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☆ Updated Novavax COVID-19 vaccine shipped to distributors, to be available this week
▼ + stars: | 2023-10-09 | by ( Michael Erman | ) www.reuters.com time to read: +1 min

Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsCompanies Novavax Inc FollowNEW YORK, Oct 9 (Reuters) - Vaccine maker Novavax Inc (NVAX.O) on Monday said it has shipped millions of doses its updated COVID-19 shots to distributors after receiving the go-ahead from U.S. regulators. The U.S. Food and Drug Administration authorized the updated vaccine last week for emergency use in individuals aged 12 years and older, but batches of the shots needed additional clearance from the FDA before they could be released. Novavax said it expects the shots to be available at U.S. pharmacies this week. The Maryland-based company, whose COVID vaccine is its lone marketed product, has adopted cost-cutting measures and is counting on commercial sales of its updated shot to help it stay afloat.

Persons: Dado Ruvic, Novavax, COVID, Michael Erman, Mark Porter, David Gregorio Our Organizations: REUTERS, Novavax Inc, U.S . Food, Drug Administration, FDA, Thomson Locations: U.S, Maryland

☆ 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

☆ 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

☆ 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

☆ Novavax to receive $350 million from Canada for unused COVID shots
▼ + stars: | 2023-07-07 | by ( ) www.reuters.com time to read: +1 min

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

☆ 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.

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.

Short interest in Novavax increased more than 13% to 37.8 million shares, or about 45% of the total float, between March 15-31, according to data compiled by FactSet. Other biotech companies that saw growing short interest are Cassava Sciences , with a 10% increase, and Fate Therapeutics , which saw a 26% boost. Meanwhile, bluebird bio had a 29% increase in its short interest to 26% of float. Cinemark and AMC Entertainment both saw increases in their short position to 28% and 27% of their respective floats. All names trade on the NYSE or Nasdaq, have short positions amounting to at least 25% of their total float and have market values of at least $100 million.

☆ Novavax cut $50 million in costs, plans to slash more, CEO says
▼ + stars: | 2023-04-12 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

April 12 (Reuters) - Novavax Inc (NVAX.O) cut about $50 million in costs in the first quarter of 2023 and plans to slash more, Chief Executive John Jacobs said in an interview on Wednesday. “We’re looking at everything from buildings, leases, land, headcount, and contractors, every aspect of our company and the way we work,” he told Reuters. Jacobs said Novavax would seek funding for its COVID/influenza combination shot, including a potential partnership, depending on whether the upcoming data is positive. The CEO added that the company did not expect to launch its individual flu vaccine this year, and will focus on the COVID vaccine. Global regulators expect vaccination campaigns to be conducted once a year, similar to annual flu inoculations.

The company — which has its COVID-19 vaccine as the only marketed product after 35 years in business — on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. "While there is the potential for a substantial booster market ... we don't expect Novavax to be a major player in the booster opportunity." As of last close, Novavax's U.S.-listed shares were down 97% from their February 2021 record high of $331.68.

☆ Futures rise in positive start to March
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

SummarySummary Companies Futures up: Dow 0.22%, S&P 0.31%, Nasdaq 0.50%March 1 (Reuters) - U.S. stock index futures rose on Wednesday, putting Wall Street on course for a positive start to March, as strong Chinese manufacturing data outweighed concerns that the Federal Reserve's policies will remain restrictive for longer. Traders are pricing in expectations that the Fed will raise rates in coming months to a 5.25%-5.50% range, from the current 4.50%-4.75% range. That's slightly higher than where Fed policymakers in December signaled they would need to take the policy rate. ET, Dow e-minis were up 71 points, or 0.22%, S&P 500 e-minis were up 12.25 points, or 0.31%, and Nasdaq 100 e-minis were up 60 points, or 0.5%. The electric carmaker is readying a production revamp of its top-selling Model Y, Reuters reported, citing people familiar with the plan.

The yield on two-year Treasury notes , which closely tracks short-term interest rate expectations, rose to 4.9%, its highest level since 2007. "You also got a tick up in the ISM prices paid, which means that prices generally are rising now for manufacturing. That's higher than where Fed policymakers in December signaled they would need to raise the policy rate. Money market traders see an about 80% chance of a 25-basis-point rate hike later this month, but the odds of a bigger 50 bps rate hike have grown recently. The main U.S. benchmarks ended February with losses as investors braced for the possibility that the Fed will hike rates more than initially thought on signs of resilience in the economy.

The stock had dropped 26.2% to $6.83 around 8:55 ET (13:55 GMT), while its Frankfurt-listed shares slumped more than 27%. The company - whose COVID vaccine is its only marketed product after 35 years in business - on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. As of last close, Novavax's U.S.-listed shares are down 97% from their February 2021 record high of $331.68.

☆ Novavax raises doubts about ability to remain in business, shares fall
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. Novavax's shares closed at $9.26 on Tuesday and fell to $6.90 in extended trading after reporting on its financial situation. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Novavax raises doubts about its ability to remain in business
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, Feb 28 (Reuters) - COVID-19 vaccine maker Novavax Inc (NVAX.O) on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign. The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Shionogi sees COVID pill reaping $2 billion in annual sales upon U.S. approval
▼ + stars: | 2023-02-27 | by ( Rocky Swift | ) www.reuters.com time to read: +3 min

Xocova, a protease inhibitor like the COVID treatments developed by Pfizer Inc (PFE.N) and Merck & Co (MRK.N), was granted emergency approval by Japanese regulators in November, making it the nation's first domestically produced oral treatment for COVID. "If you kill the virus fast enough and sharp enough, the lower the probability of long COVID. According to one study by the Veterans Affairs St. Louis Health Care System, Pfizer's antiviral drug Paxlovid cuts the risk of developing many long COVID symptoms. Shionogi is hoping for Xocova sales of around $1 billion to $1.5 billion this year. "I have no regrets," Teshirogi said, adding that expectations among shareholders and the public had demanded that Shionogi devote its resources to fighting COVID.

☆ Novavax to Sell 1.5 Million More Covid Vaccines to U.S. Government
▼ + stars: | 2023-02-13 | by ( Liz Essley Whyte | Stephanie Armour | ) www.wsj.com time to read: 1 min

The U.S. government has agreed to buy 1.5 million more doses of Novavax Inc.’s Covid-19 vaccine, the company said, part of efforts preparing for the end of government purchases and the start of a commercial market for the shots. Novavax wouldn’t provide the monetary value of the deal or the price that the federal government would pay per dose.

☆ U.S. government to buy 1.5 mln more Novavax COVID vaccine doses
▼ + stars: | 2023-02-13 | by ( ) www.reuters.com time to read: +1 min

Feb 13 (Reuters) - The U.S. government has agreed to buy 1.5 million more doses of Novavax Inc (NVAX.O) COVID-19 vaccine, the company said on Monday, adding that the modified agreement includes funds for development of an updated vaccine by fall this year. Sales of the company's vaccine have been hurt by a global supply glut and waning demand, with Novavax cutting its full-year revenue forecast for the shots twice last year. The protein-based vaccine was expected to convince those skpetical of the new mRNA-based vaccines against the virus from rivals such as Pfizer Inc (PFE.N) and Moderna (MRNA.O). The U.S. Food and Drug Administration is also in the process of simplifying its COVID-19 vaccine policy as it considers whether to recommend that Americans get an annual booster shot for the virus. Shares of the vaccine maker rose 3.2% before the bell on Monday after the Wall Street Journal first reported the news.

☆ Novavax needs 6 months to produce annual COVID shots that match new variants
▼ + stars: | 2023-01-26 | by ( Leroy Leo | ) www.reuters.com time to read: +1 min

Jan 26 (Reuters) - Novavax Inc (NVAX.O) said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States. The FDA in documents released on Monday proposed June for deciding on an annual COVID shot's make-up. It took those companies about three months to produce the currently available boosters updated to target newer Omicron subvariants. The FDA is seeking recommendations from its panel of external experts on adopting an annual COVID shot for the United States and the process for choosing the vaccine's targets each year. Reporting by Leroy Leo in Bengaluru Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

☆ Novavax's longtime CEO Stanley Erck to retire
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

Jan 9 (Reuters) - Novavax Inc (NVAX.O) said on Monday its longtime chief executive officer, Stanley Erck, would retire and be succeeded by industry veteran John Jacobs, at a time when the COVID-19 vaccine maker looks to catch up with larger rivals. He joins Novavax from Harmony Biosciences (HRMY.O), where he served as CEO since June 2018. Erck, who has been at the helm of the company since 2011, was responsible for bringing Novavax's COVID vaccine, its first commercial product, to the market. However, the shot has been plagued by manufacturing snags, regulatory delays and sluggish uptake amid a global supply glut for vaccines and waning demand. Reporting by Raghav Mahobe in Bengaluru; Editing by Saumyadeb Chakrabarty and Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

That works out to a 31.2% return on total average short interest of $973.6 billion throughout the year, according to S3 Partners. Stanphyl Capital portfolio manager Mark Spiegel, who has been short Tesla "constantly, in varying size" since 2014, said a bet against Tesla was his fund's most profitable individual short position this year. While higher interest rates have punished growth stocks, some investors believe Tesla CEO Elon Musk's purchase of Twitter is diverting his time running the electric car company. Long-short hedge funds, which bet on stock prices rising or falling, posted a 9.7% loss through November, according to data provider HFR. Charles Lemonides, portfolio manager at $226 billion hedge fund ValueWorks LLC, believes tight monetary policy will weigh on risk appetite next year.

☆ Novavax ends COVID vaccine sale agreement with Gavi
▼ + stars: | 2022-11-21 | by ( ) www.reuters.com time to read: +2 min

Nov 21 (Reuters) - Novavax Inc (NVAX.O) said on Monday it had delivered a written notice to Gavi, the Vaccine Alliance, terminating with immediate effect an agreement for the sale of the company's COVID-19 vaccine to low- and middle-income countries. The company cited Gavi's failure to procure the 350 million doses it had agreed to buy in May last year for the COVAX facility. Novavax received a non-refundable advance payment of $350 million from Gavi last year and an additional $350 million this year after the vaccine got the WHO's emergency use listing, the company said. The company had earlier this month cut its full-year forecast yet again, hurt by late authorizations of its vaccine globally. Covovax and Serum's vaccines were the ninth and tenth vaccine, respectively, to get the WHO's emergency listing.

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