Pharmaceutical giant Johnson & Johnson on Wednesday published the first data for its coronavirus vaccine, showing a lasting immune response and tolerability among trial volunteers. According to the results, published in the New England Journal of Medicine, more than 90% of study participants developed neutralizing antibodies 29 days after a single dose. This number continued to increase to 100% weeks later among participants aged 18 to 55 years.
Trial volunteers had a sustained immune response at least 71 days after vaccination.
The results of immune responses for adults over 65 will be released later this month, the company said. Fox News medical collaborator Dr. Janette Nesheiwat said the single vaccine could be a “major game changer” amid delays in the launch of previously authorized Pfizer / BioNTech and Moderna vaccines, both requiring two doses.
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While the first dose of J&J induced 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 you’re higher in the neutralizing response doesn’t necessarily mean it’s more effective,” Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia, told STAT News. “It may be that the immune response induced by the first dose is sufficient and that more is not necessarily better.”
This conclusion may become clearer in studies in the final stage.
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There are two studies in progress in the final stage, the first testing a one-dose regimen and a second test testing a two-dose regimen. The company expects Phase 3 data on the single dose vaccine later this month, although this is an estimate.
“If the single-dose vaccine proves to be safe and effective, the Company expects to submit an application for Emergency Use Authorization to the U.S. Food and Drug Administration shortly thereafter, with other regulatory requests worldwide to be made later” , says a company statement released Wednesday.
When Fox News questioned Johnson & Johnson about reports of production delays and delays of two months off schedule, the company said it was too early to detail.
“The pandemic shows no signs of slowing down and we, like everyone, are looking forward to more tools to help stop it,” says the e-mailed statement. “At the same time, it is premature to go into the details of the supply of our candidate vaccine, as we do not yet have Phase 3 data, nor do we request or receive Authorization for Emergency Use.”
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“We continue active discussions with regulators, including the approval and validation of our manufacturing processes. We have started production of our candidate vaccine and are confident in our ability to meet our 2021 supply commitments signed with governments, and we hope to share more details. after some of these steps have been achieved. “
The U.S. government has already struck a $ 1 billion deal with Johnson & Johnson to guarantee 100 million doses of the potential vaccine by June.