held a hearing on vaccine development. The subcommittee heard from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer. All five companies are working on various vaccines and therapeutics for COVID-19 and have received federal funding. Moderna, Pfizer, AstraZeneca, and Johnson & Johnson are all now conducting “phase 3” clinical trials for their COVID-19 vaccine candidates, which is the last stage of testing prior to regulatory approval. AstraZeneca and Johnson & Johnson both recently paused their studies to examine an illness in one of the participants. This is standard protocol, and should give us even more confidence that vaccine companies are following standard safety procedures in their trials — not rushing through the process.

Currently, the Trump administration is working with many pharmaceutical companies to assist in two ways: To advance research and development and to ensure that when a COVID-19 vaccine is approved for safety and efficacy, it is ready to be shipped and distributed across the United States. 

Through “Operation Warp Speed” and the “Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership, the federal government is doing everything it can to ensure that the private companies developing a vaccine have the resources they need. This assistance is also helping companies to begin establishing manufacturing capability and to initiate the purchasing of necessary raw materials including glass vials for packaging and needles and syringes for the administration of the vaccines. These programs are also facilitating the condensing of the regulatory timeline. For example, the government is currently providing financial support to a number of companies to allow for simultaneous development and production of a vaccine before it receives final approval from the Food and Drug Administration (FDA). Usually, companies will not begin to invest in producing a vaccine or treatment until it has first completed testing and received regulatory approval. We need to ensure that any COVID-19 vaccine is available as soon as it receives the final approval from the FDA.

All five companies assured the subcommittee that any vaccine they produce will meet all safety standards set by the FDA. They also vowed to be transparent about the testing and development process so there are no questions about safety or efficacy.

Many who are working closely on vaccine development are cautiously optimistic that we will

Johnson & Johnson pauses coronavirus vaccine trial following ‘unexplained illness’ in participant

Pharmaceutical giant Johnson & Johnson on Monday night announced that it had paused its late-stage COVID-19 vaccine trial after an “unexplained illness” was reported in a participant. 

“Adverse events – illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in a statement when announcing the temporary halt. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 
(iStock)

No details on the illness were revealed, and it’s not currently clear if the illness is related to the shot or was a coincidence. It’s also not clear if the volunteer had received the vaccine or the placebo. 

“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” the company added. 

CLOTH CORONAVIRUS FACE MASKS WORK — BUT ONLY IF YOU DO THIS AFTER WEARING THEM, STUDY FINDS

The pause, which was first reported by the health news site STAT, comes after the company began the Phase 3 trial of its vaccine in September. 

The temporary halt is not the first to occur in the race to find a safe and effective vaccine to protect against COVID-19. In fact, the pause is the second such hold to occur among several vaccine candidates that have reached large-scale final tests in the U.S.

RISKIEST BEHAVIORS TO AVOID DURING CORONAVIRUS PANDEMIC, ACCORDING TO AN EXPERT

Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.

Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.

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The Associated Press contributed to this report. 

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