Johnson & Johnson’s one-shot vaccine generated strong protection against COVID-19 in a large, late-stage trial, raising hopes that it can rapidly reshape a stumbling immunization campaign.

In the more than 44,000-person study, the vaccine prevented 66% of moderate to severe cases of COVID-19, according to a company statement on Friday. And it was particularly effective at stopping severe disease, preventing 85% of severe infections and 100% of hospitalizations and deaths.

Based on the result, J&J plans to file for an emergency-use authorization in the U.S. in early February. The drug giant’s top scientist said this month that he expects a clearance in March, and that it would have product ready to ship then. The company didn’t specify how much of the vaccine would be available immediately, though it reaffirmed that the U.S. would receive 100 million doses in the first half of the year.

Shares of J&J declined 2% to $165.06 in premarket trading on Friday.

If cleared, J&J’s vaccine could go a long way toward ending the pandemic. Competing vaccines from Moderna Inc. and Pfizer Inc. have generated stronger overall efficacy rates, but require two shots to be given before their full benefits take hold. J&J’s shot also can be kept in a refrigerator for three months, while those from Pfizer and Moderna must be kept frozen.

“This is a single shot that can be given easily, it protects completely from that which we fear, having to go to the emergency room or a hospital,” said Mathai Mammen, head of global research and development for J&J’s pharmaceutical division, in an interview. “It’s going to change the nature of the disease.”

Concerns about keeping second doses of the current shots on hand have complicated the push to get as many people as possible inoculated. Some countries have chosen to spread out the time between doses to address the problem, at the risk of diminishing their effectiveness.

The rise of new coronavirus variants has added to the pressure to get immunizations moving faster. The J&J trial was conducted around the globe, including at dozens of clinical-trial sites in hot spots such as South Africa and Brazil where new variants have caused infections to rise.

J&J’s results produced more evidence that the variants will be harder to ward off. In the U.S., where mutations aren’t thought to be as widespread, the vaccine was 72% effective. But in South Africa, where a variant called B.1.351 is circulating widely, it was only 57% effective. And the shot was 66% effective in Latin America.

Nonetheless, J&J’s vaccine is likely to give countries around the world a powerful new tool to fight a virus that has infected more than 101 million people and killed 2.2 million worldwide.

If confirmed, the results suggest people could get one dose of the vaccine to provide initial protection against severe consequences, allowing them to return to their pre-pandemic lives. Then, if needed, they could later take a booster shot J&J is testing in other large, late-stage trials that could produce results before year-end.

J&J said a review by a monitoring board identified no significant safety concerns. While 9% of people who took the shot developed a fever, there were no severe allergic reactions.

Different Technology

J&J’s vaccine is different from the messenger RNA-based shots made by Moderna and partners Pfizer and BioNTech SE, which each were shown to be more than 90% effective.

It is based on an adenovirus, or cold germ modified to make copies of the coronavirus spike protein, which the pathogen uses to force its way into cells. The altered virus can’t replicate in humans, but it triggers an immune response that prepares the body to defend itself against the coronavirus. J&J uses the same technology in a vaccine to fight Ebola.

J&J’s R&D head said the company’s trial, conducted at the height of the pandemic, had to deal with resistant variants that arose mainly after Moderna’s and Pfizer’s trials were completed. When counting cases, it also focused on somewhat sicker patients than other trials, Mammen said.

“If those vaccine programs accrued cases at the same time as us, when viral infections were so much higher, incidents were higher, and variants were all around us, they would have gotten different numbers,” he said. “The fact that we could do this level of efficacy with a single shot, people don’t have to come back for another, and it’s conveniently stored, well that makes this the vaccine of choice.”

At the outset of the pandemic, U.S. government officials said any vaccine showing greater than 50% efficacy would be considered a success.

Like Pfizer and Moderna, Mammen said J&J is working on next-generation versions of the shot that could provide protection specifically against certain variants. Other vaccines have seen mixed results against the newer forms of the virus.

On Thursday, Novavax Inc. reported that a large late-stage study in the U.K. found its COVID vaccine was 89% effective. However, it was just 60% effective in South Africa in people who were HIV negative, and 49.4% effective when HIV positive patients were included. Most cases of the virus seen in the trial had the new South Africa mutation, the company said.

J&J “is already testing and creating vaccines with the ability to respond quickly to the South African strain,” Mammen said.

Gaining Clearance

J&J aims to have a total of seven manufacturing facilities running by the end of the second quarter, Chief Financial Officer Joseph Wolk said Jan. 26. The company says it remains on track to hit the goal of producing 1 billion doses globally before year-end, even as production has been slow to scale up throughout the winter.

J&J’s candidate was among six vaccines tapped for the Trump administration’s Operation Warp Speed program, receiving some $1.5 billion in backing from the U.S. government. The company intends to price the vaccine on a not-for-profit basis, defined by a Gates Foundation model and determined in conjunction with independent auditors, according to Wolk. The price per shot will not exceed $10, he said.

While the trial readout marks the start of a new phase in the pandemic response, it also is the close of an anxious chapter in the lives of those who developed it. Mammen said he was in his basement office in his home in New Hope, Pennslvania, when he learned the results.

“I’ve been at this for about a year, every day, morning through night,” he said. “When it was unblinded, there was this massive, I mean massive, sense of relief. And great joy. I could finally sleep.”

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