ARKANSAS (KNWA/KFTA) — Johnson & Johnson is close to wrapping up data analysis for Phase 3 of its COVID-19 vaccine trial.
Janssen, the Belgian unit pharmaceutical division of Johnson & Johnson, reported approximately 45,000 people have participated in Phase 3 clinical trials, also known as ENSEMBLE, as of December. Participants were recruited for the third phase at the end of September after data from Phase 1 and 2 was completed, according to the Global Head of Research & Development at Janssen Mathai Mammen.
The Centers for Disease Control (CDC) reports that in the U.S. 10.2 million people have received the first dose of the Pfizer or Moderna vaccine. More than 29 million doses have been distributed as of January 13.
ABOUT THE 3RD VACCINE
- One dose is needed.
- Can “remain stable” for two years at -4 degrees F.
- Can “remain stable” for at least three months at 35-46 degrees F.
- Vaccine effectiveness data is expected to be complete later in January 2021.
- Plan to apply for an Emergency Use Authorization (EUA) in February with the U.S. FDA and file in other countries, too.
- The goal is to provide 1 billion doses globally in 2021.
- Janssen entered a U.S. agreement in August 2020 to manufacture/deliver 100 million doses once approved.
- The vaccine will be produced in Leiden, the Netherlands.
- If approved this would be the third COVID-19 vaccine following Pfizer and Moderna.
At least two national news outlets reported that Johnson & Johnson may be delayed in meeting its production goal, putting it behind by as much as two months. The company “pledged” 12 million doses by the end of February.
Johnson & Johnson statement: The pandemic shows no signs of slowing, and we, like everyone, are eager for more tools to help stop it. At the same time, it is premature to get into the specifics of the supply of our vaccine candidate, as we do not yet have Phase 3 data, nor have we filed for or been granted Emergency Use Authorization. We remain in active discussions with regulators, including on the approval and validation of our manufacturing processes. We have begun the 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.J&J STATEMENT