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A 50-year-old and immunocompromised resident receives a second booster shot of the coronavirus disease (COVID-19) vaccine in Waterford, Michigan, U.S., April 8, 2022. On Thursday, Moderna (MRNA.O) said initial data showed its updated COVID-19 vaccine is 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. Pending approval from health regulators in the United States and Europe, the companies expect the updated shots to be available in the coming weeks for the autumn vaccination season. "We will be encouraging all Americans to get those boosters in addition to flu shots and RSV shots," the official said, referring to the Respiratory Syncytial Virus.
Persons: Emily Elconin, Biden, BioNTech, Steve Holland, Lisa Shumaker Organizations: REUTERS, Rights, White, for Disease Control, Pfizer, Thomson Locations: Waterford , Michigan, U.S, Moderna, United States, Europe
New Covid vaccines from Pfizer , Moderna and Novavax will likely provide protection against the new "Eris" variant, now the dominant strain of the virus in the U.S. The drugmakers designed their updated vaccines to target the omicron subvariant XBB.1.5, which is slowly declining nationwide. Eris accounted for 17.3% of all cases in the U.S. as of earlier this month, according to the latest data from the CDC. The World Health Organization earlier this month designated Eris a "variant of interest," meaning it will be monitored for mutations that could potentially make it more severe. It's also not expected to cause a huge wave of Covid cases like other strains have in previous years.
Persons: Dr, Mark Mulligan, It's Organizations: Chicago Department of Public Health, Southwest Senior Center, Pfizer, Moderna, U.S, EG, NYU, Vaccine, CNBC, Food and Drug Administration, Disease Control, CDC, World Health Organization Locations: Covid, Chicago , Illinois, Novavax, U.S
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
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
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
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
NEW YORK, Aug 14 (Reuters) - COVID infections and hospitalizations are on the rise in the U.S., Europe and Asia. Health officials are pointing at the EG.5 "Eris" coronavirus, a subvariant of the Omicron lineage that originally emerged November of 2021. EG.5 had been found in more than 50 countries as of August 8, according to the WHO. It is the most common and fastest growing COVID-19 subvariant in the U.S., estimated to be responsible for around 17% of current COVID cases, according to the CDC. EG.5 is similar to XBB.1.5 although the newer subvariant carries one mutation to its spike protein, the part of the virus targeted by the vaccine.
Persons: Mandy Cohen, Cohen, Michael Erman, Caroline Humer, Diane Craft Organizations: Health, EG, Omicron, World Health Organization, WHO, CDC, Pfizer, Thomson Locations: U.S, Europe, Asia
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
Novavax posts quarterly profit on COVID vaccine sales
  + stars: | 2023-08-08 | by ( ) www.reuters.com   time to read: +2 min
Companies Novavax Inc FollowAstraZeneca PLC FollowBioNTech SE Follow Show more companiesAug 8 (Reuters) - Novavax (NVAX.O) reported a second-quarter profit on Tuesday, helped by strong revenue from its COVID-19 vaccines, but still trimmed its annual forecast for sales of the shot. As part of the agreement, Novavax will issue 6.5 million shares to SK Bioscience at $13 per share. Following the agreements, Novavax now owes SK Bioscience $65 million in cash. The company reported revenue of $424 million, compared with analysts' estimates of $240 million, according to Refinitiv IBES data. Novavax lowered the sales forecast for its COVID-19 vaccines to between $1.3 billion and $1.5 billion this year, compared with a previous outlook of $1.4 billion to $1.6 billion.
Persons: Novavax, Leroy Leo, Michael Erman, Varun H, Maju Samuel, Shounak Organizations: AstraZeneca, SK Bioscience, South Korean, South, Thomson Locations: KS, South Korean, United States, Bengaluru, New York
Shares of Novavax jumped as much as 20% in premarket trading Tuesday after the Covid vaccine maker reported a surprise second-quarter profit. Here's what Novavax reported compared with Wall Street's expectations, based on a survey of analysts by Refinitiv. That compares with a net loss of $510.5 million, or $6.53 per share, reported during the same quarter last year. But Jacobs noted that the adjustment reflects part of a cash settlement the Canadian government agreed to pay for forfeiting Covid vaccine doses that were previously scheduled for delivery. The company reported R&D expenses of $258 million and SG&A expenses of $162 million last year.
Persons: Novavax, John Jacobs, Jacobs, We're, it's Organizations: Refinitiv, CNBC, and Drug Administration Locations: Krakow, Poland
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
CNN —With the fall respiratory virus season just around the corner, major US pharmacy chains have begun rolling out flu and RSV vaccine appointments. CVS is now scheduling flu vaccinations, as well as allowing walk-in vaccinations at certain pharmacies, spokesperson Amy Thibault said. Rite Aid, CVS and Walgreens say they will also offer the new Covid-19 vaccines once they’re available. The US Food and Drug Administration approved the world’s first RSV vaccines, from GSK and Pfizer, this year. Those who want all three vaccines should get their RSV vaccine well before or after their flu and Covid-19 shots, Schaffner says.
Persons: Catherine Carter, Amy Thibault, Xavier Becerra, Becerra, Albert Bourla, William Schaffner, it’s, ” Schaffner, Schaffner, Dr, Sanjay Gupta, “ We’re, , Organizations: CNN, Walgreens, Aid, CVS, Walmart, Publix, Kroger, Rite, FDA, US Centers for Disease Control, US Department of Health, Human Services, Pfizer, Moderna, Food and Drug Administration, GSK, Vanderbilt University Medical Center, CDC, CNN Health
Regardless of that shift, experts say vaccine uptake may not look much different from that of the bivalent boosters. Pandemic fatigue, confusionFatigue over the pandemic and the general belief that Covid is "over" could potentially hinder the uptake of new shots this fall, experts said. Ipsos and Axios released a survey with similar findings in May, the same month the U.S. ended the national Covid public health emergency amid a downward trend in cases, hospitalizations and deaths. "That contrasts with what we've seen in the past where there are different vaccines, different timing, different age groups and something new to consider every few months." Advisors to the FDA have raised concerns about shifting to yearly Covid vaccines, noting that it's unclear if the virus is seasonal like the flu.
Persons: Antonio Perez, Axios, isn't, Dr, Kartik Cherabuddi, Brad Pollock, Pollock, they're, Ashley McGee, Justin Sullivan, CDC hasn't, Covid, KFF's Kates, Michael Nagle, Kates, we've Organizations: Chicago CVS, Tribune, Service, Getty Images Pfizer, Moderna, Pfizer, Gallup, University of Florida, CNBC, UC Davis Health's, Safeway, CDC, Food and Drug Administration, Health, Human Services Department, FDA, Xinhua News Agency, Getty Locations: Chicago, U.S, San Rafael , California, New York, United States
Investors upped their short bets on a handful of clean energy and biotechnology stocks during the first half of July, according to FactSet data. Allogene Therapeutics held the greatest short interest of the group, at about 54% of float, with Novavax and ProKidney Corp. also appearing on the list. Short interest declined slightly in ProKidney shares. Short interest in shares declined 8.6% during the first half of July, although about 35% of its shares are sold short. saw short interest leap 10% since the end of June.
Persons: BioXcel Organizations: BioXcel Therapeutics, Allogene Therapeutics, ProKidney Corp, Research, CNBC Pro, New York Stock Exchange, Nasdaq
Remember the GameStop mania of 2021, fueled as it was by forcing short sellers to cover their bets? However, when the stock jumps instead, it forces short sellers to buy back shares in order to limit their losses. The stock market is in the middle of a strong rally as inflation pressures ease and the Fed nears the end of its rate-hiking campaign. GameStop was once the most shorted stock in the market, with short interest as a percentage of shares available for trading exceeding 100%. Carvana , Novavax, Lucid Group and Beyond Meat were also heavily targeted by short sellers.
Persons: Adam Parker, Trivariate, Parker Organizations: Research, Fed, Dow Jones, GameStop, Nasdaq, Therapeutics
Against this backdrop, CNBC Pro used FactSet data to screen for stocks most vulnerable to a short squeeze. A short squeeze occurs once a shorted stock climbs higher, forcing investors who have short bets on shares to cover their positions. Novavax , meanwhile, has about 42% short interest from investors. Overall, short interest in the name increased 8.7% between June 15 and June 30. See below for the full rundown of potential short squeeze targets.
Persons: there's, Novavax Organizations: Nasdaq, Dow Jones, JPMorgan, CNBC Pro, New York Stock Exchange, Sunnova Energy Locations: Canada
The Biden administration on Thursday announced a program to provide free Covid vaccines to uninsured Americans through December 2024 after the federal government's supply of shots runs out this fall. Those free shots, which the government is purchasing at a discount, will be available to the uninsured at pharmacies and 64 state and local health departments. There are between 25 to 30 million uninsured adults in the United States and other Americans whose insurance will not cover free Covid products this fall, according to the federal Centers for Disease Control and Prevention. In the fall, the companies will begin selling shots directly to health providers, and the government's supply is expected to run out. Earlier this year, the World Health Organization declared an end to the global Covid public health emergency earlier this year.
Persons: Biden Organizations: Pfizer, BioNTech, Peabody Institute Library, The, Human Services Department, for Disease Control, Moderna, World Health Organization, HHS Locations: Peabody , Massachusetts, United States, Novavax
A nurse prepares doses of the Pfizer vaccine on Dec. 30, 2021, during a COVID-19 vaccination event at Josephine's Southern Cooking in Chatham, Illinois. The Biden administration on Thursday urged Pfizer , Moderna and Novavax to price their updated Covid vaccines at a "reasonable" rate when they roll them out in the U.S. this fall. A Moderna spokesperson reiterated the company's previous remarks about being ready in time for the fall with ample vaccine supply. Federal and corporate programs are planning to help shoulder the out-of-pocket costs of updated shots this fall for uninsured Americans. Pfizer and Moderna also intend to launch patient assistance programs for their Covid shots.
Persons: Biden Organizations: Pfizer, Moderna, Department of Health, Human Services, CNBC, U.S, HHS, Centers, Medicare, Medicaid Services, Food and Drug Administration, for Disease Control, Federal Locations: Chatham , Illinois, Novavax, U.S
It's unclear how many doses of Novavax's jab – its only commercially available product after 35 years – went unused. Under the amended agreement, Novavax will also provide Canada with fewer doses of its vaccine on a revised delivery schedule. In May, Novavax adopted a more positive outlook and announced a sweeping cost-cutting plan alongside its first-quarter earnings report. Novavax's stock price jumped around 30% on that news, but Wall Street hasn't entirely bought into the recovery plan: The company's stock price is still down roughly 15% since the start of the year after shedding more than 90% of its value in 2022. Novavax still faces a number of challenges ahead, including competing with Pfizer and Moderna in the commercial Covid vaccine market and a pending $700 million arbitration over a canceled vaccine purchase agreement.
Persons: , Novavax Organizations: SEC, Canadian, Securities and Exchange Commission, Pfizer, Moderna Locations: Maryland, Canada
Carvana — Shares soared 10% in midday trading. The company said on Monday it expected exponential growth within its used electric vehicle segment as consumer demand for EVs skyrocket. Lucid — The luxury electric vehicle company added 3.4%. Fisker — Fisker rose 2% after the electric vehicle maker said it's issuing a $340 million convertible note offering. On Friday, the company disclosed in a securities filing that it would receive $350 million from Canada for unused Covid-19 vaccines.
Persons: EVs skyrocket, Morgan Stanley, Jefferies, DraftKings, Carl Icahn's, Fisker, Jesse Pound, Sarah Min, Yun Li, Samantha Subin Organizations: EVs, Shockwave, JPMorgan, Cava, Icahn Locations: Cava, Canada
Companies Novavax Inc FollowJuly 7 (Reuters) - Novavax Inc (NVAX.O) said on Friday Canada will pay $349.6 million to settle the forfeiting of certain doses of its COVID-19 vaccine previously scheduled for delivery. The U.S. vaccine maker also reached a deal with the country's public works and government services department to amend the advance purchase contract after a sharp decline in global demand left a raft of COVID-19 doses unused. The number of vaccine doses due for delivery has been reduced and the schedule for remaining doses to be shipped revised under the amended terms, the company said. The payment will be made in two equal installments in 2023 and the original value of the contract remains unchanged. Novovax – which has its COVID-19 vaccine as the only marketed product after 35 years in business – has raised doubts about its ability to remain in business, flagging uncertainties around its revenue and funding crunch.
Persons: , Khushi, Shweta Agarwal Organizations: Novavax, Canada, Biologics, Thomson Locations: U.S, Bengaluru
Moderna seeks US FDA authorization for updated COVID vaccine
  + stars: | 2023-06-22 | by ( ) www.reuters.com   time to read: +1 min
June 22 (Reuters) - Moderna (MRNA.O) said on Thursday it has completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine to target the XBB.1.5 subvariant. The submission from the company follows the FDA's advice last week to manufacturers that are updating their COVID-19 vaccines to develop monovalent shots to target XBB.1.5. Moderna said preliminary clinical data demonstrated a robust immune response by its XBB.1.5 monovalent vaccine against XBB descendent lineage viruses. Pending authorization, the updated shot would be available in time for the fall vaccination, Moderna said. Other COVID vaccine makers Pfizer (PFE.N)/BioNTech (22UAy.DE) and Novavax (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants.
Persons: Moderna, Raghav Mahobe, Krishna Chandra Eluri Organizations: U.S . Food, Drug Administration, Pfizer, Thomson Locations: U.S, Bengaluru
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 U.S. Food and Drug Administration on Friday recommended that Covid vaccine manufacturers make single-strain shots for the fall that target omicron subvariant XBB.1.5, the dominant strain of the virus nationwide. XBB.1.5 is a descendant of the omicron variant, which caused cases in the U.S. to spike to record levels early last year. That panel unanimously voted that new jabs should be monovalent and target a member of the XBB family. The three companies have already been developing updated versions of their shots that target XBB.1.5. Dr. Peter Marks, head of the FDA's vaccine division, suggested Thursday that the updated vaccines could be available to the public around September.
Persons: Novavax, Peter Marks Organizations: . Food, Drug Administration, FDA, Pfizer, Moderna, Centers for Disease Control, Advisors, CNBC Locations: U.S
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