Tag Archives: Vaccine

Moderna Phase 1 results show coronavirus vaccine safe, induces immune response

By Julie Steenhuysen

CHICAGO (Reuters) – Moderna Inc’s experimental vaccine for COVID-19 showed it was safe and provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study, U.S. researchers reported on Tuesday.

Volunteers who got two doses of the vaccine had high levels of virus-killing antibodies that exceeded the average levels seen in people who had recovered from COVID-19, the team reported in the New England Journal of Medicine.

No study volunteers experienced a serious side effect, but more than half reported mild or moderate reactions such as fatigue, headache, chills, muscle aches or pain at the injection site. These were more likely to occur after the second dose and in people who got the highest dose.

Experts say a vaccine is needed to put an end to the coronavirus pandemic that has sickened millions and caused nearly 575,000 deaths worldwide.

Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16, 66 days after the genetic sequence of the virus was released.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, whose researchers developed Moderna’s vaccine candidate, called the results “good news,” noting that the study found no serious adverse events and the vaccine produced “reasonably high” levels of virus-killing or neutralizing antibodies.

“If your vaccine can induce a response comparable with natural infection, that’s a winner,” Fauci said in a telephone interview. “That’s why we’re very pleased by the results.”

Moderna shares jumped more than 15% in after-hours trading on Tuesday.

The U.S. government is supporting Moderna’s vaccine with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials. A successful vaccine could be a turning point for Cambridge, Massachusetts-based Moderna, which has never had a licensed product.

Moderna’s shot, mRNA-1273, uses ribonucleic acid (RNA) – a chemical messenger that contains instructions for making proteins. When injected into people, the vaccine instructs cells to make proteins that mimic the outer surface of the coronavirus, which the body recognizes as a foreign invader, and mounts an immune response against.

The results released Tuesday involved three doses of the vaccine, tested in groups of 15 volunteers aged 18-55 who got two shots, 28 days apart. The groups tested 25, 100 or 250 micro grams of the vaccine.

Adverse events after the second dose occurred in seven of the 13 volunteers who got the 25-micro gram dose, all 15 participants who received the 100 micro gram dose and all 14 who got the 250 micro gram dose. In the highest-dose group, three patients had severe reactions such as fever, chills, headache or nausea. One of these had a fever of 103.28 Fahrenheit (39.6 C).

“We didn’t see any events that are characterized as serious adverse events,” said lead author Dr Lisa Jackson of Kaiser Permanente Washington Health Research Institute in Seattle, referring to reactions that require hospitalization or result in death.

In June, Moderna said it selected the 100-micro gram dose for its late-stage study to minimize adverse reactions.

At that dose, Moderna said the company is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021, from the company’s internal U.S. manufacturing site and strategic collaboration with Swiss drug-maker Lonza.

“It’s a good first step,” said Dr William Schaffner, a vaccine expert at Vanderbilt University Medical Center who was not involved in the study.

“There’s nothing here that would inhibit one from going ahead to the Phase 2/Phase 3 trials,” he said.

In April, Moderna expanded the Phase 1 trial to include adults over 55, who are more at risk of serious disease, with the aim of enrolling 120 volunteers. Moderna said it will follow study volunteers for a year to look for side effects and check how long immunity lasts.

Moderna started its phase 2 trial in May and expects to start a phase 3 trial on July 27.

Phase 1 trials aim to ensure a treatment is safe and help determine an effective dose. Phase 2 trials test a treatment in a larger group and get an early read on effectiveness. Phase 3 trials are conducted in a large group of individuals to confirm efficacy and identify rare side effects. Moderna’s Phase 3 trial will be conducted in 30,000 volunteers.

(Reporting by Julie Steenhuysen in Chicago; Editing by Matthew Lewis and Richard Pullin)

Moderna expects to start late-stage COVID-19 vaccine trial on July 27

NEW YORK (Reuters) – Moderna Inc said on Tuesday it plans to start a late stage clinical trial for its COVID-19 vaccine candidate on or around July 27, according to its listing for the phase 3 study at clinicaltrials.gov.

Moderna said it will conduct the trial at 87 study locations, all in the United States.

The experimental vaccine will be tested in 30 states and Washington, D.C. Around half of the study locations are in hard-hit states like Texas, California, Florida, Georgia, Arizona and North and South Carolina.

The United States has reported record numbers of new coronavirus cases in recent days, with much of the surge coming from those states.

The federal government is supporting Moderna’s vaccine project with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials.

Tensions between the company and government scientists contributed to a delay of the trial launch, Reuters reported earlier this month.

Shares of Moderna rose about 2.5% on Nasdaq at midday.

(Reporting by Michael Erman, Editing by Franklin Paul and Richard Chang)

Kanye West breaks ranks with Trump, vows to win presidential race

(Reuters) – Rapper Kanye West signaled he no longer supported U.S. President Donald Trump and said he would enter the presidential race to win it, according to an interview published on Wednesday.

West, previously a vocal supporter of Trump, announced on Saturday that he would run for president in 2020.West and his reality TV star wife Kim Kardashian West have visited Trump in the White House.

“I am taking the red hat off, with this interview,” West told Forbes magazine, referring to Trump’s trademark red “Make America Great Again” baseball cap. “Like anything I’ve ever done in my life, I’m doing (this) to win.”

He said he would run under a new banner – the Birthday Party.

There was no record of West filing any official paperwork with the Federal Election Commission. The deadline to add independent candidates to the ballot has not yet passed in many states.

West denied that his aim was to split the Black vote and hurt the chances of Trump’s Democratic opponent, Joe Biden. It was “a form of racism and white supremacy” to suggest all Black people should support the Democrats, he said.

Trump, who hosted Kanye West in a widely publicized visit to the Oval Office in 2018, said the rapper’s candidacy “would be a great trial run” and that he had a “real voice,” according to an interview Tuesday with Real Clear Politics news website.

White House spokesman Hogan Gidley on Wednesday called Kanye’s announcement “a scathing indictment of the Democrat Party, not just their policies on abortion, the Planned Parenthood, but also the policies that disproportionately affected African Americans in a negative way.”

West told Forbes he believed “Planned Parenthoods have been placed inside cities by white supremacists to do the Devil’s work.” The group provides reproductive health care and education, with most of that being preventive care.

The rapper also said he had been ill in February with COVID-19, the disease caused by the new coronavirus, and would be suspicious of any vaccines developed to prevent the infection. Reiterating false theories that link vaccines with child developmental disorders, he said: “So when they say the way we’re going to fix COVID is with a vaccine, I’m extremely cautious.”

(Reporting by Kanishka Singh in Bengaluru; Editing by Peter Graff)

U.S. signs $450 million contract with Regeneron for COVID-19 therapy

By Manojna Maddipatla

(Reuters) – The U.S. government signed a $450 million contract with Regeneron Pharmaceuticals Inc for its potential COVID-19 antibody cocktail, the drug maker said on Tuesday.

The agreement, the first by the Trump administration to support a therapy, comes under the government’s “Operation Warp Speed” program that is aimed at faster distribution of vaccines and treatments to fight the new coronavirus when trials are successful.

The United States is also funding manufacturing and several trials for potential vaccines and has rushed to secure billions of doses of the vaccines being tested by companies around the world.

Earlier in the day, Novavax Inc received a $1.6 billion grant, the biggest award yet from Operation Warp Speed, to cover testing, manufacturing and sale of a potential coronavirus vaccine.

Under the contract with Regeneron, signed with the HHS’ Biomedical Advanced Research and Development Authority and the Department of Defense, the doses manufactured under the project will be owned by the federal government.

Regeneron’s cocktail, REGN-COV2, contains an antibody made by the company and another isolated from recovered COVID-19 patients. Rivals Eli Lilly and AbbVie are also pursuing antibody therapies for the respiratory illness.

REGN-COV2 is being tested separately for both preventing and treating COVID-19, with a late-stage prevention trial being run jointly with the National Institutes of Health.

The agreement covers a fixed number of bulk lots intended to be completed in the fall of 2020, Regeneron said.

A range of 70,000 to 300,000 potential treatment doses or 420,000 to 1,300,000 prevention doses are expected to be available from these lots, with initial doses to be ready as early as end of summer.

The U.S. government would make the doses available to Americans at no cost, if EUA or product approval is granted, Regeneron said.

Shares of Regeneron were up 1.4% at $636.11. They have risen 67% so far this year.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

U.S. government awards Novavax $1.6 billion for coronavirus vaccine

By Julie Steenhuysen

CHICAGO (Reuters) – The U.S. government has awarded Novavax Inc $1.6 billion to cover testing and manufacturing of a potential vaccine for the novel coronavirus in the United States, with the aim of delivering 100 million doses by January.

The award announced by the U.S. Department of Health and Human Services is the biggest yet from “Operation Warp Speed,” the White House initiative aimed at accelerating access to vaccines and treatments to fight COVID-19, the respiratory disease caused by the coronavirus.

Shares in Gaithersburg, Maryland-based Novavax rose 29% to $102 in morning trading.

“What this Warp Speed award does is it pays for production of 100 million doses, which would be delivered starting in the fourth quarter of this year, and may be completed by January or February of next year,” Novavax Chief Executive Stanley Erck told Reuters.

It will also cover the cost of running a large Phase III trial, the final stage of human testing.

Erck said Novavax expects results of its Phase I trial testing the vaccine’s safety within the next week or so. The company aims to start mid-stage trials in August or September, with Phase III testing starting in October, Erck added.

The HHS announcement follows a $456 million investment in Johnson & Johnson’s vaccine candidate in March, a $486 million award to Moderna Inc in April, and up to $1.2 billion in support in May for AstraZeneca PLC’s vaccine being developed with Oxford University. The U.S. government also awarded Emergent Biosolutions Inc $628 million to expand domestic manufacturing capacity for a potential coronavirus vaccine and drugs to treat COVID-19.

The addition of Novavax’s candidate to Operation Warp Speed’s portfolio “increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said in a statement.

Besides the massive cash infusion for Novavax, the U.S. government inked a $450 million contract with Regeneron Pharmaceuticals Inc to make and supply its antibody cocktail for COVID-19.

Novavax is somewhat of a dark horse in the race for a coronavirus vaccine. The company was not on the list of vaccine finalists for Warp Speed previously reported by the New York Times that included Moderna, AstraZeneca, Pfizer Inc, J&J and Merck & Co.

In May, Novavax received an additional $388 million in funding for COVID-19 vaccine development from the Coalition for Epidemic Preparedness Innovations (CEPI), a private foundation, after a $4 million investment in March. In June, the U.S. Defense Department awarded the company $60 million to support manufacturing of 10 million doses of its vaccine in 2020.

‘A BIG SCALE UP’

The company is in the process of transferring its vaccine technology to an unnamed contract manufacturer that has two large manufacturing facilities, its CEO said. That is in addition to the work being done by Emergent Biosolutions, which is making doses to supply the company’s smaller early and mid-stage clinical trials.

By early next year, Novavax expects to be able to make 50 million doses a month in the United States.

“It’s a big scale up in a few different manufacturing sites in the United States,” Erck said. “What it leaves us with is the capacity of making many more doses in the U.S. in 2021.”

Novavax did not start human safety trials until late May. One reason for the delay is that the vaccine is grown in insect cells, a process that can take 30 days before company scientists can start purifying it and making it in bulk.

“You lose a month or so there, but I don’t think we’re behind because of our data,” Erck said, referring to animal data showing a strong immune response and high levels of virus-killing antibodies.

Besides Moderna, the company trails two other candidates – one from AstraZeneca and Oxford University and one from Pfizer and BioNTech.

Jefferies analyst Jared Holz said the cash infusion “places Novavax in a very enviable position should its data look compelling later in the year.”

Although Novavax has not yet produced a licensed vaccine, Sanofi SA uses the same basic technology to make flu vaccine, “so the risk of us not succeeding is pretty low,” Dr. Gregory Glenn, president of research and development for Novavax, said in a telephone interview.

The Novavax vaccine works in conjunction with an adjuvant – a substance that boosts the immune response to help the body build a robust defense against the virus.

Currently, Novavax makes its adjuvant in Sweden. The company is building up U.S. manufacturing capacity for its adjuvant “so that we can make upwards of a billion doses of adjuvant in the United States,” Erck said.

Novavax also has a manufacturing plant in the Czech Republic and hopes to have two other plants in Europe and one in Asia, Erck said. The company is also working with a manufacturer in India. The aim there is to make more than 100 million doses a month, Erck said.

(Reporting by Julie Steenhuysen; Editing by Bill Berkrot and Will Dunham)

‘At war time speed’, China leads COVID-19 vaccine race

By Sangmi Cha and Miyoung Kim

SEOUL/SINGAPORE (Reuters) – China is forging ahead in the race to develop a vaccine to help control the COVID-19 pandemic, with Sinovac Biotech’s experimental vaccine set to become the country’s second and the world’s third to enter final stage testing later this month.

While a laggard in the global vaccine industry, China, where the new coronavirus is thought to have originated, has brought state, military and private sectors together in a quest to combat a disease that has killed over 500,000 people worldwide.

Many other countries, including the United States, are coordinating closely with the private sector to try to win the vaccine development race, and China faces many challenges.

Its success in driving down COVID-19 infections makes it harder to conduct large-scale vaccine trials, and so far only a few other countries have agreed to work with it. After past vaccine scandals, Beijing will also have to convince the world it has met all safety and quality requirements.

But China’s use of command economy-type tools is so far yielding results.

A state-controlled entity, for example, completed two vaccine plants at what it called the “war time speed” of a couple of months, while state-owned enterprises and the military have allowed experimental shots to be used on staff.

The People’s Liberation Army’s medical research unit, which has been a driving force in China’s efforts to fight infectious diseases, is also working with private firms including CanSino to develop COVID-19 vaccines.

Challenging the West’s traditional dominance of the industry, China is behind eight of the 19 vaccine candidates in human trials, with Sinovac’s experimental shot and one jointly developed by the military and CanSino among the front runners.

It is also focused mainly on inactivated vaccine technology – a technology that is well known and has been used to make vaccines against diseases such as influenza and measles – something which could raise the chances of success.

By contrast, several Western rivals such as U.S.-based Moderna and Germany’s CureVac and BioNTech are using a new technology called messenger RNA that has never before yielded a product approved by regulators.

‘TRIED AND TRUE’

“It’s a tried and true strategy,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, about inactivated vaccine technology.

“If I had to pick a vaccine that I think would be the most likely to be safe and effective, it would be that one,” he said. Offit is also co-inventor of the rotavirus vaccine, RotaTeq, manufactured by Merck & Co Inc.

Four of the Chinese candidates in human trials are inactivated vaccines, including Sinovac’s and two vaccines from China National Biotec Group, a unit of state-owned China National Pharmaceutical Group (Sinopharm).

There are currently only two experimental COVID-19 vaccines in final Phase III trials – one from Sinopharm and another from AstraZeneca  and the University of Oxford. Sinovac’s is set to become the third later this month.

To speed up the process, China allowed Sinopharm and Sinovac to combine Phase I and Phase II trials for their vaccine candidates.

For CanSino’s experimental vaccine, the PLA research institute played a key role, with the two working on a method using an adenovirus – a similar approach to AstraZeneca’s.

The PLA has its own approval process for “military specifically-needed drugs”, and approved the military use of the candidate developed by its research unit and CanSino last month.

PLA lead scientist Chen Wei, who has been the face of its vaccine development effort, was among the first to take the experimental COVID-19 shot developed by her team, as well as its potential SARS treatment years before, according to state media.

CHALLENGES

China has challenges, though, as the epidemic has petered out in the country, hampering efforts to conduct large trials.

It has since shifted its focus overseas, but only a handful of countries have shown willingness to collaborate – UAE, Canada, Brazil, Indonesia and Mexico. Neither major European countries nor the United States have shown interest in China’s COVID-19 vaccines as they focus on their own projects.

China must also address concerns over its vaccine quality and safety issues following several scandals over substandard vaccines in recent years.

“The Chinese national regulatory authority has been improving its oversight,” said Jerome Kim, head of the International Vaccine Institute, a non-profit agency established as an initiative of the U.N. Development Program.

China introduced a law last year to regulate the vaccine industry, with heavier penalties for selling and making fake or low-quality vaccines than other drug products.

(Reporting by Roxanne Liu and Sangmi Cha; Additional reporting by Julie Steenhuysen in Chicago; Writing by Miyoung Kim; Editing by Mark Potter and Kate Kelland)

U.S. FDA releases guidance for COVID-19 vaccine approval

(Reuters) – The U.S. Food and Drug Administration on Tuesday released guidance on its conditions for approving a vaccine for the coronavirus, saying a vaccine has to prevent or decrease disease severity in at least 50% of people who are vaccinated.

More than 100 vaccines are being tested worldwide against the virus, which has claimed over 126,100 lives in the country, according to a Reuters tally.

The Trump administration in May announced a program called “Operation Warp Speed” to speed up the development of COVID-19 therapeutics and vaccines, as the country has none approved for the respiratory illness.

“While the FDA is committed to expediting this work, we will not cut corners in our decisions,” the agency said in a statement on Tuesday.

Vaccine developers have also been asked to provide data to support use of their vaccines during pregnancy and to show safety and effectiveness in children, the agency said.

Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a vaccine through clinical trials.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

Vaccine makers face biggest medical manufacturing challenge in history

By Julie Steenhuysen and Kate Kelland

CHICAGO/LONDON (Reuters) – Developing a COVID-19 vaccine in record time will be tough. Producing enough to end the pandemic will be the biggest medical manufacturing feat in history.

That work is underway.

From deploying experts amid global travel restrictions to managing extreme storage conditions, and even inventing new kinds of vials and syringes for billions of doses, the path is strewn with formidable hurdles, according to Reuters interviews with more than a dozen vaccine developers and their backers.

Any hitch in an untested supply chain – which could stretch from Pune in India to England’s Oxford and Baltimore in the United States – could torpedo or delay the complex process.

Col. Nelson Michael, director of the U.S. Army’s Center for Infectious Disease Research who is working on the government’s “Warp Speed” project to deliver a vaccine at scale by January, said companies usually have years to figure this stuff out.

“Now, they have weeks.”

Much of the world’s attention is focused on the scientific race to develop a vaccine. But behind the scenes, experts are facing a stark reality: we may simply not have enough capacity to make, package and distribute billions of doses all at once.

Companies and governments are racing to scale-up machinery to address a critical shortage in automated filling and finishing capacity – the final step in the manufacturing process of putting the vaccine into vials or syringes, sealing them and packaging them up for shipping.

“This is the biggest logistical challenge the world has ever faced,” said Toby Peters, an engineering and technology expert at Britain’s Birmingham University. “We could be looking at vaccinating 60% of the population.”

Several developers, including frontrunner Moderna, are experimenting with new ways to mitigate the extreme cold storage demands of their vaccines, which at present need to be kept at minus 80 degrees Celsius (-112 Fahrenheit).

SiO2 Materials Science is working on producing vials that won’t shatter at super-cold temperatures.

Travel restrictions, meanwhile, are posing more prosaic problems; Johnson & Johnson, which plans to start clinical trials this summer, has struggled to send its vaccine experts to oversee the launch of production sites, for example.

‘NEVER IN HISTORY’

By setting up massive clinical trials involving 10,000 to 30,000 volunteers per vaccine, scientists hope to get an answer on whether a vaccine works as early as this October. But even if they succeed, manufacturing in bulk, getting regulators to sign off and packaging billions of doses is a monumental challenge.

Seth Berkley, chief executive of the GAVI vaccines alliance, said in reality, the world is unlikely to go straight from having zero vaccines to having enough doses for everyone.

“It’s likely to be a tailored approach to start with,” he said in an interview. “We’re looking to have something like one to two billion doses of vaccine in the first year, spread out over the world population.”

J&J has partnered with the U.S. government on a $1 billion investment to speed development and production of its vaccine, even before it’s proven to work. It has contracted Emergent Biosolutions and Catalent to manufacture in bulk in the United States. Catalent will also do some fill-and-finish work.

“Never in history has so much vaccine been developed at the same time – so that capacity doesn’t exist,” said Paul Stoffels, J&J’s chief scientific officer, who sees filling capacity as the main limiting factor.

Emergent’s manufacturing plant in Bayview, Maryland, can accommodate four vaccines in parallel using different manufacturing platforms and equipment.

Funded by the government in 2012, the plant includes single-use disposable bioreactor equipment featuring plastic bags rather than stainless steel fermentation equipment, which makes it easier to switch from one vaccine to another.

This month, the company received an additional $628 million to make those four suites available to support any candidate the government selects, CEO Bob Kramer told Reuters.

BLOW-FILL-SEAL-REPEAT

As well as working with J&J, New Jersey-based Catalent signed a deal with British drugmaker AstraZeneca last week to provide vial-filling and packaging services at its plant in Anagni, Italy. It aims to handle hundreds of millions of doses, starting as early as August 2020 and possibly running through until March 2022.

It has ordered high-speed vial-filling equipment to boost output at its Indiana plant, where it is also hiring an additional 300 workers.

Michael Riley, Catalent’s North American president for biologics, told Reuters his biggest challenge was trying to compress work that normally takes years into months.

Adding to the challenge is that glass vials are in short supply.

To save glass, companies plan to use larger vials of five to 20 doses – but this raises new problems, such as potential waste, if not all the doses are used before the vaccine spoils.

“The downside is that after a healthcare practitioner opens a vial, they need to then vaccinate 20 people in a short, 24-hour time,” said Prashant Yadav, a global healthcare supply-chain expert at the Center for Global Development in Washington.

As part of the same drive, the U.S. Department of Health and Human Services and the Department of Defense have awarded ApiJect Systems up to $138 million to upgrade its facilities to be able to make up to 100 million plastic pre-filled syringes by the end of this year, and as many as 600 million in 2021.

The company plans to use a technology called Blow-Fill-Seal, where syringes are blown out of plastic, filled with vaccine and sealed in seconds. This will need Food and Drug Administration approval, CEO Jay Walker told Reuters.

BREAKING COLD CHAIN

SiO2 Materials Science is, meanwhile, ramping up capacity of plastic vials with a glass lining, which are more stable at ultra-low temperatures.

“You can bring us down to minus 196 Celsius, which none of the vaccines need,” Chief Business Officer Lawrence Ganti said. “You can throw it against the wall and it doesn’t break. Our founder has done that. He’s thrown frozen vials at me.”

The company expects to boost production from the current 5-10 million vials a year to 120 million within three-and-a-half months, he told Reuters.

Once packaged, many vaccines need to be kept cold – and some leading contenders made from genetic material such as messenger RNA need to be kept very cold – presenting another challenge that may limit access.

“People who work with mRNA store it at minus 80 degrees centigrade, which is not something you’re gonna find in most pharmacies or doctor’s offices,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and co-inventor of the rotavirus vaccine.

Peters of Birmingham university has been gathering data from poorer regions of Africa and Asia, and said breaks in the temperature-controlled supply chain – “cold chain” – are already frequent.

In some places, it is common to lose 25% or more of vaccines because of broken cold chains, he told Reuters.

“So if you’re looking to manufacture four billion, and you reckon you’re going to lose 25%, then you have to manufacture five billion,” he said. “It’s all the elements to move it from the point of manufacture to the point of aggregation, right down to the health centres and then out to the community.”

QUARANTINE QUAGMIRE

Companies developing mRNA vaccines, including Moderna and Translate Bio, which is partnering with Sanofi, are working to make candidates stable at higher temperatures.

Ron Renaud, CEO of Translate Bio, said he was confident this would happen “within a short amount of time”.

Colleen Hussey, a Moderna spokeswoman, said: “We are getting more confident that we could run our supply chain at -20C, which is an easier storage condition than deep freezing,” she said.

Moderna plans to add a small period of time in which the vaccine can be stored at normal fridge temperatures of 2 to 8 degrees Celsius in doctors’ offices or clinics.

“We will know more in the next 2-3 months,” she said.

The pandemic is also presenting obstacles of a less technical nature.

Catalent, which has some 30 plants globally, has had to write special permission slips in eight languages explaining that their workers are considered essential.

J&J is having trouble getting experienced personnel to far-flung labs to oversee the transfer of technology to contract manufacturers because they’re subject to 14-day quarantines.

“It is absolutely a factor,” said Stoffels. “If you have to send your people to the middle of India to get to filling capacity, that’s not easy at the moment.”

(Reporting by Julie Steenhuysen in Chicago and Kate Kelland in London; Writing by Josephine Mason; Editing by Pravin Char)

What you need to know about the coronavirus right now 6-11-20

(Reuters) – Here’s what you need to know about the coronavirus right now:

Farm work is a risky business

From apple packing houses in Washington state to farmworkers in Florida and a California county known as “the world’s salad bowl,” outbreaks of the novel coronavirus are emerging at U.S. fruit and vegetable farms and packing plants.

Working side-by-side and back-to-back, factory employees face the same conditions that contributed to outbreaks at U.S. meatpacking plants.

By late May, there were more than 600 cases of COVID-19 among agricultural workers in Yakima County, Washington. Of those, 62% were workers in the apple industry and other packing operations or warehouses.

The health department in Monterrey County, California, reported 247 agricultural workers had tested positive for coronavirus as of June 5, 39% of county’s total cases.

Tracking down the duds in testing free-for-all

The market for COVID-19 antibody tests has ballooned in a matter of months as hundreds of products flood the world for people who want to find out whether they’ve already had the virus. The problem is, some of them don’t work properly.

As a result, European authorities aim to tighten regulation of the new sector, to weed out tests that give consistently inaccurate results and crack down on companies that make false claims.

Why do some people get sicker than others?

Diabetes, high body temperature, low oxygen saturation and pre-existing cardiac injury are some risk factors for severe COVID-19, South Korean doctors have found in a paper published by the Journal of Korean Medical Science on June 2.

The team of doctors observed 110 coronavirus patients at a hospital in Daegu, the epicenter of South Korea’s outbreak, from Feb. 19 to April 15, of whom 23 developed severe COVID-19. The patients with at least three of the four prognostic conditions developed severe conditions, said Ahn June-hong, professor of internal medicine.

Hopes for antibody cocktail

Regeneron Pharmaceuticals said it has begun human testing of its experimental antibody cocktail as a treatment for COVID-19.

The trial has an “adaptive” design and could quickly move from dozens of patients to eventually include thousands, Chief Scientific Officer George Yancopoulos told Reuters.

The dual antibody, called REGN-COV2, is being compared to a placebo treatment in hospitalized COVID-19 patients, and in COVID-19 patients who have symptoms but are not sick enough to be hospitalized.

Regeneron said its treatment could be useful even if a COVID-19 vaccine is developed since the elderly and people with compromised immune systems often do not respond well to vaccines.

Love in the time of COVID

Those looking for love during the COVID-19 pandemic have had to adapt to lockdown dating, but innovations such as video “pre-dates” may end up outliving the coronavirus.

In England, from Saturday, single adult households will be allowed to form a “support bubble” with one other household and stay the night, which some newspapers took as an end to what they had dubbed a sex ban. But some of the coronavirus customs that have taken root look set to persist.

Dating app Bumble is launching a feature where users can badge themselves about how they want to date, be it virtually or socially distanced with a mask.

 

(Compiled by Linda Noakes)

J&J to begin human trials of COVID-19 vaccine in second half of July

(Reuters) – Johnson & Johnson said on Wednesday it would start human trials of its potential COVID-19 vaccine in the second half of July, two months earlier than planned, as drugmakers race to develop a shot for the deadly respiratory disease.

The company has already signed deals with the U.S. government to create enough manufacturing capacity to produce more than 1 billion doses of its vaccine through 2021.

There are currently no approved treatments or vaccines for COVID-19, the illness caused by the new coronavirus that has killed more than 400,000 people globally.

J&J’s study will test the vaccine against a placebo and assess the shot’s safety and immune response in 1,045 healthy people aged 18 to 55 years, as well as those 65 years and older. The trial will take place in the United States and Belgium.

U.S. biotech Moderna Inc is at the forefront of COVID-19 vaccine development and has started testing its candidate in a mid-stage trial that will enroll 600 patients. The company expects to begin late-stage trials in July.

AstraZeneca, Sanofi, Pfizer and GlaxoSmithKline are all at various stages of development of their vaccine candidates.

There are currently about 10 coronavirus vaccines being tested in humans and experts have predicted that a safe and effective vaccine could take 12 to 18 months from the start of development.

(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Saumyadeb Chakrabarty)