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Brian Cassella | Tribune News Service | Getty ImagesA new round of Covid vaccines is finally here in the U.S. Meanwhile, the FDA is still reviewing a third updated vaccine from Novavax for people ages 12 and up. Here's everything you need to know about the updated Covid vaccines, from where to find them, whether you can get them for free and when to get them. The agency's website outlines more specific guidelines for staying up to date on Covid vaccines, which differ depending on age group and risk level. Kroger Americans will soon be able to use the federal website vaccines.gov to find other locations offering the updated Covid shots, according to a CDC spokesperson.
Persons: Brian Cassella, Covid, Biden, Megan Wallace, they've, Brian Snyder, vaccines.gov, Evelyn Twentyman, Will, Moderna's, Twentyman, Taison Bell, Bell, CDC's Wallace, Wallace Organizations: Pfizer, Tribune, Service, U.S, The, Disease Control, Moderna, Food and Drug Administration, CDC, FDA, Walgreens, CNBC, WALGREENS, CVS Albertsons, Kroger, Manufacturers, CVS, University of Virginia Health, Younger Locations: Chatham , Illinois, U.S, Covid, Somerville , Massachusetts
The head of the Centers for Disease Control and Prevention signed off on a recommendation for updated COVID-19 vaccines for everyone over the age of 6 months, setting up the shots to become available later this week. “We have more tools than ever to prevent the worst outcomes from COVID-19,” CDC Director Mandy Cohen said in a statement. The Food and Drug Administration this week authorized the shots from Moderna and Pfizer that target the omicron subvariant XBB.1.5. An FDA official said during the meeting that “there is an urgent need for alternatives to mRNA based vaccines including gene based vaccines,” like the Novavax shot. The updated shots come as the U.S. sees its eighth straight week of rising coronavirus hospitalizations.
Persons: Mandy Cohen, , “ We're, ” Cohen Organizations: Centers for Disease Control, Prevention, CDC, Drug Administration, Moderna, Pfizer, FDA, EG, ” Health Locations: COVID, U.S
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
The updated shots are part of a push by public health officials to align the next COVID vaccines more closely with the actual circulating variant of the virus, similar to the way annual flu shots are designed. The U.S. Food and Drug Administration (FDA) on Monday authorized updated COVID vaccines made by Pfizer (PFE.N) and its German partner BioNTech SE (22UAy.DE) as well as by Moderna (MRNA.O). CDC Director Mandy Cohen is expected to approve the recommendations issued by the advisers, allowing Americans to get the updated vaccines. The first COVID vaccines in 2020 were monovalent, or single-target vaccines, aimed at the original strain of the virus. They were followed by bivalent COVID vaccine booster shots that targeted both the original and the Omicron strains.
Persons: Emily Elconin, BioNTech, Caitlin Rivers, Mandy Cohen, Rivers, bivalent, Daniel Kuritzkes, Eris, Kuritzkes, Novavax, Bhanvi, Julie Steenhuysen, Will Dunham, Caroline Humer Organizations: REUTERS, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, Pfizer, Moderna, FDA, Johns Hopkins Center for Health Security, CDC, Omicron, Brigham, Women's Hospital, Vaccine, EG, Thomson Locations: Waterford , Michigan, U.S, United States, Baltimore, Europe, Asia, Boston, Moderna, Bengaluru, Chicago
An independent advisory panel to the Centers for Disease Control and Prevention on Tuesday recommended that all Americans ages 6 months and up receive updated Covid vaccines from Pfizer and Moderna , the next step toward the shots reaching Americans in the coming days. Thirteen advisors voted in favor of that "universal" recommendation for Americans, while one voted against it. It is a vaccine-preventable disease," said Dr. Beth Bell, clinical professor at the University of Washington and member of the panel, during the advisory meeting. "And so, for that reason, I favor the universal recommendation." The advisory panel's "universal" recommendation comes a day after the Food and Drug Administration approved the two mRNA jabs, which are designed to target the omicron subvariant XBB.1.5.
Persons: Mandy Cohen, Georgina Peacock, Beth Bell, Hospitalizations, hospitalizations, Megan Wallace Organizations: Moderna, Pharmacy, Centers for Disease Control, Pfizer, CDC, University of Washington, Food and Drug Administration, FDA Locations: Schwenksville , Pennsylvania, U.S
Americans Can Now Get an Updated COVID-19 Vaccine
  + stars: | 2023-09-12 | by ( Associated Press | Sept. | At P.M. | ) www.usnews.com   time to read: +5 min
Most Americans should get an updated COVID-19 vaccine, health officials said Tuesday. Here is what you need to know about the new COVID-19 shots:WHO SHOULD GET THE UPDATED VACCINE? The agency's panel of outside exerts recommended the updated COVID-19 shots by a vote of 13-1. But federal officials said the new COVID-19 shots still will be free to most Americans through private insurance, Medicare or Medicaid. Similar to how flu shots are updated each year, the FDA gave COVID-19 vaccine makers a new recipe for this fall.
Persons: they’ve, , Camille Kotton, haven’t Organizations: Centers for Disease Control, CDC, TED, Drug Administration, Pfizer, Moderna, FDA, Massachusetts General Hospital, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S, Massachusetts, Novavax
What to Know About the New Covid Booster Shots
  + stars: | 2023-09-11 | by ( Knvul Sheikh | ) www.nytimes.com   time to read: +2 min
How are the new Covid shots different from the last ones? Unlike the bivalent shots from last fall, the latest mRNA vaccines developed by Pfizer and Moderna are monovalent, meaning they are designed to protect against just one variant: XBB.1.5, a recent descendant of Omicron that emerged earlier this year. Vaccine makers Pfizer and Moderna have also announced that, according to their initial research, the new Covid vaccines provide good protection against both EG.5 and BA.2.86. The new shots do not include protection against the original virus, which may actually help broaden protection against new variants. “Our immune system, when we have seen something, is biased to seeing that again,” Dr. Ho said.
Persons: David Ho, , , ” Dr, Ho Organizations: Pfizer, Moderna, Columbia University, Vaccine, EG, Regulators, XBB
[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
The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer and Moderna , putting the shots on track to reach Americans within days as U.S. hospitalizations from the virus rise. The updated vaccines from Pfizer and Moderna won't be available to Americans just yet. The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public in mid-September. The upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations. Bourla and Moderna CEO Stéphane Bancel, in a separate statement, urged Americans to receive their updated Covid shot during the same appointment as their annual flu shot.
Persons: Biden, Pfizer's, Albert Bourla, Stéphane Bancel, hospitalizations Organizations: Pfizer, BioNTech, Peabody Institute Library, Drug Administration, Moderna, FDA, CDC, Covid, EG Locations: Peabody , Massachusetts, U.S
WASHINGTON (AP) — The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot. A CDC advisory panel is set to issue recommendations Tuesday on who most needs the updated shots. The FDA pointedly isn’t calling this latest round a “booster” but instead a vaccine updated to better match the currently circulating virus. But while the FDA's decision allows for wide use of the updated shots, the CDC will decide how strongly different groups are urged to get them.
Persons: BioNTech, they’ve, There’s, Novavax, It’s, Peter Marks Organizations: WASHINGTON, Drug Administration, Moderna, Pfizer, Disease Control, CDC, FDA, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP
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
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
"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
[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
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
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
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