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Johnson & Johnson single-dose COVID-19 vaccine trial now fully recruited with 45,000 volunteers – putting it on track for FDA approval as early as FEBRUARY
- Johnson & Johnson said on Thursday it had completed recruiting 45,000 people into its vaccine trial
- He planned to enlist 60,000 people, but the rapid spread of the coronavirus means he will likely need fewer participants to know if his shot is working
- J&J could have early efficacy data on single-dose vaccine by January
- He plans to ask US regulators for emergency approval in February
Johnson & Johnson said Thursday that it had recruited around 45,000 participants for the first advanced trial of its single-dose COVID-19 vaccine candidate and that it expects provisional data by the end of January.
The company, however, is lagging behind rivals Pfizer Inc and Moderna in the race for a vaccine to fight the COVID-19 pandemic that has infected an estimated 75 million people worldwide.
Officials for Operation Warp Speed (OWS) said this week that emergency approval of J & J’s vaccine could come as early as February.
One bright side of J & J’s vaccine: So far, it’s the only company testing a single-dose vaccination regimen.
Single-dose injections would mean a faster deployment and people would likely be protected from the coronavirus within weeks of the injection – rather than the period of around a month it takes for Moderna or Pfizer injections to reach their peak of protection. .
Johnson & Johnson has finished enrolling its trial of a single-dose COVID-19 vaccine, the company said Thursday
The United States has a contract with J&J for 100 million doses of its COVID-19 vaccine, with the option to purchase an additional 200 million.
It is not yet clear when the United States can expect J&J to deliver these doses by then.
Enrollment of 45,000 trial participants allows J&J to focus all of its energy and resources on immunization and data collection on trial participants
Now he will face a waiting game.
A sufficient number of trial participants must develop COVID-19 for J&J to assess whether there were significantly fewer cases among people who received the real vaccine, compared to placebo.
OWS co-chief Dr Moncef Slaoui noted last week that while it is unfortunate that more than 200,000 new COVID-19 infections per day are regularly recorded now, the accelerating spread of the coronavirus will likely speed the conclusion of vaccine trials.
The company had announced earlier this month a reduction in registrations for the vaccine trial from its original plan of 60,000, as higher rates of COVID-19 infections amid worsening pandemic should generate the data it needs with fewer study subjects.
The J&J study, named Ensemble, is being conducted by its Janssen unit, the drugmaker said in a statement.
While seven countries have already cleared the emergency use of candidates from Pfizer and German firm BioNTech, Moderna’s rival vaccine is set to get regulatory clearance in the United States on Friday.
J&J also confirmed its intention to submit an emergency use clearance application to the United States Food and Drug Administration (FDA) in February if the study data is safe and effective.
The Ensemble trial was suspended for more than a week in October after a patient developed “unexplained illness” during the study.
The company later said it would resume the trial after an assessment found no clear cause for the disease.
A separate advanced-stage clinical trial of an experimental COVID-19 vaccine candidate by Janssen to explore a two-dose regimen was underway, J&J said.
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