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WASHINGTON (AP) — Updated COVID-19 vaccines are coming soon, just in time to pair them with flu shots. Approval of updated COVID-19 shots is expected within days. Political Cartoons View All 1148 ImagesHere is what you need to know about fall vaccinations:WHY MORE COVID-19 SHOTS? Earlier this month, European regulators authorized Pfizer’s updated vaccine for this fall, for adults and children as young as 6 months. CAN I GET A FLU SHOT AND COVID-19 SHOT AT THE SAME TIME?
Persons: Mandy Cohen, haven’t, , , David Montefiori, it's, Carla K, Johnson Organizations: WASHINGTON, Centers for Disease Control, CDC, Food and Drug Administration, Pfizer, Moderna, FDA, Duke, WHO, GSK, AstraZeneca, AP, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group Locations: Novavax, Sanofi
FDA Approval of New COVID Boosters Could Come by Friday
  + stars: | 2023-09-07 | by ( Sept. | At A.M. | ) www.usnews.com   time to read: +2 min
Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported. This time, the FDA may grant full approval for the boosters rather than emergency use authorization, according to NBC News sources. If the FDA doesn’t approve the boosters on Friday, it could do so early next week. While protection wanes over time, about 97% of adults have some level of protective immunity from past COVID infections and vaccinations. The Biden administration has announced a “bridge” program to offer uninsured people access to free boosters through 2024.
Persons: Cara Murez HealthDay, Mandy Cohen, Jennifer Kates, Biden, Kates Organizations: U.S . Food, Drug Administration, NBC News, U.S . Centers for Disease Control, Prevention, Pfizer, Moderna, NBC, Global Health, HIV
The late summer Covid spike comes after a quiet year in which hospitalizations and deaths declined week after week since January. "We're living in a bit of a fantasy world where we're pretending Covid is not relevant," Birx told ABC in a podcast interview last week. Birx said those vaccines should have been released weeks ago to combat the predictable summer wave, adding the U.S. should already be developing new shots for January to target the emerging BA.2.86 variant. The updated shots should be effective at reducing severe disease and hospitalization from the variant, according to the agency. The first lady last caught Covid in August 2022 and the president tested positive in July of last year.
Persons: Shannon Stapleton, Reuters Covid, Deborah Birx, Trump, Covid, Birx, we're, Novavax, Moderna, Karine Jean, Pierre, Biden, Anthony Fauci, Fauci, It's, Still, Jill Biden, Joe Biden Organizations: Intensive Care Unit, Western Reserve Hospital, Reuters, hospitalizations, Centers for Disease Control, White, ABC, Pfizer, Moderna, CDC, U.S, BBC, National Institute of Allergy, White House Locations: Cuyahoga Falls , Ohio, U.S, ., Arkansas , Colorado , Indiana , Kansas , Minnesota , Oklahoma , Tennessee , Utah, Wyoming, China, Kentucky, Texas, India
"These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. "Moderna will continue to rapidly assess global public health threats and is committed to leveraging our mRNA platform against COVID-19." The company’s announcement comes as the Biden administration prepares to authorize the updated shots from Moderna, Pfizer and Novavax as soon as next week. While the shots target XBB.1.5, which was responsible for about 3% of new infections in recent weeks, researchers are optimistic that it will hold up against other circulating variants. “With governments accelerating the timing of COVID-19 vaccination campaigns due to the potential risk of BA.2.86, Moderna has shared this data with regulators and is ready to supply its updated COVID-19 vaccine pending regulatory approval,” the company wrote in a press release.
Persons: “ pirola, Stephen Hoge, Ashish Jha, ” Pirola, Biden Organizations: Moderna, Wednesday, EG, COVID, White, Centers for Disease Control, Pfizer, Novavax Locations: U.S, Moderna
Moderna 's new Covid vaccine produced a strong immune response against BA.2.86, a highly mutated omicron variant that health officials are watching closely, according to clinical trial data the biotech company released Wednesday. The updated shot produced an 8.7-fold increase in protective antibodies against BA.2.86, which has been detected in small numbers nationwide. Moderna is the first out of the companies producing updated Covid jabs to release data on how its shot fares against BA.2.86. Last month, Moderna also released clinical trial data suggesting that its new shot provides protection against the now-dominant EG.5, or "Eris," variant and another rapidly spreading strain called FL.1.5.1. New vaccines are set to arrive as Eris and other Covid variants fuel a rise in cases and hospitalizations across the country.
Persons: Stephen Hoge, Covid hospitalizations Organizations: Disease Control, Moderna, Pfizer, Novavax, U.S . Food, Drug Administration, EG, CDC Locations: U.S
[1/2] A vial and sryinge are seen in front of a displayed Moderna logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsSept 6 (Reuters) - Moderna (MRNA.O) on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly-mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 and the target of the updated shots. Moderna said it had shared the new finding on its vaccine with regulators and submitted it for peer review publication. European regulators have since backed the Pfizer/BioNTech shot, with Britain's Medicines and Healthcare products Regulatory Agency approving the vaccine on Tuesday, but have yet to make any announcements on Moderna’s updated vaccine.
Persons: Dado Ruvic, Jacqueline Miller, Moderna, COVID, BioNTech, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, CDC, Omicron, U.S . Food, Drug Administration, Pfizer, Moderna, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: The Massachusetts, Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York
Moderna said its shot generated an 8.7-fold increase in neutralizing antibodies against BA.2.86 compared with an untreated natural antibody response in clinical trials in humans. Pfizer said its updated vaccine with partner BioNTech (22UAy.DE) elicited a strong antibody response against BA.2.86 in a preclinical study in mice. Moderna, Pfizer/BioNTech and relative newcomer to the COVID vaccine market Novavax (NVAX.O) have created versions of their shots aimed at the XBB.1.5 subvariant, the dominant variant through most of 2023. Moderna shares were down 1.6% and Pfizer shares were off nearly 3% in afternoon trading. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the target of the updated shots.
Persons: Moderna, Jacqueline Miller, BioNTech, Cowen, Tyler Van Buren, Dado Ruvic, Patrick Wingrove, Michael Erman, Bill Berkrot Organizations: Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, Moderna, REUTERS, CDC, Omicron, U.S . Food, Drug Administration, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York, New Jersey
An uptick in Covid cases and hospitalizations in the U.S., and the emergence of new variants of the virus, are prompting questions about whether Americans should start masking up again. One thing's for sure: People infected with Covid should wear masks around others to prevent the spread of the virus. That includes your personal risk level, Covid rates in your region and who you might make contact with, public health experts said. Newer Covid variants like the now-dominant EG.5, or "Eris," and a handful of XBB strains have fueled the rise. New Covid shots from Pfizer , Moderna and Novavax are slated to roll out in mid-September, and will likely provide robust protection against those variants.
Persons: Michael Nason, Donna Nason, Andrew Pekosz, Francesca Torriani, Pavitra, Axios Organizations: Centers for Disease Control, Johns Hopkins Bloomberg School of Public Health, CNBC, CDC, U.S, Pfizer, Moderna, University of California, University of Washington School of Medicine Locations: Bakersfield, Los Angeles , CA, California, U.S, Covid, San Diego
Coronavirus is on the rise in the U.S., prompting questions about when Americans can roll up their sleeves for the next COVID-19 vaccine. The updated shots target XBB.1.5, which was responsible for less than 5% of new coronavirus infections in recent weeks. But all the strains circulating are still descendants of omicron, so experts believe the shots will still protect against severe COVID-19 from the variants. Historically, vaccine uptake decreases each time a new coronavirus shot is offered. Just 17% of Americans as of May rolled up their sleeves for the latest round of shots offered.
Persons: it’s, Biden, ” Mandy Cohen, Novavax, – Cohen, ” Cohen, Cohen, Organizations: Centers for Disease Control, CDC, Food and Drug Administration, Pfizer, FDA, EG Locations: U.S, COVID, Moderna
CNN —Covid-19 vaccines that have been tweaked to teach the body how to fend off the current crop of circulating variants are now expected to land in drugstores and clinics in mid-September, senior administration officials say. The US Food and Drug Administration is expected to give its nod to the updated vaccines in a few weeks. Officials said ACIP will meet quickly after the FDA decision in order to expedite the regulatory steps and get the vaccines to market. The advisory group is scheduled to meet to discuss Covid-19 vaccines on September 12, meaning the vaccines could become available soon after. The details of the pharmacy program are still being worked out, and there may be a slight lag in getting free vaccines at some stores.
Persons: CNN —, ACIP, Mandy Cohen, , Dr, Sanjay Gupta, Cohen, There’s Organizations: CNN, US Food and Drug Administration, US Centers for Disease Control, Officials, CDC, Covid, Pfizer, Moderna, FDA, EG, Affordable, CVS, Walgreens, Walmart, CNN Health Locations: drugstores, Covid
The Centers for Disease Control and Prevention expects updated Covid vaccines from Pfizer , Moderna and Novavax to be available to the public in mid-September, an agency official told reporters Thursday. CDC Director Mandy Cohen had previously provided a later timeline, telling NPR that the vaccines could be available by the "early October time frame." Those shots still need approvals from the Food and Drug Administration and the CDC, which will set eligibility guidelines for the jabs. Officials from the CDC and FDA said the agencies will encourage Americans to receive an updated Covid shot and other key vaccines ahead of the fall, when respiratory viruses typically begin to spread more widely. "Our goal, our imperative, our task is to make sure we're using those tools," the CDC official said.
Persons: Mandy Cohen Organizations: Disease Control, Pfizer, Moderna, Federal, NPR, Food and Drug Administration, CDC, FDA
Check out the companies making headlines in premarket trading. Nvidia -- Shares of the chipmaker ticked up 0.7% in heavy premarket trading. The company reported adjusted earnings of 52 cents per share, while analysts polled by Refinitiv expected 22 cents. Foot Locker -- The stock plunged more than 32% before the bell after the sneaker retailer slashed its outlook for the second time this year. Dicks Sporting Goods -- Shares were trading 2% lower a day after the company reported lower-than-expected earnings and cut its forward guidance.
Persons: Refinitiv, Apellis, Locker, Goldman Sachs, , Samantha Subin, Jesse Pound, Sarah Min Organizations: Nvidia, Revenue, Apellis Pharmaceuticals, Dicks Sporting Goods Locations: Santa Clara , California
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
Shares of Novavax jumped more than 13% on Tuesday after the biotech company said its new Covid vaccine generated a broad immune response against the now-dominant Eris variant and another fast-spreading strain of the virus in small animal trials. But the trial results suggest that the shot may still be effective against newer Covid variants gaining a greater foothold in the U.S. That includes Eris and XBB.1.16.6, both of which are also descendants of omicron. "We have a lot of confidence in our updated Covid vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall," Filip Dubovsky, Novavax's president of research and development, said in a release. The World Health Organization designated Eris a "variant of interest," meaning it will be monitored for mutations that could make it more severe. XBB.1.16.6 is also beginning to surge, accounting for 8% of all cases nationwide as of Saturday, the CDC said.
Persons: Novavax, Filip Dubovsky Organizations: Pfizer, Moderna, U.S . Food, Drug Administration, EG, Centers for Disease Control, World Health Organization, CDC Locations: U.S, hospitalizations
Covid vaccine makers' shares rose Monday as new variants of the virus emerge in the U.S. ahead of the rollout of updated shots this fall. Shares of BioNTech , which jointly develops Covid vaccines with Pfizer , popped nearly 7%. It's been a rocky few months for those stocks as sales of Covid shots and treatments plummet in the U.S.: Shares of all four companies are down more than 20% for the year. But Wall Street's enthusiasm for Covid vaccine makers is getting a fresh boost with the upcoming launch of brand-new shots this fall and the emergence of new variants of the virus. So far, there is no evidence that BA.2.86 spreads faster or causes more serious infections than previous versions.
Persons: Novavax, It's Organizations: Pfizer, EG, U.S . Health, CNBC, Moderna, Novavax, World Health Organization, U.S . Centers for Disease Control, Prevention Locations: U.S, Denmark, Israel
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
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
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
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
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