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☆ Pfizer, BioNTech start COVID-flu combination vaccine study
▼ + stars: | 2022-11-03 | by ( ) www.reuters.com time to read: +1 min

Nov 3 (Reuters) - U.S. drugmaker Pfizer Inc (PFE.N) and its German partner BioNTech SE have started an early-stage study to evaluate a combination vaccine targeting COVID-19 and influenza, the companies said on Thursday. The single-dose vaccine candidate is a combination of Pfizer's mRNA-based flu shot and the companies' Omicron-tailored COVID-19 booster shot. The early-stage study, which is being sponsored by BioNTech, aims to evaluate the combination shot's safety, tolerability and immunogenicity, or the ability to generate immune response. Rivals Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are also developing combination vaccines targeting both COVID-19 and influenza. read moreReporting by Bhanvi Satija in Bengaluru; Editing by Savio D'Souza and Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

China became Germany's single biggest trade partner in 2016. A recent survey by the Ifo think-tank found that nearly half of German industrial firms now rely on significant inputs from China. But Scholz's trip comes at a time of growing concern in the West - particularly in Germany's top security ally, the United States - about China's trade practices, human rights record and territorial ambitions. FDP General Secretary Bijan Djir-Sarai called the decision "naive" and criticized the timing of Scholz's trip to China as "deeply unfortunate". But the German chancellor declined Macron's offer, the sources said.

☆ Swiss drugs regulator looking into bubbles in COVID booster vials
▼ + stars: | 2022-11-02 | by ( ) www.reuters.com time to read: +1 min

BERLIN, Nov 2 (Reuters) - Swiss drugs regulator Swissmedic said on Wednesday it is examining potential risks in connection with bubbles that appeared in vials of COVID-19 vaccine boosters retooled to target the Omicron variant of the coronavirus. "Vials of the batch concerned contained bubbles after being removed from the fridge," said Swissmedic, adding that the phenomenon seems to be accentuated when the syringes were prepared several hours in advance. Cantons and vaccination centres have been informed as a precaution, the regulator said. A BioNTech spokesperson said Pfizer was in charge of the supply chain and distribution in Switzerland and had no further immediate comment. Writing by Miranda Murray; Editing by Thomas Escritt and Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for 2022 sales of its COVID-19 vaccine by $2 billion to $34 billion, and said new deals and drugs in development should help replace future declining vaccine sales and lost revenue from patent expirations. Sales of the Pfizer/BioNTech COVID vaccine are down from pandemic highs as many countries have neared the end of their primary vaccination campaigns. Third-quarter sales of the COVID vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion. However, $7.51 billion in sales of Paxlovid, the company's COVID-19 antiviral treatment, fell short of estimates of $7.66 billion. Pfizer reported adjusted earnings of $1.78 per share in the third quarter, beating analysts' estimates by 39 cents.

☆ Pfizer boosts COVID vaccine sales forecast by $2 bln
▼ + stars: | 2022-11-01 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for annual sales of its COVID-19 vaccine by $2 billion to $34 billion on demand for Omicron-targeted boosters, helping allay some investor worries over growth for the vaccinations. The U.S. drugmaker's shares rose 2.4% to $447.67 in morning trading as its third-quarter profit beat estimates, mainly due to better-than-expected sales of the vaccine. The upbeat earnings also sent shares of rival COVID-19 vaccine makers higher. Sales of the COVID-19 vaccine have eased from pandemic highs on soft demand for the original shots, sparking concerns over demand over the next few years. Third-quarter sales of the COVID-19 vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion.

☆ Pfizer boosts COVID vaccine sales forecast by $2 bln to $34 bln
▼ + stars: | 2022-11-01 | by ( ) www.reuters.com time to read: +2 min

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised its forecast for annual sales of its COVID-19 vaccine by $2 billion to $34 billion on demand for Omicron-targeted boosters, helping allay some investor worries over growth for the vaccinations. The U.S. drugmaker's shares rose 4.3% to $48.55 in premarket trading as its third-quarter profit beat estimates, mainly due to better-than-expected sales of the vaccine. Sales of the COVID-19 vaccine have eased from pandemic highs on soft demand for the original shots, sparking concerns over demand over the next few years. Third-quarter sales of the COVID-19 vaccine came in at $4.40 billion, blowing past estimates of $2.60 billion, according to five analysts polled by Refinitiv. However, $7.51 billion in sales of the company's COVID-19 pill Paxlovid missed estimates of $7.66 billion.

☆ Pfizer raises sales estimates for COVID vaccine by $2 billion
▼ + stars: | 2022-11-01 | by ( ) www.reuters.com time to read: +2 min

Nov 1 (Reuters) - Pfizer Inc (PFE.N) on Tuesday raised full-year estimates for sales of its COVID-19 vaccine by $2 billion to $34 billion, encouraged by demand for its new Omicron-focused booster shots. The company maintained its full-year sales forecast for COVID-19 pill Paxlovid at $22 billion. The company reported third-quarter sales of $22.60 billion, beating analysts' estimates of $21.04 billion, according to IBES data from Refinitiv. Third-quarter sales of the COVID-19 vaccine, which Pfizer sells with BioNTech , came in at $4.40 billion, blowing past estimates of $2.60 billion, according to five analysts polled by Refinitiv. However, Paxlovid, the company's pill to reduce the risk of severe COVID-19, brought in sales of $7.51 billion, missing estimates of $7.66 billion.

☆ Pfizer CEO reveals 2030 growth plan as company faces up to $18 billion revenue hit from generics
▼ + stars: | 2022-11-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Bourla said Pfizer is staring down an expected loss of between $16 billion and $18 billion in revenue from 2025 through 2030 as patent protections for some of its bestselling drugs expire. "We recognize that some are questioning Pfizer's longer-term growth prospects," Bourla told analysts during Pfizer's third-quarter earnings call Tuesday. Taken together, these five drugs represented about 40% of Pfizer's third-quarter revenue this year when the Covid vaccine and the antiviral treatment Paxlovid are excluded. Pfizer's RSV vaccine candidates for older adults and infants have the potential to generate billions in revenue, Bourla said. It would be the only RSV vaccine in the U.S. that protects infants by giving the shot to the mother, he said.

☆ Pfizer raises 2022 earnings guidance, beats third-quarter expectations
▼ + stars: | 2022-11-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Pfizer on Tuesday raised its 2022 earnings guidance after booking a strong third quarter that beat Wall Street expectations. Pfizer raised its full year sales guidance for its Covid-19 vaccine to $34 billion this year, up $2 billion from the company's previous expectations. The company sold $4.4 billion of its Covid vaccine worldwide in the quarter, a decrease of 66% compared to the third-quarter of 2021. Pfizer's antiviral treatment Paxlovid also had a strong quarter, generating $7.5 billion in sales worldwide though mostly in the U.S. Pfizer booked net income of $8.6 billion for the third quarter, a 6% increase over the same quarter last year.

☆ EU regulator recommends adding heavy periods to side effects of mRNA COVID shots
▼ + stars: | 2022-10-28 | by ( Natalie Grover | ) www.reuters.com time to read: +2 min

[1/2] A medical worker holds a vial of the "Comirnaty" Pfizer-BioNTech COVID-19 vaccine at a coronavirus disease (COVID-19) vaccination center in Nice, France, December 1, 2021. REUTERS/Eric Gaillard/File PhotoOct 28 (Reuters) - A European Medicines Agency (EMA) committee on Friday recommended adding heavy menstrual bleeding to the list of side effect of mRNA COVID-19 vaccines made by Moderna (MRNA.O), as well as Pfizer (PFE.N) and its partner BioNTech (22UAy.DE). The regulator has now concluded that there is at least a "reasonable possibility" that heavy menstrual bleeding is causally associated with these vaccines. Menstrual disorders can occur due to a range of reasons, including underlying medical conditions as well as stress and tiredness. Health authorities have highlighted that cases have also been reported following COVID-19 infection.

Pfizer plans to sell the Covid vaccine it developed with BioNTech at $110 to $130 per dose for teens and adults once the U.S. government stops paying for them, the drugmaker said Friday. Since the start of the pandemic, the government has provided Americans with free Covid tests, vaccines and treatment, through a combination of funding from Congress and other government programs. The government has already stopped providing free Covid tests. A CDC advisory committee voted Wednesday to add Covid vaccines to the Vaccines for Children program, a federal plan that provides free vaccines to children eligible for or covered by Medicaid. Pfizer said it also plans to provide free vaccines to people without insurance through its patient assistance program.

☆ Pfizer Targets Covid Vaccine Price of at Least $110 a Dose
▼ + stars: | 2022-10-21 | by ( Jared S. Hopkins | ) www.wsj.com time to read: 1 min

Pfizer said the earliest there could be a commercial rollout would be early next year. Pfizer Inc. gave some details about its plans to sell the Covid-19 vaccine it developed with BioNTech SE on the commercial market in the U.S., saying it expects to price the shot at $110 to $130 per dose for adults. The drugmaker is still negotiating with health insurers, but anticipates the discussions will lead to a list price in the range, Angela Lukin, a Pfizer official, said Thursday.

☆ Pfizer COVID vaccine price hike seen giving revenue boost for years
▼ + stars: | 2022-10-21 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

Oct 21 (Reuters) - Pfizer's plan to as much as quadruple current U.S. prices for its COVID-19 vaccines going forward could spur revenue for years, analysts said. Outside the United States, Pfizer said it already has contracts with governments in many developed markets that extend through 2023 with prices that have already been set. Moderna had previously suggested commercial price expectations in a range of $64 to $100 a shot. Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant manufacturers would need to hike prices to meet revenue forecasts for 2023 and beyond. Around 19.4 million people in the United States received the updated booster over the first seven weeks of its rollout.

☆ Beware of fad stocks. Truly owner, Snap & Zoom have plunged
▼ + stars: | 2022-10-20 | by ( Paul R. La Monica | ) edition.cnn.com time to read: +4 min

The Sam Adams brewer, which also owns the hard seltzer brand Truly, is struggling as the popularity of alcoholic seltzer appears to be fading fast. “The continuing decline of the hard seltzer segment … is deeper than previously expected,” said Boston Beer founder and chairman Jim Koch on the company’s earnings call in July. Sam Adams owner Boston Beer made a big bet on Truly Hard Seltzer. Sales have slowed, the company is still losing money, its founders have left, and the stock has plunged nearly 80% this year. E-signature software company DocuSign (DOCU) and virtual health company Teladoc (TDOC) have also plunged this year after getting huge boosts from Covid in 2020.

☆ Pfizer expects to hike U.S. COVID vaccine price to $110-$130 per dose
▼ + stars: | 2022-10-20 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

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. 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.

☆ Analysis: Falling demand for COVID boosters puts price hikes on the table
▼ + stars: | 2022-10-20 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

Last year, many on Wall Street were estimating the number of COVID-19 shots would be in line with the annual flu vaccine, which is the vaccine market leader with more than 160 million shots per year in the United States and 600 million shots globally. A recent poll by Kaiser Family Foundation found that two-thirds of American adults do not plan on getting a COVID vaccine soon. He added that instances of COVID infections in those who have been vaccinated has left many to question the effectiveness of the vaccine. The companies could make up for some of the weaker demand with price increases. That would mean annual revenue of $3 billion to $5 billion over the long-term for a company like Moderna, he added.

☆ FDA, CDC sign off on Novavax Covid-19 vaccine as a first booster shot
▼ + stars: | 2022-10-19 | by ( Jacqueline Howard | ) edition.cnn.com time to read: +4 min

CNN —Novavax’s Covid-19 vaccine is now available in the United States for use as a first booster dose for people 18 and older. The company said its booster is for adults for whom a Pfizer/BioNTech or Moderna updated booster vaccine is not accessible or clinically appropriate, and for adults who elect to receive the Novavax vaccine because they would otherwise not get a booster dose of a Covid-19 vaccine. “The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” Novavax President and CEO Stanley Erck said in a news release Wednesday. Novavax executives have long suggested that their Covid-19 vaccine could be used as a booster dose, even for people who got another vaccine type as their primary series. The most common side effects reported with the Novavax booster were pain or tenderness at the injection site, fatigue, muscle pain and headache.

☆ FDA authorizes Novavax's Covid shots as mix-and-match booster to Pfizer or Moderna
▼ + stars: | 2022-10-19 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

The authorization of Novavax's booster could significantly increase the role that its shot plays in U.S. vaccination efforts. The Centers for Disease Control and Prevention still has to give the final go ahead before pharmacies can start administering Novavax's booster. Only 35,300 people have received Novavax's shots so far in the U.S., according to data from the CDC. By comparison, some 372.5 million Pfizer shots, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. so far. People who received Novavax's vaccine as their primary series are also eligible for Pfizer and BioNTech's new omicron booster.

☆ White House Covid czar calls on seniors to get omicron booster now
▼ + stars: | 2022-10-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +4 min

Dr. Ashish Jha, head of the White House Covid taskforce, said everyone older than 50 and senior citizens in particular need to get an omicron booster as soon as possible. The elderly have faced the high risk of falling seriously ill with Covid since the beginning of the pandemic. Younger people should also get a booster this fall even though they're at lower risk of getting seriously ill from the virus, Jha said. The FDA and CDC rapidly authorized the omicron shots for children as young as 5 years old last week. But the CDC, in a study published last April, said the risk of myocarditis is higher after a Covid infection.

☆ Cancer vaccine could be available before 2030, says scientist couple behind COVID-19 shot
▼ + stars: | 2022-10-16 | by ( Joshua Zitser | ) www.businessinsider.com time to read: +3 min

Professors Ozlem Tureci and Ugur Sahin co-founded BioNTech, which partnered with Pfizer to develop a COVID-19 shot. A cancer vaccine will be widely available for patients "before 2030," said Sahin. The cancer vaccine, which would build upon breakthroughs achieved by the scientists during the development of the COVID-19 shot, may be widely available within just eight years, said Professor Ugur Sahin. That work was the "tailwind" for the COVID-19 shot development, which, in turn, now "gives back" to their cancer research, said Tureci. Keunssberg asked the couple if there was "still a chance" that the cancer vaccine doesn't work.

☆ Omicron-specific Covid boosters appear to work well, new data says—regardless of the side effects you experience
▼ + stars: | 2022-10-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

If you already got your omicron-specific Covid booster, you might have experienced some side effects. But there's no need to worry: Experts and new data say the new shots appear to work — regardless of whether you experience moderate, mild or no side effects at all. The new boosters gained approval from the U.S. Food and Drug Administration and the CDC before they finished clinical trials. Like previous Covid vaccines, the new boosters are designed to help you fight the virus by triggering an immune response in your body. Covid vaccines typically take two to three weeks to fully ramp up your immunity, which can help your body stop an infection from happening or keep it from progressing to severe disease.

☆ Fact Check-Preventing transmission never required for COVID vaccines’ initial approval; Pfizer vax did reduce transmission of early variants
▼ + stars: | 2022-10-14 | by ( Reuters Fact Check | ) www.reuters.com time to read: +11 min

To get emergency approval, companies needed to show that the vaccines were safe and prevented vaccinated people from getting ill. They did not have to show that the vaccine would also prevent people from spreading the virus to others. Pfizer ‘vaccine’ wasn’t intended to prevent transmission. The newest family of Omicron variants has further eroded vaccine effectiveness against infection and transmission (here) . But even Omicron does not escape vaccine protection completely.

☆ Omicron BA.5 is declining in the U.S. as emerging variants gain ground, CDC data shows
▼ + stars: | 2022-10-14 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Omicron BA.5 has splintered into several new but related variants that include BQ.1, BQ.1.1 and BF.7. In the U.S., omicron BA.5 makes up about 68% of all new infections, down from about 80% at the beginning of October. But Jha said the new omicron boosters that the U.S. started rolling out last month should provide better protection than the first-generation vaccines against these emerging variants. The boosters target BA.5 and the emerging variants are all omicron and most descend from BA.5. Pfizer and BioNTech on Thursday published the first human data from their BA.5 shots.

☆ Pfizer’s New Omicron-Targeting Booster Produces Strong Immune Response
▼ + stars: | 2022-10-13 | by ( Jared S. Hopkins | ) www.wsj.com time to read: 1 min

The retooled Covid-19 booster from Pfizer Inc. and BioNTech SE generated a strong immune response against the Omicron substrains BA.4 and BA.5, the companies said. The data, which the companies reported in a news release Thursday, offer the first window into how the new shots rolling out across the U.S. perform.

☆ Pfizer-BioNTech releases first human results on updated booster, citing an increase in antibodies
▼ + stars: | 2022-10-13 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

The results are based on blood samples taken from adults one week after they received the updated booster. The FDA also authorized Moderna's updated booster based on similarly limited data. The FDA authorized the updated shots based on studies in mice — plus human trial results from a similar booster that targets the original omicron strain, called BA.1. At the time, Dr. Peter Marks, the FDA's top vaccine regulator, said the agency hoped the updated vaccines will provide stronger protection against symptomatic disease than the older vaccines. Moderna didn't immediately respond to a request for comment about when it will release new data on its updated booster.

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