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

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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

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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

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Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)

Confirmation underscores Moderna’s commitment to make its vaccine available in Canada

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the initiation of a rolling submission to Health Canada for mRNA-1273, the Company’s vaccine candidate against COVID-19. This initiation follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.

The rolling submission has been accepted under the Canadian Minister of Health’s Interim Order, which permits companies to submit safety and efficacy data and information as they become available. This rolling review process allows Health Canada to begin its assessment using the information submitted by the applicant and accept

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Johnson & Johnson Pauses Coronavirus Vaccine Trials due to ‘Unexplained Illness’ in Participant | Health News

Johnson & Johson has paused the clinical trial for its coronavirus vaccine following an “unexpected illness” in a participant.

Health experts have said that pauses in vaccine trials aren’t uncommon and mean that safety precautions are working. It’s the second vaccine trial to be paused in the U.S. A vaccine from AstraZeneca and Oxford University was put on pause last month after a participant fell ill. That trial hasn’t yet resumed in the U.S.

Photos: Daily Life, Disrupted

TOPSHOT - A passenger in an outfit (R) poses for a picture as a security guard wearing a facemask as a preventive measure against the Covid-19 coronavirus stands nearby on a last century-style boat, featuring a theatrical drama set between the 1920s and 1930s in Wuhan, in Chinas central Hubei province on September 27, 2020. (Photo by Hector RETAMAL / AFP) (Photo by HECTOR RETAMAL/AFP via Getty Images)

It is unclear how long Johnson & Johnson’s pause could last. The company said there is a “significant distinction” between a study pause and a regulatory hold of a clinical trial, which could last much longer.

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a press release Monday night.

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France launches flu vaccine campaign amid COVID-19 crisis

France has launched a flu vaccine campaign in an effort to avoid facing another epidemic peak as the coronavirus is spreading rapidly in the country

Medical staff are advised to initially reserve it for priority patients, including people over 65, pregnant women and those suffering from respiratory illness and some other diseases. Others are advised to wait for December.

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Viewpoints: FDA Guidance On Vaccine Brings Relief At Right Time; Lessons On Talking Public Health To Conservatives

Opinion writers weigh in on these pandemic topics and others as well.


Bloomberg:
FDA Is Right To Hold Covid-19 Vaccines To High Safety Standards 


The FDA’s rules will indeed make it hard for a vaccine to be approved before Nov. 3 — but they’re no political ploy. They’re essential to assure the country that any shot the FDA approves quickly will be safe and effective. It’s disgraceful that, to do its job, the agency was forced to make an end run around the president. That’s hardly the FDA’s fault. Faced with a boss who often belittles them and refuses their advice without understanding it, what are the experts to do? (10/12)

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Johnson & Johnson COVID-19 vaccine trial paused by unexplained illness

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Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.

USA TODAY

Johnson & Johnson’s COVID-19 vaccine trial has been paused due to an unexplained illness in a volunteer. Now two of the four vaccine trials in the United States are now on hold.

The Phase 3 clinical trial was temporarily halted Monday, according to the company. It is not known if the unidentified illness is related to the vaccine, but clinical protocols require a pause while it is investigated.

Johnson & Johnson’s JNJ-78436735 vaccine is one of four large-scale, final-stage COVID-19 vaccine trials underway in the U.S. Another trial, run by AstraZeneca, was halted Sept. 8 after a second participant was diagnosed with a neurological condition.

Johnson & Johnson said Monday it has paused further dosing in its trial while the participant’s illness is reviewed

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I volunteered for a COVID-19 vaccine trial in New Jersey. Here’s what it’s been like since the shot.

On the afternoon of Sept. 22, I became a data point in the search for a vaccine to prevent COVID-19.

Why a vaccine for coronavirus will take longer to develop than you might think

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That’s when I received the first of two shots in a clinical trial to develop a vaccine, and became one of 30,000 volunteers to take a needlestick for science.

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Why am I doing it? A combination of altruism, curiosity, and a sense of duty as a journalist. But more on that later.

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Aside from the nurse who injected me and the hospital pharmacy that supplied her with the injection, no one else knows whether I received a placebo or the would-be vaccine. Not me. Not even Dr. Bindu Balani, the principal investigator in the

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COVID Vaccine Update as Johnson & Johnson Trial Suffers Setback, Sanofi Aims for Mid-2021 Rollout

There are currently nearly 200 potential COVID-19 vaccine candidates in development, including 42 under clinical evaluation and 151 under pre-clinical evaluation, according to a report by the World Health Organization published on October 2.



a person wearing a costume: A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi's laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.


© Joel Saget/AFP via Getty Images
A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi’s laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.

On Monday, U.S.-based Johnson & Johnson announced a pause on all of its COVID-19 vaccine candidate clinical trials due to an “unexplained illness” in one of its study participants.

French pharmaceutical company Sanofi is hoping to have its vaccine candidate rolled out by mid-next year, according to Olivier Bogillot, its chief executive officer.

“We are in a very concrete environment at the regulatory

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