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Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. Pfizer has rejected allegations made by rival Moderna that its Covid-19 vaccine is a copy, accusing the Boston biotech company of rewriting history to lay claim to technology developed by a field of scientists over many years. Pfizer asked a federal court in Massachusetts on Monday to dismiss Moderna's lawsuit seeking monetary damages for alleged patent violations related to the Boston company's Covid vaccine. "The Moderna inventions that Pfizer and BioNTech chose to copy were foundational for the success of their vaccine," the company claimed. Pfizer and BioNTech did not copy Moderna's technology," Pfizer said in its response.
Dr. Anthony Fauci, the top infectious disease expert in the U.S., criticized China's Covid lockdowns as "draconian" and said the Beijing government should focus on vaccinating the elderly. Fauci said lockdowns are only justifiable as a temporary measure to serve a larger public health goal that will make society safer when it reopens. But China's strict Covid controls don't seem to have any endgame, he said. Rare protests broke out across China over the weekend against Covid lockdowns and strict quarantine procedures. "The efficacy of the China-made vaccines are not at the level of the vaccines that have been used in the United States, particularly the mRNA vaccines of Moderna and Pfizer," Fauci said.
Pfizer said its omicron booster triggers a stronger immune response against a number of emerging Covid subvariants circulating the U.S. Pfizer developed its booster against omicron BA.5 at the request of the Food and Drug Administration. Among the emerging subvariants, the omicron booster elicited the strongest immune response against BA.4.6 with antibodies 11 times higher, and the weakest response against XBB.1 with antibodies about 5 times higher. Moderna on Monday said its omicron booster induces an immune response against BQ.1.1 though the company didn't provide specifics. Pfizer and Moderna's new boosters target both omicron BA.5 and the original strain of Covid that emerged in Wuhan, China in 2019.
The recommendation also covers a version of Moderna's (MRNA.O) Spikevax vaccine for the age group but that product is in short supply in Germany at the moment, the expert panel said. European regulators in October authorised a low-dose version of Pfizer-BioNTech's first-generation vaccine for children from six months to four years, when given as a three-dose series. "When there are parents that absolutely want the vaccine for their healthy children, there are no legal reason for physicians to deny them that," said STIKO's Terhardt. STIKO also reaffirmed a recommendation it issued in May for five- to 11-year-olds, saying one COVID-19 shot was enough for healthy youngsters in that age group because most of them had already had an infection. Only slightly more than 22% of five- to 11-year-old children in Germany have so far received at least one COVID shot.
Bezos began giving out the award in 2021, and the prize includes $100 million to be distributed within 10 years. Bezos chose Parton this year because "she gives with her heart," he explained in a video posted to his Twitter account. Upon receiving the award, Parton thanked Bezos, saying "I will do my best to do good things with this money." Over the years, Parton has donated money to a number of charitable causes, including education, Covid research and animal preservation. Bezos is also entering the world of charitable giving and has pledged to donate the majority of his $122 billion net worth.
Moderna’s updated Covid booster appears to increase the immune response to omicron subvariants BA.4 and BA.5, as well as another subvariant, called BQ.1.1, that's gaining ground in the United States, the company said in a release Monday. The results are based on blood samples taken from 511 adults who got the updated booster, which targets BA.4 and BA.5, along with the original coronavirus strain, in a single shot. In people who got the updated booster, neutralizing antibodies against BA.4 and BA.5 were about fivefold higher in those with a previous Covid infection and sixfold higher in those without a documented infection, the company said. Moderna also said an ​​additional analysis of 40 people found the updated booster demonstrated “robust neutralizing activity” against the subvariant BQ.1.1, though the response wasn’t as strong as what was seen against BA.4 and BA.5. Earlier this month, Pfizer and BioNTech said their updated booster shot generated a stronger immune response against BA.4 and BA.5 compared with their original Covid vaccine.
Nov 14 (Reuters) - Moderna Inc (MRNA.O) said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said. Moderna, however, said levels of neutralizing antibody response dropped nearly 5-fold against the emerging subvariant BQ.1.1 when compared with BA.4/5, in an analysis of about 40 participants, although the virus neutralizing activity still remained "robust". Rival Pfizer Inc (PFE.N) and its German partner, BioNTech SE , said earlier this month their Omicron-tailored shot targeting the BA.4/5 subvariants produced a strong antibody response in older adults than the original shot after one month. Reporting by Bhanvi Satija in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.
Moderna's new Covid booster triggered a stronger immune response against omicron BA.5 and also appears to work against the emerging BQ.1.1 subvariant, according to the company. Moderna, in clinical trial data published Monday, found that the new booster triggered five times more antibodies against omicron BA.5 than the old vaccines in people with prior Covid infections. Moderna said it also found the new booster triggered robust immune response against omicron BQ.1.1, an emerging Covid subvariant in the U.S. Pfizer also released data earlier this month indicating that the boosters provide better protection against omicron BA.5 than the old shots. Two independent studies from Columbia and Harvard found that the boosters did not do a much better job against omicron BA.5.
In October 2021, Da’Vion Miller was found unconscious in the bathroom of his home in Detroit a week after receiving his first dose of Pfizer's Covid vaccine. Courtesy Da’Vion MillerMiller is one of a very small group of people in the United States who have experienced myocarditis following vaccination with the Pfizer-BioNTech or the Moderna Covid vaccines based on mRNA technology. Video: CDC says waiting longer between Covid vaccine doses could reduce myocarditis risk. Cooper joined an expert advisory panel formed by Moderna to monitor its Covid vaccine safety. The Pfizer study will include people who were previously hospitalized with vaccine-associated myocarditis, and it will also follow those who were more recently diagnosed.
Moderna on Thursday lowered its 2022 sales guidance for its Covid-19 vaccine after missing Wall Street expectations for the third quarter. The Boston biotech company said it now expects to book $18 billion to $19 billion in revenue from its Covid vaccine this year, down from its previous guidance of $21 billion. Moderna said some Covid vaccine deliveries have been pushed into 2023 due to supply constraints. Moderna's third quarter revenue came in at $3.36 billion, down 32% from the same period in 2021. It is also expecting phase three immune response data from its flu vaccine candidate in the first quarter of 2023.
Nov 3 (Reuters) - Moderna Inc (MRNA.O) cut its annual sales forecast for its COVID-19 vaccine on Thursday, citing short-term supply constraints that would push some deliveries out to next year, sending its shares down nearly 16% before the bell. It now expects vaccine sales of $18 billion and $19 billion this year compared to a prior forecast of $21 billion. Some U.S. pharmacies in September had reported that government supply of Moderna's updated shot remains limited, causing appointments for the product to vary across the country. Moderna's forecast cut comes just two days after rival Pfizer Inc's (PFE.N) quarterly sales of its COVID-19 vaccine exceeded market expectations and the drugmaker raised the full-year sales forecast for its shots. The vaccine maker reported sales of $3.36 billion in the third quarter, missing Wall Street estimates of $3.53 billion.
The back half of the earnings season gets underway this week, with key companies across different sectors set to report. FactSet data shows that slightly more than 70% of the S & P 500 that have reported earnings have beaten earnings expectations. Tuesday Advanced Micro Devices is set to report earnings after the bell, followed by a conference call at 5 p.m. Wednesday Yum Brands is set to report earnings before the bell, with management holding a call at 8:15 a.m. EBay is set to report earnings after the bell, followed by a call at 5 p.m.
[1/2] A medical worker holds a vial of the "Comirnaty" Pfizer-BioNTech COVID-19 vaccine at a coronavirus disease (COVID-19) vaccination center in Nice, France, December 1, 2021. REUTERS/Eric Gaillard/File PhotoOct 28 (Reuters) - A European Medicines Agency (EMA) committee on Friday recommended adding heavy menstrual bleeding to the list of side effect of mRNA COVID-19 vaccines made by Moderna (MRNA.O), as well as Pfizer (PFE.N) and its partner BioNTech (22UAy.DE). The regulator has now concluded that there is at least a "reasonable possibility" that heavy menstrual bleeding is causally associated with these vaccines. Menstrual disorders can occur due to a range of reasons, including underlying medical conditions as well as stress and tiredness. Health authorities have highlighted that cases have also been reported following COVID-19 infection.
Snap — Shares of the Snapchat parent company cratered 30% after missing revenue estimates and sharing its slowest sales growth since going public as advertising spending slows. The results from Snap hit other ad-reliant stocks, sending shares of Pinterest and Meta Platforms down about 7.7% and 2.6%, respectively. Twitter — The social media stock sank more than 4% Friday amid a slew of media reports surrounding Twitter and Elon Musk. American Express – Shares of American Express fell about 3.5% even after the bank reported quarterly earnings and revenue that beat analysts' expectations. Huntington Bancshares — Shares gained 8% after the bank operator topped earnings estimates for the third quarter and upped its net interest income outlook for 2022.
Some people are combining the latest COVID booster with this year's flu shot. Initially, Ros had planned to wait to get her flu shot a few weeks later. Several other people told Insider they experienced headaches and nausea after their flu shots and bivalent boosters, even though they hadn't had the same side effects after previous doses of COVID vaccines. The flu shot and bivalent booster packed a punch for some peopleLyn Craven told Insider that she had "little to no reaction" to her latest booster and flu shot, which she scheduled a week apart. Craven said her husband got both the annual flu shot and the bivalent booster on the same day, just like he did last year.
The authorization of Novavax's booster could significantly increase the role that its shot plays in U.S. vaccination efforts. The Centers for Disease Control and Prevention still has to give the final go ahead before pharmacies can start administering Novavax's booster. Only 35,300 people have received Novavax's shots so far in the U.S., according to data from the CDC. By comparison, some 372.5 million Pfizer shots, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. so far. People who received Novavax's vaccine as their primary series are also eligible for Pfizer and BioNTech's new omicron booster.
The CDC's independent advisors voted unanimously on Wednesday to include Covid shots authorized for kids by the Food and Drug Administration in the federal government's Vaccines for Children program. The Vaccines for Children program provides vaccines to kids under age 19 whose families cannot afford them. The federal government has been providing Covid vaccines to everyone in the U.S. for free during the pandemic. Dr. Jeanne Santoli, a CDC official, said the public health agency will start awarding contracts for health care providers to give the Covid shots for free to uninsured kids. The decision to include Covid shots in the free vaccine program will prove crucial to maintaining access for many children.
EMA recommends Moderna's new Omicron-tailored vaccine
  + stars: | 2022-10-19 | by ( ) www.reuters.com   time to read: 1 min
Oct 19 (Reuters) - The European Medical Agency on Wednesday recommended authorization of Moderna Inc's (MRNA.O) COVID-19 vaccine tailored towards targeting the Omicron sub-variants BA.4 and BA.5 for 12 and above ages. The European Commission has already approved Moderna's vaccine targeting Omicron BA.1 last month. Register now for FREE unlimited access to Reuters.com RegisterReporting by Khushi Mandowara; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.
Dr. Ashish Jha, head of the White House Covid taskforce, said everyone older than 50 and senior citizens in particular need to get an omicron booster as soon as possible. The elderly have faced the high risk of falling seriously ill with Covid since the beginning of the pandemic. Younger people should also get a booster this fall even though they're at lower risk of getting seriously ill from the virus, Jha said. The FDA and CDC rapidly authorized the omicron shots for children as young as 5 years old last week. But the CDC, in a study published last April, said the risk of myocarditis is higher after a Covid infection.
If you already got your omicron-specific Covid booster, you might have experienced some side effects. But there's no need to worry: Experts and new data say the new shots appear to work — regardless of whether you experience moderate, mild or no side effects at all. The new boosters gained approval from the U.S. Food and Drug Administration and the CDC before they finished clinical trials. Like previous Covid vaccines, the new boosters are designed to help you fight the virus by triggering an immune response in your body. Covid vaccines typically take two to three weeks to fully ramp up your immunity, which can help your body stop an infection from happening or keep it from progressing to severe disease.
The results are based on blood samples taken from adults one week after they received the updated booster. The FDA also authorized Moderna's updated booster based on similarly limited data. The FDA authorized the updated shots based on studies in mice — plus human trial results from a similar booster that targets the original omicron strain, called BA.1. At the time, Dr. Peter Marks, the FDA's top vaccine regulator, said the agency hoped the updated vaccines will provide stronger protection against symptomatic disease than the older vaccines. Moderna didn't immediately respond to a request for comment about when it will release new data on its updated booster.
LONDON, Oct 13 (Reuters) - Data unveiled on Thursday showed GSK's (GSK.L) respiratory syncytial virus (RSV) vaccine was 82.6% effective in a keenly watched late-stage study involving older adults. The company is a key player in the race to develop a safe and effective RSV vaccine, which, if approved, is expected to generate billions in sales for its maker. If approved, Jefferies analysts have forecast $2.5 billion in global RSV vaccine peak sales in older adults for GSK. U.S. drugmaker Pfizer (PFE.N) in August disclosed positive Phase III data on its rival RSV vaccine in older adults. In trial participants with pre-existing conditions, the GSK vaccine was shown to be 94.6% effective, while in adults aged 70 to 79 it was 93.8% effective, the company said.
The Food and Drug Administration on Wednesday authorized Covid booster shots that target the omicron variant for preschoolers through elementary school students. Pfizer's new omicron boosters are now authorized for children ages 5 to 11 and Moderna's shots for kids ages 6 through 17. The new boosters target omicron BA.5 as well as the original strain of Covid that first emerged in Wuhan, China, in 2019. The first generation of Covid shots were developed in 2020 to target the original strain of Covid. More than 11 million Americans ages 12 and older have received the new booster shots so far, according to CDC data.
Pepsi products are displayed for sale in a Target store on March 8, 2022 in Los Angeles, California. Check out the companies making the biggest moves midday Wednesday:Moderna — Shares of Moderna surged 10% after the drug maker announced it will partner with Merck to jointly develop and sell a cancer vaccine. It reported preliminary month-end assets under management of $1.23 trillion as of Sept. 30. Pepsi also raised its guidance for the year as it was able to successfully raise prices on its products. Lyft — Lyft shares gained 5.8% following an upgrade from Gordon Haskett to buy from hold.
Merck opts to develop, sell cancer vaccine with Moderna
  + stars: | 2022-10-12 | by ( ) www.reuters.com   time to read: +1 min
The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File PhotoOct 12 (Reuters) - Merck & Co Inc (MRK.N) opted to jointly develop and potentially sell a personalized mRNA vaccine with Moderna Inc (MRNA.O) for a $250 million upfront payment on Wednesday, sending the vaccine maker's shares up over 8%. In 2016, Merck and Moderna entered a strategic partnership to develop a personalized vaccine for treatment of various types of cancer. Merck in 2020 sold its equity investment in Moderna, benefiting from a surge in the vaccine-maker's stock price that year. Register now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra and Khushi Mandowara in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.
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