Category: Corona Virus Vaccine

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U.S. drugmaker Merck on Tuesday said it plans to work alongside nonprofit scientific research organization IAVI to develop a potential vaccine against the coronavirus.

The news helped send Merck shares up about 3% during the premarket.

The announcement comes as drugmakers pause other clinical trials and scramble to find an antidote for Covid-19, which has infected more than 5.5 million people worldwide and killed over 346,000.

Most experts agreecould take 12 to 18 months to roll out a safe vaccine to the market. And, even if an effective vaccine becomes available, many have warned of significant logistical challenges around distributing enough doses for the global population.

In a statement, Merck and IAVI said their vaccine candidate would use the recombinant vesicular stomatitis virus technology that is the basis for its Ebola Zaire virus vaccine which was the first rVSV vaccine approved for use in humans.

Ebola Zaire is one of six known species within the genus Ebola virus, an acute deadly illness. The virus causing the current outbreak in the Democratic Republic of Congo, and the 2014 to 2016 West African outbreak, belongs to the EbolaZaire virus species, according to the World Health Organization.

Designed and engineered by IAVI scientists in New York, the vaccine candidate for Covid-19 is in preclinical development. Clinical studies are expected to start this year.

If approved, Merck said both organizations would work together to develop the vaccine and "make it accessible and affordable" worldwide.

Last month, WHO Director General Dr. Tedros Adhanom Ghebreyesus said it was important that, when a vaccine is ready, it could be equitably distributed across the globe.

"There should not be a divide between the haves and the have-nots," he stressed.

President Donald Trump has voiced ambitions for a vaccine to be developed and distributed by the end of 2020, in a project called "Operation Warp Speed."

However, medical experts including Dr. Anthony Fauci, the U.S. government's top infectious disease expert have cast doubt on Trump's goal, expressing skepticism over the time frame.

Dr. Mark Feinberg, IAVI president and CEO, said the rVSV-based vaccine strategy represented a "promising approach to combating the novel coronavirus pandemic."

Merck and IAVI said the rVSV vaccine platform uses an attenuated strain of vesicular stomatitis virus, a common animal virus that has been modified to express proteins that stimulate an immune response.

The plan, they continued, was to "leverage experience" gained with this platform during the development of Merck's rVSV-based vaccine for Ebola Zaire.

Separately, Merck said it plans to acquire privately held Themis, a company focused on vaccines and immune-modulation therapies for infectious diseases and cancer, foran undisclosed cash payment.

Upon completion of the deal, Themis would then become a wholly owned subsidiary of Merck.

Watch Merck CEO Ken Frazier in an exclusive interview on CNBC at 4 p.m. ET.

CNBC's Chloe Taylor contributed to this report.

Excerpt from:

Merck in collaboration to develop coronavirus vaccine, with clinical trials to start this year - CNBC

Care home operators have warned that easing Covid-19 shielding restrictions for 2.2 million vulnerable people risks a second wave of infections, as it emerged that government scientific advisers who previously warned against such a move were not asked to reconsider the matter.

New guidance allows the clinically extremely vulnerable to go outside and, if they live alone, meet one friend from Monday. They include many in long-term care facilities for elderly people, as well as those with chronic illnesses living at home.

Strict isolation rules were expected to stay in place for at least another two weeks. The governments Scientific Advisory Group for Emergencies (Sage) warned in April that lifting the policy of shielding the vulnerable would lead to a sharp increase in hospitalisation, ICU admissions, and the death rates within this age group.

The new guidelines say shielded people can now leave their home if they wish, as long as they are able to maintain strict social distancing. If you choose to spend time outdoors, this can be with members of your own household. If you live alone, you can spend time outdoors with one person from another household.

The sudden relaxation of the rules this weekend appeared to surprise many health officials. NHS Englands primary care medical director, Nikki Kanani, indicated on Twitter that she was not told in advance.

Local directors of public health also said they were not forewarned, with one telling the Guardian they were mystified by the change, adding: The lack of information sharing is appalling. Another said: We were led to believe during the week any change would be at the end of June, once we were more reassured about the infection rate.

Nadra Ahmed, executive chairman of the National Care Association, said the loosened restrictions could bring the virus back into care homes still struggling to contain the first wave of infection, which has caused about 15,000 deaths.

How do we guarantee that the person coming to visit is Covid-free? said Ahmed. We cant. The only way we could deal with it is by isolating the resident when they come back in and testing them, but with tests still not available to many care homes, how would we be able to do that? This is inviting a virus back into the service that a lot of care homes have worked very hard to eradicate.

Asked on Monday whether the loosening of the rules for the shielding group had been discussed at Sage, Boris Johnsons official spokesman said there had been engagement with GPs, the British Medical Association and patient groups, but that the new guidance was approved by the deputy chief medical officers and Public Health England. It is understood that Sage experts were not asked to examine the issue again or submit any new evidence before the surprise change in guidance.

Many people vulnerable to Covid-19 have complained of the mental strain and loneliness of shielding, which has prevented them from going out sincelockdown measures were imposed 10 weeks ago.

Charities representing some shielded groups last Friday warned the government: As restrictions are eased for the rest of the country, the burden on those who are being asked to stay inside or away from people will become harder to bear.

Macmillan Cancer Support, the British Lung Foundation and Asthma UK, the MS Society, Kidney Care UK and the Cystic Fibrosis Trust were among those who said they were deeply concerned about the impact on the mental health of those who are shielding. Steven McIntosh, policy director at Macmillan, said the new guidance was a step forward for a group who have felt left behind and forgotten as lockdown eases.

The Relatives and Residents Association, which represents families in social care, had also called for a rethink of the shielding measures. We know some people are getting isolated and lonely and particularly for people with dementia it can be hard to understand why that has happened, said Helen Wildbore, the director of the charity. We have heard about people who have stopped eating and drinking and have lost speech.

But with many care homes focused on stopping a second wave of infection and currently restricting residents movements by agreement, Prof Martin Green, the executive director of Care England, said the new guidance will create a tension, with people saying, We have seen the announcement, so why cant I take my relative out?.

He said his members had not been consulted and that the sudden announcement was a typical example of making an announcement and publishing guidance later. They should publish the scientific advice on why this was done and they need to publish specific guidance for care homes.

On Thursday, the prime minister gave no inkling of the lifting of restrictions, telling the Downing Street press conference: I am afraid that those who have been asked to shield themselves should continue to do so.

The housing and communities secretary, Robert Jenrick, said the government was trying to find the right balance between continuing to protect those at the greatest clinical risk, whilst easing restrictions on their daily lives to make the difficult situation more bearable particularly enabling the contact with loved ones they and we all seek.

Pressed on the timing of the announcement and the lack of advance notice for GPs, Matt Hancock, the health secretary, insisted that it had been very well received by those who are shielded.

It hasnt been rushed through, far from it, he said. Weve worked for some time to make sure any changes we make small, cautious changes can benefit people in a safe way. Being able to make changes like this is important for people. Its quite hard to imagine for even those of us practising self-isolation to understand the impact of shielding.

Once wed made the decision in collaboration with all of the government bodies, we communicated the decision, and that was the right time to be able to change that advice.

A Department of Health and Social Care spokesperson said on Monday:We have engaged extensively with partners and the healthcare system throughout this process and will continue to do, particularly in the next two weeks, when more substantive measures are considered. The announcement yesterday signalled this period of engagement.

We want to make life easier for the most vulnerable and, as the number of Covid-19 cases continues to fall, the evidence shows those shielding can choose to spend time safely outside if they wish, as long as they follow social distancing guidelines.

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Easing Covid-19 shielding in England 'risks second wave' - The Guardian

At the protest outside City Hall in support of George Floyd on Saturday, people were spaced more than 6 feet apart the recommended minimum for reducing the spread of the coronavirus. Most wore masks.

Could the protests here and elsewhere lead to a spike in COVID-19 cases? How about other recent outdoor events with large clusters of people, such as a Lake of the Ozarks pool party in Missouri on Memorial Day weekend?

The answer in either case will not be known for days, as symptoms from any new infections might not show up until two weeks after exposure.

There is one reason for cautious optimism: The events took place outside. Research to date suggests the coronavirus is far more likely to spread indoors, especially in poorly ventilated spaces.

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Yet Philadelphias own history suggests the open air is no guarantee. In 1918, a spike in deaths from influenza has been attributed to a parade that drew more than 200,000 attendees along Broad Street.

Joel Hersh, former director of the bureau of epidemiology at the Pennsylvania Department of Health, is among those worried that history may repeat itself.

The odds are not good that you would escape all these demonstrations without having somebody be positive, he said. I think its another disaster waiting to happen.

Should someone at any mass event later test positive, public health officials will have difficulty notifying individuals who may have been exposed, he said.

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Will the protests cause a spike in COVID-19 cases? Wait two weeks. - The Philadelphia Inquirer

Dr. Slaouis had an extensive web of financial interests, faces potential conflicts of interest, and should resign all drug and biotech board seats, U.S. Sens. Bob Menendez (D., N.J.), Elizabeth Warren (D., Mass.), and nine other Democratic colleagues urged in a letter to the White House. Slaoui should also disclose ties to firms making COVID-19-related products, and divest holdings in such firms, the senators wrote.

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Is a former GSK pharma exec from Phillys Main Line the right czar to speed the nations coronavirus vaccine? - The Philadelphia Inquirer

The first phase of the trial will test whether the therapy is safe and well-tolerated; those results are expected in late June. The first Covid-19 patients being treated with the therapy are hospitalized at New York University's Grossman School of Medicine in New York, Cedars-Sinai in Los Angeles and Emory University in Atlanta, the company told CNN.

If the trial ultimately shows the treatment is effective against Covid-19, it could be available by autumn, according to the Indianapolis-based company.

Scientists at AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases selected those they thought would be most potent and Lilly scientists engineered the treatment, known as a monoclonal antibody therapy. This approach has worked to treat other illnesses; there are monoclonal antibody therapies that treat HIV, asthma, lupus, Ebola and some forms of cancer.

It's not clear if such a therapy will work against Covid-19, but when this treatment was used on on cells in the lab, it blocked the ability of the virus to infect the cells, Skovronsky said. The data is not yet published, but based on those results, scientists got the green light to take the next step and prepare it to be tried in patients.

They also gave it a temporary name.

"We call it LY-CoV555, lucky triple 5," Skovronsky said.

Manufacturing has already begun

This will be a randomized, placebo-controlled, double-blind Phase I trial. Some patients will be receive the medicine and some will receive a placebo, and patients or their doctors won't be informed who received it and who didn't.

If the treatment appears to be safe, the company would move to the next phase of testing in a matter of weeks. The second phase of the trial will involve a larger number of patients, including patients who are not hospitalized, and will test whether the therapy is effective.

The company also plans to study the drug as prevention. The treatment could be used for vulnerable patient populations for whom vaccines might not be a great option, such as the elderly or people who have chronic disease or compromised immune systems.

Eli Lilly has already begun manufacturing the antibody therapy in large quantities so it could be tested and potentially for use in patients beyond the trial. Under non-pandemic circumstances, the companies would usually wait to find out if it worked first before it started making it.

"If it does work, we don't want to waste a single day, we want to have as much medicine as possible available to help as many people quickly," Skovronsky said.

In trials over the next several months, Lilly says it will test different mixtures of a few of the other antibodies scientists think might provide protection. The optimal scenario, though, Skovronsky said, is if they only need one antibody at a relatively low dose.

"The more antibodies are mixed together, higher doses, the more difficult it is to manufacture," Skovronsky said. "But if it has to be two antibodies, higher doses, or even three antibodies mixed together at higher doses, we'll do whatever it takes to make effective medicine for patients."

Other antibody therapies in development

Eli Lilly isn't the only company working on antibody treatments. Several US teams have cloned antibodies to Covid-19 and many are close to testing in patients. Regeneron Pharmaceuticals has said it hopes to start human trials this month and to have a treatment by the end of the summer.

"This approach definitely has promise and it is something we need," said Dr. Peter Hotez, a vaccine specialist at Baylor University School of Medicine who is not involved in this research. He said the challenge with Covid-19 is that there are two phases to the disease -- the initial viral infection phase and then the host response, or the inflammatory response. Generally, a treatment like this is more likely to be effective if a patient gets it early in the course of the illness, when the virus is still replicating.

"That's always the problem with treating Covid-19 with monoclonal antibodies -- if you wait until things are pretty far along, like including patients that are already on the ventilator, it may not have any clinical impact," Hotez said.

If it works though, it could also be useful if, for example, a patient in a nursing home tested positive for Covid-19, and such a treatment could be given to others at the facility; for a first responder that had just been exposed to a patient with Covid-19; or for health care workers, Hotez said.

One challenge Hotez noted: Monoclonal antibody therapies tend to be "pretty expensive," he said.

Typically, such treatments would take many years to develop, but Covid-19 treatments are on an accelerated schedule. Pharmaceutical companies have said that government approvals that normally take weeks have sometimes come within a day.

"It's really been a privilege to be able to operate in this kind of environment," Lilly's Skovronksy said. He said he and others in the pharmaceutical industry have wondered if the same collaboration and urgency could be applied to treatments for other diseases like cancer or Alzheimer's.

"For many of us, this feels a little like a moonshot or a Manhattan Project, where so many scientists are working together at breakneck speeds," Skovronksy said. "Surely there will be other advances that come of this."

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First human trial of potential antibody treatment for Covid-19 begins - CNN

HARRISBURG, PA At the request of Republican members from the southeast region of Pennsylvania, $10 million from the federal Coronavirus Aid, Relief and Economic Security (CARES) Act has been approved by the Pennsylvania House of Representatives to go to entities across the state working on research and development of a coronavirus vaccine, such as Wistar Institute in Philadelphia.

Members of the delegation, including Reps. Marcy Toepel (R-Gilbertsville), Stephen Barrar (R- Chadds Ford), Frank Farry (R-Langhorne), Tim Hennessey (R-Pottstown), John Lawrence (R-West Grove), Tom Murt (R-Hatboro), Todd Polinchock (R-Chalfont), Chris Quinn (R-Middletown), Meghan Schroder (R-Warminster), Craig Staats (R-Quakertown), Todd Stephens (R-North Wales), Wendi Thomas (R-Richboro), K.C. Tomlinson (R-Bensalem) and Martina White (R-Philadelphia), issued the following statement:

One of the most essential steps in the process on battling COVID-19 is the development of a vaccine. Here in Philadelphia, Wistar is a world leader in biomedical research in both immunology and infectious disease and is already in phase one of its DNA vaccine trials to combat the virus. They are working closely on this project with the Pennsylvania-based pharmaceutical company Inovio, located in Plymouth Meeting.

Pennsylvania has a long and proud history of being home to some of the most highly regarded medical research hospitals and institutions. This funding will provide the financial support needed for Wistar to continue its research and hopefully discover a safe and effective vaccine quickly that will help millions of people around the globe.

We were happy to advocate for this funding and look forward to learning more about the advancements in developing a coronavirus vaccine.

Thanks for visiting! MyChesCo brings reliable information and resources to Chester County, Pennsylvania. Please consider supporting us in our efforts. Your generous donation will help us continue this work and keep it free of charge. Show your support today by clicking here and becoming a patron.

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Southeast Republican House Members Work to Secure $10 Million for COVID-19 Vaccine Research and Development - MyChesCo

CAMDEN COUNTY, Mo. -- The Camden County Health Department said Friday a Boone County resident who has tested positive for COVID-19 visited the Lake of the Ozarks during Memorial Day Weekend.

According to Health Director Bee Dampier, the case arrived at the Lake on Saturday and started showing symptoms on Sunday. Dampier said it is likely COVID-19 was incubating illness during that person's visit.

"Due to the need to inform mass numbers of unknown people, we are publicly releasing the following timeline, which was provided by the case," Dampier said in a news release.

On Saturday, May 23, the positive case visited Backwater Jacks between 1 and 5 p.m. Then, they went to Shady Gators and Lazy Gators Pool from 5:40 to 9 p.m.

From Shady Gators, the case went back to Backwater Jacks from 9:40 to 10 p.m.

On Sunday, May 24, the case had lunch at Buffalo Wild Wings in Lake Ozark from 1 to 2 p.m., went to Shady Gators from 2:30 until around 7 p.m., then got a cab from Shady Gators to a private home.

The public who may have been in these places is asked to please monitor for symptoms: fever, cough, shortness of breath, body aches, headache, nausea, vomiting, diarrhea, loss of taste or smell.

If you develop symptoms, you're asked contact your physician, and isolate until test results are known.

Backwater Jacks, along with several other Lake of the Ozarks pool bars made national headlines after videos and photos of large crowds not following social distancing orders.

There have been no cases reported in Camden County residents this week.

Continued here:

A positive COVID-19 case from out of the area visited the Lake of the Ozarks pool bars on Memorial Day Weekend - KY3

The incident happened on Thursday when a lab assistant working with the Covid-19 facility of the hospital was carrying blood samples due for testing, Dr Dheeraj Baliyan, medical superintendent of Lala Lajpat Rai Memorial Medical College and Hospital, told CNN.

The monkeys attacked the lab assistant and stole the sample box with three samples, added Baliyan.

The monkeys climbed the trees with the samples and threw them after chewing the packets, Baliyan added.

The medical superintendent confirmed to CNN that no individual came into contact with the samples, and the hospital authorities have sanitized the area and disposed of the samples snatched by the monkeys.

The district administration has ordered an inquiry against the hospital authorities for alleged mishandling of the samples.

According to India's health ministry, the total number of coronavirus cases in the country as of Friday stands at 165,799, including 4,706 deaths.

CNN's Amy Woodyatt contributed to this report.

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Monkeys snatch blood samples of suspected Covid-19 patients in India - CNN

Chinese scientists working on a COVID-19 vaccine have told Sky News they are "99%" sure it will be effective.

Sinovac, a Beijing-based biotech company, currently has its coronavirus vaccine in stage 2 trials, with more than 1,000 volunteers participating. Sky News is the first British broadcaster to visit its labs.

The company also said it is in preliminary talks to hold stage 3 trials - the final part of the trials process - in the UK.

Sky News asked Luo Baishan, a researcher at Sinovac, whether he thought the vaccine would be successful.

"Yes, yes. It must be successful 99% [sure]," he replied.

Last month Sinovac published results in the academic journal Science which showed the vaccine, called CoronaVac, protects monkeys from infection by the coronavirus.

The biggest problem the company faces is the low number of COVID-19 cases in China, which makes testing the vaccine in an epidemic situation difficult. As a result, the company is looking further afield for stage 3 trials.

Helen Yang, senior director of investor relations, told Sky News: "We are speaking to several European countries and I think did discuss with the UK as well.

"Currently it's a very preliminary stage for the discussion."

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The company is pressing ahead with production, though, even as it continues research.

In the company's headquarters in northwest Beijing, orange and white packets are already ready to go.

The aim of parallel tracks is that mass production of the vaccine can begin straight away, if the trials are successful and the vaccine gets regulatory approval.

It is currently building a commercial plant in another part of Beijing with the objective of delivering 100 million doses.

That number, large as it is, means limiting who gets the vaccine.

"It is our recommendation that it is not the whole population that gets the vaccine," Ms Yang told Sky News.

"We are discussing this and recommending it to other countries as well.

"We are firstly targeting high-risk groups, for example, health workers or senior citizens, who may have a higher level of fatality rate. I think that will be the starting point. To be frank, the vaccine needs to be produced lot by lot."

And the vaccine won't be here soon. The stage 2 trials have months to run before Stage 3 can begin, Ms Yang pointed out, and then the vaccine requires regulatory approval.

Asked whether she was sure of success, Ms Yang told Sky News: "It's very hard to say, very difficult to say at the moment. There are uncertainties, but the data: so far, so good."

There is a global race to come up with a COVID-19 vaccine - but questions remain about how it would be distributed, and whether countries should prioritise their own populations.

Drugmaker AstraZeneca, which is working with researchers at Oxford University, said the UK would be the first country to get access to the vaccine it is developing.

Chinese President Xi Jinping has pledged that any Chinese vaccine would be a "global public good", even though the practical results of that are unclear. EU leaders have made a similar commitment, but US President Donald Trump has not.

Ms Yang told Sky News: "We are already considering not only China but also the whole world, not only for conducting a trial but also how to supply a solution for countries including China and outside China."

Next week from Monday to Thursday, Dermot Murnaghan will be hosting After the Pandemic: Our New World - a series of special live programmes about what our world will be like once the pandemic is over.

We'll be joined by some of the biggest names from the worlds of culture, politics, economics, science and technology. And you can take part too.

If you'd like to be in our virtual audience - from your own home - and put questions to the experts, email afterthepandemic@sky.uk

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Coronavirus: 99% confident that COVID-19 vaccine will work, says Chinese firm - Sky News

Say goodbye to the office water cooler U.S. offices that reopen this year will likely undergo substantial changes to prevent the spread of COVID-19, according to new guidelines released by the Centers for Disease Control and Prevention (CDC).

The guidelines recommend offices take a number of steps to help keep workers safe.

These include conducting daily temperature screenings and symptom checks before workers enter the office, requiring employees to wear face coverings in all areas of the work space, moving workstations to keep employees at least 6 feet apart, placing markings on the floor to facilitate social distancing and installing transparent "shields" in places where social distancing is not an option.

What's more, office perks such as coffee pots, water coolers and snack bins should be removed and replaced with pre-packaged and single-serving items, the agency said. And in addition to frequent office cleanings, employees should be provided with disposable wipes to wipe down frequently touched surfaces before use.

Related: Coronavirus outbreak: Live updates

Ventilation in the office should also be improved, for example, by opening windows when possible and increasing air filtration.

And after years of encouraging workers to take public transportation or carpool, the CDC is now recommending employers do the opposite. Workers should be encouraged to commute to work alone, and employers should offer incentives for this commute, such as reimbursements for parking and flexible work hours so employees can commute at less busy times.

Finally, handshakes, hugs and fist bumps should be prohibited.

Some businesses have already announced plans for gradually reopening their offices. For example, Google recently announced plans to open offices on a limited basis in July, keeping buildings at 10% occupancy, and growing to 30% occupancy by September, according to CNN. On the other hand, some offices are not rushing to reopen Twitter recently told its employees that they could work from home forever if they want, according to the BBC.

Originally published on Live Science.

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Here's what office life could look like amid COVID-19, according to new CDC guidelines - Live Science