Pharmaceutical giant Johnson & Johnson on Wednesday released early data for its coronavirus vaccine, showing a lasting immune response and tolerance among trial volunteers. According to the findings, published in the New England Journal of Medicine, more than 90% of participants in the trial developed 29 days after a single dose of neutralizing antibodies. This figure continued to increase to 100% weeks later among participants aged 18 to 55 years.
Trial volunteers had a sustained immune response for at least 71 days after vaccination.
Results on immune responses for adults over 65 will be announced later this month, the company said. According to medical associate of Fox News, dr. Janette Nesheiwat, the one-shot vaccine could be a ‘big time changer’ amid the delay in vaccinating vaccines from Pfizer / BioNTech and Moderna that require both conditions.
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While J & J’s first dose 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 enough to prevent the new disease.
“Just because it’s higher to neutralize the response does not necessarily mean it is more effective,” Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told STAT News. “It may be that the immune response caused by the first dose is sufficient and that more is not necessarily better.”
This conclusion may become clearer in late-stage trials.
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There are two ongoing trials underway, the first testing a one-dose regimen and a second trial testing a two-dose course. The company expects Phase 3 data on the single-dose vaccine later this month, though that is an estimate.
“If the single-dose vaccine is found to be safe and effective, the company expects to submit an emergency authorization application to the U.S. Food and Drug Administration shortly thereafter, after which other regulatory applications will be made around the world. becomes, “reads a company statement released Wednesday.
When Fox News interviewed Johnson & Johnson about reports of overdue production and a two-month delay in the schedule, the company said it was too early to describe the details.
“The pandemic is showing no signs of slowing down, and we are, like everyone, eager to help stop more resources,” the email said. “At the same time, it is premature to explore the details of the supply of our vaccine candidate, as we do not yet have Phase 3 data, nor have we submitted an emergency use authorization.”
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“We are still in talks with regulators, including 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 2021 supply commitments signed with governments , and we expect to share more detail after some of these steps are achieved. “
The US government has already entered into a $ 1 billion agreement with Johnson & Johnson to secure 100 million doses of potential vaccine by June.