The company hopes to report more details of the advanced trial later this month, and hopes to apply for authorization from the US Food and Drug Administration shortly thereafter.
Researchers who tested the vaccine in a phase 1-2 joint trial (mainly to prove its safety) found that one or two doses of the vaccine can produce antibodies and T cell responses against the coronavirus. The purpose of the trial is not to show whether the vaccine can protect people from infection or coronavirus symptoms-this is the purpose of the ongoing Phase 3 trial.
Researchers in the Netherlands, the United States, and Belgium tested the vaccine in people over 65 and people between 1
Vaccination will produce neutralizing antibodies in 90% of participants on the 29th day after the first vaccination and two months after the first vaccination-which is expected to prevent the virus from infecting cells. They report that the levels of these antibodies have stabilized for at least 71 days.
The FDA has granted emergency use authorization for two coronavirus vaccines, one produced by Pfizer and its partner BioNTech, and the other produced by Moderna. In their phase 3 clinical trials, both can effectively prevent about 95% of symptomatic diseases. They use messenger RNA or mRNA-a new vaccine technology.
Johnson & Johnson’s vaccine division, Janssen, adopted a different vaccine production method and now calls it its experimental name Ad26.COV2.S. It uses a weakened version of the common cold virus called adenovirus 26 to carry genetic material from the virus into the body, prompting human cells to produce fragments of the virus, which are then recognized by the immune system.
“A single dose of Ad26.COV2.S will cause a strong humoral response in most vaccinators. S-binding and neutralizing antibodies are present in more than 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 studying whether the second dose can improve the effectiveness or durability of the immune response.
Side effects include headache, body aches, and rarely fever.
Johnson & Johnson said in a statement: “The company expects to announce its single-dose Janssen COVID-19 vaccine candidate Phase III data in late January 2021; however, since the trial depends on disease events, the timing is approximate. “Vaccine experts said, but with the raging epidemic in the United States and Europe, the answer to the vaccine trial soon appeared.
Johnson said: “If the single-dose vaccine is proven to be safe and effective, the company hopes to submit an emergency use authorization application to the U.S. Food and Drug Administration soon, and then other regulatory applications will be filed worldwide.” & Johnson added.
All the companies that make coronavirus vaccines have been manufacturing doses during the process of testing them, so if they are authorized by the FDA, they can directly promote them to people. If Johnson & Johnson obtains the FDA’s EUA contract, it will deliver 100 million doses to the US government.
The New York Times reported on Wednesday that Johnson & Johnson’s production schedule is behind schedule.
“The pandemic shows no signs of slowing down. We, like everyone, are eager to get more tools to stop this pandemic. At the same time, we don’t know the availability of vaccine candidates in detail because we don’t. We have not applied for or obtained emergency use authorization for the three-stage data,” Johnson & Johnson said in a statement on Wednesday.
“We are still in active discussions with regulatory agencies, including the approval and confirmation of manufacturing processes.”