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☆ Moderna's combination Covid, flu vaccine is more effective than existing shots in late-stage trial
▼ + stars: | 2024-06-10 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Moderna on Monday said its combination vaccine that targets both Covid-19 and the flu was more effective than existing standalone shots for those viruses in a late-stage trial. Moderna's messenger RNA combination shot, called mRNA-1083, is made up of both the company's vaccine candidate for seasonal influenza and a newer, "next-generation" version of its Covid shot. The study compared the combination shot with an enhanced flu vaccine called Fluzone HD and Moderna's currently licensed Covid shot, Spikevax, in one group of patients ages 65 and above. Moderna is also developing a combination shot targeting the flu and RSV, and another vaccine targeting all three respiratory viruses: Covid, flu and RSV. Meanwhile, Pfizer and BioNTech also are studying a vaccine that targets both Covid and the flu in a late-stage trial.

Persons: Stephane Bancel, Novavax, Bancel, Moderna, BioNTech Organizations: Pfizer, Novavax, Moderna, Covid Locations: U.S

☆ Covid-flu combination vaccine shows positive results in late-stage trial, Moderna says
▼ + stars: | 2024-06-10 | by ( Jen Christensen | ) edition.cnn.com time to read: +5 min

CNN —There could be a combined Covid-19 and flu shot in our future, although it won’t be ready for this year’s flu season. On Monday, vaccine maker Moderna announced positive late-stage trial results for its Covid/flu combination vaccine it calls mRNA-1083. Other companies have been testing a combined Covid-flu vaccine, but Moderna is the first to announce positive late-stage trial results. The trial studied the vaccine in two different age groups with about 4,000 adults in each age category. Few people got the latest Covid shot, studies show.

Persons: ”, Francesca Ceddia, ” Ceddia, Covid, Spikevax, Moderna, Sue Peschin, Dr, Sanjay Gupta, Peschin, ” Peschin, “ Organizations: CNN, Moderna, Public, US Centers for Disease Control, Food, Covid, FDA, Alliance for Aging Research, CNN Health, CDC Locations: United States

☆ Moderna says new Covid vaccine showed stronger immune response than current shot in study
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

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

☆ Moderna files for FDA approval of updated Covid vaccine for fall
▼ + stars: | 2023-06-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

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

May 4 (Reuters) - Moderna Inc (MRNA.O) on Thursday reported stronger-than-expected sales of $1.9 billion for its COVID-19 vaccine in the first quarter, driven by a surge of revenue deferred from 2022, but left its 2023 sales expectations unchanged. Moderna said it continued to expect COVID vaccine sales of $5 billion for the year based on advance purchase agreements. Moderna expects an additional $3 billion in deferred vaccine revenue in the second half of 2023. The results came two days after the company's rival Pfizer reported better-than-expected COVID vaccine sales for the first quarter and maintained its expectations for full-year sales. Moderna had generated around $36 billion in sales over the last two years from its COVID vaccine, its only commercial product and one of the most widely used shots for the virus.

☆ CDC eases certain Covid-19 vaccine requirements for international travelers to US
▼ + stars: | 2023-04-28 | by ( Brenda Goodman | ) edition.cnn.com time to read: +2 min

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.

☆ Fact Check-COVID ‘monovalent’ vaccines not banned, FDA approval not withdrawn
▼ + stars: | 2023-04-25 | by ( Reuters Fact Check | ) www.reuters.com time to read: +6 min

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.

☆ Moderna says personalized mRNA cancer vaccine is effective for advanced melanoma
▼ + stars: | 2022-12-13 | by ( The Associated Press | ) www.nbcnews.com time to read: +2 min

The company said a possible melanoma vaccine it is studying with pharmaceutical giant Merck fared well in a small study of patients who had the cancer surgically removed. The drugmakers said a combination of the vaccine and Merck’s immunotherapy Keytruda led to a statistically significant improvement in survival before the cancer returned in patients with advanced melanoma. “We are very excited, we are moving very quickly with Merck onto phase 3 for this study,” Moderna CEO Stephane Bancel told CNBC Tuesday morning. Like Spikevax, the potential skin cancer vaccine uses mRNA technology. The patient group that took the potential vaccine and Keytruda saw a 44% reduction in the risk of death or the cancer returning, the companies said.

☆ German panel recommends COVID shot only for at-risk youngsters
▼ + stars: | 2022-11-17 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

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.

☆ EU regulator recommends adding heavy periods to side effects of mRNA COVID shots
▼ + stars: | 2022-10-28 | by ( Natalie Grover | ) www.reuters.com time to read: +2 min

[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.

☆ A series of mega-blockbuster drugs are on the horizon. How to invest in the trend
▼ + stars: | 2022-10-08 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +4 min

"That said, the biggest drugs usually feature one, or best case two, of these attributes." Seven drugs on Meacham's list are already in the market, and have already hit the $10 billion or more benchmark. That means some of these drugs may be already hitting the end of their peak sales period. Meacham has previously said that one of the drugs in this bucket, Eli Lilly's tirzepatide, could be the first $100 billion drug . But many investors are hopeful about its potential as an obesity treatment .

☆ Вакцина Moderna сменила название. Теперь это Spikevax
▼ + stars: | 2021-06-23 | by ( ) newsmaker.md time to read: 1 min

Американская компания Moderna изменила название своей вакцины от коронавируса COVID-19. Об этом 23 июня сообщили на сайте Европейского агентства лекарственных средств. Раньше название препарата совпадало с названием компании. Напомним, Всемирная организация здравоохранения (ВОЗ) и Европейское агентство лекарственных средств одобрили для экстренного использования вакцину от коронавируса, разработанную компанией Moderna. Заявленная эффективность препарата — 94,1%.

Organizations: Европейское агентство лекарственных средств, Всемирная организация здравоохранения (ВОЗ)

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