The phase 3 trial of Johnson & Johnson’s vaccine candidate will be the largest in the US, with plans to enrol 60,000 participants.
The study will compare the effects of a vaccine with those of a placebo to determine whether a single dose is effective. Johnson & Johnson have said they could know by the end of this year whether its vaccine works.
Johnson & Johnson is the fourth company in the US to enter the final stage of its clinical trials. While the study is a couple of months behind its competitors, it’s the first big US trial of an inoculation that may work after just one shot.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says the Johnson & Johnson candidate “may be especially useful in controlling the pandemic if shown to be protective after a single dose.”
Another advantage to the candidate is that it would not need to be frozen, making distribution easier.
The news of the late-stage trials caused President Donald Trump to tweet that the US Food and Drug Administration “must move quickly”, prompting health officials to reassure the public that no corners will be cut in the race for a coronavirus vaccine.
https://twitter.com/realDonaldTrump/status/1308740116643491842
Speaking at a Senate hearing on the US government’s coronavirus response, FDA commissioner Stephen Hahn said the FDA “will not authorise or approve a vaccine we won’t be confident in giving to our families”.
“Decisions to authorise or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes, and science will guide our decisions,” Hahn said.
“FDA will not permit any pressure from anyone to change that. I will fight for science … I will fight for the integrity of the agency, and I will put the interests of the American people before anything else.”
