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    Home » News » Pfizer and BioNTech are applying to the US regulator for approval of a variant-specific vaccine

    Pfizer and BioNTech are applying to the US regulator for approval of a variant-specific vaccine

    Vaccine against BA4/BA5 could be the first vaccine to get the green light without human testing

    Ibrahim Al-TarikMay 9, 2025



    Pfizer and BioNTech have filed with US regulators for an emergency use authorization for a Covid-19 vaccine specifically tailored for the predominant strain of the Omicron variant coronavirus, ahead of a nationwide booster program planned for the fall.

    The companies said Monday they had rapidly ramped up production of the newly developed vaccine against the fast-spreading BA.4/BA.5 subvariants and were ready to begin shipping doses in September.

    Deliveries could begin immediately if regulators approve the new "bivalent" vaccine, which contains the original Covid strain and the genetic code for the now dominant subvariants, they added.

    Last month, the US Food and Drug Administration urged vaccine manufacturers to tailor their shots to the BA.4/BA.5 subvariants, which together account for more than 90 percent of Covid infections.

    For the first time since the pandemic began, the agency told companies it can approve the latest generation of booster vaccines without requiring clinical data from tests of the new vaccine to speed up distribution.

    In contrast, EU authorities want to review clinical data before approving the latest generation of Covid boosters.

    Pfizer and its German partner BioNTech said their application follows FDA guidelines and includes clinical data from the companies' previous trials of a bivalent vaccine developed for the previous Omicron subvariant BA.1. The filing also includes preclinical studies in mice and manufacturing data of the companies' new vaccine.

    Albert Bourla, Pfizer's chief executive officer, said the flexibility of BioNTech/Pfizer's mRNA platform and extensive clinical experience with Covid vaccines has enabled the companies to "develop, test" the updated vaccines at an "unprecedented speed". and manufacture.

    "Having rapidly ramped up production, we are in a position to immediately begin distributing the Omicron BA.4/BA.5 bivalent booster vaccines, should they be approved, to protect individuals and families while we anticipate potential Prepare for fall and winter flare-ups," he said.

    The US authorities are preparing a booster vaccination to boost the population's immunity before winter, when respiratory viruses spread quickly because of people staying indoors.

    However, some health experts have questioned whether the vaccinations should be approved before clinical data show their effectiveness in preventing infections from the Covid strains.

    Eric Topol, founder and director of the Scripps Research Translational Institute, said companies should demonstrate a neutralizing antibody response that can be generated easily and quickly.

    Approving the vaccines "just on the basis of data from mice will undermine public confidence -- that's the last thing we need," he said.

    PfizerCorona-Impfung





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