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  • 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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  • OceanGate believes all 5 passengers on Titanic exploration sub ‘have sadly been lost’

    OceanGate believes all 5 passengers on Titanic exploration sub ‘have sadly been lost’

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    All five passengers on the missing submersible that has captured the world’s attention over the past week are believed to “have sadly been lost,” the tour company revealed on Thursday.

    OceanGate Expeditions released a statement Thursday afternoon that the Titan submersible’s pilot and the tour company’s chief executive, Stockton Rush, along with passengers including British-Pakistani businessman Shahzada Dawood and his 19-year-old son Suleman, British billionaire businessman Hamish Harding, and Titanic specialist Paul-Henri Nargeolet have been killed.

    Read more: Hamish Harding, Stockton Rush and Dawood father and son presumed dead after missing Titanic exploration sub debris found

    “We now believe that our CEO Stockton Rush, Shahzada Dawood and his son Suleman Dawood, Hamish Harding, and Paul-Henri Nargeolet, have sadly been lost,” OceanGate said in a statement.

    “These men were true explorers who shared a distinct spirit of adventure, and a deep passion for exploring and protecting the world’s oceans. Our hearts are with these five souls and every member of their families during this tragic time. We grieve the loss of life and joy they brought to everyone they knew.”

    The company did not release specifics on what led to the “loss of life,” but Rear Adm. John Mauger of the U.S. Coast Guard revealed during a press conference Thursday afternoon that the debris found in the search area of the missing submersible was consistent with “catastrophic loss of the pressure chamber,” presumably killing all five people on board.

    Also see: Secret Navy listening system detected Titan’s implosion Sunday: report

    “Upon this determination, we immediately notified the families,” said Mauger, who has been leading the search. “On behalf of the United States Coast Guard, I offer my deepest condolences to the families.”

    The submersible Titan was launched from a hired Canadian research icebreaker, Polar Prince, on Sunday morning to visit the Titanic wreckage site located in a remote area of the North Atlantic. The diving vessel went missing that same morning and was unable to communicate with the surface roughly an hour and 45 minutes after it began its descent, the Coast Guard said. This has spurred a search-and-rescue operation in the ensuing days that amounted to a race against the clock, as the Titan’s estimated 96-hour oxygen supply was expected to run out early Thursday.

    See also: U.S. Coast Guard reports identification of a debris field in search area for missing Titan submersible

    Plenty of questions remain, including how, why and when this implosion may have happened. Mauger said that it’s still “too early to tell,” as this is “an incredibly complex operating environment on the seafloor over two miles beneath the surface.” But a top-secret U.S. Navy listening system may have detected the implosion of the Titan shortly after its disappearance on Sunday, the Wall Street Journal reported.

    The Associated Press contributed.

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