DIRS.INFO The most relevant business & tech news

☆ U.S. FDA, CDC see early signal of Pfizer bivalent COVID shot's link to stroke
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +2 min

Jan 13 (Reuters) - A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities. An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain. "Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public," the health authorities said. Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot. This safety concern has not been identified with Moderna's (MRNA.O) bivalent shot and both the CDC and FDA continue to recommend that everyone aged 6 months and older stay up-to-date with their COVID-19 vaccination.

☆ CDC says it’s ‘very unlikely’ Pfizer booster carries stroke risk for seniors after launching review
▼ + stars: | 2023-01-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

A CDC spokesperson said this issue was first detected in late November. By mid-December, the CDC concluded the concern was persisting and launched an investigation into whether seniors are more likely to have a stroke in the first 21 days after receiving the Pfizer booster, the spokesperson said. The VSD monitoring system found that 130 people ages 65 and older had a stroke within 21 days of receiving the Pfizer omicron booster among about 550,000 seniors who received the shot, the CDC spokesperson said. No other surveillance system has detected a similar safety concern for the Pfizer booster so far, according to the CDC. The CDC has not changed its recommendation for the Pfizer omicron shot.

A key adviser to the Food and Drug Administration's vaccine panel is questioning whether more Covid booster shots are necessary for healthy, younger people. The FDA later backed the vaccine panel, authorizing a new formulation of the booster shots. “The people who are talking about why young people need it are missing the point,” he said, referring to the booster. Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, continues to encourage Covid boosters for everyone who is eligible. Relatively few people in the U.S. have had updated boosters.

☆ Mainland Chinese head to Hong Kong for mRNA COVID vaccines
▼ + stars: | 2023-01-12 | by ( Joyce Zhou | ) www.reuters.com time to read: +2 min

HONG KONG, Jan 12 (Reuters) - Scores of mainland Chinese travellers are rushing to Hong Kong to receive mRNA COVID-19 vaccines, which are not available on the Chinese mainland, as the country grapples with a torrent of infections which have overwhelmed its health system. A private hospital in the special Chinese administrative region of Hong Kong welcomed the first batch of mainland customers on Thursday, just five days after China reopened its borders for the first time in three years, allowing quarantine free travel. [1/5] Yoyo Liang, from mainland China, received a dose of BioNTech bivalent coronavirus disease (COVID-19) vaccine at a private clinic in Hong Kong, China January 12, 2023. There is no bivalent vaccine available in mainland Chin," she explained after she received her jab. Virtus, which has received more than 300 inquiries so far about the vaccines, is expecting more mainland customers to come to Hong Kong in the coming weeks and months, the company's chief medical officer Samuel Kwok told reporters.

☆ A Chinese bank is offering customers a Pfizer COVID-19 vaccine if they deposit $500,000 into an account
▼ + stars: | 2023-01-10 | by ( Britney Nguyen | ) www.businessinsider.com time to read: +2 min

A Chinese state-owned bank in Hong Kong is offering a Pfizer shot to customers who deposit about $500,000. The incentive signals mainland Chinese citizens' desire to receive a western developed mRNA vaccine. The "privileges" are being offered after mainland China lifted travel restrictions to Hong Kong. BioNTech's Pfizer mRNA vaccine is not widely available in mainland China, which has mostly relied on Chinese-produced vaccines that don't currently include mRNA technology. However, permanent residents of Hong Kong and Macau have had access to free Pfizer vaccines, according to Fortune.

☆ Moderna Considers Price of $110-$130 for Covid-19 Vaccine
▼ + stars: | 2023-01-09 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

Moderna Inc. said it is considering pricing its Covid-19 vaccine in a range of $110 to $130 per dose in the U.S. when it shifts from government contracting to commercial distribution of the shots. The range is similar to the one Pfizer Inc. said in October it was considering for the Covid-19 vaccine it developed with BioNTech SE .

☆ Bank of America just added these biotech stocks to its list of first-quarter picks
▼ + stars: | 2023-01-09 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

BofA has added a number of biotechnology stocks — a sector that is hot on Wall Street right now – to its list of top picks for the first quarter. The bank identified the biotech stocks, as well as some medical technology companies, as part of its thematic investing picks, on themes it says are related to a "transforming world." BofA listed the stocks under themes such as ageing, obesity and pandemic. The bank added biotech firm BioNTech , as well as medical equipment company ResMed , to its list under this theme. The bank added medical technology firm Silk Road Medical , along with biotech firms Cerevel and Denali , to its list of stocks to play this theme.

☆ Omicron COVID booster cuts hospitalization in over 65s, Israeli study finds
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

The study by researchers from healthcare provider Clalit, Ben-Gurion University of the Negev and Sapir College has not yet been peer reviewed. The study was carried out from the end of September until mid-December and looked at 622,701 people aged 65 and over who were eligible for the bivalent booster. "Hospitalization due to Covid-19 occurred in 6 bivalent recipients and 297 participants who did not" receive it, the study said. "Participants who received the bivalent vaccine had lower hospitalization and mortality rates due to Covid-19 than non-recipients up to 70 days after vaccination." While the bivalent vaccine targets the original strain and its BA.4/BA.5 Omicron subvariant, scientists have been closely watching another Omicron subvariant, XBB.1.5, which has been rapidly spreading in the United States.

☆ Chinese-made mRNA vaccine starts trial production
▼ + stars: | 2023-01-07 | by ( ) www.reuters.com time to read: +1 min

SHANGHAI, Jan 7 (Reuters) - China's CanSino Biologics Inc (6185.HK) has entered "test production phase" for its COVID-19 mRNA booster vaccine, the company said in a post on its social media account late on Thursday. The CanSino booster vaccine is one of China's first home-grown potential vaccines based on mRNA technology similar to that employed in vaccines produced internationally by Pfizer-BioNTech and Moderna. On Thursday, CanSino also reported "positive" interim data from a mid-stage clinical trial in a filing to the Hong Kong stock exchange. According to CanSino, the first phase of its mRNA vaccine production could produce 100 million doses. Reporting by Casey Hall; Editing by Jacqueline WongOur Standards: The Thomson Reuters Trust Principles.

☆ BioNTech says it will start cancer vaccine trials in the UK from September
▼ + stars: | 2023-01-06 | by ( Jenni Reid | ) www.cnbc.com time to read: +2 min

BioNTech is launching a large-scale trial of mRNA therapies to treat cancer and other diseases in the U.K.LONDON — The U.K. government on Friday announced a partnership with German firm BioNTech to test potential vaccines for cancer and other diseases, as campaigners warned any breakthrough must remain affordable and accessible. Cancer patients in England will get early access to trials involving personalized mRNA therapies, including cancer vaccines, which aim to spur the immune system to attack harmful cells. They will be administered to early and late-stage patients and target both active cancer cells and preventing their return. Peter Johnson, Britain's National Clinical Director for Cancer, said mRNA technology had the potential to transform approaches to a number of illnesses. The government confirmed to CNBC the announcement represented a private investment into the U.K., but would be supported by a new Cancer Vaccine Launch Pad funded by the NHS.

☆ Hong Kong residents rush to get vaccinated ahead of China border reopening
▼ + stars: | 2023-01-05 | by ( ) www.reuters.com time to read: +2 min

[1/2] People queue at a community vaccination centre, ahead of an expected border reopening with China, during the coronavirus disease (COVID-19) pandemic in Hong Kong, China, January 4, 2023. REUTERS/Tyrone SiuHONG KONG, Jan 5 (Reuters) - Hong Kong residents have swamped clinics to get vaccinated against COVID-19 ahead of the expected reopening of the city's border with mainland China, which some people fear will bring a surge of infections to the financial hub. The number of people getting a fourth shot jumped more than 100% this week from a week earlier. Many mainlanders have been asking on social media about how to get an mRNA vaccine in Hong Kong. A Hong Kong resident surnamed Tsoi said she was relieved to have made a booking for BioNTech's second-generation booster.

☆ Biotech investor Brad Loncar shares 10 predictions for 2023, including a hot new cancer target, Nobel Prize winners, and a biotech founder running for president
▼ + stars: | 2023-01-04 | by ( Andrew Dunn | ) www.businessinsider.com time to read: +14 min

Loncar shared his 2023 forecast, including new drugs, Nobel Prize winners, and more globalization. Brad Loncar isn't expecting a miraculous rebound for the biotech industry in 2023. In an interview with Insider, Loncar shared 10 predictions for biotech in 2023, ranging from Nobel Prize winners and presidential runs to hot cancer targets and bankruptcy worries. 2022 was a rough year for the biotech industry, which once again underperformed the stock market. The industry runs to the next super-hot cancer target: Claudin 18.2In cancer research, drug companies are always on the hunt for the next promising target.

☆ EU offers China free vaccines as COVID-19 infections surge
▼ + stars: | 2023-01-03 | by ( ) www.reuters.com time to read: +2 min

BRUSSELS, Jan 3 (Reuters) - The European Union has offered free COVID-19 vaccines to China, the EU executive said on Tuesday, as infections there surged following Beijing's relaxation of its "zero-COVID" policies. China has not responded to the offer yet, a spokesperson for the European Commission told journalists at a regular briefing. He did not specify the amount of vaccines the EU was offering or their manufacturers. "In view of the COVID situation in China, (Health) Commissioner Stella Kyriakides has reached out to her Chinese counterparts to offer EU solidarity and support," he said. Last month, Germany shipped 11,500 BioNTech (22UAy.DE) COVID vaccines to German companies and embassy and consulate locations in China for use by German nationals there.

The subvariant of omicron, named XBB.1.5, has raised concerns about another potential wave of Covid cases following the busy holiday travel season. The CDC projected Friday that about 40% of confirmed U.S. Covid cases are caused by the XBB.1.5 strain, up from 20% a week ago. There’s no indication it causes more severe illness than any other omicron virus, Dr. Barbara Mahon, director of CDC’s Coronavirus and Other Respiratory Viruses Division, told NBC News. The XBB.1.5 is a relative of the omicron XBB variant, which is a recombinant of the omicron BA.2.10.1 and BA.2.75 subvariants. Yet, only 37.5% of that age group has received the most recent omicron booster, according to the most recent CDC data.

☆ Western Covid Medicine to China’s Rescue
▼ + stars: | 2022-12-28 | by ( The Editorial Board | ) www.wsj.com time to read: 1 min

One conceit of Chinese leader Xi Jinping is that the West is in terminal decline and the Communist Party is destined to dominate the world in technology and politics. So don’t expect the Party media to celebrate the country’s emergency acceptance of Western Covid medicine. Shanghai Fosun Pharmaceutical Co. said Tuesday that Chinese users of its health app can now sign up to get doses of the Western-made BioNTech mRNA vaccine in Hong Kong. That’s happy news for affluent Chinese passport holders who can hop a flight to Hong Kong or nearby Macau, where vaccine tourism has been booming since Mainland infections began to rise.

☆ Fosun app lets China users get BioNTech COVID vaccines in Hong Kong
▼ + stars: | 2022-12-27 | by ( ) www.reuters.com time to read: +2 min

[1/2] The BioNTech logo is seen at the booth of Fosun Pharmaceutical (Group) at the 2021 China International Fair for Trade in Services (CIFTIS) in Beijing, China September 3, 2021. REUTERS/Florence LoHONG KONG, Dec 27 (Reuters) - China's Shanghai Fosun Pharmaceutical Group (600196.SS) said users of its mobile health app in China can now register to take COVID-19 booster shots in Hong Kong using BioNTech's (22UAy.DE) vaccine. BioNTech and its partner for China - Fosun - were granted approval for their COVID-19 vaccine that is adapted for the BA.4 and the BA.5 subvariants of Omicron for people aged 12 and older in Hong Kong, the German company said on Dec. 23. The vaccine is the first and currently only variant-adapted vaccine available as a booster dose for individuals 12 years and older that has been granted approval in Hong Kong, BioNTech said at the time. A shipment of BioNTech COVID-19 vaccines meant for German nationals in China arrived at the German embassy in Beijing last week as cases in China soared after policymakers dropped nearly all of previous epidemic control protocols.

SummarySummary Companies COVID infections may peak next week- Chinese health officialChina reports no new COVID deaths for 3rd dayOverstretched health system braces for more severe casesBEIJING/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. 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. Experts say China could face more than a million COVID deaths next year. NO DATAThe World Health Organization has received no data from China on new COVID hospitalizations since Beijing lifted its zero-COVID policy.

☆ BioNTech starts human trial to test malaria vaccine
▼ + stars: | 2022-12-23 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Dado Ruvic/IllustrationBERLIN, Dec 23 (Reuters) - BioNTech (22UAy.DE) on Friday initiated an early-stage study to evaluate its experimental malaria vaccine in humans, the German drugmaker said. The Phase 1 trial is expected to enrol 60 volunteers in the United States with no history of malaria to assess the vaccine candidate at three-dose levels. Known as BNT165b1, it is the first vaccine candidate from BioNTech's malaria project, which will also establish vaccine production in Africa. Another keenly-watched effort is a malaria vaccine from Oxford University. BioNTech's malaria vaccine effort is based on its mRNA technology, which was employed during the pandemic to quickly develop COVID-19 vaccines, by prompting the human body to make a protein that is part of the pathogen, triggering an immune response.

Experts say China could face more than a million COVID deaths next year. Authorities in Sanya on the southern Hainan island have lined up 18 pharmacies to distribute free drugs. mRNA VACCINES FOR GERMANSIn China, only deaths caused by pneumonia and respiratory failure after contracting COVID are being classified as COVID fatalities. Germany said it has sent its first batch of BioNTech (22UAy.DE) COVID vaccines to China to be administered initially to German expatriates. China has nine domestically developed COVID vaccines approved for use.

☆ BioNTech ships COVID shots to China for use by Germans
▼ + stars: | 2022-12-22 | by ( ) www.reuters.com time to read: +3 min

BioNTech said it is working with Shanghai Fosun Pharmaceutical (600196.SS) to deliver the shots to greater China, with availability expected in Beijing, Shanghai, Guangzhou, Shenyang and Chengdu. China would need to approve expanding access beyond the about 20,000 German nationals, the source said on Wednesday. "Most of Chinese here got the BioNTech vaccine, the vaccine that was first available. SinoVac vaccine was not available in Europe," a first-generation Chinese expatriate who has lived in Europe for more than a decade told Reuters. The expatriate, who asked to remain anonymous to protect their family in China, said that the government there might only make BioNTech shots available to Chinese nationals if it came to the worst-case scenario.

☆ Fact Check-COVID vaccinations did not ‘inject people’ with the next pandemic
▼ + stars: | 2022-12-21 | by ( Reuters Fact Check | ) www.reuters.com time to read: +3 min

There is no evidence to support a claim that COVID-19 vaccinations were a ploy to inject people with an infectious disease that will lead to a new pandemic. Fact sheets for the Janssen (J&J) and Novavax COVID-19 vaccine are available (here ) (here ). Ingredients described in the fact sheets for the Pfizer and Moderna vaccines include mRNA, lipids, sucrose and tromethamine, a chemical (here) (page 3), (here) (page 34). There is no evidence of the COVID-19 vaccines containing any substance that could cause an infectious disease pandemic. All vaccine ingredients, pharmacology and toxicology for COVID-19 vaccines approved in the United States are published online.

"I can confirm a shipment of the BioNTech vaccine is on its way to China," the person told journalists in Berlin. In return, Chinese citizens in Europe can be vaccinated with China's SinoVac (SVA.O), the spokesperson said. Experts predict that the country of 1.4 billion people could face more than a million COVID deaths next year. China is stuck between rising Covid-19 cases and stalled vaccination ratesNO WESTERN SHOTSChina has nine domestically developed COVID vaccines approved for use, more than any other country. While the shots became available in Hong Kong, Macau and Taiwan, the regulatory review for mainland China has not been concluded.

Dec 21 (Reuters) - China may be struggling to keep a tally of COVID-19 infections as the country experiences a big spike in cases, a senior World Health Organization official said on Wednesday, amid concerns about a lack of data from the country. "In China, what's been reported is relatively low numbers of cases in ICUs, but anecdotally ICUs are filling up," WHO's emergencies director Mike Ryan said. "I wouldn't like to say that China is actively not telling us what's going on. REUTERS/Denis BalibouseThe WHO said it was ready to work with China to improve the way the country collects data around critical factors such as hospitalisation and death. China has nine domestically developed COVID-19 vaccines approved for use, more than any other country, but they have not been updated to target the highly infectious Omicron variant.

☆ Germany should help China-EU ties develop 'not subject to third party' -Xi
▼ + stars: | 2022-12-20 | by ( ) www.reuters.com time to read: +1 min

BEIJING, Dec 20 (Reuters) - China and Germany should work together to foster good relations between Beijing and the European Union without any interference by a third party, President Xi Jinping told Germany's president in a phone call on Tuesday, state media reported. Xi was also quoted by state broadcaster CCTV as telling Frank-Walter Steinmeier that China hopes Germany can provide a fair, transparent and non-discriminatory operating environment for Chinese enterprises in Germany, the EU's largest market. "Leading the healthy and stable development of China-EU relations is a direction that China and Germany should work together for," Xi said, according to CCTV. BioNTech would be the first non-Chinese coronavirus vaccine to be administered in China as Beijing has hitherto insisted on administering domestically produced vaccines. Reporting by Ella Cao and Meg Shen, editing by Mark HeinrichOur Standards: The Thomson Reuters Trust Principles.

[1/2] People line up at a makeshift fever clinic set up inside a stadium, amid the coronavirus disease (COVID-19) outbreak in Beijing, China December 19, 2022. "We stand ready to help any country in the world with vaccines, treatments, anything else that we can be helpful with," he said. "We want China to get COVID right," Blinken said earlier this month. “China faces a very challenging system in reopening,” Powell said, adding that its manufacturing, exporting and supply chain remain critical. Officials set up health centers and apps that told people with symptoms how to avoid infecting others, he said.

Search resuls for: "BionTech"

25 mentions found