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Tesla — Shares dropped 2.8% after Berenberg lowered its earnings estimate for Tesla by around 25% for 2023 following the company's price cuts for its electric vehicles. Ford Motor Company — Shares fell nearly 1.4% after the company announced price cuts for its electric Mustang Mach-E crossover. The move in Ford comes after Tesla said earlier this month it would trim prices to counteract dwindling demand. AMC Entertainment — Common shares of the theater chain fell by more than 7% after AMC announced a shareholder meeting in March for a potential change to its capital structure. The preferred or "APE" shares, which trade at a large discount to the common shares, jumped by more than 16%.
REUTERS/Athit Perawongmetha/Summary WHO's executive board meets from Jan. 30-Feb. 7WHO seeking $6.86 bln for 2024-2025 budgetBody seen pushing for bigger role in global health crisesGENEVA, Jan 30 (Reuters) - The World Health Organization will push at its board meeting this week for an expanded role in tackling the next global health emergency after COVID-19, but is still seeking answers on how to fund it, according to health policy experts. Also on his list was "the position of the World Health Organization, recognizing there is a need for a reinforced central role for WHO" in the global health emergency system. "It's a huge knot," said Nicoletta Dentico, the co-chair of the civil society platform the Geneval Global Health Hub. PANDEMIC PREPARATIONThe WHO, which celebrates its 75-year anniversary having been set up in 1948, will also use the meeting to advocate for a boosted role in pandemic preparedness, documents showed. Tedros will call for a Global Health Emergency Council to be set up linked to WHO governance.
An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.
Colgate-Palmolive — Shares fell more than 4% after Colgate-Palmolive released its latest earnings results. The guidance came even as the company reported earnings that beat on top and bottom lines. Visa — The payments stock rose by more than 2% after a better-than-expected fiscal first quarter. Analysts surveyed by Refinitiv had expected earnings of $2.01 per share on revenue of $7.7 billion. Net revenue rose 12% year over year, with total cross-border volume climbing 22%.
A Pfizer spokesperson declined to comment on details of the discussions, but said the company has shown ongoing commitment to accommodating EU member state concerns. Most people in the EU who wanted a primary course of the COVID-19 vaccine, and those who were later eligible for boosters, have received them. In May 2021, Brussels signed a contract with Pfizer and BioNTech to buy 900 million doses, with an option for an additional 900 million doses, by the end of 2023. Around half or more of the first 900 million doses from that contract have not yet been delivered because demand dropped last year. That came after EU governments warned Pfizer and other companies that millions of doses could go to waste.
Jan 26 (Reuters) - Novavax Inc (NVAX.O) said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States. The FDA in documents released on Monday proposed June for deciding on an annual COVID shot's make-up. It took those companies about three months to produce the currently available boosters updated to target newer Omicron subvariants. The FDA is seeking recommendations from its panel of external experts on adopting an annual COVID shot for the United States and the process for choosing the vaccine's targets each year. Reporting by Leroy Leo in Bengaluru Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.
The CDC's Vaccine Safety Datalink, which monitors serious reactions to vaccines, showed a possible risk of stroke in late November. The FDA launched an extensive review of federal data after investigators at the Centers for Disease Control and Prevention detected a possible risk of stroke for seniors who received Pfizer's booster. The Food and Drug Administration hasn't found an increased risk of stroke for seniors who've received Pfizer's omicron booster shot, a federal health official said Thursday. The FDA reviewed CMS data from 4.25 million seniors who received Pfizer's omicron booster and did not identify any increased stroke risk. The Department of Veterans Affairs has also conducted preliminary review of its database and did not identify an increased stroke risk, Forshee said.
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. 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.
The updated Covid boosters reduce the risk of Covid infection from the predominant omicron subvariant by nearly half, according to early data published Wednesday by the Centers for Disease Control and Prevention. The findings are “quite reassuring,” Dr. Brendan Jackson, the head of the CDC’s Covid response, said on a call with reporters Wednesday. As of last Wednesday, only about 15% of people in the U.S. had received an updated booster, according to CDC data. People who were vaccinated but had not received the updated booster were compared to those who got the updated booster in the previous two to three months. People who got the updated boosters are probably "much more likely to wear masks indoors or restrain their travel or not go to indoor restaurants," he said.
"Today we have additional evidence to show that these updated vaccines are protecting people against the latest COVID-19 variants," Dr. Brendan Jackson, head of the U.S. Centers for Disease Control and Prevention's COVID-19 response, told reporters in a briefing. Released last fall, the updated boosters target the BA.4 and BA.5 Omicron variants of the SARS-CoV-2 virus, which are no longer dominant. It showed that the updated vaccine helped prevent illness in roughly half of the people who had previously received two to four doses of the original COVID-19 vaccine, CDC said. The CDC said the updated vaccine worked similarly against BA.5-related infections and XBB/XBB.1.5-related infections. Given the findings, the CDC urged people to stay up to date on their recommended COVID-19 vaccines.
The CDC study published Wednesday provides the first estimate of the omicron booster shots' real-world effectiveness against the XBB family of subvariants. Some scientists have warned the XBB subvariants could cause another Covid wave because they are so good at evading the antibodies that block infections. The study compared people who received the new booster with those who received between two and four doses of the original vaccine. People who only received the original shots generally got their last dose about 13 months ago. But the CDC study found that the omicron boosters provide about as much protection against the XBB family as they do against the BA.5 subvariant and its descendants such as BQ.1 and BQ.1.1.
Food and Drug Administration advisers will meet Thursday to discuss simplifying the Covid vaccination schedule, allowing most people to get the currently available booster, regardless of how many doses they had received before that. The FDA is proposing skipping over that primary series, meaning that most unvaccinated individuals could go ahead and get the latest booster shot if they decided to get a Covid vaccine. The FDA’s proposal, experts say, would greatly simplify the Covid vaccination schedule in the United States — aligning it more closely with the annual flu shot. In another similarity to the flu shot, the FDA is considering whether the Covid vaccine should be updated at least once a year, based on what strains are in circulation. Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University in Baltimore, said simplifying the Covid vaccine schedule makes sense.
CureVac N.V. is an "underappreciated" buying opportunity, according to UBS. CureVac said this month that it plans to hold further patient trials of its mRNA vaccines for Covid-19 and the flu. But CureVac has surged more than 50% this year, and the UBS analyst expects the stock has further to climb. Her $18 price target, up from $8, implies the shares can surge roughly 90% from Wednesday's closing price. We note additional Ph1 data is expected near-term," the UBS analyst wrote.
DAVOS, Switzerland, Jan 18 (Reuters) - Moderna (MRNA.O) chief executive Stephane Bancel said on Wednesday the U.S. company was in active discussions to supply COVID-19 vaccines to China. Beijing has so far insisted on using only Chinese-made COVID-19 vaccines for its own population, but the country is beset by a raging COVID outbreak following a U-turn from Beijing on previously ultra-tight anti-pandemic curbs. China-made COVID vaccines are of the inactivated virus type and not based on the messenger RNA technology used in the most widely used shots developed by Moderna and Pfizer (PFE.N)-BioNTech (22UAy.DE). As regards cancer treatments, Moderna has been working with Merck (MRK.N) on an experimental vaccine against melanoma based on the mRNA technology used in successful COVID-19 vaccines. The company, whose COVID-19 vaccines are made in the United States and Switzerland, is building or planning to build plants in Canada, Australia, Britain and Kenya, he said.
China needs to move past political considerations and look at importing Covid-19 jabs to end the pandemic globally, according to the chief executive of the world's latest vaccine manufacturer. The main Covid vaccines approved for use in China are from Sinovac and Sinopharm. These jabs are less effective against the Omicron variant than are other mRNA vaccines, such as Pfizer and BioNTech's, several studies have found. Poonawalla said China's pandemic reaction of 2020 — which included building hospitals and infrastructure and taking precautions — showed that Beijing could respond rapidly. He stressed China's decision not to import vaccines from the U.S., India and elsewhere, which have been "very effective."
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.
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.
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.
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 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 .
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.
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 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.
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