‘Game-changer’ COVID-19 vaccine by J&J could be in use by February

A one-shot vaccine by Johnson & Johnson (J&J) could be in use by February 2021 if approved by the US Food and Drug Administration (FDA).

Earlier in December, J&J announced it had enrolled about 45,000 participants for the first late-stage trial of its COVID-19 single-dose vaccine and that it expects interim data by late-January.

The company also said it plans to submit an emergency use authorisation application to the US Food and Drug Administration (FDA) in February if the data from the study is safe and effective.

According to Daily Mail, Moncef Slaoui, chief advisor of Operation Warp Speed, said the Janssen vaccine could prove to be a “game-changer” for the United States.

Operation Warp Speed was initiated by the US government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines.

Slaoui reportedly said the phase 3 trial recruitment for the vaccine has been completed and that the company is currently working with the Operation Warp Speed team to accelerate the availability of the vaccine doses.

“I think it can be quite a game-changer. We’re hopeful that this vaccine, which is a one-shot vaccine will have equivalent efficacy to those of Moderna and Pfizer,” Slaoui was quoted to have said.

This means that single-dose shots will be rolled out faster and people would likely be protected from the virus “in a matter of weeks” after vaccination.

Rival vaccines from Pfizer and Moderna require two doses separated by several weeks, which make them much more difficult to administer and to reach their protective peak.

J&J had kicked off a final trial of the single-shot COVID-19 vaccine in September.

The trial study, called ENSEMBLE, involved up to 60,000 adults — 18 years old and older, including a significant representation from those who are over 60.

The vaccine is modeled on an Ebola vaccine created by the company.

The US has a contract with J&J for 100 million doses of its COVID-19 vaccine with an option to buy another 200 million.