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The company plans to release details of more advanced trials later this month and hopes to seek clearance from the U.S. Food and Drug Administration soon after.
Researchers who tested the vaccine in a combined Phase 1-2 trial – primarily intended to demonstrate safety – found that one or two doses of the vaccine generated antibody and T-cell responses against the coronavirus. The trials weren’t designed to show whether the vaccine protected people against infection or symptoms of the coronavirus – that’s what the ongoing Phase 3 trials are designed to do.
The researchers – in the Netherlands, the United States and Belgium – tested the vaccine in a group of people 65 and older and a group of 18 to 55 years old.
The vaccination elicited neutralizing antibodies – believed to prevent the virus from infecting cells – in 90% of all participants on day 29 after the first dose of vaccine and in all two months after the first dose. The levels of these antibodies remained stable for at least 71 days, they reported.
The FDA has granted emergency use approval for two coronavirus vaccines – one made by Pfizer with its partner BioNTech and the other by Moderna. Both were about 95% effective at preventing symptomatic disease in their Phase 3 trials. They use messenger RNA or mRNA – a new vaccine technology.
Johnson & Johnson’s vaccine arm, Janssen, uses a different approach for their vaccine, currently referred to by its experimental name, Ad26.COV2.S. It uses a weakened version of a cold virus called adenovirus 26 to carry the genetic material of the virus around the body, causing human cells to produce pieces of the virus which are then recognized by the immune system.
“A single dose of Ad26.COV2.S elicited a strong humoral response in a majority of vaccinees, with the presence of S-binding and neutralizing antibodies in over 90% of participants, regardless of age group. or vaccine dose, “the researchers wrote.
“An effective single dose Covid-19 vaccine has obvious logistical advantages over a two-dose vaccine, especially during a pandemic. The company is investigating whether a second dose increases the effectiveness or durability of the immune response.
Side effects included headache, body aches and, more rarely, fever.
The company plans to announce Phase 3 of Phase 3 data for its single dose vaccine candidate Janssen COVID-19 at the end of January 2021; however, as this trial is dependent on disease events, the timeline is approximate, “Johnson & Johnson said in a statement. But with the pandemic raging in the United States and Europe, vaccine experts say, answers are coming quickly for vaccine trials.
“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, ”Johnson & Johnson added.
All the companies that make coronavirus vaccines are making doses as they test them, so they can release them directly to people if they get clearance from the FDA. Johnson & Johnson is tasked with delivering 100 million doses to the US government if it wins the EUA from the FDA.
The New York Times reported on Wednesday that Johnson & Johnson was late in production, however.
“The pandemic shows no signs of slowing down, and we, like everyone else, are eager to have more tools to stop it. At the same time, it is premature to enter into the specifics of the supply of our vaccine candidate, because we are not doing so. we don’t have any phase 3 data yet, nor have we applied for or been granted emergency use authorization, ”Johnson & Johnson said in a statement Wednesday.
“We remain in active discussions with regulators, including on the approval and validation of our manufacturing processes.”
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