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An independent advisory panel to the Centers for Disease Control and Prevention on Tuesday recommended that all Americans ages 6 months and up receive updated Covid vaccines from Pfizer and Moderna , the next step toward the shots reaching Americans in the coming days. Thirteen advisors voted in favor of that "universal" recommendation for Americans, while one voted against it. It is a vaccine-preventable disease," said Dr. Beth Bell, clinical professor at the University of Washington and member of the panel, during the advisory meeting. "And so, for that reason, I favor the universal recommendation." The advisory panel's "universal" recommendation comes a day after the Food and Drug Administration approved the two mRNA jabs, which are designed to target the omicron subvariant XBB.1.5.
Persons: Mandy Cohen, Georgina Peacock, Beth Bell, Hospitalizations, hospitalizations, Megan Wallace Organizations: Moderna, Pharmacy, Centers for Disease Control, Pfizer, CDC, University of Washington, Food and Drug Administration, FDA Locations: Schwenksville , Pennsylvania, U.S
[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
Syringes with needles are seen in front of a displayed Moderna logo in this illustration taken, November 27, 2021. Moderna said the companies would use Immatics' drug discovery platform to develop mRNA-based cancer vaccines, and also study its own cancer vaccine for use in combination with Immatics' cancer therapy IMA203. Moderna is already developing a cancer vaccine with Merck (MRK.N), which was shown to cut the risk of recurrence or death by 44% in patients with deadly skin cancer melanoma, in a mid-stage trial. Under the terms of collaboration, Moderna will lead the development and commercialization of the cancer vaccines resulting from the collaboration, while Immatics will be responsible for pre-clinical and potential early-stage studies. Immatics will also receive research funding and is eligible for development, regulatory, and commercial milestone payments that could exceed $1.7 billion, Moderna said.
Persons: Dado Ruvic, Moderna, Immatics, Christy Santhosh, Anil D'Silva, Shounak Organizations: REUTERS, Moderna, Merck, Thomson Locations: COVID, Bengaluru
The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer and Moderna , putting the shots on track to reach Americans within days as U.S. hospitalizations from the virus rise. The updated vaccines from Pfizer and Moderna won't be available to Americans just yet. The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public in mid-September. The upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations. Bourla and Moderna CEO Stéphane Bancel, in a separate statement, urged Americans to receive their updated Covid shot during the same appointment as their annual flu shot.
Persons: Biden, Pfizer's, Albert Bourla, Stéphane Bancel, hospitalizations Organizations: Pfizer, BioNTech, Peabody Institute Library, Drug Administration, Moderna, FDA, CDC, Covid, EG Locations: Peabody , Massachusetts, U.S
Moderna 's new Covid vaccine produced a strong immune response against BA.2.86, a highly mutated omicron variant that health officials are watching closely, according to clinical trial data the biotech company released Wednesday. The updated shot produced an 8.7-fold increase in protective antibodies against BA.2.86, which has been detected in small numbers nationwide. Moderna is the first out of the companies producing updated Covid jabs to release data on how its shot fares against BA.2.86. Last month, Moderna also released clinical trial data suggesting that its new shot provides protection against the now-dominant EG.5, or "Eris," variant and another rapidly spreading strain called FL.1.5.1. New vaccines are set to arrive as Eris and other Covid variants fuel a rise in cases and hospitalizations across the country.
Persons: Stephen Hoge, Covid hospitalizations Organizations: Disease Control, Moderna, Pfizer, Novavax, U.S . Food, Drug Administration, EG, CDC Locations: U.S
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
Moderna's new Covid vaccine generated a robust immune response against the now-dominant Eris variant and another rapidly spreading strain of the virus in an early clinical trial, the biotech company said Thursday. The updated shot is designed to target omicron subvariant XBB.1.5, but the results suggest that the jab may still be effective against newer variants of the virus that are gaining ground nationwide. That includes Eris and another variant nicknamed Fornax, both of which are also descendants of the omicron virus variant. The World Health Organization designated Eris a "variant of interest," meaning it will be monitored for mutations that could make it more severe. A Pfizer spokesperson on Thursday said the company's own updated Covid shot effectively neutralized XBB.1.5 and Eris, among other variants, in a recent trial on mice.
Persons: Eris Organizations: omicron, Pfizer, Novavax, U.S . Food, Drug Administration, EG, Centers for Disease Control, World Health Organization, CDC Locations: U.S
Some public health experts hope that Americans will welcome the new shot as they would a flu jab. In the fall of 2022, by which time most people had either had the COVID virus or the vaccine, fewer than 50 million people got the shots. Its biggest rival, Moderna, conceded demand could be as few as 50 million shots. POST PANDEMIC VACCINEThe COVID public health emergency ended in May and the government has handed much of the duty of vaccinating America to the private sector. As with the flu, Pfizer (PFE.N)/BioNTech SE (22UAy.DE), Moderna (MRNA.O) and Novavax (NVAX.O), have created versions of the COVID vaccine to try to match the variant they believe will be circulating this fall.
Persons: Dado Ruvic, Ashley Kirzinger, Kirzinger, BioNTech, Jefferies, Michael Yee, " Yee, Mandy Cohen, William Schaffner, Schaffner, David Boulware, Michael Erman, Caroline Humer, Diane Craft Organizations: REUTERS, CVS Health, Family, Reuters, Pfizer –, Moderna, Pfizer, U.S . Centers for Disease Control, Prevention, CDC, U.S . Food, Drug Administration, EG, Vanderbilt University, University of Minnesota, Thomson Locations: U.S, America, United States, COVID, CDC's
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
Shares of Moderna rose Thursday after the biotech company hiked its full-year outlook for its Covid vaccine, its only marketable product, despite reporting a quarterly loss and sharp drop in revenue. But Moderna hopes to end the sales slump on strong demand for its updated Covid vaccine targeting the omicron subvariant XBB.1.5. The forecast includes around $4 billion in previously announced Covid vaccine purchase agreements and $2 billion to $4 billion in "signed and anticipated" contracts in the U.S. and other markets. Pfizer on Tuesday warned that Covid shot sales in the commercial market are uncertain, adding that vaccination rates will help the company better predict sales for 2023 and beyond. ET, which will likely provide more updates on its upcoming Covid vaccine rollout and drug pipeline.
Persons: Novavax haven't, Mandy Cohen Organizations: Moderna, Pfizer, Novavax, Food and Drug Administration, NPR, Merck Locations: U.S, Union, Massachusetts, Covid
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailWe've only seen the beginning of Moderna's story, says Goldman Sachs' Salveen RichterSalveen Richter, Goldman Sachs lead biotech analyst, joins 'Closing Bell Overtime' to discuss the biotech sector and how investors should play in the space.
Persons: Goldman Sachs, Salveen Richter Salveen Richter
Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will "be exclusively for the Chinese people" and won't "be exported," a Moderna spokesperson told CNBC. The Moderna spokesperson did not confirm the report or comment on the size of the deal. Moderna in May said it was keen to sell its mRNA Covid vaccine to China after registering a legal entity in the world's second-largest economy. The country has also struggled to develop mRNA technology at home during the pandemic.
Persons: Stéphane Bancel, It's, drugmakers, Biden Organizations: Moderna, U.S, CNBC, The Moderna, Pfizer, China's Ministry of Commerce, AstraZeneca, Novo Nordisk, Merck, Sanofi, GE HealthCare Technologies Locations: China, The Massachusetts, Shanghai, Japan, Canada, Australia, Kenya, Beijing, New York
Investors aren't fully appreciating the broader uses for Moderna's mRNA vaccines, creating a big buying opportunity, UBS said Monday. UBS did lower its price target to $191 from $221, though the new forecast implies upside of 61% from Friday's close. MRNA YTD mountain Moderna stock has declined nearly 35% so far this year. Merle pointed toward vaccines for respiratory syncytial virus (RSV), the flu and cytomegalovirus (CMV) as promising upside drivers for the company. "We think MRNA's CMV vaccine could be a major potential upside driver over the next 1-2 years, with limited priced in (leading cause of birth defects, no approved vaccines)," Merle said.
Persons: Eliana Merle, Merle, Michael Bloom Organizations: UBS, Moderna, UBs Locations: Moderna, Friday's, CMV
Moderna on Thursday applied for U.S. Food and Drug Administration approval of the biotech company's updated Covid vaccine for the fall. Moderna and rivals Pfize r and Novavax already began to develop versions of their vaccines targeting XBB.1.5 months before the FDA's recommendation. Clinical trial data on more than 100 people similarly demonstrates the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received four Covid vaccine doses. The U.S. is expected to shift Covid vaccine distribution to the private sector as soon as the fall.
Persons: Moderna's, Stéphane Bancel Organizations: U.S . Food, Drug Administration, Moderna, . Food, Drug, FDA, Pfizer, Novavax, Moderna's, Centers for Disease Control Locations: U.S
But facing pressure to deliver new shots by the fall, Pfizer, Moderna and Novavax began development on versions of their vaccines targeting XBB.1.5 months before the FDA's decision. That doesn't include Johnson & Johnson , a once-leading Covid vaccine developer. Moderna expects a minimum of $5 billion in revenue from its Covid vaccine, its only available product. The cash-strapped company won U.S. approval for its Covid vaccine under emergency use just last year due to regulatory and manufacturing delays. The company hopes to rake in $1.06 billion to $1.24 billion in sales of its Covid vaccine this year.
Persons: Novavax, Dr, Melinda Wharton, Johnson Organizations: Chicago Department of Public Health, Southwest Senior Center, The U.S . Food, Pfizer, Moderna, FDA, Centers for Disease Control, National Center, Manufacturers, U.S, Moderna's Locations: COVID, Chicago , Illinois, The U.S, Novavax, U.S
The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family. Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall. But it's unclear how many Americans will roll up their sleeves to take the updated shots later this year.
Persons: Melinda Wharton, Novavax, John Jacobs, Peter Marks, David Kaslow Organizations: . Food, Centers for Disease Control, Advisors, Pfizer, Moderna, National Center, FDA, CDC, Novavax, omicron Locations: U.S, Novavax
Jakub Porzycki | NurPhoto | Getty ImagesNovavax has a clear message for Wall Street: The cash-strapped Covid vaccine maker sees a pathway to survival. The 36-year-old company will continue to rely on its protein-based Covid vaccine – its only commercially available product – for most of its revenue this year. Once the U.S. government's supply of free Covid vaccines runs out, all three companies will sell updated shots directly to health-care providers. A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. But Taylor emphasized that the plan will help Novavax refocus on its top priority: delivering an updated vaccine in the coming months.
Persons: Jakub Porzycki, Novavax, Covid, Cowen, Brendan Smith, John Jacobs, Smith, that's, Silvia Taylor, Taylor, Jefferies, Roger Song, Patrick Van Katwijk, Mayank Mamtani, let's, Mamtani, Let's, Song, Ding Genhou Organizations: NurPhoto, Getty, Pfizer, Moderna, CNBC, Food and Drug Administration, World Health Organization, FDA, Dutch Health Service Organization, Riley Securities, U.S, Centers for Disease Control, CDC, Reuters, Visual China Locations: Krakow, Poland, Maryland, U.S, The Hague, Netherlands, Moderna, Geneva, Hohhot, Inner Mongolia Autonomous Region, China
U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign. That means all three companies will start selling their updated Covid shots directly to health-care providers. The FDA staff's decision comes weeks after an advisory group to the World Health Organization recommended that Covid booster shots target XBB variants. Scientists have said that XBB strains are some of the most immune-evasive subvariants to date. Last year's Covid boosters were bivalent, meaning they targeted the original strain of the virus and omicron variants BA.4 and BA.5.
Organizations: . Food, Drug Administration, FDA, Pfizer, Moderna, World Health Organization, Moderna's, Centers for Disease Control Locations: U.S
Scott Olson | Getty ImagesThree years and billions of Covid vaccinations into the pandemic, Pfizer and Moderna say their work is far from over. Here's what Moderna and Pfizer say is next for their Covid shots. Annual Covid shotsPfizer and Moderna aim to keep up with a shift in the U.S. toward annual Covid shots rather than frequent booster doses. Miller, who helped lead the development of Moderna's Covid shot in 2020, said the advantages of using mRNA became evident earlier on in the pandemic. 'Next-generation' Covid shotsPfizer's and Moderna's Covid vaccines both deliver robust protection against the virus, but that immunity can start to fade after four to six months.
Vanessa Leroy | Bloomberg | Getty ImagesBut the vast majority of Americans will not have to pay out of pocket for Covid vaccines even after the federal government's stockpile runs out. Insured Americans will be able to access Covid shots as part of their coverage, without having to pay out of pocket. Under the arrangement, the CDC will continue to purchase Covid vaccines at a discount and distribute them through 64 state and local health departments. That HHS effort will leverage the "public commitments" by drug manufacturers to provide free Covid vaccines and treatments to uninsured people. Pfizer and Moderna have not said whether they would supply free shots to pharmacies.
A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. The company's Covid vaccine is its lone marketed product after 35 years in business. The company reported R&D expenses of $258 million and SG&A expenses of $162 million last year. The company raced against Pfizer and Moderna to develop the first Covid vaccine early in the pandemic. Novavax's shot is the first Covid vaccine to use protein technology, a decades-old method for fighting viruses used in routine vaccinations against hepatitis B and shingles.
Moderna on Thursday blew past estimates for first-quarter earnings and revenue, posting a surprise quarterly profit, despite lower demand for Covid vaccines, its only marketable product. The biotech company generated first-quarter sales of $1.9 billion, driven by Covid shot revenue deferred from 2022. Moderna maintained its full-year guidance of around $5 billion in revenue from its Covid vaccine, which will come from signed government contracts for the shot. But Covid shot demand is still falling as the pandemic eases and the U.S. shifts to an annual vaccination schedule rather than repeated booster doses. Moderna in April said it hopes to offer a new set of life-saving vaccines targeting cancer, heart disease and other conditions by 2030.
The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. London-based GSK during an earnings presentation last week said it has "millions" of doses of the RSV vaccine ready to ship. In March, an independent panel of advisors to the FDA recommended GSK's RSV vaccine based on data from a phase three trial on older adults. A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK's vaccine, according to an FDA briefing document. The FDA flagged the disorder as a potential safety issue with Pfizer's RSV vaccine for older adults.
French businessman Stéphane Bancel made $393 million in stock options in 2022, according to securities filings. Bancel, 50, also owns stocks valued around at least $2.8 billion, and received a 50% raise from 2021 to 2022. Moderna's chief executive officer Stéphane Bancel raked in about $393 million in 2022 thanks to stock options, and then received a raise on top of it — compensation that's giving some analysts pause. In addition to exercising his stock options in 2022, 50-year-old Bancel earned a $1.5 million salary — a 50% jump from 2021, according to securities filings from March. Meanwhile, Amazon CEO Andy Jassy's pay dropped from $212 million in 2021 to $1.3 million in 2022 due to receiving any stock awards.
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.
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