Tag Archives: Vaccine

J&J eyes one billion doses of potential COVID-19 shot in 2021, weighs challenge trials

By Francesco Guarascio

BRUSSELS (Reuters) – Johnson & Johnson could produce 1 billion doses of its potential COVID-19 vaccine next year if it proves successful and would consider injecting healthy volunteers with the novel coronavirus if there are not enough patients for final trials, a company executive said.

J&J kicked off in July early-stage human safety trials for its potential COVID-19 vaccine after releasing details of a study in monkeys that showed its best-performing candidate offered strong protection in a single dose.

It is developing the vaccine in collaboration with its Belgian subsidiary, Janssen.

Large-scale trials are set to start by the beginning of October and J&J aims to have results on the vaccine’s efficacy between the end of this year and mid-2021, Johan Van Hoof, head of vaccines at Janssen, told Reuters on Tuesday in a telephone interview.

Earlier on Tuesday, President Vladimir Putin said Russia had become the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, and before large-scale trials had been conducted.

Van Hoof said that production of the vaccine had already begun despite the financial risks involved, to make sure it would be available as soon as possible should it prove effective against the new coronavirus.

Several million doses will be ready by the beginning of 2021, with a total capacity of 1 billion shots by the end of the year, he said. He added that the company was likely to favor a single-jab approach, although a final decision on whether a booster would be needed had not yet been made.

ETHICAL ISSUES

Outcomes of large-scale, or Phase III, trials will depend on the incidence of infections, Van Hoof said, with faster results expected with higher virus transmission.

That is why J&J is likely to conduct those trials in the United States and Latin America, the world’s regions currently with the highest number of cases.

If infections drop significantly, J&J is also considering so-called challenge trials, in which volunteers are infected with the virus so that a vaccine candidate can be tested on them.

“We are looking into that possibility,” Van Hoof said, noting though that such trials posed ethical issues that needed to be resolved before they could be conducted. For instance, an effective therapy against the disease should be available to minimize risks for volunteers exposed to the virus.

In May British drugmaker AstraZeneca, which is developing a leading coronavirus vaccine with Oxford University, said it was too early to deliberately expose trial participants to the pathogen, but that may become an option if ongoing tests hit a snag.

Van Hoof said that preparations to stock the virus for possible challenge trials were already underway and J&J was part of ongoing discussions with universities and other bodies involved in these projects.

“We find it a very interesting idea,” he said, adding however, that setting up facilities for such trials would perhaps take longer than testing vaccines on people who are already infected in the community – as long as transmission remained relatively high.

(Reporting by Francesco Guarascio; editing by Emelia Sithole-Matarise)

Mexico to conduct late-stage trials for China, US COVID-19 vaccines

MEXICO CITY (Reuters) – Mexico will conduct late-stage clinical trials for COVID-19 vaccines in development by Johnson & Johnson and two Chinese companies, the foreign ministry said on Tuesday.

Large-scale, phase three human testing for the J&J unit Janssen Pharmaceuticals’ candidate could start in the second half of September, the company has previously said.

Mexico will also help test candidates for Chinese companies CanSino Biologics Inc and Walvax Biotechnology Co Ltd, the ministry said in a presentation at a news conference.

More than 150 vaccines are being developed and tested around the world to stop the COVID-19 pandemic, with 25 in human clinical trials, according to the World Health Organization.

Russia is the first country to approve a COVID-19 vaccine, which it named ‘Sputnik V’ for foreign markets, an official said on Tuesday.

Johnson & Johnson kicked off U.S. human safety trials in July 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.

Walvax’s experimental vaccine is currently under early testing at a Chinese military research institute.

CanSino Biologics’ vaccine candidate is already in clinical trials. The company is also collaborating with Canada’s National Research Council to “pave the way” for future trials in Canada, the research council in May.

Mexico has lobbied in world forums including at the G20 group of nations and the United Nations to secure equitable access for an eventual vaccine.

Latin America’s second largest economy has suffered more than 50,000 deaths from COVID-19, according to official data, making it the third country with most deaths globally.

It ranks 13th adjusted for deaths per capita, according to Johns Hopkins University School of Medicine.

(Reporting by Frank Jack Daniel; Editing by Chizu Nomiyama and Alistair Bell)

It’s not for me: speed of COVID-19 vaccine race raises safety concerns

By Francesco Guarascio and Josephine Mason

BRUSSELS/LONDON (Reuters) – The frenetic race to develop a COVID-19 vaccine has intensified safety concerns about an inoculation, prompting governments and drugmakers to raise awareness to ensure their efforts to beat the coronavirus aren’t derailed by public distrust.

There are more than 200 COVID-19 vaccine candidates in development globally, including more than 20 in human clinical trials. U.S. President Donald Trump has vowed to have a shot ready before year’s end, although they typically take 10 years or longer to develop and test for safety and effectiveness.

In the drive to find a potential COVID-19 vaccine “fast is good for politicians,” said Heidi Larson, who leads the Vaccine Confidence Project (VCP), a global surveillance program on vaccine trust. “But from the public perspective, the general sentiment is: ‘too fast can’t be safe'”, she told Reuters.

Regulators around the world have repeatedly said speed will not compromise safety, as quicker results would stem from conducting in parallel trials that are usually done in sequence.

However, these reassurances have failed to convince many, including in Western countries where skepticism about vaccinations was already growing before the pandemic.

Preliminary results of a survey conducted over the last three months in 19 countries showed that only about 70% of British and U.S. respondents would take a COVID-19 vaccine if available, Scott Ratzan, co-leader of ‘Business Partners to CONVINCE’, told Reuters.

Business Partners to CONVINCE, a U.S./UK initiative that is partly government funded, conducted the survey jointly with VCP and the results were broadly in line with a Reuters/Ipsos poll of the U.S. public in May.

“We just see this distrust growing against science and government,” said Ratzan.

“We need to address legitimate concerns about the rapid pace of development, political over-promises and the risks of vaccination.”

The VCP/Business Partners’ survey, expected to be published in a few weeks, will also show that Chinese participants were the most trusting of vaccines, while Russians were the least so, Ratzan said.

Drugmakers and governments had hoped the scale of the COVID-19 crisis would allay concerns about vaccines, which they see as crucial to defeating the pandemic and enabling economies to fully recover from its impact.

Vaccine hesitancy – or the reluctance or refusal to be vaccinated – is also known as “anti-vax,” a term that is sometimes associated with conspiracy theories when often it simply reflects many people’s concerns about side-effects or industry ethics.

In January 2019 the World Health Organisation named vaccine hesitancy as one of the top 10 global health threats for that year.

TAILORED MESSAGES

In Europe, skepticism among the public was high before the pandemic due to a range of factors including negative coverage of pharmaceutical companies as well as false theories including suggested links between childhood immunizations and autism.

Only 70% of French people considered vaccines safe in a 2018 survey commissioned by the European Union executive. The EU average was 82%, but trust fell to 68% for the shot against seasonal flu.

The VCP project on vaccine trust, funded by the European Commission and pharmaceutical companies among others, aims to identify early signs and causes of public mistrust and tackle them with information campaigns before it is too late.

Larson said headlines referring to Warp Speed – the name of the U.S. operation aimed at delivering a COVID-19 vaccine to the U.S. population by next year – could increase vaccine hesitancy even more than perceptions that the disease could become less lethal.

“One of the most frequent things that comes up in people’s conversations is concerns about how quick it is. If I have to pick one theme that is more recurrent than others it is this one,” Larson said.

Data collected by VCP from social media show that by the end of June about 40% of Britons’ posts concerning a COVID-19 vaccine, for example, were negative, with many distrusting any coronavirus vaccine and the medical establishment.

Announcements about fast progress in COVID vaccines in Russia and China in particular could also contribute to rising skepticism. “We don’t have transparency and don’t know how accurate or valid their data are,” Ratzan said, adding that errors there could boost skepticism elsewhere.

Key for any information campaign to be successful is to tailor it to different audiences as there is no uniform profile of anti-vaxxers, said Kate Elder of Doctors Without Borders, a non-governmental organisation.

“They go from the highly educated to those who don’t believe in science,” she said, urging politicians to be more careful in their messages on vaccines and to better explain the reasons behind potentially fast results against COVID-19.

“We are exploring the idea of a chatbot that will speak in different languages,” said Ratzan, adding it could be something similar to Smokey Bear, the U.S. Forest Service’s campaign to educate about preventing wildfires.

“Different parts of the world will require different strategies. We know we need to tailor it and to be specific,” he said.

Risks are high if hesitancy is not addressed quickly.

During the 2009 swine flu pandemic, growing skepticism about the vaccine led to a failure of the vaccination campaign in France, where only 8% of the population got a shot against the virus which is estimated to have killed around 280,000 people across the world.

A study published in May in the Lancet by a group of French scientists warned of similar risks now in the country where vaccine hesitancy went up from 18% in mid-March when a lockdown was imposed on the French to 26% by the end of that month.

“Distrust is likely to become an issue when the vaccine will be made available,” the scientists concluded.

(Reporting by Francesco Guarascio @fraguarascio in Brussels and Josephine Mason in London; Editing by Susan Fenton)

U.S. to pay over $1 billion for 100 million doses of Johnson & Johnson’s potential COVID-19 vaccine

(Reuters) – The United States government will pay Johnson & Johnson over $1 billion for 100 million doses of its potential coronavirus vaccine, its latest such arrangement as the race to tame the pandemic intensifies, the drugmaker said on Wednesday.

It said it would deliver the vaccine to the Biomedical Advanced Research and Development Authority (BARDA) on a not-for-profit basis to be used after approval or emergency use authorization by the U.S. Food and Drug Administration (FDA).

J&J has already received $1 billion in funding from the U.S. government – BARDA agreed in March to provide that money for the company to build manufacturing capacity for more than 1 billion doses of the experimental vaccine.

The latest contract equates to roughly $10 per vaccine dose produced by J&J. Including the first $1 billion deal with the U.S government, the price would be slightly higher than the $19.50 per dose that the United States is paying for the vaccine being developed by Pfizer Inc. and German biotech BioNTech SE.

The U.S. government may also purchase an additional 200 million doses under a subsequent agreement. J&J did not disclose that deal’s value.

J&J plans to study a one- or two-dose regimen of the vaccine in parallel later this year. A single-shot regimen could allow more people to be vaccinated with the same number of doses and would sidestep issues around getting people to come back for their second dose.

This is J&J’s first deal to supply its investigational vaccine to a country. Talks are underway with the European Union, but no deal has yet been reached.

J&J’s investigational vaccine is currently being tested on healthy volunteers in the United States and Belgium in an early-stage study.

There are currently no approved vaccines for COVID-19. More than 20 are in clinical trials.

(Reporting by Michael Erman in Maplewood, New Jersey, Shariq Khan in Bengaluru and Josephine Mason; Editing by Shinjini Ganguli, Emelia Sithole-Matarise and Jonathan Oatis)

Next big COVID-19 treatment may be manufactured antibodies

By Deena Beasley

(Reuters) – As the world awaits a COVID-19 vaccine, the next big advance in battling the pandemic could come from a class of biotech therapies widely used against cancer and other disorders – antibodies designed specifically to attack this new virus.

Development of monoclonal antibodies to target the virus has been endorsed by leading scientists. Anthony Fauci, the top U.S. infectious diseases expert, called them “almost a sure bet” against COVID-19.

When a virus gets past the body’s initial defenses, a more specific response kicks in, triggering production of cells that target the invader. These include antibodies that recognize and lock onto a virus, preventing the infection from spreading.

Monoclonal antibodies – grown in bioreactor vats – are copies of these naturally-occurring proteins.

Scientists are still working out the exact role of neutralizing antibodies in recovery from COVID-19, but drugmakers are confident that the right antibodies or a combination can alter the course of the disease that has claimed more than 675,000 lives globally.

“Antibodies can block infectivity. That is a fact,” Regeneron Pharmaceuticals executive Christos Kyratsous told Reuters.

Regeneron is testing a two-antibody cocktail, which it believes limits the ability of the virus’ to escape better than one, with data on its efficacy expected by late summer or early fall. “Protection will wane over time. Dosing is something we don’t know yet,” said Kyratsous.

The U.S. government in June awarded Regeneron a $450 million supply contract. The company said it can immediately begin production at its U.S. plant if regulators approve the treatment.

Eli Lilly and Co, AstraZeneca, Amgen, and GlaxoSmithKline were cleared by the U.S. government to pool manufacturing resources in order to scale up supplies if any of these drugs prove successful.

Even with that unusual cooperation among rivals, manufacturing these medicines is complex and capacity is limited. There is also a debate over whether a single antibody will be powerful enough to stop COVID-19.

AstraZeneca said it plans to start human trials of its dual-antibody combination within weeks.

Lilly, which began human testing in June of two antibody candidates in separate trials, is focusing on a one-drug approach.

“If you need a higher dosage or more antibodies, fewer people can be treated,” Lilly Chief Scientific Officer Dan Skovronsky said.

‘INSTANT IMMUNITY’

Unlike vaccines, which activate the body’s own immune system, the impact of infused antibodies eventually dissipates.

Still, drugmakers say monoclonal antibodies could temporarily prevent infection in at-risk people such as medical workers and the elderly. They could also be used as a therapeutic bridge until vaccines become widely available.

“In a prophylactic setting we think we may achieve coverage for up to six months,” said Phil Pang, chief medical officer of Vir Biotechnology, which aims to start testing an antibody in non-hospitalized patients next month with partner GSK.

“The advantage of an antibody is that it is basically instant immunity,” said Mark Brunswick, senior vice president at Sorrento Therapeutics, which aims to begin human trials next month of a single antibody candidate.

Safety risks for monoclonal antibodies are considered low, but their cost can be quite high. These type of drugs for cancer can cost over $100,000 a year.

There is also concern that the coronavirus could become resistant to specific antibodies. Researchers are already at work on second-generation compounds with targets other than the crown-like spikes the virus uses to invade cells.

“We are trying to develop something that is complementary,” Amgen research chief David Reese said. Amgen is working with Adaptive Biotechnologies Corp.

Researchers in a recent paper published in the journal Nature said they had discovered several new, very potent, antibodies directed to an area where the virus attaches to human cells and to a region of the spike that has not attracted attention.

“To avoid development of resistance you want to target different sites,” study author and Columbia University professor David Ho told Reuters.

There are also questions about when in the course of the illness it might be best to employ these new weapons.

“Giving an antibody later on after infection might not be that helpful, said Florian Krammer, microbiology professor at New York’s Icahn School of Medicine. “Given early, they probably work well.”

(Reporting By Deena Beasley, editing by Peter Henderson and Bill Berkrot)

Anxious WHO implores world to ‘do it all’ in long war on COVID-19

By Michael Shields and Emma Farge

GENEVA (Reuters) – The World Health Organization warned on Monday that there might never be a “silver bullet” for COVID-19 in the form of a perfect vaccine and that the road to normality would be long, with some countries requiring a reset of strategy.

More than 18.14 million people around the world are reported to have been infected with the disease and 688,080​ have died, according to a Reuters tally, with some nations that thought they were over the worst experiencing a resurgence.

WHO Director-General Tedros Adhanom Ghebreyesus and WHO emergencies head Mike Ryan exhorted nations to rigorously enforce health measures such as mask-wearing, social distancing, hand-washing and testing.

“The message to people and governments is clear: ‘Do it all’,” Tedros told a virtual news briefing from the U.N. body’s headquarters in Geneva. He said face masks should become a symbol of solidarity round the world.

“A number of vaccines are now in phase three clinical trials and we all hope to have a number of effective vaccines that can help prevent people from infection. However, there’s no silver bullet at the moment – and there might never be.”

The WHO head said that, while the coronavirus was the biggest health emergency since the early 20th century, the international scramble for a vaccine was also “unprecedented”.

But he underscored uncertainties. “There are concerns that we may not have a vaccine that may work, or its protection could be for just a few months, not more. But until we finish the clinical trials, we will not know.”

“THE WAY OUT IS LONG”

Ryan said countries with high transmission rates, including Brazil and India, needed to brace for a big battle: “The way out is long and requires a sustained commitment,” he said, calling for a “reset” of approach in some places.

“Some countries are really going to have to take a step back now and really take a look at how they are addressing the pandemic within their national borders,” he added.

Asked about the U.S. outbreak, which White House coronavirus experts say is entering a “new phase,” he said officials seemed to have set out the “right path” and it was not the WHO’s job to do so.

The WHO officials said an advance investigation team had concluded its China mission and laid out the groundwork for further efforts to identify the origins of the virus.

The study is one of the demands made by top donor the United States which plans to leave the body next year, accusing it of being too acquiescent to China.

A larger, WHO-led team of Chinese and international experts is planned next, including in the city of Wuhan, although the timing and composition of that was unclear. Ryan said China had already given some information but knowledge gaps remained.

(Reporting by Michael Shields, Emma Farge and Francesco Guarascio; Writing by Andrew Cawthorne; Editing by Kevin Liffey)

Large U.S. COVID-19 vaccine trials will exclude pregnant women for now

By Julie Steenhuysen

CHICAGO (Reuters) – The first two COVID-19 vaccines to enter large-scale U.S. trials will not be tested in pregnant women this year, raising questions about how this vulnerable population will be protected from the coronavirus, researchers told Reuters.

Moderna and Pfizer, which has partnered with Germany’s BioNTech, this week separately launched clinical trials that use a new and unproven gene-based technology. Both companies are requiring proof of a negative pregnancy test and a commitment to using birth control from women of childbearing age who enroll.

Drugmakers say they first need to make sure the vaccines are safe and effective more generally. In addition, U.S. regulators require that drugmakers conduct safety studies in pregnant animals before the vaccines are tested in pregnant women to ensure they don’t harm the fetus or lead to miscarriage.

Bioethicists, vaccine and maternal health experts have argued for years that pregnant women should be included early in trials of pandemic vaccines so they would not need to wait until long after a successful candidate emerges. That debate fell on deaf ears in recent outbreaks of Ebola and Zika, but has taken on new urgency in the era of COVID-19, as studies show pregnant women are at increased risk of severe disease from the new coronavirus.

“It’s a problem because if (vaccines) are not tested in pregnancy, then they may not be available or people may not be comfortable offering them,” said Dr. Denise Jamieson, chief of gynecology and obstetrics for Emory Healthcare in Atlanta.

According to the 2012 Census, 75.4 million U.S. women were of childbearing age, defined as 15 to 50 years old. Currently, pregnant women are recommended to take flu and whooping cough vaccines and certain others depending on individual circumstances, but none of these have been specifically tested and proven safe for pregnant women.

“We have an enormous number of women of childbearing age and potentially getting pregnant, and what’s the safest vaccine for them?” said Dr. Larry Corey, a vaccine expert at Fred Hutchinson Cancer Center in Seattle who is helping oversee vaccine trials conducted by Moderna and other drugmakers in collaboration with the U.S. government.

Doctors may want to see even more data for completely new vaccine technologies, such as those used by Moderna and Pfizer, compared with one that has already been used in pregnant women.

Such differences highlight why “we need multiple vaccines” to best address the needs of specific populations, Corey said.

A PRECEDENT IN PREGNANCY

Johnson & Johnson, which kicked off a small-scale safety trial for its COVID-19 vaccine this week, is using the same underlying technology that it used with its Ebola vaccine, which has been used in 1,000 pregnant women in Democratic Republic of Congo. Larger studies with that vaccine are now under way.

J&J’s chief scientific officer, Dr. Paul Stoffels, told Reuters the company has done many years of “extensive” pre-clinical study with the Ebola vaccine, including on pregnant animals, and “has not see any challenges.”

Stoffels said J&J would decide in the next few weeks whether it will include pregnant women in its large Phase 3 late-stage trial for a COVID-19 vaccine due to start in September. Pfizer expects to start toxicology studies in pregnant animals shortly, with data ready for review by the U.S. Food and Drug Administration in the first quarter of 2021. Studies in pregnant women could start some time afterward.

“We continue to explore potential ways to shorten the time to studies in pregnant women,” Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told Reuters.

Of course, unplanned pregnancies can happen even when women are using reliable contraception. Based on past experiences in such trials, Gruber said he expects about 1% of women in Pfizer’s Phase 3 trial, or about 150 women, will become pregnant. And those women and their babies will be followed closely.

Moderna said in an emailed statement that the company launched its safety study in pregnant animals at the end of June and expects results by the end of this year.

“Once we have generated additional safety data for our vaccine, and importantly demonstrated that it is efficacious, we intend to conduct additional studies in this important population,” a Moderna spokesperson said.

Sanofi, whose coronavirus vaccine is based on its flu vaccine platform, is doing reproductive toxicology in animals, but those results won’t be ready before the start of the company’s large Phase 3 trials, expected to start by year-end.

Sanofi may establish a pregnancy registry after the vaccine is approved to track outcomes in pregnant women, as has been done in the past.

Merck & Co. said it has not made any decisions yet on when to test its vaccine candidate in pregnant women. Novavax and AstraZeneca Plc declined to comment on their plans.

Dr. Flor Munoz, an expert in maternal use of vaccines at Baylor College of Medicine, said companies have been reluctant to test anything in pregnant women since the 1950’s and 60’s, after the drug thalidomide, which was used to treat nausea in pregnancy, caused widespread birth defects. She agrees that preliminary testing is needed.

The vaccines “need to be reasonably safe and reasonably effective,” she said. “We don’t necessarily have to finish the Phase 3 trials.”

(Reporting by Julie Steenhuysen; editing by Michele Gershberg and Leslie Adler)

Chinese-backed hackers targeted COVID-19 vaccine firm Moderna

By Christopher Bing and Marisa Taylor

WASHINGTON (Reuters) – Chinese government-linked hackers targeted biotech company Moderna Inc <MRNA.O>, a leading U.S.-based coronavirus vaccine research developer, earlier this year in a bid to steal valuable data, according to a U.S. security official tracking Chinese hacking activity.

Last week, the U.S. Justice Department made public an indictment of two Chinese nationals accused of spying on the United States, including three unnamed U.S.-based targets involved in medical research to fight the COVID-19 pandemic. The indictment states the Chinese hackers “conducted reconnaissance” against the computer network of a Massachusetts biotech firm known to be working on a coronavirus vaccine in January.

Moderna, which is based in Massachusetts and announced its COVID-19 vaccine candidate in January, confirmed to Reuters that the company had been in contact with the FBI and was made aware of the suspected “information reconnaissance activities” by the hacking group mentioned in last week’s indictment.

Reconnaissance activities can include a wide range of actions, including probing public websites for vulnerabilities to scouting out important accounts after entering a network, cybersecurity experts say.

“Moderna remains highly vigilant to potential cybersecurity threats, maintaining an internal team, external support services and good working relationships with outside authorities to continuously assess threats and protect our valuable information,” spokesman Ray Jordan said, declining to provide further detail.

The U.S. security official, who spoke on condition of anonymity, did not provide further details. The FBI and the U.S. Department of Health and Human Services declined to disclose the identities of companies targeted by Chinese hackers.

Moderna’s vaccine candidate is one of the earliest and biggest bets by the Trump administration to fight the pandemic. The federal government is supporting development of the company’s vaccine with nearly half a billion dollars and helping Moderna launch a clinical trial of up to 30,000 people beginning this month.

China is also racing to develop a vaccine, bringing together its state, military and private sectors to combat a disease that has killed over 660,000 people worldwide.

A July 7 indictment released last week alleges that the two Chinese hackers, Li Xiaoyu and Dong Jiazhi, conducted a decade-long hacking spree that most recently included the targeting of COVID-19 medical research groups.

Prosecutors said Li and Dong acted as contractors for China’s Ministry of State Security, a state intelligence agency. Messages left with several accounts registered under Li’s digital alias, oro0lxy, were not returned. Contact details for Dong were not available.

The Chinese Embassy in Washington referred Reuters to recent Chinese Foreign Ministry comments that said: “China has long been a major victim of cyber thefts and attacks” and its officials “firmly oppose and fight” such activities. The Chinese government has consistently denied any role in hacking incidents across the globe. The embassy spokesperson did not address specific questions sent via email.

The two other unnamed medical research companies mentioned in the Justice Department indictment are described as biotech companies based in California and Maryland. Prosecutors said the hackers “searched for vulnerabilities” and “conducted reconnaissance” against them.

The court filing describes the California firm as working on antiviral drug research and suggested the Maryland company had publicly announced efforts to develop a vaccine in January. Two companies that could match those descriptions: Gilead Sciences Inc <GILD.O> and Novavax Inc <NVAX.O>.

Gilead spokesperson Chris Ridley said the firm does not comment on cybersecurity matters. Novavax would not comment on specific cyber security activities but said: “Our cyber security team has been alerted to the alleged foreign threats identified in the news.”

A security consultant familiar with multiple hacking investigations involving premier biotech firms over the last year said Chinese hacking groups believed to be broadly associated with China’s Ministry of State security are one of the primary forces targeting COVID-19 research, globally. This matches the description of the indicted hackers, as MSS contractors.

(Reporting by Christopher Bing and Marisa Taylor; Editing by Chris Sanders and Lisa Shumaker)

Johnson & Johnson starts human study of COVID-19 vaccine after promising monkey data

By Julie Steenhuysen

(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 vaccine candidate 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 drugmaker said it had started early-stage human trials in the United States and Belgium and would test its vaccine candidate in more than 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.

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.

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.

“The Johnson & Johnson vaccine is exciting because it’s a single dose,” White House Coronavirus Task Force Coordinator Deborah Birx said in an interview with Fox News.

Having one dose “show protection in monkeys like the other vaccines have shown with two doses does shorten the time period for development because your readout becomes 30 days quicker,” she said.

J&J’s vaccine uses a common cold virus known as adenovirus 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 capable 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 Israel Deaconness who led the research in collaboration with J&J.

J&J shares were up nearly 2% at $149.93 before the market open on Thursday.

(Reporting by Julie Steenhuysen in Chicago; Additional reporting by Ankur Banerjee in Bengaluru and Lisa Lambert in Washington; Editing by Richard Pullin, Shounak Dasgupta and Paul Simao)

What you need to know about the coronavirus right now

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

Republicans and Democrats in tough talks

U.S. Republicans and Democrats faced difficult talks on Tuesday over how best to recover from the coronavirus pandemic, after Republicans unveiled a relief proposal four days before millions of Americans lose unemployment benefits.

Senate Republicans announced on Monday a $1 trillion aid package hammered out with the White House, which Senate Majority Leader Mitch McConnell touted as a “tailored and targeted” plan to reopen schools and businesses while protecting firms from lawsuits.

But the proposal brought opposition from both sides. Democrats decried it as too limited compared with their $3 trillion proposal that passed the House of Representatives in May. Some Republicans called it too expensive.

Vaccine updates

U.S. and company officials are hopeful Moderna Inc’s vaccine against COVID-19 could be ready for widespread use by the end of this year, after the drugmaker announced the start of a 30,000-subject trial to demonstrate it is safe and effective, the final hurdle prior to regulatory approval.

German biotech BioNTech and U.S. drugmaker Pfizer Inc said on Monday they would begin a pivotal global study to evaluate their lead vaccine candidate. If the study is successful, the companies could submit the vaccine for regulatory approval as early as October.

Meanwhile, European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & are mired in wrangles over price, payment method and potential liability costs, three EU officials told Reuters.

‘Negligence’ blamed for Germany’s virus case rise

Negligence is behind Germany’s steady rise in new coronavirus infections, the head of a state-funded research body said on Tuesday, adding it was unclear if a second wave was underway.

“The new developments in Germany make me very worried,” said Lothar Wieler, of the Robert Koch Institute (RKI) for infectious diseases. “The rise has to do with the fact that we have become negligent,” he added, urging people not to flout social distancing rules.

The number of daily new cases almost doubled on Tuesday to 633, and the RKI linked that to increased contact at parties and the workplace.

Swift moves in Vietnam

Vietnam suspended all flights to and from Danang for 15 days after at least 14 coronavirus cases were detected in the city. Two people were in critical condition.

“All evacuation flights now are cancelled,” CAAV deputy director Vo Huy Cuong told Reuters by phone on Tuesday. “We operated 90 flights to evacuate tourists stranded in Danang yesterday but most tourists had already left Danang on Sunday, mostly by coach or train to nearby provinces.”

All bus and train services to and from Danang have also been suspended from Tuesday. With over 95 million people, Vietnam is the most populous country in the world to have recorded no COVID-19 fatalities.

Fly all you want

China Southern Airlines, China’s biggest carrier by passengers, on Tuesday rolled out a “Fly Happily” deal, which allows buyers to use passes for as many flights as they wish for destinations across the country from Aug. 26 to Jan. 6 for 3,699 yuan ($529).

At least eight of China’s dozens of airlines have introduced similar deals since June. Industry watchers say the packages have been a shot in the arm.

But Luya You, transportation analyst at BOCOM International, said these promotional packages can only stimulate demand when coronavirus risks are already sufficiently reduced. “While these packages may work in domestic markets, we do not expect similar rollouts for outbound routes anytime soon,” she said.

(Compiled by Linda Noakes and Karishma Singh; Editing by Andrew Cawthorne)