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Pharmaceutical giant Johnson & Johnson on Wednesday released the first data from its coronavirus vaccine, showing a long-lasting immune response and tolerability among trial volunteers. According to results published in the New England Journal of Medicine, more than 90% of the trial participants developed neutralizing antibodies 29 days after a single dose. This figure continued to increase to 100% weeks later in participants aged 18 to 55.
The trial volunteers had a sustained immune response at least 71 days after vaccination.
Results on immune responses in adults over 65 will be released later this month, the company said. Fox News medical contributor Dr. Janette Nesheiwat said the single-dose vaccine could “be a game-changer” amid vaccine rollout delays for previously licensed vaccines from Pfizer / BioNTech and Moderna, both requiring two doses.
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While the first dose of J&J elicited an immune response (224 to 354 geometric mean titers), a booster dose more than doubled the level of neutralizing antibodies. The question then is whether the immune response after the first dose will be sufficient to prevent the new disease.
“Just because the neutralizing response is higher doesn’t mean it’s more effective,” Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told STAT News. “It may be that the immune response induced by the first dose is sufficient and more is not necessarily better.”
This conclusion may become clearer in late stage trials.
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There are two advanced stage trials underway, the first testing a single-dose regimen and a second trial testing two-dose treatment. The company expects Phase 3 data on the single-dose vaccine later this month, although that is an estimate.
“If the single-dose vaccine proves safe and effective, the company plans to submit an emergency use authorization application to the United States Food and Drug Administration shortly thereafter, along with others. regulatory applications around the world to be done later, ”read a statement from the company released Wednesday.
When Fox News asked Johnson & Johnson about the overdue and two-month overdue production reports, the company said it was too early to go into details.
“The pandemic shows no signs of slowing down, and we, like everyone else, look forward to having more tools to help stop it,” the emailed statement read. “At the same time, it is premature to go into the details of the procurement of our vaccine candidate, as we do not yet have the phase 3 data, nor have we applied for or obtained an authorization for emergency use. “
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“We are continuing active discussions with regulators, including on the approval and validation of our manufacturing processes. We have started production of our vaccine candidate and are confident in our ability to meet our signed 2021 procurement commitments with governments, and plan to share more details after some of these steps are completed. “
The US government has already reached a billion dollar deal with Johnson & Johnson to secure 100 million doses of the potential vaccine by June.
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