WASHINGTON — Johnson & Johnson hopes to have the Food and Drug Administration (FDA) approve their single-dose vaccine and be the third on the market in the U.S.
The company announced promising trial results in January:
"72% effective in the US and 66% effective overall at preventing moderate to severe COVID-19...85% effective overall in preventing severe disease and demonstrated complete protection against COVID-19 related hospitalization and death" 28 days after vaccination.
So far both approved vaccines require two doses to reach their approximately 95% efficacy rates. Johnson & Johnson's announcement sparked questions about why they are sticking with just one jab, and whether we could see a second in the future. So, let's Verify:
QUESTION:
Is Johnson & Johnson working on a two-dose vaccine?
ANSWER:
Yes. The company's two-dose regimen is still in trials.
SOURCE:
Johnson & Johnson
PROCESS:
Johnson & Johnson provided the VERIFY team with an infographic that illustrates the phases of their COVID-19 vaccine trials, run by its Janssen pharmaceutical companies. It shows they have two ongoing phase three trials: one for a single-dose regimen, and another for a two-dose regimen.
The trial results announced in January are the topline results for the single-dose, which they believe has a high enough efficacy to go to market on its own.
"Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” said Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson in that January press release.
In an emailed statement, Dr. Mathai Mammen, the Global Head of Janssen Research & Development, told the Verify team: “Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with a fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible."
"The ability to avoid hospitalizations and deaths would change the game in combating the pandemic,” Dr. Mammen added.