Top related persons:
Top related locs:
Top related orgs:

Search resuls for: "bivalent"


25 mentions found


Moderna on Tuesday said a new version of its Covid vaccine triggered a stronger immune response against the virus than its current shot in a late-stage trial. Moderna's current Covid vaccine, known as Spikevax, is its only commercially available product. The biotech company's new shot could offer a longer shelf life and easier storage than its Covid vaccine. The company will accomplish that by shortening the length of the mRNA strand in the vaccine, Moderna previously told CNBC. The company's shot against respiratory syncytial virus is expected to win Food and Drug Administration approval in May.
Persons: Moderna Organizations: Moderna, Pfizer, CNBC, subvariants, Food, Drug Locations: U.S, Canada, Covid
Fact Check: Iceland has not banned COVID vaccines
  + stars: | 2023-11-30 | by ( Reuters Fact Check | ) www.reuters.com   time to read: +2 min
A headline shared online falsely claims that Iceland has banned COVID-19 vaccines and cites sudden deaths for which there is no evidence, according to the Icelandic national health authority. Iceland has not banned COVID vaccines and “there are no soaring sudden deaths,” Guðrún Aspelund, chief epidemiologist at the Icelandic Directorate of Health, told Reuters in a Nov. 29 email. In 2021, Iceland along with other Scandinavian countries temporarily discontinued giving some COVID vaccines to younger adults. As of Oct. 5, 80.5% of the population (archived) in Iceland has received the primary course, that is two doses of a COVID vaccine. Iceland has not banned COVID vaccines and vaccination is recommended for specific groups of the population.
Persons: ” Guðrún Aspelund, epidemiologist, Aspelund, Moderna's Spikevax, Read Organizations: Icelandic Directorate of Health, Reuters, Twitter, Facebook, Health, Iceland’s, Pfizer, BioNTech's, Thomson Locations: Iceland
CNN —With holiday season underway, you may be realizing that you forgot to get your Covid-19 and flu vaccines, and now you’ll be sitting across the table from your elderly relatives. Covid-19 vaccines were updated this year to target one strain of the coronavirus rather than two. “The flu vaccine might have been an adjuvant for the Covid vaccine,” she said. Moss led a recent study that compared neutralizing antibody responses of 53 Israeli health care workers who received their bivalent Covid-19 vaccines separately or with a flu shot. Blood samples from these health care workers were equally able to prevent Covid-19 and flu viruses from infecting cells, whether they got their vaccines together or separately.
Persons: Mandy Cohen, ” Cohen, , , Susanna Barouch, Barouch, they’re, Stephen Moss, Moss, ” Moss, Dr, Sanjay Gupta, William Schaffner Organizations: CNN, US Centers for Disease Control, CDC, US Food and Drug Administration, University of Michigan, Pfizer, CNN Health, Vanderbilt University Locations: Boston, Cambridge , Massachusetts, Netherlands
Pfizer on Thursday said its combination vaccine candidates targeting Covid and the flu will move to a final-stage trial in the coming months after showing positive initial results in an early to mid-stage study. Covid vaccine rates in the U.S. were bleak last year, and could look the same this year. The trial measured the safety, tolerability and efficacy of Pfizer's combination vaccine candidates among adults ages 18 to 64. The results showed that "lead" formulations of Pfizer's combination vaccine demonstrated robust immune responses to influenza A, influenza B and Covid strains, according to Pfizer. The safety profiles of the combination vaccine candidates were also consistent with the company's Covid vaccine.
Persons: BioNTech, Annaliesa Anderson, Pfizer's, Albert Bourla Organizations: Pfizer, BioNTech, Moderna Locations: U.S
Moderna on Tuesday announced that its combination shot for flu and COVID-19 is the first candidate to make it to late-stage trial. It “offers greater convenience and has the potential to lead to increased compliance with vaccine recommendations,” it added. The shots won’t be available for this respiratory virus season, as Moderna said it is targeting regulatory approval for the shot in 2025. Moderna earlier this month announced positive data from its earlier studies of the combo shot, finding that it produced an immune response similar to or greater than licensed flu shots and Moderna’s bivalent COVID-19 shot. “We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses.”
Persons: , Moderna, bivalent, Stéphane Bancel Organizations: Moderna, Tuesday, Northern Hemisphere, Disease Control, ” Moderna Locations: Moderna
A new study from the Centers for Disease Control and Prevention warns that COVID-19 hospitalization is a “continued public health threat” that predominantly affects adults ages 65 and older. The study looked at hospitalizations from January to August and found that adults ages 65 and older accounted for 63% of all hospitalizations associated with COVID-19. Nearly all hospitalized individuals ages 65 and older had two or more underlying medical conditions. Despite the issues, uptake of the shot is likely to be significantly higher than the last round of boosters. Broken down by age group, about two-thirds of adults ages 65 and older are likely to get the vaccine.
Persons: , Biden Organizations: Centers for Disease Control Locations: hospitalizations, U.S
Moderna on Wednesday said its combination vaccine targeting Covid and the flu will move to a final stage trial in adults ages 50 and above this year after showing positive results in an early to mid-stage study. The trial evaluated the combination shot in two different age groups: people 50 to 64 years of age and participants 65 to 79. The safety data of mRNA-1083 was similar to that of the stand-alone Covid shot, according to Moderna. No new safety concerns were identified with the combination vaccine. Moderna is also developing a combination shot targeting the flu and RSV, and another vaccine targeting all three respiratory viruses: Covid, flu and RSV.
Persons: Stéphane Bancel, BioNTech Organizations: Moderna, Pfizer, GlaxoSmithKline Locations: Moderna
A nurse fills a syringe with malaria vaccine before administering it to an infant at the Lumumba Sub-County hospital in Kisumu, Kenya, July 1, 2022. REUTERS/Baz Ratner/File photo Acquire Licensing RightsGENEVA, Oct 2 (Reuters) - The World Health Organization (WHO) recommended on Monday the use of a second malaria vaccine to curb the life-threatening disease spread to humans by some mosquitoes. recommended the broad use of the world's first malaria vaccine called RTS,S," WHO chief Tedros Adhanom Ghebreyesus told a briefing in Geneva. "Today, it gives me great pleasure to announce that WHO is recommending a second vaccine called R21/Matrix-M to prevent malaria in children at risk of the disease." "GSK has always recognised the need for a second malaria vaccine, but it is increasingly evident that RTS,S, the first ever malaria vaccine and the first ever vaccine against a human parasite, set a strong benchmark," GSK said in a statement.
Persons: Baz Ratner, Tedros Adhanom Ghebreyesus, Tedros, Poonawalla, Takeda, Hanna Nohynek, Gabrielle Tétrault, Farber, Leroy Leo, Gareth Jones, Mark Potter Organizations: Lumumba, REUTERS, Rights, World Health Organization, WHO, Britain's University of Oxford, UNICEF, Serum Institute of India, Reuters, GSK plc, United Nations, GSK, Takeda Pharmaceuticals, Thomson Locations: Kisumu, Kenya, Geneva, Ghana, Malawi, Bengaluru
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 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
So if people are less likely to be hospitalized or die from a Covid-19 infection now, has the danger passed? Through genetic bad luck, some people may just be at higher risk of serious reactions to Covid-19 infections, and they probably wouldn’t know it. Researchers defined it as any new or continuing symptoms more than 90 days after a Covid-19 infection. Based on his experience treating long Covid patients, Griffin said that the percentage reported in the Australian paper seems high. Earlier in the pandemic, pediatric infectious disease specialists were on the lookout for a rare complication of Covid-19 infection in kids called multisystem inflammatory syndrome in children, or MIS-C.MIS-C starts two to six weeks after a Covid-19 infection.
Persons: CNN —, we’ve, aren’t, Good, , Megan Ranney, Covid, ” Ranney, that’s, Evusheld, haven’t, you’ve, they’re, They’re, Mandy Cohen, It’s, , Jesse Bloom, Daniel Griffin, it’s ‘, Griffin, , Peter Chin, Chin, Hong, Nathaniel Hendrix, Hendrix, it’s, hasn’t, she’s, Kristin Englund, shouldn’t, Dr, Sanjay Gupta, “ It’s, Ellie Murray, ” Murray Organizations: CNN, US Centers for Disease Control, Yale School of Public Health, Covid, National Institutes of Health, FDA, US Department of Health, Human Services, CDC, Fred Hutchinson Cancer Center, HHS, Columbia University, University of California, Census Bureau, Nature Medicine, American Board of Family Medicine, Nature, Veterans Affairs, Cleveland Clinic, CNN Health, Boston University School of Public Health Locations: South Africa, Botswana, United States, China, Seattle, Israel, Denmark, United Kingdom, Portugal, US, Switzerland, Thailand, Australia, San Francisco, Ohio
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
“And since the masks that are most effective are N95 that are now readily available, that’s the kind of mask you should wear,” he added. But the agency doesn’t make a broad recommendation for everyone to adopt masks. Morris Brown College in Atlanta announced a return to mandated physical distancing and masks just one week after classes started in August. And pediatricians are poised for the typical return-to-school surge in all kinds of respiratory illness, whether colds, flu or Covid. “The virus is always lurking, waiting for openings, so I think Covid is just going to be a bit of a roller coaster, probably forever,” Wachter said.
Persons: Joe Biden, Jonathan Reiner, , ” Reiner, Biden, , Reiner, Eric Topol, ” Topol, ” What’s, Robert Wachter, ” Wachter, haven’t, Peter Chin, Topol, Dr, Sara Bode, Bode, It’s, , ” Chin, Hong, You’ve, you’ve, Amanda Musa, Brenda Goodman, Deidre McPhillips, Meg Tirrell Organizations: CNN, George Washington University School of Medicine & Health Sciences, US Centers for Disease Control, CDC, Scripps, Research, Covid, Department of Medicine, University of California San, University of California, Morris Brown College, Nationwide Children’s Hospital, American Academy of Pediatrics ’, School Health, Internal Locations: Covid, Florida, University of California San Francisco, San Francisco, Atlanta, Columbus , Ohio, Washington
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
Regardless of that shift, experts say vaccine uptake may not look much different from that of the bivalent boosters. Pandemic fatigue, confusionFatigue over the pandemic and the general belief that Covid is "over" could potentially hinder the uptake of new shots this fall, experts said. Ipsos and Axios released a survey with similar findings in May, the same month the U.S. ended the national Covid public health emergency amid a downward trend in cases, hospitalizations and deaths. "That contrasts with what we've seen in the past where there are different vaccines, different timing, different age groups and something new to consider every few months." Advisors to the FDA have raised concerns about shifting to yearly Covid vaccines, noting that it's unclear if the virus is seasonal like the flu.
Persons: Antonio Perez, Axios, isn't, Dr, Kartik Cherabuddi, Brad Pollock, Pollock, they're, Ashley McGee, Justin Sullivan, CDC hasn't, Covid, KFF's Kates, Michael Nagle, Kates, we've Organizations: Chicago CVS, Tribune, Service, Getty Images Pfizer, Moderna, Pfizer, Gallup, University of Florida, CNBC, UC Davis Health's, Safeway, CDC, Food and Drug Administration, Health, Human Services Department, FDA, Xinhua News Agency, Getty Locations: Chicago, U.S, San Rafael , California, New York, United States
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 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
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
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
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
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
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.
CNN —The US Centers for Disease Control and Prevention is still requiring international visitors boarding flights to the United States to be vaccinated against Covid-19, but it’s easing vaccine requirements for those travelers. International travelers boarding flights to the United States will now be considered fully vaccinated two weeks after getting a single dose of either the Pfizer or Moderna mRNA vaccine any time after August 16, 2022, when bivalent formulations first became available. Previously, foreign travelers entering the United States were considered fully vaccinated two weeks after the second dose of a vaccine that required two primary doses, or two weeks after a vaccine that only required a single shot, such as the Johnson & Johnson vaccine. A number of older, monovalent vaccine regimens also qualify a foreign visitor as fully vaccinated. As part of the update, the older monovalent mRNA Covid-19 vaccines are no longer recommended in the United States, and updated vaccines are recommended for everyone age 6 months and older.
But the original vaccines remain licensed in the United States and are not “banned” as suggested by some social media users. An FDA spokesperson also commented on the agency’s official Twitter account: “It's probably worth clarifying that the monovalent vaccines are still approved (licensed). EUA information for the Moderna and Pfizer vaccines can be seen on the FDA website (here) , (here). The FDA withdrew authorizations for emergency use of Pfizer-BioNTech and Moderna monovalent COVID vaccines while authorizing use of the updated, bivalent versions in all age groups. The agency did not withdraw its approval or license of the original vaccines, nor “ban” their use.
Total: 25