Tag Archives: BIODRG

U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot

Jan 26 (Reuters) – New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer (PFE.N)/BioNTech (22UAy.DE) COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday.

U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases.

The new data was presented at a meeting of outside experts that advise the FDA on vaccine policy.

Earlier this month, U.S. health officials said they had detected the possible link to ischemic strokes in people over age 65 who received the newer booster shots in its Vaccine Safety Datalink (VSD) database. They said at the time it was very unlikely to represent a true clinical risk.

Dr. Nicola Klein of healthcare company Kaiser Permanente, which maintains VSD data for the CDC, said the rate of strokes observed in the database had slowed in recent weeks, but the signal was still statistically significant, meaning likely not by chance.

Most of the confirmed cases had also received a flu vaccine at the same time, which might be a factor, she said.

FDA scientist Richard Forshee said the agency plans to study whether there is any increased risk of stroke from receiving the two shots at the same time.

Both agencies still recommend older adults receive the booster shots, now tailored to target Omicron variants as well as the original coronavirus.

Dr. Walid Gellad, professor of medicine at University of Pittsburgh, said the issue required further investigation.

“Sometimes signals are not clear,” Gellad said in an email. “It makes sense to look into it more, and it doesn’t make sense to change practice given the known benefits (of getting the booster) in this age group.”

(This story has been corrected to fix the name to Nicola from Nicole in paragraph 5)

Reporting by Michael Erman; Editing by Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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Chinese hospitals, funeral homes ‘extremely busy’ as COVID spreads unchecked

  • Hospitals, funeral parlours report surge in COVID infections
  • China reports three new COVID deaths for Tuesday
  • Some countries consider travel rules for Chinese visitors

CHENGDU, Dec 28 (Reuters) – Chinese hospitals and funeral homes were under intense pressure on Wednesday as a surging COVID-19 wave drained resources, while the scale of the outbreak and doubts over official data prompted some countries to consider new travel rules on Chinese visitors.

In an abrupt change of policy, China this month began dismantling the world’s strictest COVID regime of lockdowns and extensive testing, putting its battered economy on course for a complete re-opening next year.

The lifting of restrictions, which came after widespread protests against them, means COVID is spreading largely unchecked and likely infecting millions of people a day, according to some international health experts.

The speed at which China, the last major country in the world moving towards treating the virus as endemic, has scrapped COVID rules has left its fragile health system overwhelmed.

China reported three new COVID-related deaths for Tuesday, up from one for Monday – numbers that are inconsistent with what funeral parlours are reporting, as well as with the experience of much less populous countries after they re-opened.

Staff at Huaxi, a big hospital in the southwestern city of Chengdu, said they were “extremely busy” caring for COVID patients.

“I’ve been doing this job for 30 years and this is the busiest I have ever known it,” said one ambulance driver outside the hospital who declined to be identified.

There were long queues inside and outside the hospital’s emergency department and at an adjacent fever clinic on Tuesday evening. Most of those arriving in ambulances were given oxygen to help with their breathing.

“Almost all of the patients have COVID,” one emergency department pharmacy staff member said.

The hospital has no stocks of COVID-specific medicine and can only provide drugs for symptoms such as coughing, she said.

Car parks around the Dongjiao funeral home, one of the biggest in Chengdu, were full. Funeral processions were constant as smoke billowed from the crematorium.

“We have to do this about 200 times a day now,” said one funerals worker. “We are so busy we don’t even have time to eat. This has been the case since the opening up. Before it was around 30-50 a day.”

“Many have died from COVID,” said another worker.

At another Chengdu crematorium, privately-owned Nanling, staff were equally busy.

“There have been so many deaths from COVID lately,” one worker said. “Cremation slots are all fully booked. You can’t get one until the new year, maybe Jan. 3 at the earliest.”

China has said it only counts deaths of COVID patients caused by pneumonia and respiratory failure as COVID-related.

Zhang Yuhua, an official at the Beijing Chaoyang Hospital, said most recent patients were elderly and critically ill with underlying diseases. She said the number of patients receiving emergency care had increased to 450-550 per day, from about 100 before, according to state media.

The China-Japan Friendship Hospital’s fever clinic in Beijing was also “packed” with gray-haired patients, state media reported.

Nurses and doctors have been asked to work while sick and retired medical workers in rural communities were being rehired to help. Some cities have been struggling to secure supplies of anti-fever drugs.

TRAVEL RULES

In a major step towards freer travel, China will stop requiring inbound travellers to go into quarantine from Jan. 8, authorities said this week, prompting many Chinese, cut off from the world for so long, to check travel platforms.

But while online searches for flights spiked on Tuesday from extremely low levels, residents and travel agencies suggested a return to anything like normal would take some months yet, as caution prevails for now.

Moreover, some governments were considering extra travel requirements for Chinese visitors.

U.S. officials cited “the lack of transparent data” as reasons for doing so.

India and Japan would require a negative COVID test for travellers from mainland China, with those testing positive in Japan having to undergo a week in quarantine. Tokyo also plans to limit airlines increasing flights to China.

The Philippines was also considering imposing tests”.

ECONOMIC PAIN

China’s $17 trillion economy is expected to suffer a slowdown in factory output and domestic consumption as workers and shoppers fall ill.

News of re-opening borders sent global luxury stocks higher, but the reaction was more muted in other corners of the market.

U.S. carmaker Tesla (TSLA.O) plans to run a reduced production schedule at its Shanghai plant in January, according to an internal schedule reviewed by Reuters. It did not specify a reason.

Once the initial shock of new infections passes, some economists expect Chinese growth to bounce back with a vengeance from what is this year expected to be its lowest rate in nearly half a century, somewhere around 3%.

Morgan Stanley economists expect 5.4% growth in 2023, while those at Goldman Sachs see 5.2%.

Reporting by Marting Quin Pollard in Chengdu, Chen Lin in Singapore and Shanghai and Beijing bureaus; Writing by Marius Zaharia; Editing by Lincoln Feast.

Our Standards: The Thomson Reuters Trust Principles.

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Chinese make travel plans as Beijing dismantles zero-COVID rules

  • China to ease border restrictions from Jan. 8
  • Online searches for flights spike – travel platforms
  • COVID wave overwhelms hospitals, weighs on economy

BEIJING, Dec 27 (Reuters) – Chinese people, cut off from the rest of the world for three years by stringent COVID-19 curbs, flocked to travel sites on Tuesday ahead of borders reopening next month, even as rising infections strained the health system and roiled the economy.

Zero-COVID measures in place since early 2020 – from shuttered borders to frequent lockdowns – last month fuelled the Chinese mainland’s biggest show of public discontent since President Xi Jinping took power in 2012.

His subsequent abrupt U-turn on the curbs, which have battered the $17-trillion economy, the world’s second-largest, means the virus is now spreading largely unchecked across the country of 1.4 billion people.

Official statistics, however, showed only one COVID death in the seven days to Monday, fuelling doubts among health experts and residents about the government’s data. The numbers are inconsistent with the experience of much less populous countries after they re-opened.

Doctors say hospitals are overwhelmed with five-to-six-times more patients than usual, most of them elderly. International health experts estimate millions of daily infections and predict at least one million COVID deaths in China next year.

Nevertheless, Chinese authorities are determined to dismantle the last vestiges of their zero-COVID policies.

In a major step towards freer travel – cheered by global stock markets on Tuesday – China will stop requiring inbound travellers to go into quarantine from Jan. 8, the National Health Commission (NHC) said late on Monday.

“It finally feels as if China has turned the corner,” AmCham China Chairman Colm Rafferty said of the imminent lifting of the quarantine rule.

There are no official restrictions on Chinese people going abroad but the new rule will make it much easier for them to return home.

Travel platform Ctrip’s data showed that within half an hour of the news, searches for popular cross-border destinations had increased 10-fold. Macau, Hong Kong, Japan, Thailand and South Korea were the most sought-after, Ctrip said.

Data from Trip.com showed outbound flights bookings were up 254% early on Tuesday from the day before.

China’s National Immigration Administration said on Tuesday that it would resume processing passport applications of Chinese nationals seeking to travel abroad and approving visits of mainland residents to Hong Kong.

China will also resume the implementation of a policy allowing visa-free transit of up to 144 hours for travellers. The extension or renewal of foreigners’ visas will also be restored, the immigration administration added.

Shares in global luxury goods groups, which rely heavily on Chinese shoppers, rose on Tuesday on the easing of travel restrictions. China accounts for 21% of the world’s 350-billion euro luxury goods market.

Ordinary Chinese and travel agencies, however, suggested that a return to anything like normal would take some months yet, given worries about COVID and more careful spending because of the impact of the pandemic.

Separately, once the border with Hong Kong reopens next month, mainland Chinese will be able to take BioNTech-made mRNA vaccines, seen as more effective than the domestically-developed options available on the mainland.

‘GREAT PRESSURE’

China’s classification of COVID will also be downgraded to the less strict Category B from the current top-level Category A from Jan. 8, the health authority said, meaning authorities will no longer be compelled to quarantine patients and close contacts and impose lockdowns.

But for all the excitement of a gradual return to a pre-COVID way of life, there was mounting pressure on the healthcare system, with doctors saying many hospitals are overwhelmed while funeral parlours report a surge in demand for their services.

Nurses and doctors have been asked to work while sick and retired medical workers in rural communities were being rehired to help, state media reported. Some cities have been struggling to secure supplies of anti-fever drugs.

“Some places are facing great pressure at hospital emergency wards and intensive care units,” NHC official Jiao Yahui told reporters.

While the Chinese economy is expected to see a sharp rebound later next year, it is in for a rough ride in the coming weeks and months as workers increasingly fall ill.

Many shops in Shanghai, Beijing and elsewhere have closed in recent days with staff unable to come to work, while some factories have already sent many of their workers on leave for the late January Lunar New Year holidays.

“The concern of a temporary supply chain distortion remains as the labour force is impacted by infections,” JPMorgan analysts said in a note, adding that their tracking of subway traffic in 29 cities showed that many people were restricting their movements as the virus spreads.

Data on Tuesday showed industrial profits fell 3.6% in January-November from a year earlier, versus a 3.0% drop for January-October, reflecting the toll of the anti-virus curbs in place last month, including in major manufacturing regions.

Authorities said they would step up financial support to small and private businesses in the hard-hit catering and tourism sectors.

The lifting of travel restrictions is positive for the economy, but strong caveats apply.

Japan Prime Minister Fumio Kishida said his country would require a negative COVID test for travellers from mainland China. The government would also limit airlines increasing flights to China, he said.

“International travel … will likely surge, yet it may take many more months before volumes return to the pre-pandemic level,” said Dan Wang, chief economist at Hang Seng Bank China.

“COVID is still spreading in most parts of China, greatly disrupting the normal work schedule. Loss in productivity is significant.”

Reporting by Beijing and Shanghai bureaus and Chen Lin in Singapore; Writing by Marius Zaharia and Sumeet Chatterjee; Editing by Lincoln Feast, Robert Birsel and Frank Jack Daniel

Our Standards: The Thomson Reuters Trust Principles.

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Beijing, Shanghai residents back to work as China limps towards living with COVID

  • Life limping back to normal in Shanghai, Beijing
  • Cities across China report large numbers of infections
  • China reports no COVID deaths for 6th consecutive day

BEIJING/SHANGHAI, Dec 26 (Reuters) – Mask-wearing Beijing and Shanghai commuters crowded subway trains on Monday as China’s two biggest cities edged closer to living with COVID-19 even as frontline medical workers scrambled to cope with millions of new infections.

After three years of harsh anti-coronavirus curbs, President Xi Jinping scrapped the country’s zero-COVID policy of lockdowns and relentless testing this month in the face of protests and a widening outbreak.

The virus is now spreading largely unchecked across the country, with doubts mounting among health experts and residents over China’s statistics, which show no new COVID deaths reported for the six days through Sunday.

Doctors say hospitals are overwhelmed with five-to-six-times more patients than usual, mostly elderly.

But after the initial shock of the policy U-turn, and a few weeks in which people in Beijing and Shanghai stayed indoors, either dealing with the disease or trying to avoid it, there are signs that life, at least for those able to cope with the disease, is on track to returning closer to normal.

Subway trains in Beijing and Shanghai were packed, while some major traffic arteries in the two cities were jammed with slow-moving cars on Monday as residents commuted to work.

“I am prepared to live with the pandemic,” said 25-year-old Shanghai resident Lin Zixin. “Lockdowns are not a long-term solution

This year, in an effort to prevent infections from spiralling out of control across the country, the 25 million people in China’s commercial hub endured two months of bitter isolation under a strict lockdown that lasted until June 1.

Shanghai’s lively streets were a sharp contrast with the atmosphere in April and May, when hardly anyone went outside.

An annual Christmas market held at the Bund, a commercial area in Shanghai, was popular with city residents over the weekend. Crowds thronged the winter festive season at Shanghai Disneyland and Beijing’s Universal Studios on Sunday, queuing up for rides in Christmas-themed outfits.

The number of trips to scenic spots in the southern city of Guangzhou this weekend increased by 132% from last weekend, local newspaper The 21st Century Business Herald reported.

“Now basically everyone has returned to a normal routine,” said a 29-year-old Beijing resident surnamed Han.

China is the last major country to move toward treating COVID as endemic. Its containment measures had slowed the $17 trillion economy to its lowest growth rate in nearly half a century, disrupting global supply chains and trade.

The world’s second-largest economy is expected to suffer further in the short-term, as the COVID wave spreads toward manufacturing areas and workforces fall ill, before bouncing back next year, analysts say.

Tesla suspended production at its Shanghai plant on Saturday, bringing ahead a plan to pause most work at the plant in the last week of December. The company did not give a reason.

‘OVERWHELMED’

The world’s most populous country has narrowed its definition for classifying deaths as COVID-related, counting only those involving COVID-caused pneumonia or respiratory failure, raising eyebrows among world health experts.

The country’s healthcare system has been under enormous strain, with staff being asked to work while sick and retired medical workers in rural communities being rehired to help, according to state media.

“The hospital is just overwhelmed from top to bottom,” doctor Howard Bernstein at the privately owned Beijing United Family Hospital said.

The provincial government of Zhejiang, a big industrial province near Shanghai with a population of 65.4 million, said on Sunday it was battling about a million new daily COVID-19 infections, a number expected to double in the days ahead.

Health authorities in the southeastern Jiangxi province have said infections would hit an apex in early January, adding that there could be other peaks as people travel next month for Lunar New Year celebrations, state media reported.

They warned that the wave of infections would last three months and that about 80% of the province’s 45 million residents could get infected.

The city of Qingdao, in the eastern Shandong province, has estimated that up to 530,000 residents were being infected each day.

Cities across China have been racing to add intensive-care units and fever clinics, facilities designed to prevent the wider spread of contagious disease in hospitals.

The Beijing municipal government has said the number of fever clinics in the city had increased from 94 to almost 1,300, state media said. Shanghai has 2,600 such clinics and has transferred doctors from less-strained medical departments to help out.

Worries remain about the ability of less-affluent cities in China to cope with a surge in severe infections, especially as hundreds of millions of rural migrant workers are expected to return to their families for Lunar New Year.

“I am worried the flow of people will be huge … (and) the epidemic will break out again,” said Lin, the Shanghai resident.

Reporting by the Beijing and Shanghai bureaus; Writing by Marius Zaharia; Editing by Gerry Doyle and Muralikumar Anantharaman

Our Standards: The Thomson Reuters Trust Principles.

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China’s stretched health system braces for peak in COVID infections

  • COVID infections may peak next week – Chinese health official
  • China reports no new COVID deaths for 3rd day
  • China still ill-prepared for major outbreak – experts

BEIJING/SHANGHAI, Dec 23 (Reuters) – China is expecting a peak in COVID-19 infections within a week, a health official said, with authorities predicting extra strain on the country’s health system even as they downplay the disease’s severity and continue to report no new deaths.

In the face of a surging outbreak and widespread protests against its “zero-COVID” regime of lockdowns and testing, China began dismantling it this month, becoming the last major country to move towards living with the virus.

Its containment measures had slowed the economy to its lowest growth rate in nearly half a century, jamming global supply chains and trade. As Chinese workers increasingly fall ill, more disruption is expected in the short term before the economy bounces back later next year.

China reported less than 4,000 new symptomatic local COVID cases nationwide for Dec. 22, and no new COVID deaths for a third consecutive day. Authorities have narrowed the criteria for COVID deaths, prompting criticism from many disease experts.

Zhang Wenhong, director of the National Center for Infectious Diseases, was quoted in Shanghai government-backed news outlet The Paper on Thursday as saying China “is expected to reach the peak of infections within a week.”

“The peak infection will also increase the rate of severe disease, which will have a certain impact on our entire medical resources,” he said, adding the wave will last another one or two months after that.

“We must be mentally prepared that infection is inevitable.”

Nevertheless, Zhang said he had visited nursing homes around Shanghai, noticing the number of elderly dealing with severe symptoms was low.

Worries over the near-term impact of China’s COVID wave pushed stock markets in China (.SSEC), Hong Kong (.HSI) and elsewhere in Asia lower. The yuan also weakened.

Infections in China are likely to be more than a million a day with deaths at more than 5,000 a day, a “stark contrast” from official data, British-based health data firm Airfinity said this week.

A Shanghai hospital has estimated half of the commercial hub’s 25 million people would get infected by the end of next week. Experts say China could face more than a million COVID deaths next year.

UNPREPARED

China’s abrupt change in policy caught a fragile health system unprepared, with hospitals scrambling for beds and blood, pharmacies for drugs and authorities racing to build clinics.

More than a dozen global health experts, epidemiologists, residents and political analysts interviewed by Reuters identified the failure to vaccinate the elderly and communicate an exit strategy to the public, as well as excessive focus on eliminating the virus, as causes of the strain on China’s medical infrastructure.

A drive to vaccinate the elderly that began three weeks ago has yet to bear fruit. China’s overall vaccination rate is above 90% but the rate for adults who have had booster shots drops to 57.9%, and to 42.3% for people aged 80 and older, according to government data.

China spent big on quarantine and testing facilities over the past three years rather than bolstering hospitals and clinics and training medical staff, these people said.

“There is an incredible lack of preparation for the virus coming despite them having … ample warning,” said Leong Hoe Nam, an infectious diseases doctor at Rophi Clinic in Singapore.

China’s National Health Commission did not respond to requests for comment on the criticisms.

The country has nine domestically developed COVID shots approved for use, all seen as less effective than Western-made vaccines that use the new mRNA technology.

A shipment of 11,500 BioNTech (22UAy.DE) mRNA vaccines for German nationals in China have arrived at the German embassy in Beijing, an embassy spokesperson told Reuters on Friday.

The embassy hopes the first doses will be given out “as soon as possible”, the spokesperson said.

NO DATA

The World Health Organization has received no data from China on new COVID hospitalizations since Beijing lifted its zero-COVID policy. The WHO has said gaps in data might be due to Chinese authorities simply struggling to tally cases.

Amid mounting doubts about Beijing’s statistics, U.S. Secretary of State Antony Blinken on Thursday said all countries, including China, need to share information on their experiences with COVID.

As COVID rages through China, residents who previously faced long periods of isolation are now learning to live with the virus.

Chinese teacher Yang Zengdong, whose whole family is isolating in their downtown Shanghai apartment, mildly ill with COVID, welcomes the change in policy. Only weeks ago, they would have all been sent to a quarantine facility, and their building would have been locked down.

“When I think of this situation my feeling is just, wow, we are so lucky because now we can isolate at home,” Yang said.

“This wave is something we have to face, because it is impossible to stay closed forever.”

Reporting by Bernard Orr in Beijing, Casey Hall and David Stanway in Shanghai, Farah Master in Hong Kong and Chen Lin in Singapore; Writing by Marius Zaharia; Editing by Lincoln Feast.

Our Standards: The Thomson Reuters Trust Principles.

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First foreign COVID vaccines head to China from Germany

  • Batch of BioNTech shots on the way to China
  • German citizens will get shot; Berlin pushes for wider use
  • Shipment comes after Scholz visit to China last month
  • Comes as infections spike in world’s No. 2 economy

BERLIN, Dec 21 (Reuters) – Berlin has sent its first batch of BioNTech (22UAy.DE) COVID-19 vaccines to China to be administered initially to German expatriates, a German government spokesperson said on Wednesday, the first foreign coronavirus vaccine to be delivered to the country.

No details were available on the timing and size of the delivery, although the spokesperson said Berlin is pushing for foreigners other than German nationals, estimated at about 20,000, to be allowed access to the shot if they want it.

The shipment comes after China agreed to allow German nationals in China to get the shot following a deal during Chancellor Olaf Scholz’s visit in Beijing last month, with the German leader pressing for Beijing to allow the shot to be made freely available to Chinese citizens as well.

In a letter to be sent to German citizens in mainland China, the government said it would offer basic immunisations and booster shots of vaccines approved for use in the European Union for free to anyone over 12 years of age.

Family members of other nationalities would not be included. Vaccinations for children under 12 may follow at a later date.

“We are working on the possibility that besides Germans also other foreigners can be vaccinated with BioNTech,” the spokesperson told journalists in Berlin.

The shots will be delivered to German companies in China as well as embassy locations and talks are underway with other EU governments about getting them to citizens of other nationalities, a source familiar with the situation said.

China would need to approve expanding access beyond German nationals, the source said.

In return, Chinese citizens in Europe can be vaccinated with China’s SinoVac (SVA.O), the spokesperson said.

The comment comes after a report earlier this month that Germany’s health ministry had granted a permit allowing China’s Sinovac COVID-19 vaccine to be imported to Germany to be given to Chinese citizens in that country.

The shot has not been approved for use by Europe’s drug regulator, but the World Health Organization has given its green light for its use.

Beijing has so far insisted on using only domestically produced vaccines, which are not based on the Western mRNA technology but on more traditional technologies.

The shipment comes amid Beijing dismantling its strict “zero-COVID” regime of lockdowns, which has led to a surge of cases that caught a fragile health system unprepared.

Experts predict that the country of 1.4 billion people could face more than a million COVID deaths next year.

Allowing German expats access to a Western shot is a big gesture to Berlin, reflecting Beijing’s effort to strengthen ties with EU’s biggest economy after years of tensions over trade and climate between the two countries.

Shares in BioNTech rose on news of the shipment, closing 2.3% higher in Frankfurt while Pfizer shares in New York were up 1.25% in late morning New York trade.

BioNTech was not immediately available to comment on the situation on Wednesday.

China is stuck between rising Covid-19 cases and stalled vaccination rates

NO WESTERN SHOTS

China has nine domestically developed COVID vaccines approved for use, more than any other country. But none has been updated to target the highly infectious Omicron variant, as Pfizer-BioNTech and Moderna (MRNA.O) have for boosters in many developed countries.

The two shots developed by Pfizer-BioNTech and Moderna are the most widely used around the world.

Early on in the pandemic, BioNTech struck a deal with Shanghai Fosun Pharmaceutical (600196.SS) with a view to supply the shots to greater China.

While the shots became available in Hong Kong, Macau and Taiwan, the regulatory review for mainland China has not been concluded. BioNTech has said that decision was up to Chinese regulators and has not given a reason for the delay.

China’s zero-COVID policy and lockdown measures have kept death and infection rates minimal over the past months but caused massive disruptions both domestically and in global trade and supply chains.

China uses a narrow definition of COVID deaths and reported no new fatalities for Tuesday, even crossing one off its overall tally since the pandemic began, now at 5,241 – a fraction of the tolls of many much less populous countries.

The National Health Commission said on Tuesday only deaths caused by pneumonia and respiratory failure in patients who had the virus are classified as COVID deaths.

Reporting by Thomas Escritt, Alexander Ratz and Christian Kraemer; additional reporting by Danilo Masoni in Milan and Amanda Cooper in London;
Writing by Miranda Murray;
Editing by Josephine Mason and David Evans

Our Standards: The Thomson Reuters Trust Principles.

Thomas Escritt

Thomson Reuters

Berlin correspondent who has investigated anti-vaxxers and COVID treatment practices, reported on refugee camps and covered warlords’ trials in The Hague. Earlier, he covered Eastern Europe for the Financial Times. He speaks Hungarian, German, French and Dutch.

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Positive Moderna, Merck cancer vaccine data advances mRNA promise, shares rise

CHICAGO, Dec 13 (Reuters) – An experimental cancer vaccine from Moderna Inc (MRNA.O) based on the messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, sending Moderna shares more than 20% higher and driving up of other biotechs working on similar treatments.

A combination of Moderna’s personalized cancer vaccine and Merck & Co’s (MRK.N) blockbuster immunotherapy Keytruda cut the risk of recurrence or death of the most deadly skin cancer by 44% compared with Keytruda alone in a mid-stage trial, the companies said on Tuesday.

The result was considered a “statistically significant and clinically meaningful improvement,” the companies said.

Moderna shares were up nearly 23% at $202.80 on Tuesday, while Merck’s shares rose 1%. Shares of BioNTech SE (22UAy.DE), which also has successful mRNA vaccine technology, were up 6%, and tiny Gritstone Bio Inc (GRTS.O), which has a cancer vaccine in development, jumped 20% to $3.09.

The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that revs up the immune response would offer a better result for melanoma patients and potentially for other cancers.

“It’s a tremendous step forward in immunotherapy,” Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.

Paul Burton, Moderna’s chief medical officer, said in a separate interview that the combination “has the capacity to be a new paradigm in the treatment of cancer.”

The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.

The combination was generally safe and demonstrated the benefit compared with Keytruda alone after a year of treatment. Serious drug-related side effects occurred in 14.4% of patients who received the combination compared with 10% with Keytruda alone.

A PROMISING FIELD

In October, Merck exercised an option to jointly develop and commercialize the treatment, known as mRNA-4157/V940, sharing costs and any profits equally. Merck and Moderna plan to discuss the results with regulatory authorities and start a large Phase III study in melanoma patients in 2023.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. They are designed to target highly mutated tumors.

The personalized vaccine works in concert with Merck’s Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.

To build the vaccine, researchers took samples of patients’ tumors and healthy tissue. After analyzing the samples to decode their genetic sequence and isolate mutant proteins associated only with the cancer, that information was used to design a tailor-made cancer vaccine.

When injected into a patient, the patient’s cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.

Moderna’s personalized vaccine can be made in about eight weeks, a time frame the company eventually hopes to halve, Burton said.

Barr said the companies intend to study the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancers and some breast cancers.

Moderna mRNA rival BioNTech has several cancer vaccine trials in the works including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche’s (ROG.S) Tecentriq in patients with pancreatic cancer.

Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s (BMY.N) immunotherapies Opdivo and Yervoy in a midstage trial in patients with advanced solid tumors.

Experts said the personalized vaccines were among several promising cancer vaccine ideas in the works after many failures in the field.

“In general, I think cancer vaccines are kind of at a tipping point, and there are going to probably be a lot of vaccines coming down the pipeline in the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.

Although the COVID-19 pandemic demonstrated the speed, ease and safety of mRNA vaccines, they came out of years of cancer vaccine research, Disis said.

Reporting by Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Aditya Samal in Bengaluru; Editing by Caroline Humer, Edwina Gibbs and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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Pfizer expects to hike U.S. COVID vaccine price to $110-$130 per dose

NEW YORK, Oct 20 (Reuters) – Pfizer Inc expects to roughly quadruple the price of its COVID-19 vaccine to about $110 to $130 per dose after the United States government’s current purchase program expires, Pfizer executive Angela Lukin said on Thursday.

Lukin said she expects the vaccine – currently provided for free to all by the government – will be made available at no cost to people who have private insurance or government paid insurance.

Reuters earlier on Thursday reported that Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant vaccine makers would need to hike prices to meet revenue forecasts for 2023 and beyond.

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The U.S. government currently pays around $30 per dose to Pfizer and German partner BioNTech SE (22UAy.DE). In 2023, the market is expected to move to private insurance after the U.S. public health emergency expires.

“We are confident that the U.S. price point of the COVID-19 vaccine reflects its overall cost effectiveness and ensures the price will not be a barrier for access for patients,” Lukin said.

It is not yet clear what kind of access people without health insurance will have to the vaccine.

Pfizer said it expects the COVID-19 market to be about the size of the flu shot market on an annual basis for adults, but that the pediatric market would take longer to build based on shots given so far.

So far the U.S. rollout of updated COVID-19 booster shots which target both the original coronavirus strain and the Omicron strain has lagged last year’s rate despite more people being eligible for the shots.

Around 14.8 million people in the U.S. received a booster shot over the first six weeks of the rollout of the new shots. In the first six weeks of the 2021 revaccination campaign, over 22 million people received their third shot even though only older and immunocompromised people were eligible at that point.

Lukin said she does not expect purchasing of the vaccines to transfer to the private sector until the first quarter of 2023 “at the earliest.” The move is dependent on the government contracted supply being depleted.

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Reporting by Michael Erman; Writing by Caroline Humer; Editing by Bill Berkrot and Richard Pullin

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COVID wave looms in Europe as booster campaign makes slow start

Oct 6 (Reuters) – A new COVID-19 wave appears to be brewing in Europe as cooler weather arrives, with public health experts warning that vaccine fatigue and confusion over types of available vaccines will likely limit booster uptake.

Omicron subvariants BA.4/5 that dominated this summer are still behind the majority of infections, but newer Omicron subvariants are gaining ground. Hundreds of new forms of Omicron are being tracked by scientists, World Health Organisation (WHO) officials said this week.

WHO data released late on Wednesday showed that cases in the European Union (EU) reached 1.5 million last week, up 8% from the prior week, despite a dramatic fall in testing. Globally, case numbers continue to decline.

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Hospitalisation numbers across many countries in the 27-nation bloc, as well as Britain, have gone up in recent weeks.

In the week ended Oct 4, COVID-19 hospital admissions with symptoms jumped nearly 32% in Italy, while intensive care admissions rose about 21%, compared to the week before, according to data compiled by independent scientific foundation Gimbe.

Over the same week, COVID hospitalisations in Britain saw a 45% increase versus the week earlier.

Omicron-adapted vaccines have launched in Europe as of September, with two types of shots addressing the BA.1 as well as the BA.4/5 subvariants made available alongside existing first-generation vaccines. In Britain, only the BA.1-tailored shots have been given the green light.

European and British officials have endorsed the latest boosters only for a select groups of people, including the elderly and those with compromised immune systems. Complicating matters further is the “choice” of vaccine as a booster, which will likely add to confusion, public health experts said.

But willingness to get yet another shot, which could be a fourth or fifth for some, is wearing thin.

“For those who may be less concerned about their risk, the messaging that it is all over coupled with the lack of any major publicity campaign is likely to reduce uptake,” said Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine.

FALSE SENSE OF SECURITY

“So on balance I fear that uptake will be quite a bit lower.”

“Another confounder is that quite a high proportion of the population might have also had a COVID episode in recent months,” said Penny Ward, visiting professor in pharmaceutical medicine at King’s College London.

Some may erroneously feel that having had a complete primary course and then having fallen ill with COVID means they will remain immune, she added.

Since Sept. 5, when the roll-out of new vaccines began in the European Union, about 40 million vaccine doses produced by Pfizer-BioNTech (22UAy.DE) and Moderna (MRNA.O) have been delivered to member states, according to data from the European Centre for Disease Prevention and Control (ECDC).

However, weekly vaccine doses administered in the EU were only between 1 million and 1.4 million during September, compared with 6-10 million per week during the year-earlier period, ECDC data showed.

Perhaps the biggest challenge to uptake is the perception that the pandemic is over, creating a false sense of security.

“There must be some complacency in that life seems to have gone back to normal – at least with regards COVID and people now have other financial and war-related worries,” said Adam Finn, chair of ETAGE, an expert group advising the WHO on vaccine preventable diseases in Europe.

He added that some law-makers, too, were dropping the ball.

Italy’s Gimbe science foundation said the government, soon to be replaced after an election, was ill prepared for the autumn-winter season, and highlighted that a publication on the government’s management of the pandemic had been blocked.

The health ministry declined to comment.

Meanwhile, British officials last week warned that renewed circulation of flu and a resurgence in COVID-19 could pile pressure on the already stretched National Health Service (NHS).

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Reporting by Ludwig Burger in Frankfurt, Natalie Grover and Jennifer Rigby in London, Emilio Parodi in Milan, Editing by William Maclean

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Bluebird’s $2.8 million gene therapy becomes most expensive drug after U.S. approval

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

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Aug 17 (Reuters) – The U.S. Food and Drug Administration on Wednesday approved bluebird bio’s (BLUE.O) gene therapy for patients with a rare disorder requiring regular blood transfusions, and the drugmaker priced it at a record $2.8 million.

The approval sent the company’s shares 8% higher and is for the treatment of beta-thalassemia, which causes an oxygen shortage in the body and often leads to liver and heart issues.

The sickest patients, estimated to be up to 1,500 in the United States, need blood transfusions every two to five weeks.

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The therapy, to be branded as Zynteglo, is expected to face some resistance from insurers due to its steep price, analysts say.

Gene therapies usually come with a high price tag as they are often curative and have faced hurdles in securing insurance coverage.

For instance, Novartis (NOVN.S) was in 2019 forced to offer discounts and work out “outcome-based” installments payments for its $2.1 million therapy Zolgensma after insurers balked at the drug’s price.

Bluebird has pitched Zynteglo as a potential one-time treatment that could do away with the need for transfusions, resulting in savings for patients over the long term.

The average cost of transfusions over the lifetime can be $6.4 million, Chief Operating Officer Tom Klima told Reuters before the approval. “We feel the prices we are considering still bring a significant value to patients.”

Bluebird has been in talks with insurers about a one-time payment option.

“Potentially, up to 80% of that payment will be reimbursed if a patient does not achieve transfusion independence, they (insurers) are very excited about that,” Klima said.

The FDA warned of a potential risk of blood cancer with the treatment but noted studies had no such cases.

Bluebird expects to start the treatment process for patients in the fourth quarter. No revenue is, however, expected from the therapy in 2022 as the treatment cycle would take an average of 70 to 90 days from initial cell collection to final transfusion.

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Reporting by Mrinalika Roy in Bengaluru; Editing by Aditya Soni

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