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FDA OKs First Meningococcal Vaccine for Infants
FDA OKs First Meningococcal Vaccine for Infants

WebMD

time30-05-2025

  • General
  • WebMD

FDA OKs First Meningococcal Vaccine for Infants

May 30, 2025 – The FDA has approved the first-ever meningococcal vaccine for babies as young as 6 weeks old. Sanofi Pasteur's quadrivalent MenQuadfi shot was first cleared in 2020 for adults and children ages 2 years or older. It protects against invasive meningococcal disease (IMD) caused by the four most common strains of meningococcal bacteria (Neisseria meningitidis): A, C, W, and Y. IMD is rare but can turn deadly within hours, causing brain swelling, blood infection, or death. Even with fast treatment, 10% to15% of patients don't survive, and many survivors face serious complications such as hearing loss or nerve problems, according to the CDC. Infants younger than 1 year old are at the highest risk, followed by children up to 4 years old. Teens and young adults (ages 16 to 23) are at higher risk, by being in college dorms, kissing, and sharing drinks. Early vaccination is key to preventing infection and long-term harm. The approval was based on positive results from clinical studies involving 4,273 infants ages 6 weeks to 23 months, who received at least one dose of either a four-dose or two-dose series of MenQuadfi. After each shot, they were monitored for immediate reaction, and parents worked closely with doctors during follow-up visits. The results showed the vaccine was effective, safe, and well-tolerated in the newly approved age group, with no new safety concerns reported. Infants can be given the shot at 6 weeks old, with four doses given at 2, 4, 6, and between 12 and 18 months. Babies ages 6 to 23 months will get two doses, with the second given in their second year and at least three months after the first dose, whereas anyone age 2 years or older only needs one dose. A single booster shot of MenQuadfi can be given to people ages 13 years or older who are at a continued risk of IMD if it's been at least three years since their last meningococcal vaccine. MenQuadfi doesn't protect against strain B of N meningitidis. Common side effects of MenQuadfi in infants ages 6 weeks to below 2 years include soreness, redness, or swelling where the needle went in, crankiness or fussiness, unusual crying, sleepiness, loss of appetite, fever, and sometimes vomiting. Older people may have pain where the needle went in, muscle aches, headaches, and tiredness.

Child dies from meningococcal disease in Fiji
Child dies from meningococcal disease in Fiji

RNZ News

time27-05-2025

  • General
  • RNZ News

Child dies from meningococcal disease in Fiji

Photo: 123RF A child has died from meningococcal disease in Fiji. FBC reported the country's Ministry of Health has recorded four laboratory-confirmed cases of meningococcal disease within the Central Division in the past three weeks, including two children. Meningococcal disease is a serious bacterial infection which can lead to life-threatening complications. Common symptoms include fever, neck stiffness, confusion or altered mental status, headache, sensitivity to light, nausea, and vomiting. The Ministry said while there are still no direct epidemiological links that have been identified among the cases, they have been reported from densely populated areas, and there is a need for heightened awareness and preventative measures. It said it has provided prophylactic treatment to close contacts of confirmed cases to reduce the risk of spreading the disease, and has strengthened surveillance and reporting mechanisms to detect and respond to suspected cases quickly. Fiji declared a meningococcal outbreak in March 2018, following 48 reported cases in 2017, nearly double the number in 2016, and more cases in early 2018. Six people died, including five children under five. In response, more than 281,000 children in Fiji below the age of 19 were immunised during a mass meningococcal vaccination programme . In 2019, Fijians were urged to stop sharing the kava bowl to prevent the disease - which is shared through saliva - spreading. In Aotearoa, from 2019 to December 2024, there were 364 cases which resulted in 21 deaths. Māori and Pasifika people accounted for 195 of the 364 cases. New Zealand's Ministry of Health recommends students are vaccinated against the disease before heading to tertiary education .

US FDA Approves Use Of Sanofi's Meningococcal Vaccine in Infants
US FDA Approves Use Of Sanofi's Meningococcal Vaccine in Infants

Medscape

time27-05-2025

  • Business
  • Medscape

US FDA Approves Use Of Sanofi's Meningococcal Vaccine in Infants

(Reuters) -French drugmaker Sanofi said the U.S. Food and Drug Administration has approved its meningococcal vaccine for use in infants as young as six weeks, making it the first shot intended for the age group. The vaccine, branded as MenQuadfi, is already approved for individuals aged two years and older to protect against the four most common strains of meningococcal bacteria - A, C, W and Y, the company said on Friday. Meningococcal infections, caused by the Neisseria meningitidis bacteria, can cause serious, sometimes deadly, bloodstream infections, as well as severe swelling in the brain and spinal cord. British drugmaker GSK's shot Menveo is approved in children as young as two months and adults up to 55 years of age. "I think for convenience factor and accessibility... it is nice to have options," said Dr. Patty Sabey, a pediatrician with Stanford Medicine Children's Health, ahead of the decision. The approval was based on data from three late-stage studies involving more than 6,000 participants aged six weeks to 19 months, which showed that MenQuadfi was as effective as Menveo when co-administered with other routine pediatric vaccines. Sabey said meningococcal vaccine is not a routine vaccine for infants in the U.S. even though young infants, especially under one year, are at higher risk of infection. The U.S. Centers for Disease Control and Prevention currently recommends all adolescents aged 11 to 12 years should receive a meningococcal vaccine, followed by a booster dose at age 16 years. The agency also recommends that individuals aged two months and older who are at increased risk of the disease should receive the vaccine. According to preliminary data from the CDC, 503 confirmed and probable cases of meningococcal disease were reported last year, the highest since 2013. (Reporting by Siddhi Mahatole and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila and Leroy Leo)

US FDA approves use of Sanofi's meningococcal vaccine in infants
US FDA approves use of Sanofi's meningococcal vaccine in infants

Reuters

time27-05-2025

  • Business
  • Reuters

US FDA approves use of Sanofi's meningococcal vaccine in infants

May 27 (Reuters) - French drugmaker Sanofi ( opens new tab said the U.S. Food and Drug Administration has approved its meningococcal vaccine for use in infants as young as six weeks, making it the first shot intended for the age group. The vaccine, branded as MenQuadfi, is already approved for individuals aged two years and older to protect against the four most common strains of meningococcal bacteria - A, C, W and Y, the company said on Friday. Meningococcal infections, caused by the Neisseria meningitidis bacteria, can cause serious, sometimes deadly, bloodstream infections, as well as severe swelling in the brain and spinal cord. British drugmaker GSK's (GSK.L), opens new tab shot Menveo is approved in children as young as two months and adults up to 55 years of age. "I think for convenience factor and accessibility... it is nice to have options," said Dr. Patty Sabey, a pediatrician with Stanford Medicine Children's Health, ahead of the decision. The approval was based on data from three late-stage studies, opens new tab involving more than 6,000 participants aged six weeks to 19 months, which showed that MenQuadfi was as effective as Menveo when co-administered with other routine pediatric vaccines. Sabey said meningococcal vaccine is not a routine vaccine for infants in the U.S. even though young infants, especially under one year, are at higher risk of infection. The U.S. Centers for Disease Control and Prevention currently recommends all adolescents aged 11 to 12 years should receive a meningococcal vaccine, followed by a booster dose at age 16 years. The agency also recommends that individuals aged two months and older who are at increased risk of the disease should receive the vaccine. According to preliminary data from the CDC, 503 confirmed and probable cases of meningococcal disease were reported last year, the highest since 2013.

‘My daughter went into hospital with flu symptoms – and ended up a quadruple amputee'
‘My daughter went into hospital with flu symptoms – and ended up a quadruple amputee'

The Independent

time24-05-2025

  • Health
  • The Independent

‘My daughter went into hospital with flu symptoms – and ended up a quadruple amputee'

A student who went into hospital thinking she had the flu ended up losing all four of her limbs to a rare but aggressive infection. Lily McGarry, 23, had flu-like symptoms on 14 January when her flatmates took her to the University Hospital of Wales in Cardiff – but she rapidly deteriorated within hours. The 23-year-old developed a rash while waiting in A&E, which signalled alarm bells for medical staff, who hurriedly treated her for septic shock. She was later diagnosed with meningococcal septicaemia, a severe type of blood poisoning that is caused by the same kind of bacteria that cause the most common form of bacterial meningitis. The Cardiff University medical student suffered two cardiac arrests, spent two weeks in a coma, and suffered brain, spleen and liver damage. She also had to have all four of her limbs shortened in surgeries that took place over five weeks. She is still in hospital. Her mother Jo Gorrod, 54, told The Independent of the 'terrifying' moment she found out what had happened to her daughter. The 54-year-old was in Melbourne, Australia, visiting her other daughter, having spoken to the 23-year-old on the phone who said she was feeling unwell but being taken care of. But just hours later, Ms Gorrod, of Jersey, said: 'I had a phone call from the hospital asking for consent for her to intubated, and at the time they had to put her into an induced coma. 'We were there within 48 hours with her. 'You don't sleep – you just, every moment, I'm not a religious person, but pray in whatever way, just thinking 'hang in, just hang in till I get there'. 'Since that point we've lost her probably about five times, she's been very close to not making it – so it's not as if you're going through it once but multiple times.' The family are now fundraising for Ms McGarry's treatment, including for prosthetic limbs, having so far raised more than £378,000 on their GoFundMe page. Ms McGarry was an avid swimmer, runner, and surfer before her illness and is determined to return to doing these sports again – as well as to complete her medical degree. Her family are also calling on people to ensure they get the meningitis vaccine, including for the B strain, which is not a routine injection. And they are aiming to raise awareness of sepsis, urging people to look out for the warning signs, such as discoloured skin or a rash that does not fade, flu-like symptoms, and breathing difficulties. Ms Gorrod explained that had her daughter gone to A&E any earlier or later then she may not have made it due to the rapid onset of the infection and how difficult it is to spot. But the 23-year-old is determined in her recovery journey, described as an 'optimist, strong and funny' by her mother. 'She has a smile which lights up the room,' said Ms Gorrod. 'She is genuinely happy to see people, always asking other people how they're doing, and grateful for the care she's had. ''Yes, there are going to be challenges, but it doesn't stop me from trying' – Lily is of that mindset, she wants to do things herself, she wants her independence.'

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