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Tag: Infant/Child/Teenage Health

  • Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

    Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

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    Pfizer Inc.
    PFE,
    -1.73%
    said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal disease. 

    The new Pfizer shot, Penbraya, protects against the five most common subgroups of meningococcal disease, a rare but serious and potentially fatal illness that most often affects babies and teenagers. 

    Penbraya “has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, Pfizer senior vice president and head of vaccine research and development, said in a statement. 

    The U.S. Centers for Disease Control and Prevention currently recommends that all 11- to 12-year-olds get a meningococcal vaccine protecting against four of the subgroups — A, C, W and Y — and get a booster dose of the same vaccine type at age 16. Teenagers and young adults age 16 to 23 may also get a meningococcal B vaccine, the CDC says, particularly if they’re at increased risk due to other health conditions. 

    The complex vaccination schedule has weighed on uptake of the meningococcal shots, and the COVID-19 pandemic may have compounded the problem, as many families missed routine appointments when vaccinations were due, researchers say. Among teenagers who were born in 2008 — who were due for their routine adolescent vaccinations as the pandemic was raging in 2020 — uptake of meningococcal and other recommended vaccines declined, according to CDC research. Only about 60% of the 17-year-olds surveyed by the CDC last year had received both recommended doses of the ACWY vaccine, and fewer than 30% had received at least one dose of the meningococcal B vaccine. 

    The new Pfizer shot combines components of a meningococcal group B vaccine and an ACWY vaccine. 

    A CDC immunization advisory committee is set to meet Oct. 25 to discuss recommendations for the use of Penbraya in teenagers and young adults, Pfizer said. 

    The green light for Penbraya gives Pfizer the edge in its race with GSK
    GSK,
    +0.54%    ,
    which is also working on a five-in-one meningococcal shot. GSK earlier this year released positive late-stage clinical-trial results for that vaccine. 

    The FDA approval of Pfizer’s shot caps a rocky week for the pharmaceutical giant, which late last Friday cut $9 billion from its full-year revenue guidance due to reduced COVID sales expectations and announced a cost-cutting program designed to deliver savings of at least $3.5 billion. Pfizer executives said on a call with analysts Monday that development of combination respiratory vaccines, such as those that provide COVID and flu protection in one shot, remains a focus for the company, in part because they can help boost vaccine uptake.

    Pfizer shares were down 1.7% Friday and have dropped 40% in the year to date, while the S&P 500
    SPX
    has gained 10%.

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  • A robust booster campaign could prevent millions of missed school days among children ages 5 to 17, report finds

    A robust booster campaign could prevent millions of missed school days among children ages 5 to 17, report finds

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    If 80% of children ages 5 and older get their COVID booster shots by the end of 2022, it could prevent about 29 million missed days of school and almost 51,000 hospitalizations, according to a new report.

    And if COVID booster coverage simply matches 2020-21 flu-vaccination levels by year’s end, it would prevent about 22 million missed school days, said the report published by the Commonwealth Fund.

    “We expand our previous analysis to include the impact on pediatric hospitalizations, pediatric isolation days, and school absenteeism (among children ages 5 to 17), demonstrating both the health benefits of vaccination and the importance of vaccination uptake for maintaining uninterrupted in-school education,” the authors wrote in the report.

    The number of days absent from school was calculated based on five days of required isolation for children in that age group who experience mild symptomatic illness and 10 days for children who have severe illness or require hospitalization.


    Source: Commonwealth Fund

    An effective booster campaign would considerably reduce the strain on pediatric hospitals this winter, many of which are currently seeing high numbers of children with respiratory syncytial virus, known as RSV, and the flu, the authors wrote.

    “Throughout the pandemic, children have experienced direct health burdens as well as enormous upheaval in their personal and educational lives,” the report said. “Accelerated vaccination campaigns that achieve high coverage across all ages have the potential to prevent a possible imminent surge in COVID-19, protecting children both directly and indirectly and providing them with additional stability in terms of school attendance and other social engagement.”

    Now read: A strong fall COVID booster campaign could save 90,000 U.S. lives and avoid more than 936,000 hospitalizations, study finds

    The report comes as known U.S. cases of COVID are climbing again for the first time in a few months. The daily average for new cases stood at 39,459 on Monday, according to a New York Times tracker, up 4% versus two weeks ago.

    Cases are rising the most in the Southwest, led by Arizona, Colorado, Nevada and New Mexico — states that are also seeing hospitalization numbers climb by more than 30% in the last two weeks.

    The daily average for U.S. hospitalizations was up 1% at 27,662.

    On a brighter note, the daily death tally continues to fall and is down 13% to 302 from two weeks ago.

    Physicians are reporting high numbers of respiratory illnesses like RSV and the flu earlier than the typical winter peak. WSJ’s Brianna Abbott explains what the early surge means for the winter months. Photo illustration: Kaitlyn Wang

    Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began

    Other COVID-19 news you should know about:

    • China’s ruling party called for strict adherence to its hard-line “zero-COVID” policy Tuesday in an apparent attempt to guide public perceptions after regulations were eased slightly in places, the Associated Press reported. The news may disappoint Chinese citizens who have clashed with police and COVID workers to show their frustration over lockdowns and restrictions on movement. The People’s Daily, the Communist Party’s flagship newspaper, said in an editorial that China must “unswervingly implement” the policy that requires mass obligatory testing and places millions under lockdown in an attempt to eliminate the coronavirus from the nation of 1.4 billion people.

    • Japan will lift a ban on international cruise ships that has lasted more than two and half years, transport officials said Tuesday, the AP reported separately. The ban was imposed following a deadly coronavirus outbreak on the cruise ship Diamond Princess at the beginning of the pandemic. The Transport Ministry said cruise-ship operators and port authorities associations have adopted antivirus guidelines and that Japan is now ready to resume its international cruise operations and to receive foreign ships at its ports.

    The new bivalent vaccine might be the first step in developing annual COVID shots, which could follow a similar process to the one used to update flu vaccines every year. Here’s what that process looks like, and why applying it to COVID could be challenging. Illustration: Ryan Trefes

    • Cambodian Prime Minister Hun Sen tested positive for COVID-19 after meeting with world leaders, including President Joe Biden, at a summit of Southeast Asian nations last week, the Wall Street Journal reported. Mr. Hun Sen held one-on-one talks with Biden on Saturday on the sidelines of the regional discussions in Phnom Penh. Biden — who is on a five-day trip to Asia to attend a series of summits — then traveled to Bali, Indonesia, where he sat down on Monday with Chinese leader Xi Jinping for a face-to-face meeting that stretched over three hours.

    • Australia will overturn a three-year ban on tennis player Novak Djokovic entering the country, paving the way for the former top-ranked player to take part in the 2023 Australian Open, CNN reported, citing a source with direct knowledge of the matter. Australian Immigration Minister Andrew Giles will lift the ban, the source said.

    Here’s what the numbers say:

    The global tally of confirmed cases of COVID-19 topped 635.6 million on Monday, while the death toll rose above 6.61 million, according to data aggregated by Johns Hopkins University.

    The U.S. leads the world with 98 million cases and 1,074,691 fatalities.

    The Centers for Disease Control and Prevention’s tracker shows that 227.8 million people living in the U.S., equal to 68.6% of the total population, are fully vaccinated, meaning they have had their primary shots.

    So far, just 31.4 million Americans have had the updated COVID booster that targets the original virus and the omicron variants, equal to 10.1% of the overall population.

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  • COVID-19 may be to blame for the surge in RSV illness among children. Here’s why.

    COVID-19 may be to blame for the surge in RSV illness among children. Here’s why.

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    A number of young children are being hospitalized because of respiratory syncytial virus, or RSV, and it’s happening at an unusual time of year and among older children than in years past.

    RSV infections and related emergency-room visits and hospitalizations are nearing seasonal peaks in some U.S. regions, according to the Centers for Disease Control and Prevention.

    But the current RSV outbreak is different from previous outbreaks in several ways: It’s happening in the fall rather than the winter (RSV commonly peaks after the holidays, starting in late December); older children and not just infants are being hospitalized; and cases are occurring that are more severe than in previous years. And this year, RSV is circulating at the same time as COVID, influenza, and other viruses like the biennial enterovirus, which was behind a rise in pediatric hospitalizations earlier this fall. 

    “The theory is that everyone’s now back together, and this is a rebound phenomenon,” said Jeffrey Kline, a physician and associate chair of research for emergency medicine at Wayne State University School of Medicine in Detroit.

    Kline runs a national surveillance network that gathers data about viral infections from about 70 hospitals, including four pediatric hospitals. He says those data show that 318 children were hospitalized with acute respiratory illness brought on by RSV in the week starting Oct. 9, compared with 45 hospitalizations in the week starting July 25.  

    “If we think about the relative increase — ninefold increase — that’s not nothing, especially in the pediatric [emergency departments],” Kline said. “Holy mackerel.”


    Source: CDC

    The U.S. saw a massive spike in RSV cases in the summer of 2021, after masking and social distancing resulted in a lull in infections the previous year. Even with that spike, fewer young children — 2-, 3-, and 4-year-olds — have been exposed to RSV than in a normal year. Most children have usually had at least one RSV infection by the time they are 2 years old, and as children get older, RSV becomes less worrisome, according to the CDC. Infants are at higher risk for severe disease brought on by RSV because babies have more immature immune responses than older children and because infants younger than 6 months of age breathe exclusively through their noses and cannot breathe through their mouths if they are congested.

    “Age by itself is a risk factor for more severe disease, meaning that the younger babies are usually the ones that are sick-sick,” said Asuncion Mejias, a principal investigator with the Center for Vaccines and Immunity at the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio. Now, she added, “we are seeing also older kids, probably because they were not exposed to RSV the previous season.”

    But there’s another reason that COVID may be worsening some RSV infections in the youngest children. Mejias is studying whether a prior COVID infection or exposure somehow changes the way a baby’s immune system responds to RSV and whether it may lead to more severe illness from an RSV infection. 

    “That is something to work on and understand,” she said. 

    For now, however, worries are tied to the possibility of a “tripledemic” of COVID, influenza, and RSV as the U.S. heads into what is expected to be a complicated season for respiratory infections. Stat News reported in mid-October that flu season is already underway, and the CDC said this week that this year’s flu activity may have “atypical timing and intensity.” 

    COVID itself remains a threat, as well. There are still more children being hospitalized with COVID than with RSV, Kline said, and some kids are getting sick from both viruses at the same time. About 5% of children are thought to test positive for both RSV and COVID, and 60% of the children in that group were hospitalized, according to Kline’s surveillance network. 

    “All these things are going on all at once right now,” said Alex Frost, managing director for StudyMaker, which is providing software infrastructure to the network. “But the shape of pediatric cases that are showing up in the emergency room is different than it used to be.”

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