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☆ Cramer's Lighting Round: 'Hold on to' BioNTech
▼ + stars: | 2024-01-16 | by ( Julie Coleman | ) www.cnbc.com time to read: +1 min

Stock Chart Icon Stock chart icon Amphastar's year-to-date stock performance. Stock Chart Icon Stock chart icon Moderna's year-to-date stock performance. Stock Chart Icon Stock chart icon BioNTech's year-to-date stock performance. Stock Chart Icon Stock chart icon Pan American Silver's year-to-date stock performance. Stock Chart Icon Stock chart icon Lockheed Martin's year-to-date stock performance.

Persons: Becton Dickinson, let's, Stephane Bancel, Lockheed Martin, Barry Sternlicht Organizations: Pan, Lockheed, Starwood, Starwood Property Locations: Moderna

☆ Fact Check: Iceland has not banned COVID vaccines
▼ + stars: | 2023-11-30 | by ( Reuters Fact Check | ) www.reuters.com time to read: +2 min

A headline shared online falsely claims that Iceland has banned COVID-19 vaccines and cites sudden deaths for which there is no evidence, according to the Icelandic national health authority. Iceland has not banned COVID vaccines and “there are no soaring sudden deaths,” Guðrún Aspelund, chief epidemiologist at the Icelandic Directorate of Health, told Reuters in a Nov. 29 email. In 2021, Iceland along with other Scandinavian countries temporarily discontinued giving some COVID vaccines to younger adults. As of Oct. 5, 80.5% of the population (archived) in Iceland has received the primary course, that is two doses of a COVID vaccine. Iceland has not banned COVID vaccines and vaccination is recommended for specific groups of the population.

Persons: ” Guðrún Aspelund, epidemiologist, Aspelund, Moderna's Spikevax, Read Organizations: Icelandic Directorate of Health, Reuters, Twitter, Facebook, Health, Iceland’s, Pfizer, BioNTech's, Thomson Locations: Iceland

☆ BioNTech cuts 2023 revenue target on reduced prospects for vaccine
▼ + stars: | 2023-11-06 | by ( ) www.reuters.com time to read: +3 min

The logo of BioNTech is pictured at Biontech's research laboratory for individualised vaccines against cancer in Mainz, Germany, July 27, 2023. In a statement on Monday, the German biotech company cut its outlook for full-year COVID-19 vaccine revenues to about 4 billion euros from 5 billion previously expected and the 17.2 billion reported last year. But the reduced revenue prospects prompted the Mainz-based company to cut its 2023 research and development (R&D) budget for the second time, forecasting a range from 1.8 to 2 billion euros, down from between 2 and 2.2 billion euros laid out in August. Third-quarter revenues were 895 million euros, broadly in line with an analyst consensus compiled by LSEG and down from 3.46 billion from a year earlier. ($1 = 0.9306 euros)Reporting by Ludwig Burger, Editing by Rachel More and Barbara LewisOur Standards: The Thomson Reuters Trust Principles.

Persons: Wolfgang Rattay, Jens Holstein, LSEG, BioNTech, Ludwig Burger, Rachel More, Barbara Lewis Organizations: REUTERS, Pfizer writedowns, Pfizer, Thomson Locations: Mainz, Germany, FRANKFURT

REUTERS/Wolfgang Rattay/File PhotoFRANKFURT, Aug 7 (Reuters) - Germany's BioNTech (22UAy.DE), Pfizer's (PFE.N) partner on COVID-19 vaccines, cut its drug development budget for this year after quarterly revenues were hurt by a plunge in pandemic-related demand. The quarterly net loss was 190 million euros, down from a COVID-19-fuelled profit of 1.67 billion euros a year earlier. The company said it cut its projected research and development (R&D) budget for this year to between 2 and 2.2 billion euros, down from between 2.4 and 2.6 billion euros previously forecast. R&D expenditures were 1.54 billion euros last year. BioNTech reaffirmed its outlook for COVID-19 vaccine revenues to reach about 5 billion euros in 2023, down from 17.2 billion euros last year, expecting a renewed sales boost from an inoculation campaign in the fall.

Persons: Wolfgang Rattay, Jens Holstein, BioNTech, Ludwig Burger, Miranda Murray, Friederike Heine, Louise Heavens Organizations: REUTERS, Pfizer, Thomson Locations: Mainz, Germany

HAMBURG, June 11 (Reuters) - BioNTech (22UAy.DE) will go to court on Monday to defend itself against a lawsuit from a German woman who is seeking damages for alleged side effects of its COVID-19 vaccine, the first of potentially hundreds of cases in the country. The plaintiff claims she suffered upper-body pain, swollen extremities, fatigue and sleeping disorder due to the vaccine. Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile. Almost 768 million vaccine doses have been administered in the European Economic Area (EEA), which includes the 27 EU member states plus Iceland, Liechtenstein and Norway. Rogert & Ulbrich says it has filed about 250 cases for clients seeking damages for alleged side-effects of COVID-19 vaccines.

Persons: Tobias Ulbrich, Caesar, Preller, Ludwig Burger, Patricia Weiss, Emilio Parodi, Natalie Grover, Sam Tobin, Josephine Mason, Mark Potter Organizations: Reuters, European Union, Pfizer, European Medicines Agency, EMA, Economic, BioNTech, United, Thomson Locations: HAMBURG, Hamburg, Germany, Iceland, Liechtenstein, Norway, United States, Italy, Milan, London

☆ U.S. FDA expands authorization of Pfizer bivalent COVID-19 shots in kids
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 14 (Reuters) - Pfizer Inc (PFE.N) said on Tuesday that the U.S. Food and Drug Administration had expanded the emergency use authorization (EUA) of the company and its partner BioNTech SE's (22UAy.DE) bivalent COVID-19 vaccine as a single booster dose in certain children. The amended authorization is for children six months through four years of age who have completed their initial three-dose vaccination with Pfizer's original shot. In December, the U.S. health regulator had authorized Pfizer/BioNTech's updated shot as a third dose to those aged six months through four years, who have not completed their primary vaccination series or are yet to receive the third dose. Shots for youngest children in the United States were only approved in June last year, making them the last group to become eligible for vaccination. Reporting by Pratik Jain; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ FDA authorizes Pfizer's Covid omicron booster as fourth shot for kids under 5
▼ + stars: | 2023-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Tuesday authorized Pfizer's omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company's original vaccine. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5. Pfizer's primary series for young children consists of three doses, while rival drugmaker Moderna's primary series for that same age group is only two. Since December, children in that age group who completed two doses of Pfizer's original vaccine have been eligible to receive the omicron booster as their third shot, or last dose in their primary series. One month after the children received the omicron booster, they demonstrated an immune response to both the original Covid strain and omicron BA.5 and BA.5

☆ Pfizer/BioNTech seeks U.S. nod for updated COVID vaccine as booster in kids under 5
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE (22UAy.DE) have applied for emergency use authorization of their Omicron-adapted COVID-19 vaccine in the United States as a booster dose for children aged six months through four years, the companies said on Wednesday. The Omicron-adapted vaccine is currently authorized by the U.S. health regulator as the third dose of the three-dose primary course of vaccination in the country for children in this age group. If the Food and Drug Administration (FDA) authorizes the vaccine as a booster dose, children who have completed their primary series - either with three doses of the Pfizer-BioNTech's original vaccine or with two doses of their original and one dose of the adapted vaccine - would be eligible to receive the booster dose at least two months after the completion of their primary series. Last week, the companies also filed an application to the FDA for a full approval of their Omicron-adapted COVID vaccine as a primary course and a booster dose for individuals 12 years of age and above. Reporting by Sriparna Roy in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ China should set aside politics and look at Covid jab imports, world's largest vaccine maker says
▼ + stars: | 2023-01-16 | by ( Jenni Reid | ) www.cnbc.com time to read: +1 min

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."

☆ 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.

☆ 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.

☆ 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.

☆ 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.

☆ 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.

☆ 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.

☆ 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.

☆ China to allow German expats to use German COVID-19 vaccines
▼ + stars: | 2022-12-10 | by ( ) www.reuters.com time to read: +1 min

BEIJING, Dec 10 (Reuters) - The Chinese foreign ministry said China and Germany had reached an agreement on providing "German vaccines" to German nationals in China, after the German Chancellor recently said that BioNTech's COVID-19 vaccine would be used by German expatriates. Relevant arrangements will be discussed and determined by the two sides through diplomatic channels, Mao Ning, a spokeswoman at the Chinese foreign ministry told reporters on Friday at a regular press conference. On Nov. 4, German Chancellor Olaf Scholz, on his visit to Beijing, announced an agreement to let expatriates in China use the COVID-19 vaccine from Germany's BioNTech. BioNTech's (22UAy.DE) COVID vaccine would be the first non-Chinese coronavirus vaccine to be administered in China, although to just German nationals, as Beijing had until now insisted on administering domestically produced vaccines. Reporting by Ryan Woo; Editing by Himani SarkarOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA authorizes bivalent COVID shots for kids as young as 6 months old
▼ + stars: | 2022-12-08 | by ( ) www.reuters.com time to read: +2 min

The amended authorization on Thursday from the Food and Drug Administration allows use of Moderna's bivalent shot as a booster in children 6 months through 5 years of age, two months after their initial vaccination. Children who have completed their initial three-dose vaccination with Pfizer's original shot are not yet eligible to receive the bivalent booster, the agency said. The regulator added that data supporting use of Pfizer/BioNTech's bivalent shot as a booster in this age group is expected in January. Moderna's vaccine for children under 6 is a two-dose, 25 microgram vaccine, with the shots given about four weeks apart. Overall, 39.7 million people in United States have received a bivalent booster as of Nov. 30, data from the Centers for Disease Control and Prevention showed.

☆ Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +2 min

Nov 18 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the variant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly 2-fold increase in participants with the original shot, according to data posted on online archive bioRxiv. The variant and related BQ.1 are gaining ground in the United States, and are expected to cause a rise in cases in the winter in Europe. The companies had recently released data that showed their Omicron-tailored shot produced a strong antibody response in older adults than the original shot after one month against the BA.4/5 subvariants. Pfizer and BioNTech said the bivalent shot also produced an immune response against newer Omicron subvariants including BA.4.6, BA.2.75.2 and XBB.1.

☆ German panel recommends COVID shot only for at-risk youngsters
▼ + stars: | 2022-11-17 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

The recommendation also covers a version of Moderna's (MRNA.O) Spikevax vaccine for the age group but that product is in short supply in Germany at the moment, the expert panel said. European regulators in October authorised a low-dose version of Pfizer-BioNTech's first-generation vaccine for children from six months to four years, when given as a three-dose series. "When there are parents that absolutely want the vaccine for their healthy children, there are no legal reason for physicians to deny them that," said STIKO's Terhardt. STIKO also reaffirmed a recommendation it issued in May for five- to 11-year-olds, saying one COVID-19 shot was enough for healthy youngsters in that age group because most of them had already had an infection. Only slightly more than 22% of five- to 11-year-old children in Germany have so far received at least one COVID shot.

☆ Sanofi, GSK score late win with EU COVID booster approval
▼ + stars: | 2022-11-10 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

The shot is based on lab-made viral proteins provided by Sanofi and an adjuvant ingredient from GSK that increases the immune response. Adapting the older protein technology chosen by Sanofi and GSK to a new virus variant requires several months longer than under the mRNA approach, which saw a breakthrough during the pandemic. Work on the shot by Sanofi and GSK, two of the world's largest vaccine makers by sales, was delayed repeatedly. The partners later pivoted to targeting the Beta variant, requiring months in additional development time. While the shot tested at the time was bivalent - meaning it was based both on original Wuhan strain of the virus and Beta - Sanofi and GSK later focused on a monovalent shot based on Beta only.

☆ UK approves Pfizer-BioNTech's COVID booster targeting BA.4/5
▼ + stars: | 2022-11-09 | by ( ) www.reuters.com time to read: +1 min

Nov 9 (Reuters) - Britain's health regulator on Wednesday approved a COVID-19 booster from Pfizer Inc (PFE.N) and partner BioNTech SE (22UAy.DE) targeting the Omicron BA.4 and BA.5 sub-variants and the original coronavirus strain. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) said the vaccine was approved for use as a booster dose in people aged 12 years and older after it was found to meet safety, quality and effectiveness standards. "All approved COVID booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19," according to the MHRA. Pfizer and BioNTech last week said their so-called bivalent COVID-19 vaccine tailored for BA.4/5 produced a strong antibody response in older adults than the original shot after one month, and in October said it generated a strong immune response. Reporting by Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

☆ BioNTech lifts lower end of vaccine sales target range
▼ + stars: | 2022-11-07 | by ( ) www.reuters.com time to read: +1 min

FRANKFURT, Nov 7 (Reuters) - COVID-19 vaccine maker BioNTech (22UAy.DE) on Monday raised the lower bound of its 2022 COVID-19 vaccine revenue guidance for the full year, citing demand for its adapted shots and higher prices. The German biotech firm, the vaccines partner of U.S. pharma giant Pfizer (PFE.N), said in a statement that it is now targeting 16 to 17 billion euros ($16-$17 billion) in vaccine sales, compared with a previous range of 13-17 billion but down from 19 billion euros reported for last year. Partner Pfizer last week raised its forecast for its 2022 sales of the COVID-19 vaccine by $2 billion to $34 billion. Sales during the July-to-September quarter dropped 43% to 3.46 billion euros while net profit fell 44% to 1.78 billion euros. Sales of the Pfizer/BioNTech COVID vaccine are down from pandemic highs as many countries have neared the end of their primary vaccination campaigns.

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