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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
REUTERS/Amir Cohen Acquire Licensing RightsJERUSALEM, Sept 12 (Reuters) - Israel's health ministry on Tuesday advised people with compromised immune systems to wear masks in crowded indoor spaces as it marks an increase in COVID-19 hospitalisations ahead of the Jewish holidays. In a statement, the ministry said there was a "moderate rise" in hospitalisations due to a number of COVID variants found both in Israel and around the world. "Ahead of the holidays and as a result of increased morbidity, the health ministry recommends people in at-risk groups or those who want to limit the risk of infection wear a mask in crowded indoor spaces." Large family gatherings are common during the Jewish holiday season, which begins on Sept. 15 and extends over about a month. COVID infections and hospitalisations have been on the rise in the U.S., Europe and Asia but are well below previous peaks.
Persons: Amir Cohen, Henriette Chacar, Alexandra Hudson Organizations: Arazim Elementary, REUTERS, Rights, Alexandra Hudson Our, Thomson Locations: Tel Aviv, Israel, COVID, hospitalisations, U.S, Europe, Asia
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
“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
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
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
Now that the national emergency is no longer in effect, many are wondering if their insurance will cover the latest booster shots. Will insurance cover the newest Covid booster? If you get your vaccines at your local pharmacy, consider asking a pharmacist at the location if your insurance covers Covid boosters, she adds. If you don't have insurance or your provider isn't covering the cost of your vaccine, booster shots should also be available for free through local public health authorities, Patel adds. What else should you know about the 'Eris' Covid variant?
Persons: Payal Patel, Patel, Sorana Segal, Maurer, Segal, you'll, who've Organizations: EG, Intermountain Health, World Health Organization, CNBC, Presbyterian Queens Locations: Salt Lake City, U.S, NewYork, Covid
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
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
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
Covid Is Coming Back in China; Lockdowns Are Not
  + stars: | 2023-05-27 | by ( Chris Buckley | ) www.nytimes.com   time to read: +1 min
In December, China abruptly abandoned its draconian “Zero Covid” policies, battered by a surge of infections and rising public anger against lockdowns. The Chinese health authorities have reported a rise in Covid cases since April, especially from newer subvariants that are spreading across the world. (That would be up from what he estimated at 40 million infections a week in late May. China no longer publishes regular official nationwide estimates of infections.) By comparison, after “Zero Covid” controls were set aside in December, new infections reached 37 million a day in China at their peak, according to estimates cited by Bloomberg.
U.S. Covid-19 Deaths and Hospitalizations Near New Lows
  + stars: | 2023-04-28 | by ( Jon Kamp | ) www.wsj.com   time to read: 1 min
New Covid-19 subvariants are on the rise, but the U.S. has broadly recorded declining numbers this year. Photo: Gabby Jones for The Wall Street JournalU.S. Covid-19 hospitalizations and deaths are hovering near new lows, providing fresh evidence that even as the virus endures it has become less damaging in a population with strengthened immune defenses. New subvariants are on the rise, and cutbacks in data reporting have clouded the view of recent trends. But the U.S. has broadly recorded declining numbers this year following a winter of less intense Covid-19 spread.
China OKs its first mRNA vaccine, from drugmaker CSPC
  + stars: | 2023-03-22 | by ( ) www.reuters.com   time to read: +2 min
BEIJING, March 22 (Reuters) - China's CSPC Pharmaceutical Group Limited (1093.HK) said on Wednesday its messenger RNA (mRNA) COVID-19 vaccine had received emergency use authorisation from Chinese health authorities, making it the country's first domestically developed mRNA shot. China has declined to use mRNA vaccines from abroad and vaccines available in China are widely considered less effective than the Moderna (MRNA.O) and Pfizer (PFE.N)-BioNTech (22UAy.DE) mRNA shots. The company said its independently developed mRNA vaccine SYS6006 targets some major Omicron variants and its booster dose showed good neutralization effect against Omicron subvariants BA.5, BF.7, BQ.1.1., XBB.1.5 and CH.1.1. The firm got emergency approval to conduct clinical trials of the mRNA shot in April last year, around the same time as CanSino, another China-based company that is testing an mRNA Omicron booster shot. Shares in the company rose as much as 7.7% after the result and the announcement of the mRNA approval.
The agency continues to closely monitor the emerging data in the United States and globally, and that data will dictate any decision on additional updated boosters, the FDA said in a statement. The Centers for Disease Control and Prevention would have to recommend the shots after the FDA authorizes the second Omicron-tailored boosters from Pfizer-BioNTech (PFE.N)/(22UAy.DE) and Moderna (MRNA.O) for them to become widely available. Updated boosters have helped prevent symptomatic infections against the new XBB-related subvariants, according to data released by the CDC in January. The FDA authorized the so-called bivalent COVID boosters in August that target the BA.4 and BA.5 Omicron subvariants, along with the original strain of the coronavirus. Rollout of the updated boosters in the United States started the following month.
"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Eli Lilly and Co (LLY.N) made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.
An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.
The FDA pulled Evusheld from the market because it is not effective against more than 90% of the Covid subvariants that are currently circulating in the U.S. People with compromised immune systems, such as cancer chemotherapy and organ-transplant patients, are some of the groups most vulnerable to severe disease from Covid. More than 7 million adults in the U.S. have a compromised immune system. He said lawmakers' failure to pass additional Covid funding means there isn't money to invest in new antibodies. President Joe Biden told people with compromised immune systems to consult with a doctor.
The Centers for Disease Control and Prevention on Friday urged people with weak immune systems to take extra precautions to avoid Covid after the dominant omicron subvariants knocked out a key antibody treatment. The guidance comes after the Food and Drug Administration on Thursday pulled its authorization of Evusheld, a combination antibody injection that people with weak immune systems took as an additional layer of protection to prevent Covid infection. The FDA pulled Evusheld because it is not effective against 95% of the omicron subvariants circulating in the U.S. People with weak immune systems include cancer patients who are on chemotherapy, organ transplant patients who are taking medication for their transplant, people with advanced HIV infection, and those born with immune deficiencies. Some 7 million adults in the U.S. have a condition, like cancer, that compromises their immune system, according to the CDC.
Jan 26 (Reuters) - Novavax Inc (NVAX.O) said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States. The FDA in documents released on Monday proposed June for deciding on an annual COVID shot's make-up. It took those companies about three months to produce the currently available boosters updated to target newer Omicron subvariants. The FDA is seeking recommendations from its panel of external experts on adopting an annual COVID shot for the United States and the process for choosing the vaccine's targets each year. Reporting by Leroy Leo in Bengaluru Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.
The updated Covid boosters reduce the risk of Covid infection from the predominant omicron subvariant by nearly half, according to early data published Wednesday by the Centers for Disease Control and Prevention. The findings are “quite reassuring,” Dr. Brendan Jackson, the head of the CDC’s Covid response, said on a call with reporters Wednesday. As of last Wednesday, only about 15% of people in the U.S. had received an updated booster, according to CDC data. People who were vaccinated but had not received the updated booster were compared to those who got the updated booster in the previous two to three months. People who got the updated boosters are probably "much more likely to wear masks indoors or restrain their travel or not go to indoor restaurants," he said.
The CDC study published Wednesday provides the first estimate of the omicron booster shots' real-world effectiveness against the XBB family of subvariants. Some scientists have warned the XBB subvariants could cause another Covid wave because they are so good at evading the antibodies that block infections. The study compared people who received the new booster with those who received between two and four doses of the original vaccine. People who only received the original shots generally got their last dose about 13 months ago. But the CDC study found that the omicron boosters provide about as much protection against the XBB family as they do against the BA.5 subvariant and its descendants such as BQ.1 and BQ.1.1.
"Today we have additional evidence to show that these updated vaccines are protecting people against the latest COVID-19 variants," Dr. Brendan Jackson, head of the U.S. Centers for Disease Control and Prevention's COVID-19 response, told reporters in a briefing. Released last fall, the updated boosters target the BA.4 and BA.5 Omicron variants of the SARS-CoV-2 virus, which are no longer dominant. It showed that the updated vaccine helped prevent illness in roughly half of the people who had previously received two to four doses of the original COVID-19 vaccine, CDC said. The CDC said the updated vaccine worked similarly against BA.5-related infections and XBB/XBB.1.5-related infections. Given the findings, the CDC urged people to stay up to date on their recommended COVID-19 vaccines.
Food and Drug Administration advisers will meet Thursday to discuss simplifying the Covid vaccination schedule, allowing most people to get the currently available booster, regardless of how many doses they had received before that. The FDA is proposing skipping over that primary series, meaning that most unvaccinated individuals could go ahead and get the latest booster shot if they decided to get a Covid vaccine. The FDA’s proposal, experts say, would greatly simplify the Covid vaccination schedule in the United States — aligning it more closely with the annual flu shot. In another similarity to the flu shot, the FDA is considering whether the Covid vaccine should be updated at least once a year, based on what strains are in circulation. Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University in Baltimore, said simplifying the Covid vaccine schedule makes sense.
Jan 13 (Reuters) - The fast-spreading Omicron subvariant XBB.1.5 is estimated to account for 43% of the COVID-19 cases in the United States for the week ended Jan. 14, data from the Centers for Disease Control and Prevention showed on Friday. The subvariant accounted for about 30% of cases in the first week of January, higher than the 27.6% the CDC estimated last week. The World Health Organization (WHO) said earlier this week XBB.1.5 may spur more COVID-19 cases based on genetic characteristics and early growth rate estimates. The rise in the new variant correlated with an uptick in COVID-19 cases in United States over the last six weeks. Increased prevalence of XBB.1.5 cases has eclipsed the previously dominant Omicron subvariant BQ.1.1 and BQ.1, which were offshoots of BA.5.
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