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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

☆ Moderna shares rise on better Covid vaccine outlook despite sharp drop in sales
▼ + stars: | 2023-08-03 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

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

☆ Vaccines for flu and RSV now available ahead of fall virus season
▼ + stars: | 2023-08-01 | by ( Amanda Musa | ) edition.cnn.com time to read: +5 min

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

☆ Biden administration asks Pfizer, Moderna and Novavax for 'reasonable' prices on updated Covid vaccines
▼ + stars: | 2023-07-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

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

☆ 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 files for FDA approval of updated Covid vaccine for fall
▼ + stars: | 2023-06-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

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

☆ Pfizer, Moderna and Novavax gear up for fall Covid vaccine rollout with an important head start
▼ + stars: | 2023-06-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

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

☆ Next Covid Shots in the U.S. Will Target Omicron Offshoot XBB.1.5
▼ + stars: | 2023-06-17 | by ( Liz Essley Whyte | ) www.wsj.com time to read: 1 min

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Persons: Dow Jones

☆ FDA advisors raise doubts about seasonal updates to Covid vaccines as with flu shots
▼ + stars: | 2023-06-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The U.S. Food and Drug Administration's independent panel of advisors raised doubts about the need to "periodically" update Covid vaccines, noting that it's unclear if the virus is seasonal like the flu. But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots. But several advisors cautioned against calling Covid seasonal like the flu. "It's not clear to me that this is a seasonal virus yet," said Henry Bernstein, a pediatrician at Cohen Children's Medical Center. In response to the advisors, FDA's Marks emphasized that Covid shots will likely require another update "at some point."

Persons: Peter Marks, Arthur Reingold, Henry Bernstein, Mark Sawyer, Sawyer, FDA's Marks Organizations: Union Station, The U.S . Food, University of California, Children's Medical Locations: Los Angeles , California, The U.S, Berkeley, U.S, San Diego

☆ FDA recommends that updated Covid shots target omicron subvariant XBB.1.5 this fall
▼ + stars: | 2023-06-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

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

☆ FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall
▼ + stars: | 2023-06-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

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

☆ F.D.A. Panel Advises Vaccine Makers to Aim at Only One Covid Variant
▼ + stars: | 2023-06-15 | by ( Christina Jewett | ) www.nytimes.com time to read: +2 min

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

☆ Covid vaccine maker Novavax sees a pathway to survival – but it won’t be easy
▼ + stars: | 2023-06-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +10 min

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

☆ Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says
▼ + stars: | 2023-06-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

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

☆ China's latest Covid surge pressures 3 Club stocks, but doesn't change our conviction in each
▼ + stars: | 2023-05-24 | by ( Paulina Likos | ) www.cnbc.com time to read: +5 min

Investor concern has been spilling over into the Club holdings doing the most business in China: Wynn Resorts (WYNN), Estee Lauder (EL), and Starbucks (SBUX). That ultimately bodes well for Estee Lauder, Starbucks and Wynn, even if increasing consumer demand appeared somewhat uneven in the latest round of quarterly results. And we're expecting Estee Lauder's China business to recover as travel continues to accelerate. We remain optimistic about the growth trajectory in the country, and see this latest Covid wave as a temporary speedbump. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.

Persons: Estee Lauder, Wynn, Jim Cramer, Jim, Laxman Narasimhan, Beijing's, hasn't, Estee, Jim Cramer's, WYNN Organizations: Wynn Resorts, WYNN, Starbucks, Wynn, Management, CNBC, China News Service, Getty Locations: China, Shanghai, Beijing, Macao, Asia

☆ 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.

☆ Arcturus: WHO watching XBB.1.16 as a coronavirus variant of interest
▼ + stars: | 2023-04-24 | by ( Brenda Goodman | ) edition.cnn.com time to read: +2 min

CNN —The World Health Organization has elevated the fast-growing Omicron sublineage XBB.1.16 as a new variant of interest, and says it is outcompeting the previously dominant XBB.1.5 in many regions. XBB.1.16 is a descendant of the recombinant XBB, which is a mashup of two BA.2 sublineages. On social media, the variant has been nicknamed Arcturus, like the brightest star in the northern celestial hemisphere. Currently, it is the dominant variant in India, where it is causing a wave of mostly mild illnesses. The XBB.1.5 variant continues to be the dominant cause of new infections in the United States, according to data from the US Centers for Disease Control and Prevention.

☆ FDA authorizes additional omicron Covid booster for seniors and people with weak immune systems
▼ + stars: | 2023-04-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

(Photo by Scott Olson/Getty Images)The Food and Drug Administration on Tuesday authorized an additional dose of Pfizer and Moderna 's Covid-19 vaccines targeting the omicron variant for seniors and people with weak immune systems. People with weak immune systems can receive another omicron shot at least two months after their last dose and receive additional shots at the discretion of their doctor. Children 6 months through 5 years of age who are unvaccinated can now receive the full two-dose series of Moderna's omicron vaccine. The FDA first authorized the omicron BA.5 shots last August, but that subvariant has long since been displaced by a version of omicron called XBB.1.5. In June, the agency will likely update the variant that the Covid vaccines target, ahead of the fall respiratory virus season.

☆ Fact Check-New COVID sublineages identified since Fauci’s retirement
▼ + stars: | 2023-04-17 | by ( Reuters Fact Check | ) www.reuters.com time to read: +3 min

Reuters reported on Jan. 5, 2023, (here) that the Omicron sublineage XBB.1.5, the most transmissible one to date, was already spreading rapidly in the U.S. in December 2022. PANGO’s website (here) shows multiple new lineages identified from virus samples deposited around the world, and given names, in 2023. These include: XBB.1.24 and XBB.1.22.2 first spotted on Feb. 2, XBB.2.3.1 first seen on Jan. 29 and XBB.2.3.2 first identified on Jan. 18. The claims allude to the theory that the COVID-19 virus or its variants were planned or fabricated by the government or by Fauci. More than one new Omicron sublineage of the SARS-CoV-2 virus has been identified since Anthony Fauci’s retirement.

☆ India asks states to ramp up testing as COVID-19 cases climb
▼ + stars: | 2023-04-07 | by ( ) www.reuters.com time to read: +1 min

MUMBAI, April 7 (Reuters) - India's federal government asked states to identify emergency hotspots and ramp up-testing for COVID-19, after the country recorded its highest daily case count since September, a Reuters tally showed on Friday. There were 6,050 new cases of COVID-19 in the last 24 hours, the federal health ministry said on Friday, continuing a sharp upward trend since a lull last year. At a meeting to review the degree to which the states are prepared, health minister Mansukh Mandaviya asked them to ramp up genome testing and conduct mock drills in hospitals, a government statement said. Active cases totalled more than 28,300 with 14 deaths during the last 24 hours, taking the country's official death toll from the disease to 530,943. India has recorded more than 44.7 million confirmed cases of COVID-19 since the start of the pandemic three years ago, the third-highest tally after the United States and China.

☆ China OKs its first mRNA vaccine, from drugmaker CSPC
▼ + stars: | 2023-03-22 | by ( ) www.reuters.com time to read: +2 min

BEIJING, March 22 (Reuters) - China's CSPC Pharmaceutical Group Limited (1093.HK) said on Wednesday its messenger RNA (mRNA) COVID-19 vaccine had received emergency use authorisation from Chinese health authorities, making it the country's first domestically developed mRNA shot. China has declined to use mRNA vaccines from abroad and vaccines available in China are widely considered less effective than the Moderna (MRNA.O) and Pfizer (PFE.N)-BioNTech (22UAy.DE) mRNA shots. The company said its independently developed mRNA vaccine SYS6006 targets some major Omicron variants and its booster dose showed good neutralization effect against Omicron subvariants BA.5, BF.7, BQ.1.1., XBB.1.5 and CH.1.1. The firm got emergency approval to conduct clinical trials of the mRNA shot in April last year, around the same time as CanSino, another China-based company that is testing an mRNA Omicron booster shot. Shares in the company rose as much as 7.7% after the result and the announcement of the mRNA approval.

☆ U.S. FDA to soon decide on second round of Omicron-tailored boosters - WSJ
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

The agency continues to closely monitor the emerging data in the United States and globally, and that data will dictate any decision on additional updated boosters, the FDA said in a statement. The Centers for Disease Control and Prevention would have to recommend the shots after the FDA authorizes the second Omicron-tailored boosters from Pfizer-BioNTech (PFE.N)/(22UAy.DE) and Moderna (MRNA.O) for them to become widely available. Updated boosters have helped prevent symptomatic infections against the new XBB-related subvariants, according to data released by the CDC in January. The FDA authorized the so-called bivalent COVID boosters in August that target the BA.4 and BA.5 Omicron subvariants, along with the original strain of the coronavirus. Rollout of the updated boosters in the United States started the following month.

☆ China's COVID-19 epidemic has 'basically' ended, but not completely over
▼ + stars: | 2023-02-23 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Tingshu WangBEIJING, Feb 23 (Reuters) - Health authorities in China said on Thursday the country's COVID-19 epidemic has "basically" ended, but it is not completely over as it found seven imported cases of the highly-transmissible XBB.1.5 variant since Jan. 8. Officials, speaking at a news event with several departments attending, said China's "major decisive victory" over COVID has set an example for populous nations in prevention and control. Health officials and experts were also monitoring the XBB.1.5 sub-variant of Omicron for months. Officials said on Thursday one local case of the variant was linked with an imported case on Feb. 3. Reporting by Beijing newsroom; Writing by Bernard Orr; Editing by Jacqueline Wong and Emelia Sithole-MatariseOur Standards: The Thomson Reuters Trust Principles.

HONG KONG, Feb 8 (Reuters) - The world should "calm down" about the possibility of new COVID-19 variants circulating in China, leading Chinese scientist George Gao said. "The world should completely calm down from the fear that there are new variants or special variants circulating (in China)," Gao, professor at the Institute of Microbiology at the Chinese Academy of Sciences and former head of the Chinese Center for Disease Control and Prevention (CDC), told Reuters. The variants causing infections in China were the same Omicron sub-variants - BA.5.2 and BF.7 - seen elsewhere in the world, he said by email. Gao said China was continuing widespread viral genomic sequencing, and would identify any new variants if they emerged. A total of 13 cases of variants were found, including 1 case of XBB.1, 5 cases of BQ.1.1, 1 case of BQ.1.1.17, 4 cases of BQ.1.2 and 2 cases of BQ.1.8.

☆ FDA pulls authorization for AstraZeneca’s Covid antibody drug Evusheld
▼ + stars: | 2023-01-27 | by ( ) www.nbcnews.com time to read: +1 min

The Food and Drug Administration has withdrawn emergency use authorization for AstraZeneca’s Covid-19 antibody cocktail Evusheld as the treatment is not expected to neutralize the currently dominant XBB.1.5 subvariant of omicron. Omicron subvariant XBB.1.5 has been spreading rapidly in the country since December and it made up nearly half of all U.S. Covid cases last week, according to government data. The drugmaker plans to continue to share relevant data with the FDA and other health authorities regarding Evusheld and SARS-CoV-2 variants. In November, the U.S. health regulator also pulled emergency use authorization for Eli Lilly's Covid drug bebtelovimab, citing similar concerns. Evusheld was first authorized in late 2021 by the FDA to prevent Covid infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.

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