The pharmaceutical giant Johnson & Johnson released early data on its coronavirus vaccine on Wednesday, showing that test volunteers have a durable immune response and tolerance. According to the results of the study published in the New England Journal of Medicine, more than 90% of trial participants developed neutralizing antibodies 29 days after a single dose. Among participants aged 18 to 55, this number continued to increase to 100% after a few weeks.
At least 71 days after vaccination, the test volunteers had a sustained immune response.
The company said that the results of the immune response to adults over 65 will be released later this month. Dr. Janette Nesheiwat, a medical contributor to Fox News, said that the one-time vaccination could be a “major change”
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Johnson’s first dose can induce an immune response (224 to 354 geometric mean titers), and the booster dose can more than double the level of neutralizing antibodies. The question then is whether the immune response after the first dose is sufficient to prevent this new disease.
Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told STAT News: “Just because it has a higher role in the neutralization response does not necessarily mean it is more effective.” The immune response caused by the drug is sufficient, not necessarily better.”
In later trials, this conclusion may become clearer.
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Two late-stage trials are currently underway, the first trial one-dose regimen, and the second trial two-dose regimen. The company hopes to obtain Phase III data on single-dose vaccines later this month, although this is an estimate.
“If the single-dose vaccine proves to be safe and effective, the company hopes to submit an emergency use authorization application to the U.S. Food and Drug Administration in the near future, followed by other regulatory applications worldwide.” The company statement issued Wednesday.
When Fox News questioned Johnson & Johnson about the news that it was out of production and delayed the plan for two months, the company said that it did not have details yet.
The emailed statement read: “This pandemic shows no signs of slowing down, and we, like everyone else, are eager to have more tools to stop this pandemic.” “At the same time, understand. The availability of our vaccine candidates is still too early because we do not have the data for the third phase, nor have we applied for or obtained emergency use authorization.”
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“We have been in active discussions with regulatory agencies, including in terms of approving and verifying our production process. We have already started producing vaccine candidates and are confident that we will be able to fulfill the 2021 supply commitments signed with the government, and we hope Share more of these steps when you are done, and then explain them in detail.”
The US government has reached a $1 billion deal with Johnson & Johnson to obtain 100 million doses of potential vaccines by June.