Nestle gets peanut allergy treatment with $2 billion Aimmune buyout

By Silke Koltrowitz and Manas Mishra

(Reuters) – Nestle will pay $2 billion to buy the remaining stake in Aimmune Therapeutics Inc., gaining full ownership of the first U.S.-approved peanut allergy treatment which has struggled with a slow launch due to the COVID-19 pandemic.

Nestle said on Monday its offer for Aimmune values the California-based drugmaker, in which it already has a stake of around 25.6%, at $2.6 billion.

Aimmune’s shares more than doubled on Monday, just shy of Nestle’s offer price of $34.50 per share.

The U.S. company’s shares have slumped this year, as the pandemic led to many clinician’s offices remaining shut, leading to a slow launch of its therapy, Palforzia, which was approved in January.

Shares “started 2020 right about at this level before the pandemic, and resultant shut-down of allergy clinics across the U.S. essentially killed the launch of Palforzia,” Piper Sandler analyst Christopher Raymond said.

“As pandemic-related disruption recedes and Palforzia’s true demand begins to manifest, it will be deemed that Nestle got itself a bargain here,” Raymond added.

Peanut allergies are prevalent in an estimated 1.6 million teens and children in the United States alone, making it a lucrative market that could eventually help Aimmune bring in billions of dollars in sales.

The deal helps Nestle, known for its KitKat chocolate bars and Nescafe instant coffee, expand its Nestle Health Science division which it set up in 2011 to open up a new area of business.

With Nestle’s prior investment of $473 million, it would be making a cash payment of just under $2 billion, Nestle Health head Greg Behar told Reuters.

The unit was on track to more than double sales by 2022, from 2 billion Swiss francs ($2.21 billion) in 2014, and was expected to close 2020 at 3.3 billion francs, Behar added.

($1 = 0.9035 Swiss francs)

(Reporting by Silke Koltrowitz in Zurich and Manas Mishra in Bengaluru; Editing by John Miller, Alexander Smith and Shounak Dasgupta)

Scientists see downsides to top COVID-19 vaccines from Russia, China

By Allison Martell and Julie Steenhuysen

TORONTO/CHICAGO (Reuters) – High-profile COVID-19 vaccines developed in Russia and China share a potential shortcoming: They are based on a common cold virus that many people have been exposed to, potentially limiting their effectiveness, some experts say.

CanSino Biologics’ vaccine, approved for military use in China, is a modified form of adenovirus  type 5, or Ad5. The company is in talks to get emergency approval in several countries before completing large-scale trials, the Wall Street Journal reported last week.

A vaccine developed by Moscow’s Gamaleya Institute, approved in Russia earlier this month despite limited testing, is based on Ad5 and a second less common adenovirus.

“The Ad5 concerns me just because a lot of people have immunity,” said Anna Durbin, a vaccine researcher at Johns Hopkins University. “I’m not sure what their strategy is … maybe it won’t have 70% efficacy. It might have 40% efficacy, and that’s better than nothing, until something else comes along.”

Vaccines are seen as essential to ending the pandemic that has claimed over 845,000 lives worldwide. Gamaleya has said its two-virus approach will address Ad5 immunity issues.

Both developers have years of experience and approved Ebola vaccines based on Ad5. Neither CanSino nor Gamaleya responded to requests for comment.

Researchers have experimented with Ad5-based vaccines against a variety of infections for decades, but none are widely used. They employ harmless viruses as “vectors” to ferry genes from the target virus – in this case the novel coronavirus – into human cells, prompting an immune response to fight the actual virus.

But many people already have antibodies against Ad5, which could cause the immune system to attack the vector instead of responding to the coronavirus, making these vaccines less effective.

Several researchers have chosen alternative adenoviruses or delivery mechanisms. Oxford University and AstraZeneca based their COVID-19 vaccine on a chimpanzee adenovirus, avoiding the Ad5 issue. Johnson & Johnson’s candidate uses Ad26, a comparatively rare strain.

Dr. Zhou Xing, from Canada’s McMaster University, worked with CanSino on its first Ad5-based vaccine, for tuberculosis, in 2011. His team is developing an inhaled Ad5 COVID-19 vaccine, theorizing it could circumvent pre-existing immunity issues.

“The Oxford vaccine candidate has quite an advantage” over the injected CanSino vaccine, he said.

Xing also worries that high doses of the Ad5 vector in the CanSino vaccine could induce fever, fueling vaccine skepticism.

“I think they will get good immunity in people that don’t have antibodies to the vaccine, but a lot of people do,” said Dr. Hildegund Ertl, director of the Wistar Institute Vaccine Center in Philadelphia.

In China and the United States, about 40% of people have high levels of antibodies from prior Ad5 exposure. In Africa, it could be as high as 80%, experts said.

HIV RISK

Some scientists also worry an Ad5-based vaccine could increase chances of contracting HIV.

In a 2004 trial of a Merck & Co Ad5-based HIV vaccine, people with pre-existing immunity became more, not less, susceptible to the virus that causes AIDS.

Researchers, including top U.S. infectious diseases expert Dr. Anthony Fauci, in a 2015 paper, said the side effect was likely unique to HIV vaccines. But they cautioned that HIV incidence should be monitored during and after trials of all Ad5-based vaccines in at-risk populations.

“I would be worried about the use of those vaccines in any country or any population that was at risk of HIV, and I put our country as one of them,” said Dr. Larry Corey, co-leader of the U.S. Coronavirus Vaccine Prevention Network, who was a lead researcher on the Merck trial.

Gamaleya’s vaccine will be administered in two doses: The first based on Ad26, similar to J&J’s candidate, and the second on Ad5.

Alexander Gintsburg, Gamaleya’s director, has said the two-vector approach addresses the immunity issue. Ertl said it might work well enough in individuals who have been exposed to one of the two adenoviruses.

Many experts expressed skepticism about the Russian vaccine after the government declared its intention to give it to high-risk groups in October without data from large pivotal trials.

“Demonstrating safety and efficacy of a vaccine is very important,” said Dr. Dan Barouch, a Harvard vaccine researcher who helped design J&J’s COVID-19 vaccine. Often, he noted, large-scale trials “do not give the result that is expected or required.”

(Additional reporting by Christine Soares in New York, Kate Kelland in London, Polina Ivanova in Moscow and Roxanne Liu in Beijing; Editing by Caroline Humer and Bill Berkrot)

What you need to know about the coronavirus right now

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

Global records

India reported 78,512 new novel coronavirus infections on Monday, slightly fewer than its record set the previous day when it posted the biggest, single-day tally of infections of any country in the pandemic. On Sunday, India’s total of 78,761 new cases exceeded the previous record of 77,299 in the United States on July 16, a Reuters tally of official data showed.

Despite the surging case numbers, Prime Minister Narendra Modi has been pushing for a return to normalcy to lessen the economic pain of the pandemic, having earlier imposed strict lockdowns of the country’s 1.3 billion people.

U.S. cases of the novel coronavirus surpassed 6 million on Sunday as many states in the Midwest reported increasing infections, according to a Reuters tally. While the United States has the most recorded infections in the world, it ranks tenth based on cases per capita.

More than eight months into the pandemic, the United States continues to struggle with testing. The number of people tested has fallen in recent weeks. Public health officials believe the United States needs to test more frequently to find asymptomatic coronavirus carriers to slow the spread of the COVID-19 disease.

Mutation found in Indonesia

A more infectious mutation of the new coronavirus has been found in Indonesia, the Jakarta-based Eijkman Institute for Molecular Biology said on Sunday, as the Southeast Asian country’s caseload surges.

The “infectious but milder” D614G mutation of the virus has been found in genome sequencing data from samples collected by the institute, deputy director Herawati Sudoyo told Reuters, adding that more study is required to determine whether that was behind the recent rise in cases.

The strain, which the World Health Organization said was identified in February and has been circulating in Europe and the Americas, has also been found in neighboring Singapore and Malaysia.

Vaccine approval and use underway in China

Sinovac Biotech Ltd’s coronavirus vaccine candidate CoronaVac was approved for emergency use as part of a program in China to vaccinate high-risk groups such as medical staff, a person familiar with the matter said.

China National Biotec Group (CNBG), a unit of state-owned pharmaceutical giant China National Pharmaceutical Group (Sinopharm), also said it had obtained emergency use approval for a coronavirus vaccine candidate in social media platform WeChat last Sunday. CNBG, which has two vaccine candidates in phase 3 clinical trials, did not say which of its vaccines had been cleared for emergency use.

China has been giving experimental coronavirus vaccines to high-risk groups since July, though officially it has given little details on which vaccine candidates have been given to high-risk people under the emergency use program and how many people have been vaccinated.

Lighter traffic in Seoul; masks on in Auckland

Private tuition centers shut for the first time and traffic was lighter in South Korea’s capital on Monday, the first working day of tighter social-distancing rules designed to halt a second wave of coronavirus outbreaks.

The decision came after earlier restrictions on movement failed to prevent a second wave of coronavirus infections from erupting at churches, offices, nursing homes and medical facilities.

Meanwhile in Auckland, schools and businesses reopened on Monday after the lifting of a lockdown in New Zealand’s largest city to contain the resurgence of the coronavirus, but face masks were made mandatory on public transport across the country. Prime Minister Jacinda Ardern said she was confident the new measure would be taken up across New Zealand, adding that “a bit of smiling with the eyes behind the mask” and kindness to Aucklanders in particular, would help get the country through the latest outbreak.

(Compiled by Karishma Singh; Editing by Jacqueline Wong)

GSK, partner Vir join race to find COVID-19 antibody treatment

(Reuters) – GlaxoSmithKline and partner Vir Biotechnology have started testing their experimental antibody on early-stage COVID-19 patients, entering the race to find a winner in a promising class of antiviral drugs to combat the pandemic.

The British drugmaker said on Monday the long-acting single injection will be tested on recently diagnosed high-risk cases for its ability to prevent hospitalization, typically a life threatening disease stage.

GSK, which in April moved to invest $250 million in Vir and agreed to collaborate on the antibody, is behind some peers in developing the class.

Regeneron, which is working on antibody manufacturing with Roche, expects initial data from ongoing trials of its COVID-19 two-antibody combination in September.

Eli Lilly, working with biotech firm AbCellera, early this month started testing whether their antibody can prevent the infections in nursing homes. A separate trial testing the compound on recently diagnosed COVID patients may yield initial data in September or shortly after.

“We’re coming into the clinic a little bit later and part of that is because we spent some time selecting what we believe will be a best-in-class antibody,” Vir Chief Executive George Scangos told Reuters.

The antibody is designed to not only block the virus from invading cells but also to recruit immune cells to kill already infected cells, which would otherwise replicate the virus.

It also has been altered to stay effective for several months on a single shot and to cling to a part of the virus’s outer spike protein that has shown no tendency to mutate.

After testing the drug on an initial 20 U.S. participants over two weeks for safety, the trial will expand to 1,300 patients globally.

GSK said initial results could be available by the end of the year, complete results during the first quarter of 2021, and early access to patients could be on the cards before June.

GSK’s more prominent role so far in combating the pandemic has been in providing adjuvants, efficacy boosters that play a vital role in many vaccines.

The global effort to develop a vaccine against the virus, which has so far claimed more than 800,000 lives globally, has seen recent launches of late-stage trials, but work on treatments has also gone into overdrive.

While one approach has been to quell a dangerous overreaction of the immune system, known as cytokine storm, another has been to block the virus from invading cells with antibodies.

Antibodies, part of the body’s adaptive immune system, are normally made by white blood cells in response to a foreign substance in the body.

But pharma companies, also including AstraZeneca and Molecular Partners, are working on manufactured monoclonal antibodies, made in bioreactors from living cells, for a more targeted attack on the virus.

Using plasma from recovered COVID-19 patients, which contains a range of antibodies, is a similar approach but it may be fraught with more complex logistics and less consistent quality than manufactured antibodies.

In future studies, GSK and Vir plan to run more trials on their antibody’s ability to prevent the infection and treat patients that are already in hospital care. Later this year, they plan to start a trial of a second antibody from the collaboration.

(Reporting by Ludwig Burger; editing by David Evans)

COVID-19 can wipe out health care progress in short order: WHO

By Emma Farge

GENEVA (Reuters) – More than 90% of countries have seen ordinary health services disrupted by the COVID-19 pandemic, with major gains in medical care attained over decades vulnerable to being wiped out in a short period, a World Health Organization survey showed.

The Geneva-based body has frequently warned about other life-saving programs being impacted by the pandemic and has sent countries mitigation advice, but the survey yielded the first WHO data so far on the scale of disruptions.

“The impact of the COVID-19 pandemic on essential health services is a source of great concern,” said a report on the study released on Monday. “Major health gains achieved over the past two decades can be wiped out in a short period of time…”

The survey includes responses from between May and July from more than 100 countries. Among the most affected services were routine immunizations (70%), family planning (68%) and cancer diagnosis and treatment (55%), while emergency services were disturbed in almost a quarter of responding countries.

The Eastern Mediterranean Region, which includes Afghanistan, Syria and Yemen, was most affected followed by the African and Southeast Asian regions, it showed. The Americas was not part of the survey.

Since COVID-19 cases were first identified in December last year, the virus is thought to have killed nearly 850,000 people, the latest Reuters tally showed.

Researchers think that non-COVID deaths have also increased in some places due partly to health service disruptions, although these may be harder to calculate.

The WHO survey said it was “reasonable to anticipate that even a modest disruption in essential health services could lead to an increase in morbidity and mortality from causes other than COVID-19 in the short to medium and long-term.” Further research was needed.

It also warned that the disruptions could be felt even after the pandemic ends. “The impact may be felt beyond the immediate pandemic as, in trying to catch up on services, countries may find that resources are overwhelmed.”

(Reporting by Emma Farge; Editing by Mark Heinrich)

Beyond Meat begins direct online sales of plant-based patties

(Reuters) – Beyond Meat Inc on Thursday launched a new website to sell its plant-based meat products to U.S. customers, just nearly three months after rival Impossible Foods started its direct-to-consumer sales.

The move comes at a time when demand for vegan products has surged amid rising beef prices due to the COVID-19 pandemic and restaurant traffic has not recovered to normal levels.

Impossible Foods, which began direct online sales in June, and Beyond Meat currently sell their plant-based meat products in thousands of retail stores across the United States, including Kroger and Walmart Inc.

Beyond Meat has been seeing a jump in consumer demand in its retail channels during the lockdown and said direct online sales would include the Beyond Beef and Sausage patties, with two-day shipping included in all orders.

(Reporting by Aditi Sebastian; Editing by Ramakrishnan M.)

Moderna’s COVID-19 vaccine shows similar immune response in old and young

(Reuters) – Moderna Inc said on Wednesday that an analysis of the early-stage data of its experimental COVID-19 vaccine showed it induced immune responses in older adults that were similar to younger participants.

The drug developer is one of the leading U.S. contenders in the race to develop a safe and effective vaccine against the novel coronavirus and its candidate, mRNA-1273, is already in the Phase 3 stage of human testing.

Moderna is now reporting interim data from the Phase 1 study, which includes new analysis from 20 additional people and details on how the vaccine performs in older people.

The analysis looked at 100 micro gram dosage that has been selected for the larger Phase 3 trial. Moderna said the immune responses in those aged between 56 and 70 years, above 70 and those in the age-group of 18 and 55 were similar.

The data is being presented at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday.

The company has so far enrolled over 13,000 participants in the late-stage study and about 18% of the total participants are Black, Latino, American Indian or Alaska Native, groups that are the hardest hit by the pandemic.

Moderna, which has no drugs in the market, has received nearly $1 billion from the U.S. government under a plan to speed up vaccine development for COVID-19. It has also struck a $1.5 billion supply agreement with the United States.

Shares of the drug developer rose more than 7% to $71.35 after the data. They have more than tripled in value so far this year and results from its studies have boosted the broader market.

(Reporting by Manojna Maddipatla in Bengaluru; Additional reporting by Ankur Banerjee; Editing by Arun Koyyur)

White House says Trump could act unilaterally to avoid U.S. airline layoffs

WASHINGTON (Reuters) – President Donald Trump could take executive action to avoid massive layoffs at U.S. airlines, while the coronavirus pandemic weighs on air travel and talks on a new COVID-19 stimulus bill remain stall in Congress, White House Chief of Staff Mark Meadows said on Wednesday.

“We’re looking at other executive actions,” Meadows said in an online interview with Politico. “If Congress is not going to work, this president is going to get to work and solve some problems. So hopefully, we can help out the airlines and keep some of those employees from being furloughed.”

His remarks came a day after American Airlines said its workforce will shrink by 40,000, including 19,000 involuntary cuts, in October without an extension of government aid.

Meadows said he has spoken to American Airlines, as well as United Airlines, which has warned that 36,000 jobs are on the line, and to Delta Air Lines, which announced furloughs of nearly 2,000 pilots on Monday.

“So we’ve raised this issue. It would take a CARES package, I believe, to do it,” Meadows said, referring to a $3 trillion coronavirus relief package that Congress passed earlier this year.

Talks between Meadows, Treasury Secretary Steven Mnuchin, House of Representatives Speaker Nancy Pelosi and Senate Democratic leader Chuck Schumer ended in early August, with top Democrats and the administration far apart on new legislation. Meadows told Politico that he is not optimistic that negotiations will restart soon.

(Reporting by David Morgan; Editing by Chizu Nomiyama and Alistair Bell)

U.S. rejects U.N. rights panel upholding access to abortions during pandemic

An exam room at the Planned Parenthood South Austin Health Center is shown in Austin, Texas, U.S. June 27, 2016. REUTERS/Ilana Panich-Linsman

By Stephanie Nebehay

GENEVA (Reuters) – The United States on Wednesday hit back at a U.N. women’s rights panel that said some U.S. states limited access to abortions during the COVID-19 pandemic, rejecting its interference and the notion of “an assumed right to abortion”.

“The United States is disappointed by and categorically rejects this transparent attempt to take advantage of the COVID-19 pandemic to assert the existence of such a right,” the U.S. mission in Geneva said in a release posted on Twitter.

“This is a perversion of the human rights system and the founding principles of the United Nations,” it said, citing an Aug. 11 letter it sent to the U.N. experts responding to the “spurious allegations”.

The U.N. working group on discrimination against women and girls said on May 27 that some U.S. states “appear to be “manipulating the COVID-19 crisis to curb access to essential abortion care”.

The panel of five independent U.N. experts said that states including Texas, Oklahoma, Alabama, Iowa, Ohio, Arkansas, Louisiana and Tennessee had issued COVID-19 emergency orders suspending procedures not deemed immediately medically necessary to restrict access to abortion.

“This situation is also the latest example illustrating a pattern of restrictions and retrogressions in access to legal abortion care across the country,” Elizabeth Broderick, panel vice-chair, said at the time.

The U.S. statement cited allegations of forced abortions and sterilizations in China’s western region of Xinjiang and urged the panel to focus on “actual human rights abuses”.

A lack of comment on such issues was “one of the reasons that the United States and others increasingly see the U.N.’s human rights system as utterly broken”.

U.S. President Donald Trump, seeking re-election in November, works closely with evangelical Christians and puts their causes of restricting abortion and preserving gun ownership at the top of his policy agenda.

(Reporting by Stephanie Nebehay; Editing by Nick Macfie)

Pandemic pace slows worldwide except for southeast Asia, eastern Mediterranean: WHO

By Stephanie Nebehay

GENEVA (Reuters) – The COVID-19 pandemic is still expanding, but the rise in cases and deaths has slowed globally, except for southeast Asia and the eastern Mediterranean regions, the World Health Organization (WHO) said.

In its latest epidemiological update, issued on Monday night, it said that the Americas remains the hardest-hit region, accounting for half of newly reported cases and 62% of the 39,240 deaths worldwide in the past week.

More than 23.65 million people have been reported to be infected by the coronavirus globally and 811,895​ have died, according to a Reuters tally on Tuesday.

“Over 1.7 million new COVID-19 cases and 39,000 new deaths were reported to WHO for the week ending 23 August, a 4% decrease in the number of cases and (a 12% decrease) in the number of deaths compared to the previous week,” the WHO said.

Southeast Asia, the second most affected region, reported a jump accounting for 28% of new cases and 15% of deaths, it said. India continues to report the majority of cases, but the virus is also spreading rapidly in Nepal.

In WHO’s eastern Mediterranean region, the number of reported cases rose by 4%, but the number of reported deaths has consistently dropped over the last six weeks, the WHO said. Lebanon, Tunisia and Jordan reported the highest increase in cases compared to the previous week.

The number of cases and deaths reported across Africa decreased by 8% and 11% respectively in the past week, “primarily due to a decrease in cases reported in Algeria, Kenya, Ghana, Senegal and South Africa”, it said.

“In the European region, the number of cases reported has consistently increased over the last three weeks,” it said. “However, only a slight decrease (1%) was reported in the most recent week, and the number of deaths have continued to decrease across the region.”

In WHO’s western Pacific region, the number of new cases dropped by 5%, driven by less spread in Japan, Australia, Singapore, China and Vietnam. South Korea reported an 180% jump in cases, “mainly due to an increase in cases associated with religious gatherings”.

(Reporting by Stephanie Nebehay; Editing by Giles Elgood)