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Experimental Vaccine

Experimental J&J vaccine protects monkeys in a single dose-study – Yahoo Finance

By Julie Steenhuysen

CHICAGO, July 30 (Reuters) – Johnson & Johnson on Thursday kicked off U.S. human safety trials for its COVID-19 vaccine after releasing details of a study in monkeys that showed its best-performing vaccine candidate offered strong protection in a single dose.

When exposed to the virus, six out of six animals who got the candidate vaccine were completely protected from lung disease and five out of six were protected from infection as measured by the presence of virus in nasal swabs, according to the study published in the journal Nature.

“This gives us confidence that we can test a single-shot vaccine in this epidemic and learn whether it has a protective effect in humans,” Dr. Paul Stoffels, J&J’s chief scientific officer, told Reuters in a telephone interview.

The U.S. government is backing J&J’s vaccine effort with $456 million in funding as part of a spending spree aimed at speeding production of a vaccine to end the pandemic, which has infected millions and killed more than 660,000 people.

Stoffels said prior tests of this type of vaccine in other diseases found that a second shot significantly increases protection. But in a pandemic a single-shot vaccine has a significant advantage, sidestepping a lot of the logistical issues involved in getting people to come back for their second dose.

The company plans to take up the question of one or two doses in its phase 1 trial, which kicked off this week in the United States.

Depending on those results, J&J plans to start large-scale, phase 3 testing with a single-shot regimen in the second half of September. Around the same time, the company will start a parallel phase 3 study testing a two-shot regimen of the vaccine, Stoffels said.

J&J’s vaccine uses a common cold virus known as adnovirus type 26 or Ad26 to ferry coronavirus proteins into cells in the body, causing the body to mount an immune defense against the virus.

In the monkey study, scientists from J&J and Harvard’s Beth Israel Deaconess Medical Center studied seven different potential vaccines in 32 animals and compared the results to 20 control animals who got placebo shots.

Six weeks later, all of the animals were exposed to the SARS-CoV-2 virus. All 20 animals that received the placebo developed high levels of virus in their lungs and nasal swabs.

In the best-performing candidate, which J&J selected for human testing, none of the animals had virus in their lungs and only one showed low levels of virus in nasal swabs. Lab tests showed they all had developed antibodies capapable of neutralizing the virus after a single shot.

“This study shows that even just a single immunization with the Ad26 vaccine leads to neutralizing antibody responses and robust protection of monkeys against COVID-19,” said Dr. Dan Barouch, a vaccine researcher at Beth Isreal Deaconness who led the research in collaboration with J&J.

(Reporting by Julie Steenhuysen; editing by Richard Pullin)

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Coronavirus Vaccine

Who should get a coronavirus vaccine first? – The Washington Post

Discussions have begun to identify priority groups for initial vaccination against covid-19, the disease caused by the virus. Those discussions, involving federal health officials and outside experts, are based on planning developed during the 2009 H1N1 influenza pandemic. The highest priority would go to health-care and essential workers and high-risk populations. This proposed group would also include older adults, residents of long-term-care facilities and people with underlying medical conditions.

A federal advisory panel that provides vaccine recommendations to the Centers for Disease Control and Prevention presented an overview of the priority groups last month and met again Wednesday to discuss the issue.

As officials and experts race to stop the pandemic, they are grappling with the fraught nature of establishing vaccination priorities. Clinical trials of at least two experimental vaccines have shown encouraging results and this week moved into final-stage testing for safety and effectiveness in 30,000 participants. U.S. officials have said that if a vaccine is shown to be effective, the first doses could be available by the end of the year.

The decision-making will take place over the next few months and is certain to be controversial, experts said. Officials and experts must address a host of issues, including how much consideration should be given to race and ethnicity because of the disproportionate effect of covid-19 on communities of color. Aside from doctors and nurses, will cafeteria workers and cleaning staff at hospitals be considered essential personnel? What about teachers who keep schools running so parents and others can go back to work?

“This is going to be controversial and not everybody’s going to like the answer,” said Francis Collins, director of the National Institutes of Health, referring to the process of establishing priorities. He spoke last week at the kickoff meeting of a committee of experts helping with planning. “There will be many people who feel that they should have been at the top of the list, and not everybody can be.”

That committee of experts is developing a framework to help the federal advisory panel and the CDC set final vaccination priorities. The experts are from an independent advisory group, the National Academies of Sciences, Engineering and Medicine, and from the National Academy of Medicine. The panel, which is supposed to have an initial draft ready by the end of August and a final version by the end of September, was formed at the request of the directors of NIH and CDC.

The overview of proposed priority groups laid out by the federal advisory panel includes subsets within those that should get the highest consideration. At the top of the list: an estimated 12 million critical health-care and other workers. The first doses would go to a subset described as the “highest-risk medical, national security and other essential workers” needed to protect health-care infrastructure and critical societal functions, according to presentations and discussions at the June meeting of the Advisory Committee on Immunization Practices.

But what’s at stake goes beyond allocation of the first shots. The process of identifying priority groups is a chance for health officials and scientists to adjust sometimes-unrealistic expectations about when a vaccine is likely to be available.

It is also an opportunity to reset public trust in government and institutions at a time when “there is a profound sense of people feeling they are not being protected by the people and institutions that are supposed to protect them,” said Monica Schoch-Spana, a medical anthropologist at the Johns Hopkins Center for Health Security. She co-chaired a working group that recently released a report on covid-19 vaccination.

“We have a socially, politically and racially fragmented society that is under the stress of a disease that causes illness and death. And we’ve seen an uneven — I’m being polite — response to it,” Schoch-Spana said. “If there was ever a time when public perception of fairness and justness was important, that would be now.”

Top federal officials need to make sure the public is hearing a clear and consistent message and show the government is able to keep its promises, Schoch-Spana said. During the 2009 H1N1 pandemic, there were overly optimistic projections of vaccine supply during the second wave of the disease in October, when demand was high. By the time an adequate supply of vaccine arrived, demand had fallen.

In addition to essential workers and those most affected by health disparities, Collins said a priority list should include the military and locations where the virus is most active. He said the committee should consider giving priority to volunteers in vaccine clinical trials who received a placebo instead of a vaccine dose.

“I think probably we owe them as a consequence of their participation in the trial some special priority in terms of access to the vaccine if it’s proven to be successful,” Collins said.

During Wednesday’s meeting of the CDC’s Advisory Committee on Immunization Practices, the discussion about priority groups focused on essential workers, including health-care personnel. At the next meeting in August, the committee is planning to review considerations for other high-risk groups, including people in long-term care facilities.

Workers at greatest risk for exposure to infectious diseases fall into six categories, according to a presentation by Sarah Mbaeyi, a medical officer at CDC’s National Center for Immunization and Respiratory Diseases:

· Health-care support (home health aides and medical assistants)

· Health-care practitioners (doctors, dentists, nurses and pharmacists)

· Protective service (police officers and firefighters)

· Personal care and service (child-care workers, barbers and fitness trainers)

· Community support (social workers, probation officers and health educators)

· Education, training and library (K-12 teachers and librarians)

People of color are more likely to work in jobs deemed essential or with increased risk of disease exposure, she said.

She also provided greater detail about risks facing health-care personnel. CDC uses a broad definition that includes people not involved in direct patient care: clerical, dietary, environmental services, laundry, security, maintenance, engineering and facilities management, administrative billing and volunteer personnel.

Citing a recent study of risk for severe covid-19 illness among health-care personnel, Mbaeyi said 39 percent have a high-risk medical condition or are older than 65. Those who work in support roles, such as medical assistants or home health aides, or others with less than a bachelor’s degree, have the highest rates of underlying conditions. These groups in general, she said, also have a higher proportion of workers who are African American, Latinx, uninsured or have lower incomes.

One committee member, Paul Hunter, an associate professor of family medicine at the University of Wisconsin School of Medicine and Public Health, offered this summary: “If I was looking at the data correctly, if you’re a middle-aged-to-older African American female medical assistant with diabetes and hypertension, it looks to me like you’re on top of the list to get the vaccine.”

Consideration of race or ethnicity as a criteria for vaccine prioritization has drawn considerable discussion.

At the June meeting, Jose Romero, a pediatric infectious-disease specialist at Arkansas Children’s Hospital Research Institute who chairs the CDC immunization committee, spoke of Black, Latinx and Native American communities hit hard by the coronavirus. The covid-19 death toll is twice as high among people of color younger than 65 as for White Americans, according to a recent CDC report.

“If we fail to address this issue of racial and ethnic groups as a high risk in prioritization, whatever comes out of our group will be looked at very suspiciously and with a lot of reservation,” he said.

Another committee member, Sharon Frey, an infectious-disease specialist at Saint Louis University School of Medicine, agreed that it was important to include racial and ethnic groups in a high-priority group. Consideration should be given to the urban poor and working poor who often have other underlying medical conditions, live in crowded homes and can’t take off work “because they have to bring money home to feed their families,” Frey said.

Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, said Wednesday that racial and ethnic disparities have long existed in routine immunization coverage for adults, with much lower vaccination rates among Blacks and Hispanics.

“The current social situation likely exacerbates the issues that surround this lower vaccine coverage,” she said. “As we start planning for immunization with covid, we need to be mindful that this is a starting place, and we need to take seriously that we need novel and more robust strategies to increase uptake of the covid vaccine once it becomes available.”

Re

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Vaccine Virus

Virus vaccine put to final test in thousands of volunteers – FOX 11 Los Angeles

The world’s biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the U.S. government — one of several candidates in the fin…
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Moderna Vaccine

Moderna Vaccine Results Spark Stock Rally – MSN Money

© (Maddie Meyer/Getty Images)
CAMBRIDGE, MASSACHUSETTS – MAY 08: A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts. Moderna was given FDA approval to continue to phase 2 of…
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COVID Vaccine

COVID-19 vaccine program to start production by late summer – US official – The Jerusalem Post

The US government has given grants ranging from several hundred million dollars to over $1 billion to Johnson & Johnson, Moderna Inc, AstraZeneca Plc and Novovax Inc.

By REUTERS
 

JULY 14, 2020 01:56

Bottles labeled

Bottles labeled “Vaccine” stand near medical syringe in front of “Coronavirus COVID-19” display (illustrative)

(photo credit: REUTERS/DADO RUVIC/ILLUSTRATION/FILE PHOTO)

Drugmakers partnered with the US government are on track to begin actively manufacturing a vaccine for COVID-19 by the end of the summer, a senior administration official said on Monday.

“If you say exactly when will literally the vaccine materials be in production and manufacturing, it is probably four to six weeks away, but we will be actively manufacturing by the end of summer,” the official, who declined to be identified by name, said.

He added that the administration is already working with companies to equip and outfit manufacturing facilities and acquire raw materials.

The Trump administration has helped finance the development of four COVID-19 vaccines so far though its Operation Warp Speed Program, which aims to produce 300 million vaccine doses by the end of 2021.

The US government has given grants ranging from several hundred million dollars to over $1 billion to Johnson & Johnson, Moderna Inc, AstraZeneca Plc and Novovax Inc.

It also signed a $450 million contract earlier this month with Regeneron Pharmaceuticals Inc to help it supply therapies for patients who are sick with the virus.

Clinical trials for therapeutics can produce results in a matter of weeks, making it possible to produce hundereds of thousands of doses by fall, the senior administration official said.

“While we think is fair to say that vaccine progress is occurring at warp speed pace, faster than any vaccines have been developed in history, therapeutics are even faster,” the official said.

The “slate is not closed” for additional funding agreements and the administration plans to announce more in the future, the official said.

The novel coronavirus has infected more than 3 million people in the United States and killed more than 130,000.

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Coronavirus Vaccine

A coronavirus vaccine rooted in a government partnership is fueling financial rewards for company executives – Charleston Gazette-Mail

As shares of biotech firm Moderna soared in May to record highs on news that its novel coronavirus vaccine showed promise in a clinical trial, the nation’s senior securities regulator was asked on CNBC about news reports that top executives had been selling their stock in the company.

Jay Clayton, chairman of the Securities and Exchange Commission, responded that companies should avoid even the appearance of impropriety. “Why would you want to even raise the question that you were doing something that was inappropriate?” he said.

Notwithstanding Clayton’s statement, there is little public evidence that company leaders slowed their stock selling. Now, corporate governance experts and some lawmakers say the trades could cast a shadow over Moderna, one of the biopharmaceutical industry’s most remarkable stories. The questions come as the 10-year-old company is leading the race in the United States for a coronavirus vaccine — a feat rooted in a government partnership formed years ago that could change the path of a disease afflicting the world.

In total, seven corporate executives and board members as well as a venture capital fund run by Moderna’s board chairman collectively sold almost $101 million following Clayton’s comments. The trades were part of more than $200 million in sales by insiders since Moderna announced Jan. 21 that it was pursuing a vaccine in partnership with the National Institutes of Health. That’s according to an analysis of SEC filings that the national executive compensation research firm Equilar performed at the request of The Washington Post — the first such comprehensive examination of the company’s stock sales this year.

Insiders selling included Moderna Chief Executive Officer Stéphane Bancel, Chief Financial Officer Lorence Kim and Chief Medical Officer Tal Zaks. The trades were preprogrammed, according to the company’s required public disclosure filings, meaning they were made in accordance with a predetermined schedule or triggering event such as a share-price threshold. Moderna said it will not disclose any details of the preprogrammed trading rules for its executives.

On May 21 and 22, the co-founder and chairman of the company, Noubar Afeyan, reported selling $68 million worth of stock held by Flagship Pioneering, the venture capital fund he founded that is Moderna’s largest shareholder. Afeyan did not sell any of his personal stock holdings in Moderna, according to Flagship and public filings. These trades were not preprogrammed, according to the company’s public disclosures.

Moderna’s stock rose by 200 percent from January to June — as company news releases and news reports described early progress in its quest for a vaccine. In May, it was up as high as 300 percent after the release of the results of the clinical trial. The company made a public offering of stock on May 18 at the very peak of its share value.

Federal securities law requires officers, directors and large shareholders of publicly traded companies to report their trades in company stock to the SEC. Companies typically prohibit sales of stock by executives for 180 days after the initial public offering, specialists said.

The very first insider stock sales reported at Moderna occurred infrequently last fall, with the first in September 2019, 10 months after the company went public in a record-setting IPO in December 2018. Bancel began routinely selling shares starting in the fourth quarter of 2019 under his preprogrammed plan. The pace of selling picked up among Moderna’s other executives in 2020, according to the public filings.

“Executive sales are made under preplanned 10b5-1 plans, which are entered into during open trading windows in accordance with the company’s insider trading policy,’” said company spokesman Ray Jordan in an email. “As a matter of practice, Moderna does not intend to comment on any alleged or potential litigation or investigation; nor on purchases or sales by individual executives, investors or groups.”

Moderna did not make company officials available for interviews.

Bancel has a “long-term commitment to Moderna and to the development of the … technologies being developed by the company,” which he joined as its second employee nine years ago, Jordan added. “He has liquidated a small portion of his holdings each month through a planned 10b5-1 selling program. … Substantially all of his family’s assets remain invested in Moderna.”

The company has nearly 150 employees who operate under 10b5-1 plans, he added.

Flagship spokesman Gregory Kelley said in an email that the fund’s stock sales, which were not preprogrammed, “were made in accordance with [Moderna’s] policies and during an open trading window as determined by [Moderna’s] general counsel.”

Experts in securities law say the rules for preprogrammed stock trading plans are ambiguous enough that executives could gain unfair advantages, particularly when it comes to their control over the timing of release of market-moving data, and deserve scrutiny. The sales at Moderna in May raise potential concerns, the experts said.

“All of the activity in the days leading up to the announcement and the offering, and the days following the announcement, are ripe fodder for SEC investigation,” said Jacob Frenkel, a former top SEC investigator now in private practice as chair of government investigations and securities enforcement at the law firm Dickinson Wright. Frenkel said a likely subject of scrutiny would be what policies Moderna has for “blackouts” on executive trades during major news events and whether such policies were followed. The company said blackout dates are included in its insider trading policies, but the dates are not public.

The SEC said it would not comment. The agency typically does not publicly disclose whether it is investigating a company.

Nell Minow, an expert in corporate governance and vice chair at ValueEdge Advisors, said it is inadvisable for Moderna’s corporate insiders to be selling stock, particularly in the midst of major news about its leading product.

“It can send the market a signal that is opposite to all of the positive things that they are trying to communicate,” she said. “By definition, it is very concerning.

“Whether it is preprogrammed or not, it’s hard to believe that anybody who thought the company was going to be tremendously successful with this vaccine would be selling,” Minow said.

Harvey Pitt, a former SEC chairman who now heads Kalorama Partners, told CNN in May that the timing of the trades was “highly problematic” and that the SEC should review communications inside the company to find out “what was going on in people’s minds before all these transactions.”

Bloomberg in May estimated Bancel’s stake in the company as worth more than $2.2 billion, when measured at Moderna’s peak stock price. He has sold about $17 million worth of shares since Jan. 21, according to the Equilar analysis. Flagship’s 11 percent share of the company was worth $3.2 billion, Bloomberg said, and its sales of Moderna stock represented about 2 percent of that value. Given the large value of those holdings, the relatively small value of stock sales does not raise a major concern, said Jesse Fried, a Harvard Law School professor and expert on executive pay and insider trading.

“You don’t want to be exploiting a crisis to make money, but the truth is that any company that is going to sell the vaccine is going to be making money on the crisis,” Fried said, “and that’s great, because we want to incentivize people to wake up early in the morning and stay in their labs late at night coming up with something that will help us.”

But the Moderna sales are triggering political debate.

“Moderna executives used this opportunity to capitalize on the COVID-19 crisis, and to add insult to injury, the value of their stocks increased based on the taxpayer-funded investment in the development of the vaccine,” Sen. Chris Van Hollen (D-Md) said in an email. Van Hollen is the sponsor of legislation that would require the SEC to revisit its rules for preprogrammed insider trades.

The enormous success of Moderna shows how pharmaceutical companies, often with help from the government, can achieve fantastic results even without delivering a product to market.

Its speedy response to the COVID-19 pandemic was enabled by its vaccine technology based on messenger RNA, which carries genetic codes instructing human cells to produce what is known as a “spike protein” molecule. The spike protein, which was invented jointly by scientists at the National Institutes of Health and the University of Texas at Austin, triggers the immune system to create antibodies against the coronavirus. The technology allowed Moderna in March to become the first company to test a vaccine in a human, just 66 days after the coronavirus genetic code was published.

On May 18, Moderna announced partial clinical results from 45 human test subjects suggesting the vaccine was safe and triggered an immune response. It said it measured neutralizing antibodies in eight test subjects, which was seen as early evidence that its vaccine may work. The news release did not contain detailed data from the patients in the trial, and crucial test results on some subjects were not available at the time the release was issued.

The news drove the share price to a record peak of $80. On that day, the chief financial officer, Kim, who is leaving the company in a previously planned departure, sold $19.5 million in shares in preprogrammed trades, according to public filings. In all since Jan. 21, Kim sold $54 million in shares, according to the Equilar analysis. As of June 2, he still held $70 million worth of shares.

Minutes after the end of trading on May 18, Moderna announced it would issue $1.3 billion worth of new stock at $76 per share. The company said cash from the offering would be plowed into coronavirus vaccine manufacturing, including hiring 150 new production staff, as well as other company priorities. But as the stock dropped from its peak in subsequent days and weeks, plaintiff lawyers quickly announced that they would prepare class-action lawsuits, suggesting that the company’s news release overhyped the data.

Moderna said it “worked cooperatively” with NIH on the content of its news release and expects NIH to make detailed data from the Phase 1 trial public at a later date. NIH confirmed that it reviewed the data in the news release and said it was accurate.

The chain of events in the midst of the pandemic has generated negative attention for a company that is competing with much larger corporations — including Pfizer, Merck, Johnson & Johnson, and AstraZeneca — to develop the first coronavirus vaccine.

Unlike those companies, Moderna has no approved products and zero revenue stream from sales, according to the company’s disclosure reports. Fifteen drugs in its pipeline, ranging from virus vaccines to heart treatments and a cancer vaccine, are still in early or mid-stage development.

The company is built on the notion that cells inside the body can produce drugs and vaccines, if they are directed to do it by delivering the messenger RNA directly into the cells. Investors are wagering that Moderna’s technology will work for other medicines down the road, including more viral targets and a cancer vaccine, say drug industry specialists.

“If it works for this one virus, you can bet that it works for many, many others . . . and that kind of franchise will be incredibly valuable,” said Andrew W. Lo, the Charles E. and Susan T. Harris professor of finance at the MIT Sloan School of Management, who does not have holdings in Moderna but who has personal investments and financial ties to other biotechnology companies and biotech venture capital funds.

– — –

The Cambridge, Mass., company, founded in 2010, has attracted more than $5 billion in private-sector investment, according to company figures, including partnerships with Merck and AstraZeneca, multiple rounds of venture capital financing, and public stock offerings worth about $2.5 billion. The company has $483 million in government commitments to develop a coronavirus vaccine but said it has not tapped the money yet. Over its history, Moderna has received about $77 million in funding for various projects, the company said.

Moderna’s rapid response gave it a leg up in the markets. Older vaccines relied on deactivated or weakened virus, grown in chicken eggs, in a slow process. The new breed of RNA vaccines like Moderna’s can be designed on computers based on the genetic code of the virus and manufactured quickly. Pfizer also is working to develop an RNA-based coronavirus vaccine and began a Phase 1 trial in May.

Still, the delivery system needs to be proved safe and effective in large numbers of people.

“There is not a single drug approved with this technology. This is really the bet we are making, that all this is going to work,” said Otello Stampacchia, the founder and managing director of Omega Funds, a life sciences venture capital firm in Boston.

– — –

The foundation of the Moderna vaccine was laid years before a mysterious respiratory illness was reported in Wuhan, China. In 2012, another deadly coronavirus, Middle East respiratory syndrome, jumped from camels into humans. Barney Graham, the deputy director of the federal Vaccine Research Center, which is part of NIH, said in an interview that he wanted to use cutting-edge technologies that examined the precise shape of a virus — down to individual atoms — to design a vaccine against the threat.

But Graham and academic collaborators had to solve a problem. The target the scientists were interested in — the distinctive spiky protein on the virus surface — was unstable and tended to shape-shift.

Nianshuang Wang, a postdoctoral researcher then at Dartmouth, spent months trying to identify genetic mutations that would stabilize the shape-shifting spike protein, eventually finding a solution that worked in multiple coronaviruses. The paper, published in 2017, took persistence to publish — it was rejected five times.

“People generally at that time said, ‘Coronavirus is not a big concern,’ “ Wang said. “They didn’t get the idea that this can be a great technology in the future, to prevent another coronavirus pandemic.”

Graham was interested in using new technologies to speed up MERS vaccine development and in October 2017 began working with Moderna. The company’s technology could deliver messenger RNA to normal human cells that instructs them to churn out the spike protein with the crucial mutations. The presence of the spike protein in the body triggers the creation of antibodies against the virus. But with MERS sparking only small, occasional outbreaks, it wasn’t until January 2020 that the approach drew the world’s attention.

Even before anyone knew for certain what was causing a mysterious pneumonia in Wuhan, Graham and Bancel began talking about working together. Graham also called Wang’s boss, Jason McLellan, now at the University of Texas at Austin, to see if they could design a stabilized spike protein that could be used in a vaccine.

Researchers in Graham’s and McLellan’s labs designed the protein through computer modeling in a single weekend. Moderna scientists helped finalize the genetic sequence for the vaccine platform they had spent years developing. Within days, the company began producing the coronavirus vaccine in a factory south of Boston. The NIH and UT Austin teams filed a joint patent application on the mutated spike protein. Moderna has a “nonexclusive” license to the protein, which means that NIH can license it to other companies, NIH said.

In record time — 66 days after the genome of a never-before-seen virus was posted on an online server — the first doses were injected into human beings through a clinical trial supported by more than $700,000 in federal funding. Moderna announced the beginning of a Phase 2 trial in May and said its Phase 3 trial in 30,000 subjects is scheduled to start in July.

Bancel has said it may be known whether the vaccine works by Thanksgiving — a view echoed in an interview with Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.

McLellan said that his laboratory has created a second version of the spike protein that is even more potent and that it has already signed an agreement with the Bill & Melinda Gates Foundation to ensure global access, which will enable companies with different technologies the ability to test and further develop potential COVID-19 vaccines.

Two months after the first human subject was dosed with the Moderna vaccine, the public got its first glimpse of its potential effectiveness.

Before stock markets opened on May 18, Moderna issued a news release with positive but preliminary results of its Phase 1 safety trial. Eight trial subjects who received the vaccine had virus-fighting antibodies in their blood at levels similar or greater than people who have recovered from COVID-19. Another 37 had promising immune responses, but tests were not available to see whether they had neutralizing antibodies.

As soon as markets opened on May 18, Moderna’s stock jumped. By the close of trading, it had risen more than 20 percent. But Moderna was criticized for releasing limited data by Fauci in an interview published by Stat on June 1.

“I didn’t like that. What we would have preferred to do, quite frankly, is to wait until we had the data from the entire Phase 1 — which I hear is quite similar to the data that they showed — and publish it in a reputable journal and show all the data,” he told Stat. “But the company, when they looked at the data, as all companies do, they said, wow, this is exciting. Let’s put out a news release.”

Two days later, Bancel offered an explanation for the company’s actions. A concern about leaks drove the decision to issue early information, he said in a June 3 video hosted by the Wall Street investment banking firm Jefferies that was publicly posted online.

Moderna had received preliminary data from NIH, which sponsored the Phase 1 trial, on May 14, Bancel said. The next day, Moncef Slaoui, a Moderna board member who had just left the company to go to the White House and assume leadership of President Trump’s Operation Warp Speed initiative to develop vaccines, expressed confidence in a Rose Garden news conference that a vaccine could be ready by the end of 2020. Slaoui said from the lectern that he had just seen positive data from a vaccine manufacturer. Slaoui did not identify the trial or manufacturer.

Moderna determined that too many people knew about the data, Bancel said, and that the company needed to publicly release limited results to level the playing field for all investors.

“I have no idea if tomorrow it’s going to be tweeted by somebody, it’s going to be mentioned at a conference, on TV,” he said. “That’s a risk our legal team said you cannot take.”

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Against Vaccine

An Old Vaccine May Help Against Coronavirus – The Wall Street Journal

The Global Virus Network is a collaboration among virology researchers and social scientists to improve pandemic preparedness and response. We know that life must go on while work on a Covid-19 vaccine continues. We believe that as people return to work, their risk of infection can be minimized by applying an old vaccine known to be a potent stimulus of the innate immune system.

Whether there will be a Covid-specific vaccine is still unclear. The sequence of the Covid-19 viral genome, published in January by Chinese scientists,…

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Coronavirus Vaccine

In race for coronavirus vaccine, will Operation Warp Speed focus the work or politicize it? – USA TODAY

CLOSE

Health and Human Services Secretary Alex Azar talked about a timeline for a COVID-19 vaccine.

USA TODAY

Four months into one of the largest medical emergencies in United States history, President Donald Trump announced a goal to develop 300 million doses of COVID-19 vaccine by January, enough to protect most Americans. 

Charged with this task was Operation Warp Speed, a newly-created program to tie together all major U.S. federal, medical and oversight entities, and the military, into one massive coordinated push for a vaccine and treatments.

However, how the operation functions, its budget, what power it has and what resources it controls have either not been determined or not been made public, a puzzlement to public health and vaccine policy experts.

The hope is that Operation Warp Speed will provide crucial coordination between government entities, create clear lines of responsibility and control, streamline funding and focus work, speeding the timeline.

The fear is it might politicize scientific and logistical processes under an administration that has at times been disdainful of science and its experts, potentially slowing work on a vaccine.

“We just need to ensure that decisions are made thoughtfully and in an apolitical manner so as to not undermine the existing structures and expertise in place to keep vaccines safe,” said Lois Privor-Dumm, policy director at the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.

The creation of the project underscores the president’s penchant for keeping a firm grip on the experts and bureaucrats coordinating his response, even as he has battled publicly with Health and Human Services Secretary Alex Azar, Centers for Disease Control and Prevention director Robert Redfield and others.

Experts agree facilitation is necessary to bring the combined might of the U.S. academic, medical and pharmaceutical realms to bear on creating a COVID-19 vaccine — the prerequisite for life to return to normal.

That oversight must come from outside the existing agencies, said Dr. Margaret Hamburg, current foreign secretary for the U.S. National Academy of Medicine and the commissioner of the U.S. Food and Drug Administration from 2009 to 2015.

“Any one agency can’t direct sister agencies to do things, can’t knock heads together as required, can’t rise above to see what the landscape looks like and make sure all the different components are being adequately utilized and held accountable,” she said.

Many questions, so far few answers

A week in, the operation made its first announcement — as much as $1.2 billion had been pledged to accelerate a possible vaccine developed at the University of Oxford in England and licensed by AstraZeneca. Azar called the contract “a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021.”

Yet as an example of the lack of transparency, few details about the deal are available beyond those in a news release issued Thursday. The agreement was with the United States’ Biomedical Advanced Research and Development Authority (BARDA), one of the federal programs whose COVID-19 responsibilities now seem to be under the wing of the operation.

Whether the actual agreement was coordinated or organized through Warp Speed wasn’t clarified. Emails and calls to Health and Human Services were not answered. Operation Warp Speed does not appear to have its own media contact.

The White House did not answer questions about reports Trump’s son-in-law and senior adviser Jared Kushner and his top trade and manufacturing adviser Peter Navarro are helping to lead the effort. Both have promoted partnerships between government and private industry to address challenges facing the nation. Neither has prior experience with public health crises.

Who’s in charge

What is known about the framework and leadership of the program comes from a release posted on the HHS website on May 15 and a news conference held with Trump in the White House Rose Garden the same day.

There he introduced Warp Speed’s chief advisor, Moncef Slaoui, an expert in molecular biology and immunology who has spent his career developing vaccines and working in pharmaceutical companies.

On the logistics side will be four-star Army General Gustave Perna who will serve as the chief operating officer. Perna is the commanding general at U.S. Army Materiel Command in Huntsville, Alabama.

Slaoui and Perna may make a great team because Slaoui understands complex research ecosystems and Perna knows how to galvanize big operations and deal with logistical concerns, said Hamburg.

“I just hope the politicians will get out of the way and let them do their work,” she said.

One worry is Slaoui’s lack of government experience, said Dr. Andrew Pavia, chief of pediatric infectious diseases at the University of Utah School of Medicine.

Anything that involves all of government has many pieces that need to mesh smoothly. That’s difficult even for somebody with years of government leadership experience, said Pavia, who has served on the board of the Infectious Disease Society of America and as a member of the National Vaccine Advisory Committee.

Coming from industry, Pavia fears Slaoui may not have a deep understanding of how BARDA, CDC, the FDA, the National Institutes of Health and the Department of Defense work together.

“He is smart and capable but there needs to be a clear set of guidelines in government. That has often not been the case,” he said.

14 vaccines winnowed to 8

Warp Speed has so far identified 14 COVID-19 vaccine possibilities. It will select the eight most promising and provide coordinated government support for their development and testing in early stage small clinical trials. Large-scale randomized trials will proceed in three to five of them.

As of Thursday, four vaccine coronavirus candidates had received major funding by the U.S. government:

Whether these four that have been funded represent the semi-finalists is not known.

Operation Warp Speed appears to have access to substantial resources. Congress has directed almost $10 billion through supplemental funding, including the CARES Act. In addition, over $6.5billion was designated for countermeasure development through BARDA and $3 billion for NIH research.

How Warp Speed fits into those agencies usual distribution systems isn’t known. Will it have the ability to designate which contracts are signed or which projects are funded, or will it merely make suggestions?

The list of institutions involved in the operation includes almost every medical entity within the federal government, including the FDA, CDC, NIH and BARDA as well as DoD, private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs.

Given the vast number of bureaucratic and organization systems these represent, how “in charge” Slaoui will be is of concern to some.

His role is officially “chief advisor,” said Dr. Harvey Fineberg, an expert on health policy and vaccines, current president of the non-profit Gordon and Betty Moore Foundation and former president of the National Academy of Medicine.

He called the appointment a solid step in the direction of creating a unified command structure but noted that Slaoui’s scope of authority and range of responsibility are unclear.

“Is he advisor to the president, to the vice president, to the secretary of Health and Human Services or to whom? Ulysses Grant was not ‘chief advisor’ to President Lincoln; he was general-in-chief and commander of the Union Army,” said Fineberg.

Listening to scientists

There is also concern over the ability of the Warp Speed program to avoid bureaucratic quagmires in the midst of an effort that will require the work of some of the top minds in science.

“You need to recruit the best and brightest in the field and give them some flexibility to act on their own initiative. We have to trust them to find the best way to get from A to B and not micromanage,” said Kendall Hoyt, a professor at the Geisel School of Medicine at Dartmouth College where she studies biomedical research and development strategy.

Trump in his speech introducing Operation Warp Speed likened it to World War II’s Manhattan Project, which brought together military, public and private organizations to create the atomic bomb.

Warp Speed will be run by a mix of scientists, regulators and the military, with the presumption that only the U.S. military will have the capability to rapidly distribute and deploy a vaccine or vaccines once they are available. 

When the project was announced last week, the vaccine development portion of the operation was to be overseen by Dr. Peter Marks, who directs the FDA’s Center for Drug Evaluation and Research. As of Friday he has transitioned out of that role and back to the FDA after helping to set up the initial infrastructure for Operation Warp Speed, FDA said. 

On the Department of Defense vaccine side, Dr. Matt Hepburn, project lead for the office for Chemical, Biological Radiological and Nuclear Defense, will be the subject matter expert.

How the program will interface with the White House Coronavirus Task Force, led by Vice President Mike Pence, is not entirely clear.

Ideally, Warp Speed will leverage expertise that has gone underutilized during the epidemic, say some experts.

What about the CDC?

Historically, the public health face of a crisis of this magnitude would have been the CDC, but it has largely been sidelined in coronavirus. Last weekend Navarro, director of the Office of Trade and Manufacturing Policy and Trump’s coordinator on the use of the National Defense Production Act, leveled scathing criticisms at the CDC on NBC News’ “Meet the Press.”

This troubles observers.

“They have thousands of person-years of expertise and it seems that they’ve been marginalized,” said Glenn Melnick, a professor of health economics at the University of Southern California.

The agency that normally would have played a major role in developing a vaccine is HHS’ Biomedical Advanced Research and Development Authority, created in 2006 under President George W. Bush to find and develop countermeasures to first bioterrorism and later epidemics and emerging diseases.

It had a political setback when its head of vaccines, Rick Bright, was removed from his position after he opposed the use of chloroquine and hydroxychloroquine – drugs touted by Trump and others in the administration – due to the serious risks associated with taking them.

CLOSE

Whistleblower Dr. Rick Bright warned on Thursday that the U.S. lacks a plan to produce and fairly distribute a coronavirus vaccine when it becomes available. (May 14)

AP Domestic

Both CDC and BARDA are part of the White House Task Force and now Warp Speed, but have not played as large a role as they have in previous public health crises such as the H1N1 influenza, Ebola and Zika.

Under pressure

Also unanswered is how Operation Warp Speed will work with the at least two other large-scale public/private consortia created in the past three months to focus efforts on COVID-19 vaccine and treatments.

On April 17 the NIH launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. It includes biopharmaceutical companies, the HHS Office of the Assistant Secretary for Preparedness and Response, the CDC, the FDA and the European Medicines Agency. 

Its stated goal is to coordinate regulatory processes, create a framework for prioritizing vaccine and drug candidates and streamline clinical trials.

On March 10 the COVID-19 Therapeutics Accelerator was launched by two of the world’s largest health non-profits, the Bill & Melinda Gates Foundation and England’s Wellcome Trust together with the Mastercard Impact Fund. The Accelerator, with $125 million in seed funding, is committed to coordinating research and development efforts for COVID-19 therapies.    

Most experts interviewed said they had hope for a vaccine and were pleased a high-level  group was working to cut through red tape and speed the process as much as possible.

The note of caution they all raised was concern that pressure to have a vaccine ready to use within the president’s proposed timeline will either cause corners to be cut or make Americans worry that corners had be cut. Either could contribute to distrust of vaccines overall.

“Any misstep risks eroding confidence in vaccines that could have lasting implications,” said Privor-Dumm at Johns Hopkins Bloomberg School of Public Health.

In the end, the ability to meet the Trump’s desired deadline will depend on the biology of the virus as well as how much authority Slaoui is given and how much control he has over the resources available to him, said Fineberg.

“The first element for success is to establish a unified command structure,” he said. “The appointments of Dr. Slaoui and General Perna are a step in this direction.”

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