Johnson & Johnson has kicked off a final 60,000-person trial of a single-shot Covid vaccine that potentially would simplify the distribution of millions of doses compared with leading rivals using two doses.
The company expects results of the Phase III trial by year-end or early next year, Paul Stoffels, J&J’s chief scientific officer, said in a press conference with officials from the National Institutes of Health and the Trump administration.
Rival vaccines from Moderna, Pfizer, and AstraZeneca all require two shots separated by several weeks, which makes them much more difficult to administer.
“The benefits of a single-shot vaccine are potentially profound in terms of mass immunisation campaigns and global pandemic control,” Dan Barouch, a Harvard vaccine researcher who helped design J&J’s Covid-19 vaccine, said. J&J shares rose.
“Big news. Numerous great companies are seeing fantastic results. FDA (Food and Drug Administration) must move quickly,” US President Donald Trump said in a tweet.
J&J published a detailed study protocol for its phase 3 trial on the company’s website, joining the three other vaccine makers that have made these study plans available in recent weeks after calls for increased transparency in the trials.
JUST IN: #JNJ has announced the start of our Phase 3 clinical trial for our investigational #COVID19 vaccine candidate. We are fully focused on developing a safe, effective and urgently-needed preventive solution for people around the world. Read more: https://t.co/gi5PpMMcgu pic.twitter.com/vx0tpuH6Tc— Johnson & Johnson (@JNJNews) September 23, 2020
Mr Stoffels said J&J started the phase 3 trial after seeing positive results in its initial trial in the US and Belgium. The company plans to release those results imminently.
He said the safety and level of protection in the study were on par with what was seen in the company’s animal studies, and said the results showed a single dose could offer sufficient protection “for a long time”.
J&J’s late-stage trial will use as many as 215 sites in the US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico, and Peru. The company plans to manufacture as many as 1 billion doses in 2021, and more after that, Mr Stoffels said.
The goal of the trial is to test whether the vaccine can prevent moderate to severe Covid-19 after a single dose, but it will also look to see if the vaccine can prevent serious disease requiring medical intervention.
Mr Stoffels predicts it will take six weeks to two months to enroll the trial, and said the company hopes to get an answer on whether the vaccine works “around the end of the year or early next year”. It is not clear how fast the company could get regulatory approval, but J&J plans to manufacture doses before approval.