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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
Vials labelled "VACCINE Coronavirus COVID-19" and a syringe are seen in front of a displayed U.S. flag in this illustration taken December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsCompanies Icon Plc FollowBioNTech SE FollowModerna Inc Follow Show more companiesSept 13 (Reuters) - Contract research firm ICON Plc (ICLR.O) said on Wednesday it is partnering with the U.S. government for a clinical trial to test the effectiveness of next generation COVID-19 vaccine candidates. As part of the collaboration with Biomedical Advanced Research and Development Authority, ICON will conduct a mid-stage trial of 10,000 participants to assess the efficacy of a next generation COVID-19 vaccine relative to currently available shots. The U.S. agency will select the vaccine candidate for the trial. The U.S. Food and Drug Administration on Monday authorized updated COVID-19 vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O) that target the XBB.1.5 subvariant of the virus.
Persons: Dado Ruvic, Pratik Jain, Saumyadeb Chakrabarty, Shounak Organizations: REUTERS, U.S, Research, Development Authority, U.S . Food, Drug Administration, Pfizer, Moderna, Thomson Locations: U.S, Bengaluru
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
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
Updated Covid vaccinesOn Monday, the Food and Drug Administration approved the new Covid vaccine, which will target a variant of Omicron called XBB.1.5. When should you get your updated Covid vaccine? Older adults, and people with heart and lung disease, should also consider getting the RSV vaccine, says Pavia. "Because the ACIP gave a softer recommendation to the RSV vaccine, coverage is going to be variable," says Pavia. For those with certain Medicare plans, the RSV vaccine should be covered, specifically under a Part D plan.
Persons: there's, Andrew Pavia, It's, Don't, Biden, you've, they're, hasn't, it's Organizations: CNBC, Centers for Disease Control, University of Utah, Children's Hospital, CDC, Food and Drug Administration, COVID, FDA, CDC's, U.S . Department of Health, Human Services, Infants, The New York Times Locations: Pavia
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
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
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
[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
The Food and Drug Administration on Monday authorized updated COVID-19 shots that could roll out as soon as this week. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. The fall booster shot campaign comes as the U.S. sees its seventh straight week of rising COVID-19 hospitalizations. COVID-19 deaths appear to be rising slightly, but the provisional data from the CDC is prone to amendments and delays.
Persons: , Peter Marks Organizations: Drug Administration, FDA’s, Biologics, Centers for Disease Control, EG Locations: U.S
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
Sept 8 (Reuters) - Early research data has shown that antibodies produced by prior infection or existing vaccines against the coronavirus were sufficient to protect against the new BA.2.86 variant, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday. The Food and Drug Administration in the coming days is expected to authorize the updated vaccines that target the XBB.1.5 subvariant of Omicron, and early data provide encouraging signs for the new shots, CDC said. Since CDC's initial risk assessment last month, BA.2.86 has been identified in nine U.S. states as of Friday. The Omicron offshoot has also been identified from both human and wastewater specimens in countries including Japan, UK and Canada. Reporting by Vaibhav Sadhamta in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.
Persons: coronavirus, Vaibhav, Shailesh Organizations: U.S . Centers for Disease Control, Prevention, Drug Administration, CDC, Omicron, Canada, Thomson Locations: United States, Japan, Bengaluru
NEXU Science Communication/via Acquire Licensing Rights Read moreSept 8 (Reuters) - UK Health Security Agency (UKSHA) said on Friday that 34 COVID-19 cases linked to the highly mutated variant BA.2.86 had been identified in England. Of the 34 confirmed cases identified as of Sept. 4, five patients were hospitalised and no deaths had been linked to the new emerging variant. The agency said 28 of the confirmed cases were identified from a single outbreak at a care home in Norfolk. Moderna (MRNA.O) and rival Pfizer (PFE.N) said on Wednesday their updated COVID-19 vaccines generated strong responses in testing against the BA.2.86 subvariant. Reporting by Khushi Mandowara in Bengaluru; Editing by Saumyadeb ChakrabartyOur Standards: The Thomson Reuters Trust Principles.
Persons: Renu Bindra, Khushi, Saumyadeb Organizations: Science, Trinity College, Reuters, Health Security Agency, Omicron, Moderna, Pfizer, Thomson Locations: Dublin, Wuhan, England, Norfolk, Denmark, Switzerland, South Africa, Israel, U.S, Bengaluru
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
Nicknamed "Pirola" on social media, the BA.2.86 Omicron subvariant is being tracked by both the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC). As of Aug. 30, CDC said the BA.2.86 variant was detected in at least four U.S. states in people or wastewater. Delaware on Tuesday said it had detected a BA.2.86 infection at a hospital. Moderna on Wednesday said clinical data showed that its retooled COVID vaccine generated a nearly 9-fold increase in human antibodies that can neutralize BA.2.86. Pfizer said on Wednesday that its updated COVID shot showed neutralizing activity against BA.2.86 and EG.5 in studies conducted on mice.
Persons: Emily Elconin, David Dowdy, Dowdy, Dan Barouch, David Ho, Deena Beasley, Julie Steenhuysen, Bill Berkrot Organizations: REUTERS, Moderna, Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, CDC, EG, Omicron, East, Johns Hopkins Bloomberg School of Public Health, Center, Virology, Vaccine, Beth Israel Deaconess Medical, Columbia University, U.S . Food, Drug Administration, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, Delaware, East Coast, Boston, Sweden, China
"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 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
[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 '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
WASHINGTON (AP) — President Joe Biden turned up in a mask for the first time in months on Tuesday, a day after his wife tested positive for COVID-19. People who are exposed to the coronavirus should wear a mask and monitor for symptoms for 10 days, according to the Centers for Disease Control and Prevention. White House Press Secretary Karine Jean-Pierre said Biden would be following CDC protocols and would mask indoors unless he was far enough away from someone. The Bidens had COVID-19 last summer, which is about the last time the president wore a mask in public. Officials already are expecting updated COVID-19 vaccines that contain one version of the omicron strain, called XBB.1.5.
Persons: Joe Biden, octogenarians, Biden, Larry Taylor, Jill Biden, COVID, hospitalizations, Karine Jean, Pierre, , , , Jake Sullivan, we’ve, ” Sullivan, Mike Stobbe Organizations: WASHINGTON, White, Centers for Disease Control, Labor, House, Group, CDC, White House Press, India Locations: Vietnam, Florida, Delaware, Philadelphia, Rehoboth, Virginia, India, Alaska, New York
Kent Sepkowitz CNNThere are several plausible reasons why this latest bump is occurring now after months and months of calm. To sort it out, I decided to perform an at-home rapid antigen test. One negative test on the first day of symptoms, especially with the rapid antigen test, is not determinative. The virus that causes Covid-19 infection is a simple scrap of RNA that cannot survive without a living cell to support it. This won’t be the last alarm, real or false, for me (and others) in the months ahead.
Persons: Kent Sepkowitz, Covid, , overconfidence Organizations: Memorial Sloan Kettering Cancer Center, CNN, Kent Sepkowitz CNN, US, Twitter Locations: New York, United States, XBB
CNN —US heavy metal legends Metallica have been forced to postpone their September 3 concert in Phoenix after announcing that frontman James Hetfield has tested positive for Covid-19. We look forward to returning to complete the M72 No Repeat Weekend in Glendale next Saturday,” the band added. The show, originally scheduled for Sunday, would have been the last of two in Glendale, Arizona. The band is currently on its M72 tour in the US and plays two concerts in every city. Tickets for the September 3 show “would be honored on September 9,” the band said.
Persons: James Hetfield, , Covid, James, , “ We’re Organizations: CNN, EG, US Centers for Disease Control Locations: Phoenix, Glendale, Glendale , Arizona
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