Latest news with #ModernaInc
Time of India
10-07-2025
- Health
- Time of India
Moderna's COVID vaccine gets full US approval for at-risk children aged 6 months and older
US regulators have granted Moderna Inc. full approval for its COVID-19 vaccine, Spikevax, for children aged 6 months through 11 years, but only for those at increased risk from the virus. Tired of too many ads? go ad free now The move marks a shift in federal policy under Health and Human Services Secretary Robert F. Kennedy Jr., who has led a controversial effort to scale back universal access to pediatric COVID shots. The Food and Drug Administration's decision, announced Thursday, means that healthy children in this age group will no longer have routine access to the vaccine unless it is prescribed off-label. Moderna's shares rose more than 4% in early trading in New York following the announcement. Under emergency use authorization during the pandemic, COVID-19 vaccines from Moderna and Pfizer were made widely available to all children. But Kennedy, a longtime vaccine skeptic, has reversed course. In 2021, he petitioned the FDA to revoke temporary approval for children's vaccines, citing low risk of severe illness in healthy children. Now, the vaccine's full approval ensures it remains available for high-risk kids, but also restricts broader access. What are the risks of SPIKEVAX? For most people, getting the SPIKEVAX COVID-19 vaccine is safe and simple. But like any vaccine, there are some rare risks you should know about. There's a very small chance of having a serious allergic reaction, usually within a few minutes to an hour after the shot. That's why your doctor or nurse may ask you or your child to wait for a short time after getting vaccinated—just to be safe. As per the official website of Moderna, signs of a serious allergic reaction may include: Difficulty breathing Swelling of the face or throat A fast or racing heartbeat A rash all over the body Dizziness or weakness In rare cases, some people—mostly boys and young men between 12 and 24 years old—have developed myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining around the heart) after getting an mRNA COVID-19 vaccine like SPIKEVAX. Tired of too many ads? go ad free now If you or your child experiences any of the following symptoms within two weeks of the vaccine, it's important to see a doctor right away: Chest pain Shortness of breath A fast, fluttering, or pounding heartbeat In children, signs to watch for can include chest pain, shortness of breath, pounding heartbeat, fainting, being unusually tired or irritable, poor feeding, stomach pain, vomiting, or cool, pale skin. What are the possible side effects of SPIKEVAX? Common side effects around the injection site: pain or tenderness, redness, swelling or firmness, and swollen lymph nodes in the same arm or sometimes in the groin General side effects: feeling tired or sleepy, headache, muscle or joint pain, chills or fever, nausea or vomiting, rash, irritability or crying (especially in young children) and loss of appetite. In some cases, people have also reported fainting or febrile seizures (seizures caused by a fever). While these are less common, it's helpful to be aware of them.
The Hill
30-06-2025
- Health
- The Hill
Experimental Moderna flu shot more effective than approved vaccine, company says
Moderna Inc. said Monday its experimental flu shot showed positive results in a late-stage trial. In a Phase 3 study, the company's mRNA-1010 flu vaccine's efficacy was nearly 27 percent higher for adults 50 and older than a currently available shot. The shot also showed strong efficacy against each of the major influenza strains in the shot including A/H1N1, A/H3N2 and the B/Victoria lineages. Efficacy appeared consistently strong across age groups, flu vaccination status and among people with various risk factors, Moderna said in a statement. The trial enrolled more than 40,800 adults 50 and older from 11 countries. 'The severity of this past flu season underscores the need for more effective vaccines,' said Stephane Bancel, chief executive officer of Moderna. 'An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines.' Seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-25 season, according to the CDC. At least 600,000 Americans were hospitalized last year due to flu-related illness, agency data show. According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. [2] More than 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work After consulting the Food and Drug Administration, Moderna withdrew its application last month for a dual flu and COVID-19 vaccine for adults 50 years old and older. Moderna plans to resubmit the application for the combination vaccine with the new data, according to CNBC. The company also plans to submit the data on the mRNA-1010 shot to U.S. regulators this year.
Bloomberg
30-06-2025
- Business
- Bloomberg
Moderna's Flu Vaccine Hits Goal, Paving Way for Combo Shot
By Updated on Save Moderna Inc. said its experimental flu shot met its goal in a late-stage trial, clearing the path for its broader strategy of selling combination vaccines. The shot's efficacy was 27% higher than a licensed influenza vaccine in adults 50 years and older, the company said in a statement Monday. The trial enrolled more than 40,000 adults across 11 countries.
Bloomberg
12-06-2025
- Health
- Bloomberg
FDA Approves Moderna's RSV Vaccine for Younger Adults
US regulators approved Moderna Inc. 's vaccine to prevent a common respiratory illness for more adults, a potential easing of the Trump administration's opposition to mRNA technology. Moderna may sell the shot for adults under 60 who are at increased risk from respiratory syncytial virus, or RSV. The Food and Drug Administration approved it last year for adults 60 and older, giving the company a second product after its Covid vaccine.
Yahoo
12-06-2025
- Business
- Yahoo
Moderna explores outside financing for vaccine trials, shares dip
-- Moderna Inc (BMV:MRNA) (NASDAQ:MRNA) shares fell 2.2% Thursday as the company confirmed it is seeking outside investment to support its late-stage vaccine programs. The move underscores the biotech firm's effort to align capital efficiency with strategic advancement across its product pipeline amid slowing COVID-19 revenue. 'We are very actively talking to potential partners right now,' CEO Stéphane Bancel said Wednesday at the Goldman Sachs Annual Global Healthcare Conference. He added that the discussions involved both pharmaceutical companies and financial partners, enabling the company to progress stalled late-stage candidates while controlling costs. A key focus for potential funding includes its latent virus vaccine programs, such as those targeting Epstein-Barr virus (EBV), herpes simplex virus (HSV), and varicella-zoster virus (VZV). 'We are working actively with [a] pharma company on the one hand and [a] financial partner on the other hand because we want those products to get to phase three,' Bancel said. Moderna has paused internal spending for those programs, opting instead to secure external capital and avoid further capital expenditure. 'We could launch EBV without adding $1 of CapEx. We could launch HSV without adding $1 of CapEx,' Bancel said, noting that Moderna's existing facilities have sufficient capacity to support production without the need for additional investment. The company's earlier collaboration with Blackstone (NYSE:BX) on financing a flu vaccine program stands as a precedent for these new deal structures. 'We would rather wait a few months to get the best partnership than being in a hurry and destroy value for shareholders by being in a hurry,' Bancel noted. While the company has over $8.5 billion in cash on hand, Bancel indicated this financing effort is about maximizing efficiency, not bridging funding gaps. 'We want to figure out who is the best partner in terms of capabilities and in terms of value,' he said, reiterating that securing the right structure is more important than speed. The funding push comes as Moderna aims to return to profitability by 2028 while ramping its oncology and respiratory portfolios. Shares finished the day down 2.2%, reflecting cautious sentiment amid uncertainty around vaccine uptake, trial timelines, and partnering outcomes. Related articles Moderna explores outside financing for vaccine trials, shares dip Israel considers military action against Iran, sources tell ABC News Micron boosts planned U.S. investment by $30 billion amid AI-driven demand Sign in to access your portfolio
