Michigan Medicine, Janssen now recruiting for phase 3 COVID-19 vaccine trial

ANN ARBOR – Michigan Medicine and Janssen, a division of Johnson & Johnson, are now recruiting for a double-blind phase III COVID-19 vaccine clinical trial.

Known as the ENSEMBLE study, the trial will test an investigational vaccine to prevent COVID-19.

The University of Michigan is one of several test sites around the globe supporting the trial, which aims to enroll up to 60,000 volunteers. Researchers hope to enlist a diverse group of participants in the latest trial as part of Operation Warp Speed, a U.S. Department of Health and Human Services public/private partnership.

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“Michigan Medicine is committed to supporting the continued study of the investigational Janssen vaccine and other vaccine candidates. These trials are crucial to moving us toward an effective vaccine,” Marschall Runge, M.D., Ph.D., Dean, U-M Medical School, Executive Vice President, Medical Affairs and CEO,

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A vaccine can provide better immunity than infection, expert says

Two recent studies have confirmed that two people previously infected with SARS-CoV-2, the virus that causes Covid-19, can be reinfected with the virus.



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Interestingly, the two people had different outcomes. The person in Hong Kong showed no symptoms on the second infection, while the person from Reno, Nevada, had a more severe version of the disease the second time around. It is therefore unclear if an immune response to SARS-CoV-2 will protect against subsequent reinfection.

Does this mean a vaccine will also fail to protect against the virus? Certainly not. First, it is still unclear how common these reinfections are. More importantly, a fading immune response to natural infection, as seen in the Nevada patient, does not mean we cannot develop a successful, protective vaccine.

READ MORE: Big pharma’s safety pledge isn’t enough to build public confidence in a

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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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As Globe Gallops Into Vaccine Trials, Insurers Remain Unfazed | Top News

By Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger

LONDON/FRANKFURT (Reuters) – The world is racing towards a vaccine in record time, stirring public concerns about safety to the extent that nine leading developers have felt compelled to issue a pledge to uphold scientific standards and testing rigour.

Yet, while more than 40 experimental COVID-19 vaccines are being tested on humans, the insurance companies with decades of experience in assessing the risks of clinical trials don’t see anything to be unduly concerned about.

Executives at insurer Allianz and brokers Gallagher and Marsh, among the leading players in clinical trials insurance, told Reuters that premiums had only marginally increased so far in the current pandemic.

They argued there was little structural difference to trials carried out in the past, despite drugmakers around the world competing to shatter the fastest time in history for developing a vaccine, which stands at around four

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Baker names 17-member coronavirus vaccine advisory group

A 17-member group of doctors, public health experts, lawmakers and community activists will guide Gov. Charlie Baker’s administration on how to distribute a coronavirus vaccine — once one is available — equitably, safely and efficiently.

There are currently 11 vaccine candidates in the last phase of clinical trials testing for safety and efficacy, according to the New York Times vaccine tracker. Massachusetts’ own Moderna is currently conducting some of its trials at Brigham & Women’s Hospital in Boston. Moderna and Pfizer are leading the pack, most likely to cross the finish line to a viable vaccine first, experts have said.

The advisory group held its first meeting last week and the governor’s office said its work will build on vaccine planning that has been underway since August.

Members are working closely with leaders from the Department of Public Health and adding to the commonwealth’s state-of-the-art Massachusetts Immunization Information System, which

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How patent law and medicine regulations could affect New Zealand’s access to a COVID-19 vaccine

New Zealand has allocated an undisclosed sum, in the order of hundreds of millions of dollars, to access COVID-19 vaccines when they become available.

The funding is on top of a NZ$37 million vaccine strategy, but the government has not released specifics because of commercial sensitivities that “could prevent the best possible deal for New Zealanders”.

Apart from the intricacies of global efforts to develop, test and distribute a vaccine, there are also domestic legal issues the government might need to consider, particularly in patent law and the regulatory review of medicines.

Legislative changes to future-proof the law could avoid delays and lower access costs.

Patent law and access

Some fear pharmaceutical companies could patent a COVID-19 vaccine and hold the world hostage, demanding monopoly prices.

But to get a patent the invention has to be novel and non-obvious. There is possibly enough public information about vaccines currently under investigation

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Brazil coronavirus vaccine trials: Volunteers counter anti-vaxxers

“A two-front war,” she said.

It’s one reason the 33-year-old physician is participating in clinical trials for an experimental vaccine by the Chinese manufacturer Sinovac. It might be a chance to inoculate herself against a disease that terrified her. But it was also an opening to align herself with evidence and logic — rather than the doubts and medical falsehoods she saw proliferating across Brazil.

Brazil has long been recognized as one of the vaccine-friendliest countries in the world. It has universal health care, a strong public medical system, a population that has trusted vaccines and a history of carrying out massive and logistically challenging immunization campaigns. Yellow fever, measles and other pathogens have all been brought into submission.

That record, and a relentless coronavirus outbreak that has killed more than 150,000 Brazilians and infected more than 5 million, have made Brazil an inviting testing ground in the global race

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UK study tests if BCG vaccine protects against COVID

LONDON (Reuters) – The widely used BCG tuberculosis vaccine will be tested on frontline care workers in Britain for its effectiveness against COVID-19, researchers running the UK arm of a global trial said.

Bacillus Calmette-Guérin (BCG) vaccine, used to protect against tuberculosis, induces a broad innate immune-system response and has been shown to protect against infection or severe illness with other respiratory pathogens.

“BCG has been shown to boost immunity in a generalised way, which may offer some protection against COVID-19,” Professor John Campbell, of the University of Exeter Medical School, said.

“We are seeking to establish whether the BCG vaccine could help protect people who are at risk of COVID-19. If it does, we could save lives by administering or topping up this readily available and cost-effective vaccination.”

The UK study is part of an existing Australian-led trial, which launched in April and also has arms in the Netherlands,

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UK Study Tests if BCG Vaccine Protects Against COVID | Top News

LONDON (Reuters) – The widely used BCG tuberculosis vaccine will be tested on frontline care workers in Britain for its effectiveness against COVID-19, researchers running the UK arm of a global trial said.

Bacillus Calmette-Guérin (BCG) vaccine, used to protect against tuberculosis, induces a broad innate immune-system response and has been shown to protect against infection or severe illness with other respiratory pathogens.

“BCG has been shown to boost immunity in a generalised way, which may offer some protection against COVID-19,” Professor John Campbell, of the University of Exeter Medical School, said.

“We are seeking to establish whether the BCG vaccine could help protect people who are at risk of COVID-19. If it does, we could save lives by administering or topping up this readily available and cost-effective vaccination.”

The UK study is part of an existing Australian-led trial, which launched in April and also has arms in the Netherlands,

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BioNTech expects pre-reserved vaccine bottling capacity to be freed up

By Ludwig Burger

FRANKFURT (Reuters) – BioNTech said global capacity to bottle new COVID-19 vaccines, which is in tight supply as producers hoping to develop successful candidates book up slots, will likely be more freely available once some drop out of the race.

“If clinical trials fail or get delayed, capacity may be freed up again,” Sierk Poetting, BioNTech’s head of operations and finance, told an online news conference on Thursday.

“The (fill and finish) market is indeed very tight because everyone has reserved capacity, but I believe we will see some adjustments there once the first products are on the market,” he said.

“This is certainly a type of capacity that can be more easily transferred (than production capacity).”

More than 40 experimental vaccines are currently being tested on volunteers around the globe to combat the new coronavirus, which has claimed more than 1 million lives.

Also speaking at

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