- Johnson & Johnson will within days disclose results from a large clinical trial showing whether the company's closely watched coronavirus vaccine can prevent COVID-19, data that could prove crucial in determining how quickly the U.S. and other countries are able to immunize large portions of their populations.
- "We look forward to sharing further details from our Phase 3 study by early next week," said J&J CEO Alex Gorksy on a conference call with analysts and investors on Tuesday. About 45,000 volunteers in the U.S., Brazil, South Africa and five other nations enrolled in the trial, which tested a single dose of J&J's vaccine.
- Company executives declined to speculate about the vaccine's efficacy on Tuesday's call, but expectations are high that the shot can provide strong protection. Moncef Slaoui, formerly the head of the U.S. vaccine initiative Operation Warp Speed, recenty predicted greater than 80% efficacy.
Should J&J's study prove its vaccine protective, the drugmaker would be in position to offer the world a logistically simpler and easier-to-distribute shot.
In contrast to Pfizer and Moderna, which studied two-dose regimens for their now-authorized vaccines, J&J bet a single injection of its vaccine would be enough. Even if the efficacy of J&J's vaccine is comparatively lower, the companies supplies could stretch twice as far while easing the administration challenges that are currently weighing on roll-out of Pfizer's and Moderna's shots.
J&J's vaccine can also be shipped and stored at refrigerator temperatures, rather than the ultra-cold temperatures required for Pfizer's and Moderna's.
In the U.S., the federal government pre-ordered 100 million doses from J&J, which would expand the vaccine supply available to the country by 25% if study results are positive. Pfizer and Moderna have each agreed to sell 200 million doses to the U.S.
"We're very comfortable meeting our commitments," said J&J's chief financial officer Joe Wolk on Tuesday's call, referring to manufacturing agreements with the U.S., EU, U.K. and GAVI, The Vaccine Alliance.
If study results show the vaccine works, J&J would then need to ask the Food and Drug Administration for an emergency use authorization. The agency would likely need several weeks to review the data, as well as convene a committee of independent experts to publicly vet the company's application.
About one month passed between when first Pfizer and then Moderna each reported their vaccines were protective and when the FDA cleared emergency use.
Like the Phase 3 trials that tested both Pfizer's and Moderna's shots, J&J's study is "event driven," meaning researchers count cases of COVID-19 as they happen. An independent committee monitors this data and, after enough cases have occurred, can begin assessing whether or not the vaccine is effective.
In J&J's case, the trial was set up to determine efficacy following 154 cases of moderate or severe COVID-19. But the company also needs to follow study participants for a median of two months following vaccination before it can ask the FDA for authorization — a standard meant to help assure a skeptical public on vaccine safety.
Aside from the study that's about to have results, J&J is hedging its bets with another large trial testing two doses of vaccine. That trial started in November and could produce data by "the back end of this year," J&J's Gorsky said.
J&J also reported earnings for the fourth quarter on Tuesday, disclosing sales of $22.5 billion between October and December. Pharmaceutical sales were boosted by growth from psoriasis drugs Stelara and Tremfya, as well as cancer therapies Darzalex and Imbruvica.
Shares in J&J rose by 3% Tuesday.