Johnson & Johnson’s one-time vaccine provided strong protection against Covid-19 at a large, late stage of research, raising hopes that it can quickly reshape a stumbling immunization campaign.
In a study of more than 44,000 people, the vaccine was able to prevent 66% of moderate to severe cases of Covid-19, a company statement released Friday. And it was particularly effective in stopping serious illness, preventing 85% of serious infections, and 100% of hospitalizations and deaths.
“If you can prevent serious illness in a high percentage of people, it will alleviate so much of the stress and human suffering of the pandemic,” said Anthony Fauci, the top US infectious diseases official, during a briefing on the results of the pandemic. company and government officials.
Based on the result, J&J plans to file an application with the U.S. Food and Drug Administration for an emergency use license next week. The drug giant’s top scientist said this month that he expects a clearance in March, and that the product would then be ready to ship. The company did not specify how much of the vaccine would be immediately available, although it reaffirmed that the US would receive 100 million doses by the end of June.
Shares of J&J fell 3.9% to $ 162.63 Friday at 9:59 a.m. in New York. According to Wall Street analysts, investors had hoped for an aggregate employment rate of 80% or higher.
If approved, J & J’s vaccine could go a long way towards ending the pandemic. Competitive vaccines from Moderna Inc. and Pfizer Inc. has generated stronger overall efficacy rates of over 90%, but requires two injections to be given for their full benefits to take effect. J & J’s shot can also be stored in the refrigerator for three months, while those from Pfizer and Moderna should be stored frozen.
“This is a single injection that can be easily given, it completely protects against what we fear, because we have to go to the emergency room or a hospital,” said Mathai Mammen, head of global research and development for the pharmaceutical division. J & J, in an interview. “It’s going to change the nature of the disease.”
White House press secretary Jen Psaki said during a briefing Friday that President Joe Biden is encouraged by J & J’s “positive data” and believes that “now is the time for the FDA to do its job on safety and efficacy. of the vaccine. “
Varieties abound
Concerns about keeping second doses of current shots on hand have complicated the pressure to get as many people vaccinated as possible. Some countries have chosen to stagger the time between doses to address the problem, at the risk of reducing its effectiveness.
The emergence of new coronavirus variants has increased the pressure to speed up immunizations. The J&J study was conducted around the world, including at dozens of clinical trial sites in hotspots such as South Africa and Brazil, where new variants have triggered the proliferation of infections.
J & J’s results provided more evidence that the variants will be more difficult to fend off. In the US, where mutations are not as widespread, the vaccine was 72% effective. But in South Africa, where a variant called B.1.351 is widespread, it was only 57% effective. And the shot was 66% effective in Latin America.
Nevertheless, the vaccine from J&J countries around the world is likely to provide a powerful new tool to combat a virus that has infected more than 101 million people and killed 2.2 million people worldwide.
If confirmed, the results suggest that people can receive one dose of the vaccine to provide initial protection against serious consequences, allowing them to return to their pre-pandemic lives. Then, if needed, they can later take a booster shot that J&J is testing in other large, late studies that could yield results before the end of the year.
Protection was consistent across race, age groups, including those over 60, and regions. J & J’s Mammen added that the shot appears to generate immunity that builds up over time and sustains itself.
The drug giant is also studying the shots’ ability to prevent asymptomatic infections and will report data on this shortly, Mammen said.
J&J said a review by a supervisory board did not reveal any significant safety concerns. While 9% of the people taking the injection developed a fever, there were no serious allergic reactions.
Different technology
J & J’s vaccine differs from the messenger RNA-based shots made by Moderna and partners Pfizer and BioNTech SE.
It is based on one adenovirus, or cold germ that has been modified to make copies of the coronavirus spike protein, which the pathogen uses to make its way into cells. The altered virus cannot multiply in humans, but it activates 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 chief said the company’s trial, conducted at the height of the pandemic, was related to resistant variants that mainly emerged after Moderna and Pfizer’s trials were completed. When counting cases, it also targeted slightly sicker patients, Mammen said.
“If those vaccination programs had fallen 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 achieve this level of efficacy with a single injection, people don’t have to come back for a new one, and it’s conveniently stored, well that’s what makes this the vaccine of choice.”
At the outset of the pandemic, US government officials said any vaccine with 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 recording that can specifically protect against certain variants. Other vaccines have had mixed results against the newer forms of the virus.
On Thursday, Novavax Inc. reported that a large late-stage study in the UK found the Covid vaccine to be 89% effective. However, it was only 60% effective in South Africa in people who were HIV negative, and 49.4% effective when HIV positive patients were included. Most of the cases of the virus seen in the trial had the new mutation in South Africa, the company said.
J&J “is already testing and creating vaccines with the ability to respond quickly to the South African strain,” Mammen said.
Fauci said Friday that the US and its pharmaceutical partners must be active in responding to current and future variants.
“It’s a wake-up call for us to be nimble and to adapt as this virus will certainly continue to evolve and mutate,” he said.
Obtain clearance
J&J aims to have a total of seven manufacturing facilities by the end of the second quarter, said Chief Financial Officer Joseph Wolk. January 26. The company says it remains on track to meet its goal of producing 1 billion doses worldwide by the end of the year.
J & J’s candidate was one of six vaccines tapped for the Trump administration’s Operation Warp Speed program and received approximately $ 1.5 billion in aid from the U.S. government. The company plans to price the vaccine on a nonprofit basis that will not exceed $ 10 per injection, Wolk said.
The Centers for Disease Control and Prevention are reading Johnson & Johnson’s data “as soon as we can,” said John Brooks, chief medical officer, CDC Covid-19 response, in an appeal with the Infectious Diseases Society of America.
“Any vaccine is better than no vaccine,” as long as it meets FDA emergency authorization standards, Brooks said. He added that he would encourage anyone offering a vaccine that has been issued an emergency permit to take it.
While the trial readout marks the beginning of a new phase in the pandemic response, it is also the conclusion of an anxious chapter in the lives of those who developed it. Mammen said he was in his basement office at his home in New Hope, Pennsylvania, when he heard the results.
“I’ve been doing this for about a year now, every day, from morning to night,” he said. “When it was unblinded, there was a tremendous, I mean tremendous feeling of relief. And great joy. I could finally sleep. “
– With the help of Emma Court and Josh Wingrove
(Updates with White House commentary in the eighth paragraph)