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☆ Moderna loses less than expected as Covid vaccine sales beat estimates, cost cuts take hold
▼ + stars: | 2024-05-02 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Moderna on Thursday posted a narrower-than-expected loss for the first quarter as the company's cost-cutting efforts took hold and sales of its Covid vaccine, its only commercially available product, topped estimates. The biotech company booked first-quarter sales of $167 million, with revenue from its Covid shot dropping roughly 90% from the same period a year ago. The company reiterated its full-year 2024 sales guidance of roughly $4 billion, which includes revenue from its RSV vaccine. For the first quarter, Mock said the company is "more encouraged by what we're seeing from a productivity perspective" than the higher sales of its Covid vaccine. Cost of sales was $96 million for the fourth quarter, down 88% from the same period a year ago.

Persons: we've, Stéphane Bancel, Jamey Mock, Mock, OpenAI Organizations: Moderna, LSEG, CNBC, Research, Mock, Merck Locations: Moderna, U.S, America

☆ A simple options trade on a steady health care stock benefitting from an aging population
▼ + stars: | 2024-02-01 | by ( Michael Khouw | ) www.cnbc.com time to read: +3 min

The U.S. population is getting older and per capita health care spending has been rising — other than the pandemic blip — very steadily for half a century. We'll detail a simple trade on a resilient health care industry stock that stands to benefit from that long-term trend. Becton Dickinson (BDX) has a large array of healthcare products and consequently doesn't exhibit the volatility that some other health care companies have like biotech. Unsurprisingly, when we look at the health care sector, we also see consistent long-term growth. The Health Care Select Sector Index (IXV) includes more than 60 companies in pharmaceuticals, biotech, equipment, managed care, service providers and distribution.

Persons: Becton Dickinson Organizations: Moderna Inc

☆ Moderna reaffirms annual COVID vaccine sales forecast
▼ + stars: | 2023-10-16 | by ( ) www.reuters.com time to read: 1 min

Syringes with needles are seen in front of a displayed Moderna logo in this illustration taken, November 27, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsCompanies Moderna Inc FollowPfizer Inc FollowOct 16 (Reuters) - Moderna (MRNA.O) on Monday reaffirmed its forecast of $6 billion to $8 billion in COVID vaccine sales for the year, after rival Pfizer (PFE.N) slashed forecast for its vaccine last week. Moderna said it will have "improved visibility" about the expected U.S. market size for vaccines after observing trends through October 2023. Shares of Moderna were down about 4% in premarket trading. Reporting by Bhanvi Satija in Bengaluru; Editing by Shilpi MajumdarOur Standards: The Thomson Reuters Trust Principles.

Persons: Dado Ruvic, Bhanvi, Shilpi Majumdar Organizations: REUTERS, Moderna Inc, Pfizer, Moderna, Thomson Locations: Bengaluru

Vaccine makers are depending on the U.S. market as many countries have more limited yearly campaigns for giving updated shots. For BioNTech, Moderna, and Novavax (NVAX.O), COVID vaccines remain their only approved products. Shares of Pfizer were up nearly 5%, however, buoyed by a $3.5 billion cost-cutting plan the drugmaker announced late on Friday alongside its new COVID sales outlook. Moderna, in a statement on Monday, maintained its current revenue forecast of $6 billion to $8 billion for its COVID vaccine for 2023. Jefferies analyst Michael Yee said Pfizer's new COVID outlook implies lower vaccine sales for Moderna than it had forecast.

Persons: Dado, BioNTech, Albert Bourla, Bourla, Mani Foroohar, Foroohar, Jefferies, Michael Yee, Ludwig Burger, Rachel More, Michael Erman, Bhanvi Satija, Manas, Jonathan Oatis, Caroline Humer, Bill Berkrot Organizations: COVID, Institute for Health, Food, REUTERS, Pfizer, Moderna, Manas Mishra, Thomson Locations: Zenica, Bosnia, Herzegovina, Frankfurt, Novavax, U.S, New York, Bengaluru

☆ Moderna to scale down manufacturing of COVID vaccine
▼ + stars: | 2023-09-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

The downsizing, Hoge added, will help Moderna adjust to the endemic phase of the disease, which had led to falling demand for COVID vaccines as payers scale back orders for the shots. Moderna predicted in August that U.S. demand for the vaccine would reach 50 to 100 million doses in the fall season. Following the U.S. Food and Drug Administration's authorization on Monday, Moderna said it would start shipping COVID vaccine doses across the United States. The effectiveness of Moderna's flu vaccine was demonstrated across all age groups, including older patients, and was found to be safe and tolerable, according to the company. Moderna also said it had found that its shot was equal or superior to Sanofi's high-dose flu vaccine in a separate early head-to-head study.

Persons: Stephen Hoge, Hoge, Moderna, we've, We've, COVID, Patrick Wingrove, Bhanvi, Will Dunham Organizations: Moderna, Sanofi, Wednesday, U.S . Centers for Disease Control, U.S . Food, Thomson Locations: Moderna, Massachusetts, United States, Britain, Canada, Japan, China, New York, Bengaluru

☆ ICON to partner with US govt agency to test COVID vaccine candidates
▼ + stars: | 2023-09-13 | by ( ) www.reuters.com time to read: +1 min

Vials labelled "VACCINE Coronavirus COVID-19" and a syringe are seen in front of a displayed U.S. flag in this illustration taken December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsCompanies Icon Plc FollowBioNTech SE FollowModerna Inc Follow Show more companiesSept 13 (Reuters) - Contract research firm ICON Plc (ICLR.O) said on Wednesday it is partnering with the U.S. government for a clinical trial to test the effectiveness of next generation COVID-19 vaccine candidates. As part of the collaboration with Biomedical Advanced Research and Development Authority, ICON will conduct a mid-stage trial of 10,000 participants to assess the efficacy of a next generation COVID-19 vaccine relative to currently available shots. The U.S. agency will select the vaccine candidate for the trial. The U.S. Food and Drug Administration on Monday authorized updated COVID-19 vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O) that target the XBB.1.5 subvariant of the virus.

Persons: Dado Ruvic, Pratik Jain, Saumyadeb Chakrabarty, Shounak Organizations: REUTERS, U.S, Research, Development Authority, U.S . Food, Drug Administration, Pfizer, Moderna, Thomson Locations: U.S, Bengaluru

☆ COVID vaccine manufacturers set list price between $120-$130 per dose
▼ + stars: | 2023-09-12 | by ( ) www.reuters.com time to read: +1 min

A patient receives their coronavirus disease (COVID-19) vaccine booster during a Pfizer-BioNTech vaccination clinic in Southfield, Michigan, U.S., September 29, 2021. REUTERS/Emily Elconin/File photo Acquire Licensing RightsCompanies BioNTech SE FollowModerna Inc FollowNovavax Inc Follow Show more companiesSept 12 (Reuters) - U.S. COVID vaccine manufacturers set list prices for their shots between $120 and $130 per dose, company executives said at an advisory panel meeting of U.S. Centers for Disease Control and Prevention on Tuesday. Pfizer (PFE.N) and German partner BioNTech (22UAy.DE) set the list price at $120 per dose, while Moderna (MRNA.O) said the list price for its shot is $129 per dose, for their respective COVID vaccines. Novavax (NVAX.O) said the list price for its COVID vaccine was $130 per dose. Reporting by Bhanvi Satija and Sriparna Roy in Bengaluru; Editing by Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

Persons: Emily Elconin, BioNTech, Bhanvi Satija, Sriparna Roy, Shounak Dasgupta Organizations: Pfizer, REUTERS, U.S . Centers for Disease Control, Moderna, Thomson Locations: Southfield , Michigan, U.S, Bengaluru

☆ US FDA authorizes Pfizer-BioNTech and Moderna's updated COVID shots
▼ + stars: | 2023-09-11 | by ( ) www.reuters.com time to read: +2 min

[1/3] Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. A third shot, made by Novavax (NVAX.O), is still under review by the FDA. But obviously that requires that FDA have decided the data supports it," said Jesse Goodman, a professor at Georgetown and former FDA chief scientist. Moderna and Pfizer, which is partnered with German biotech firm BioNTech SE (22UAy.DE), said the updated vaccines were expected to be available the United States in the coming days. An endorsement by CDC Director Mandy Cohen, expected shortly, should clear the way for the new shots.

Persons: Andrew Kelly, Novavax, Jesse Goodman, —, Mandy Cohen, Cohen, Sriparna Roy, Mariam Sunny, Michael Erman, Shinjini Organizations: Food and Drug Administration, FDA, REUTERS, Pfizer, Moderna, U.S . Food, Drug Administration, for Disease Control, Prevention, Georgetown, EG, CDC, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru, New York

☆ US CDC says new COVID lineage could cause infections in vaccinated individuals
▼ + stars: | 2023-08-23 | by ( ) www.reuters.com time to read: +1 min

CDC said it was too soon to know whether this might cause more severe illness compared with previous variants. But due to the high number of mutations detected in this lineage, there were concerns about its impact on immunity from vaccines and previous infections, the agency said. Scientists are keeping an eye on the BA.2.86 lineage because it has 36 mutations that distinguish it from the currently-dominant XBB.1.5 variant. The agency had earlier this month said it was tracking the highly mutated BA.2.86 lineage, which has been detected in the United States, Denmark and Israel. CDC said on Wednesday the current increase in hospitalizations in the United States is not likely driven by the BA.2.86 lineage.

Persons: Pratik Jain, Shilpi Majumdar Organizations: Science, Trinity College, Reuters, U.S . Centers for Disease Control, Prevention, CDC, Thomson Locations: Dublin, Wuhan, United States, Denmark, Israel, hospitalizations, Bengaluru

Scientists are keeping an eye on the new lineage, named BA.2.86, because it has 36 mutations that distinguish it from the currently-dominant XBB.1.5 variant. So far there is no evidence that BA.2.86 spreads faster or causes more serious illness than previous versions. COVID infections and hospitalizations have been rising in the U.S., Europe and Asia, with more cases in recent months attributed to the EG.5 "Eris" subvariant, a descendant of the Omicron lineage that originally emerged in November 2021. But many countries have drastically reduced testing of patients and their efforts to analyze the genomes of the viruses causing new COVID cases. Updated COVID booster shots now being developed have been designed to target the Omicron subvariant XBB.1.5.

Persons: Emily Elconin, Wesley Long, Eric Topol, Topol, Long, Moderna, Eris, Deena Beasley, Nancy Lapid, David Gregorio Our Organizations: REUTERS, Moderna Inc, Pfizer, World Health Organization, U.S . Centers for Disease Control, CDC, EG, Omicron, Houston Methodist Hospital, Scripps Research, COVID, U.S, Pfizer Inc, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, United States, Israel, Denmark, La Jolla , California

☆ Pfizer's updated COVID shot effective against 'Eris' variant in mice study
▼ + stars: | 2023-08-17 | by ( ) www.reuters.com time to read: +1 min

Pfizer, along with its German partner BioNTech SE (22UAy.DE), as well as other COVID-19 vaccine makers Moderna (MRNA.O) and Novavax (NVAX.O) have created versions of their shots, which are aimed at the XBB.1.5 subvariant. EG.5, nicknamed by some as "Eris", is similar to the XBB.1.5 subvariant and a sub-lineage of the still-dominant Omicron variant. EG.5 accounted for about more than 17% of COVID-19 cases in the United States, according to the latest government data. In the United States, COVID-19 related hospitalizations are up more than 40% off of recent lows hit in June, but are still more than 90% below peak levels hit during the January 2022 Omicron outbreak. Reporting by Pratik Jain in Bengaluru; Editing by Shilpi MajumdarOur Standards: The Thomson Reuters Trust Principles.

Persons: Chris Aluka Berry, BioNTech, Pratik Jain, Shilpi Majumdar Organizations: Dekalb Pediatric Center, REUTERS, Pfizer, Pfizer Inc, Moderna, EG, World Health Organization, Thomson Locations: Dekalb, Georgia, Decatur , Georgia, U.S, United States, China, South Korea, Japan, Canada, Bengaluru

☆ Moderna's updated COVID vaccine effective against 'Eris' variant in humans
▼ + stars: | 2023-08-17 | by ( ) www.reuters.com time to read: +2 min

Vials of the Moderna COVID-19 vaccine are seen at Apotex pharmaceutical company as Humber River Hospital's mobile vaccine clinic vaccinate employees as part of the coronavirus disease (COVID-19) vaccination campaign, in Toronto, Ontario, Canada April 13, 2021. REUTERS/Carlos Osorio/File Photo Acquire Licensing RightsCompanies BioNTech SE FollowModerna Inc FollowNovavax Inc Follow Show more companiesAug 17 (Reuters) - Moderna (MRNA.O) said on Thursday an initial study data showed its updated COVID-19 vaccine to be effective against the "Eris" and "Fornax" subvariants in humans. Moderna and other COVID-19 vaccine makers Novavax (NVAX.O), Pfizer (PFE.N) and German partner BioNTech SE (22UAy.DE) have created versions of their shots aimed at the XBB.1.5 subvariant. Earlier on Thursday, Pfizer reported that its updated COVID-19 shot, co-developed with BioNTech, showed neutralizing activity against the Eris subvariant in a study conducted on mice. Eris, the nickname for EG.5, is similar to the XBB.1.5 subvariant and a sub-lineage of the still-dominant Omicron variant.

Persons: Carlos Osorio, BioNTech, Pratik Jain, Shilpi Majumdar Organizations: Moderna, REUTERS, Pfizer, EG, Omicron, World Health Organization, Thomson Locations: Humber, Toronto , Ontario, Canada, United States, Europe, U.S, Bengaluru

☆ With Eris on the rise, US CDC sees no major shift in COVID variants
▼ + stars: | 2023-08-09 | by ( ) www.reuters.com time to read: +2 min

Updated vaccines should be available by mid- to late September, she said. The vaccines still need to be authorized by the U.S. Food and Drug Administration and the CDC needs to make its recommendations, she said. "We are likely to see this as a recommendation as an annual COVID shot just like we have an annual flu shot," she said. Pfizer (PFE.N)/BioNTech SE (22UAy.DE), Moderna (MRNA.O) and Novavax (NVAX.O) have all said they expect to have supplies of the updated vaccine ready for the roll out this autumn. Eris is the fasting-growing COVID-19 subvariant in the U.S., estimated to be responsible for around 17% of current COVID cases, according to the CDC.

Persons: Mandy Cohen, Biden, Andy Slavitt's, we've, Cohen, Michael Erman, Lisa Shumaker Organizations: EG, U.S . Centers for Disease Control, U.S . Food, Drug Administration, Pfizer, World Health Organization, CDC, Thomson Locations: United States, China, U.S, New York

COVID vaccine makers Moderna and Pfizer are pinning their hopes on private markets sales and strong demand for their new updated shots targeting XBB.1.5 variant to turn around a slump in sales of the products that had bumper growth during the peak of the pandemic. The company sees between $2 billion and $4 billion in the vaccine sales from commercial contracts in the United States and other places. However, it said $1 billion of a total $5 billion in sales from signed government contracts would be deferred to next year. Pfizer on Tuesday warned that sales of COVID vaccines were uncertain, adding that the COVID vaccination rates this fall should be a good predictor for annual rates. For Moderna, second-quarter COVID vaccine sales slumped 94% to $293 million, which was still higher than analysts' average estimate of $233.6 million, according to Refinitiv data.

Persons: Dado Ruvic, Leroy Leo, Patrick Wingrove, Shinjini Organizations: REUTERS, Moderna Inc, Moderna, Pfizer, Thomson Locations: United States, Bengaluru, New York

☆ Pfizer, Flagship Pioneering to invest $100 mln in drug discovery
▼ + stars: | 2023-07-18 | by ( ) www.reuters.com time to read: +2 min

July 18 (Reuters) - U.S. drugmaker Pfizer (PFE.N) and venture firm Flagship Pioneering on Tuesday said they would invest $100 million together to develop up to 10 new potential drugs for areas including internal medicine, oncology, infectious diseases and immunology. Flagship, which has incubated biotech companies, most famously Moderna Inc (MRNA.O), and Pfizer will each invest $50 million. Flagship's drug discovery initiative Pioneering Medicines will lead the exploration process. Paul Biondi, president of Flagship's Pioneering unit and a former top Bristol Myers Squibb (BMY.N) executive, said the partnership will take advantage of Flagship's abilities to develop novel technologies towards bigger disease areas. Drug developers such as Denali Therapeutics (DNLI.O), Foghorn Therapeutics (FHTX.O) and Sana Biotechnology (SANA.O) are some of the other companies backed by Flagship.

Persons: Paul Biondi, Biondi, Mikael Dolsten, Foghorn, Bhanvi, Michael Erman, Shilpi Majumdar, Alexandra Hudson Organizations: drugmaker Pfizer, Moderna Inc, Pfizer, Flagship's, Bristol Myers Squibb, Flagship, Therapeutics, Foghorn Therapeutics, Sana Biotechnology, Alexandra Hudson Our, Thomson Locations: Bengaluru, New Jersey

☆ Moderna agrees deal in China with view to developing mRNA medicines
▼ + stars: | 2023-07-05 | by ( ) www.reuters.com time to read: +2 min

Companies Moderna Inc FollowSHANGHAI, July 5 (Reuters) - Vaccine maker Moderna Inc (MRNA.O) said on Wednesday it had signed a memorandum of understanding and a land collaboration agreement to work towards opportunities for it to research, develop and manufacture mRNA medicines in China. Moderna said in May it was looking for opportunities in China after registering a legal entity in the world's second-largest economy. The company prior to this had no presence in mainland China. Its expansion into mainland China comes as its revenue growth slows sharply due to waning global demand for its COVID-19 vaccine, the U.S. company's only approved product. Those vaccines, based on the same mRNA platform as its COVID shot, have yet to be filed for regulatory approval decisions.

Persons: Stéphane Bancel, Brenda Goh, Andrew Heavens, Louise Heavens Organizations: Moderna Inc, Reuters, Moderna, Thomson Locations: China, Shanghai, Moderna, Hong Kong, Asia, U.S, Beijing

☆ Cancer vaccines poised to unlock 'new treatment paradigm' with Merck/Moderna data
▼ + stars: | 2023-06-05 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +5 min

The hope is for "a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients' tumors," said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck. The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed. With standard treatment, 90% of pancreatic cancer patients die within five years of diagnosis. The approach first primes the immune system with an older technology called a chimpanzee adenovirus vaccine that targets patients' tumors.

Persons: Andrew Kelly, Keytruda, Jane Healy, Germany's BioNTech, Vinod Balachandran, we've, we're, Andrew Allen, Healy, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Merck & Co, REUTERS, CHICAGO, Moderna Inc, American Society of Clinical Oncology, Merck, Moderna, Memorial Sloan Kettering Cancer Center, Thomson Locations: Kenilworth , New Jersey, U.S, Chicago, New York, Nature

☆ Catalent cuts annual forecast hurt by operational challenges
▼ + stars: | 2023-05-19 | by ( ) www.reuters.com time to read: +2 min

May 19 (Reuters) - Catalent Inc (CTLT.N) cut its full-year net revenue and profit forecast on Friday, reflecting operational challenges and higher-than-expected costs after it flagged an over $400 million hit to both its annual sales and core profit forecasts earlier this month. The contract drug manufacturer now sees its full-year revenue in the range of $4.25 billion to $4.35 billion compared with its prior forecast of $4.63 billion to $4.88 billion. Catalent said it now sees adjusted net income for the year in the range of $187 million to $228 million, compared with the previous forecast of $567 million to $648 million. Shares of Catalent reversed losses to be up 7.7% at $34.63 before the bell. Reporting by Bhanvi Satija, Sriparna Roy and Pratik Jain in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ WHO recommends new COVID shots should target only XBB variants
▼ + stars: | 2023-05-18 | by ( ) www.reuters.com time to read: +2 min

May 18 (Reuters) - A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants. New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered. The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected. The bivalent booster shots developed and distributed last year targeted two different strains - the Omicron variant as well as the original virus. WHO's advisory group, which recommends if changes are needed to the composition of future COVID-19 shots, said currently approved vaccines should continue to be used in accordance with the agency's recommendations.

☆ Catalent shares tank on warning of $400 mln cut to annual revenue forecast
▼ + stars: | 2023-05-08 | by ( ) www.reuters.com time to read: +2 min

May 8 (Reuters) - Catalent Inc (CTLT.N) expects to cut by more than $400 million both its full-year revenue and core profit forecasts, the contract drug manufacturer said on Monday, sending its shares tumbling 27% to a three-year low. In April, Catalent had flagged productivity issues and warned that a slower-than-expected ramp up in production capacity would hit quarterly results. Catalent had been the sole contract manufacturer for Novo Nordisk's (NOVOb.CO) weight-loss drug Wegovy, but the Danish company last month unveiled a second contract manufacturer to help meet sky-rocketing demand. Catalent in February forecast full-year net revenue of $4.63 billion to $4.88 billion and adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) of $1.22 billion to $1.30 billion. Reporting by Sriparna Roy in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.

May 4 (Reuters) - Moderna Inc (MRNA.O) on Thursday reported stronger-than-expected sales of $1.9 billion for its COVID-19 vaccine in the first quarter, driven by a surge of revenue deferred from 2022, but left its 2023 sales expectations unchanged. Moderna said it continued to expect COVID vaccine sales of $5 billion for the year based on advance purchase agreements. Moderna expects an additional $3 billion in deferred vaccine revenue in the second half of 2023. The results came two days after the company's rival Pfizer reported better-than-expected COVID vaccine sales for the first quarter and maintained its expectations for full-year sales. Moderna had generated around $36 billion in sales over the last two years from its COVID vaccine, its only commercial product and one of the most widely used shots for the virus.

☆ Futures waver as PacWest slide offsets Fed pause optimism
▼ + stars: | 2023-05-04 | by ( ) www.reuters.com time to read: +3 min

The Fed over the past 14 months has raised rates by 500 basis points to tame price pressures in its most aggressive policy tightening since the 1980s. The KBW Regional Banking index (.KRX) and S&P 500 Banks index (.SPXBK) have lost around 29% and 15% so far in 2023. Investors will also monitor weekly jobless claims for further clues on the state of the labor market. Qualcomm Inc (QCOM.O) slumped 6.7% after third-quarter forecasts missed estimates, while Etsy Inc (ETSY.O) gained 3% on beating expectations for quarterly revenue. Reporting by Ankika Biswas in Bengaluru; Editing by Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

☆ US FDA approves first RSV vaccine from GSK
▼ + stars: | 2023-05-03 | by ( ) www.reuters.com time to read: +1 min

May 3 (Reuters) - The U.S. Food and Drug Administration has approved GSK Plc's (GSK.L) respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people. The vaccine was approved for people aged 60 and older, the company said. The approval makes GSK, which has been neck-and-neck with Pfizer (PFE.N) in RSV vaccine development, the first company to tap into a multi-billion-dollar market and puts it ahead of rivals such as Moderna Inc (MRNA.O) and Bavarian Nordic (BAVA.CO). Analysts have estimated the market for RSV vaccines to cross $10 billion by 2030. GSK expects the vaccine to be available before the next RSV season in the United States, Chief Commercial Officer Luke Miels told Reuters on Wednesday before the approval.

Chief Judge Colm Connolly's ruling for Alnylam Pharmaceuticals Inc (ALNY.O) came just over a month after a different judge in Delaware rejected Moderna's similar motion in another vaccine patent lawsuit. Representatives for Moderna and Alnylam did not immediately respond to requests for comment. Moderna made the same argument in a motion to dismiss part of another patent lawsuit brought by Arbutus Biopharma Corp (ABUS.O) and Genevant Sciences GmbH. U.S. District Judge Mitchell Goldberg rejected Moderna's motion in that case last year and said it had not yet proven the government was more than an "incidental beneficiary" of the shots. Goldberg denied the motion for a second time last month after the federal government backed Moderna's position.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

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