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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
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
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
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
The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines. It remains unclear whether or when the vaccine makers or the F.D.A.
Persons: , Peter Marks, Natalie Thornburg Organizations: Pfizer, Moderna, Centers for Disease Control, World Health Organization, Agency Locations: United States
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
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailLightning Round: Jim Cramer says 'absolutely not' on buying Tyson Foods'Mad Money' host Jim Cramer weighs in on stocks including: Jazz Pharmaceuticals, ON Semiconductor, Novavax, Golar and Tyson Foods.
Persons: Jim Cramer Organizations: Tyson Foods, Jazz Pharmaceuticals, ON Semiconductor
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