Johnson & Johnson’s one-shot vaccine provided strong protection against Covid-19 in a large, late-stage test, raising hopes that it could quickly reshape a shaky vaccination campaign.
In a study of more than 44,000 people, the vaccine prevented 66% of moderate to severe cases of Covid-19, according to a company statement on Friday. And it was particularly effective in stopping serious illnesses, preventing 85% of serious infections and 100% of hospitalizations and deaths.
“If you can prevent serious illness in a high percentage of individuals, it will greatly relieve stress and human suffering” from the pandemic, said Anthony Fauci, the top infectious disease officer in the United States, in a briefing on the results with the company and government officials.
Based on the result, J&J plans to file a lawsuit with the U.S. Food and Drug Administration to obtain an emergency use permit next week. The drug giant’s chief scientist said this month he hopes a release in March, and that would have product ready to ship then. The company did not specify how much of the vaccine would be available immediately, but reaffirmed that the United States would receive 100 million doses by the end of June.
J&J shares fell 3.9% to $ 162.63 at 9:59 am in New York on Friday. Investors expected an overall effectiveness figure of 80% or more, according to Wall Street analysts.
If released, the J&J vaccine can go a long way toward ending the pandemic. Competitive vaccines from Moderna Inc. and Pfizer Inc. has generated stronger overall efficacy rates, over 90%, but requires that two injections be administered before their full benefits are established. The doses of J&J can also be kept in the refrigerator for three months, while those of Pfizer and Moderna must be kept frozen.
“This is a single injection that can be given easily, completely protects from what 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 will change the nature of the disease.”
White House press secretary Jen Psaki said at a briefing on Friday that President Joe Biden is excited about J&J’s “positive data” and believes that “now is the time for the FDA to do its assessment work. vaccine safety and efficacy “.
Abundant variants
The concern to keep the second doses of current injections close at hand has complicated the effort to inoculate as many people as possible. Some countries have chosen to allocate the time between doses to solve the problem, at the risk of decreasing its effectiveness.
The emergence of new variants of the coronavirus has increased the pressure for immunizations to be faster. The J&J trial was conducted around the world, including at dozens of clinical trial sites at critical points like South Africa and Brazil, where new variants have caused an increase in infections.
The J&J results produced more evidence that the variants will be more difficult to avoid. In the United States, where the mutations are not considered 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 injection was 66% effective in Latin America.
However, the J&J 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 that people could receive a dose of the vaccine to provide initial protection against serious consequences, allowing them to return to their pre-pandemic lives. Then, if necessary, they could later give a booster injection that J&J is testing in other major end-stage tests that could produce results before the end of the year.
Protection was consistent across all races, age groups, including those over 60 and regions. Mammen of J&J added that the shot appears to generate immunity that increases and sustains over time.
The drug giant is also studying the vaccines’ ability to prevent asymptomatic infections and will soon present data for that purpose, said Mammen.
J&J said that a review by a monitoring board did not identify significant security problems. While 9% of people who got the injection developed a fever, there were no serious allergic reactions.
Different Technology
The J&J vaccine is different from the messenger RNA-based vaccines made by Moderna and its partners Pfizer and BioNTech SE.
It is based on a adenovirus, or germ of the cold modified to make copies of the coronavirus spike protein, which the pathogen uses to force its entry into cells. The altered virus cannot 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.
The head of R&D at J&J said the company’s test, conducted at the height of the pandemic, had to deal with resistant variants that emerged mainly after the completion of the Moderna and Pfizer tests. In counting the cases, he also focused on slightly sicker patients, said Mammen.
“If these vaccine programs accumulated cases at the same time as us, when viral infections were much higher, the incidents were higher and the variants were around us, they would have obtained different numbers,” he said. “The fact that we can achieve this level of effectiveness with a single injection, people don’t have to go back to another one and it is conveniently stored, which makes this vaccine the choice.”
At the beginning of the pandemic, US government officials said that any vaccine more than 50% effective would be considered a success.
Like Pfizer and Moderna, Mammen said that J&J is working on next generation versions of the photo that can provide specific protection 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 United Kingdom found that its Covid vaccine was 89% effective. However, it was only 60% effective in South Africa for people who were HIV negative and 49.4% when HIV positive patients were included. Most of the virus cases seen in the test had the new South African mutation, the company said.
J&J “is already testing and creating vaccines with the ability to respond quickly to the South African strain,” said Mammen.
Fauci said on Friday that the United States and its pharmaceutical partners must be active in responding to current and future variants.
“It is an alert for us to be agile and adjust, as this virus will certainly continue to evolve and mutate,” he said.
Getting authorization
J&J plans to have a total of seven manufacturing facilities up and running by the end of the second quarter, said CFO Joseph Wolk January 26th. The company says it remains on track to achieve the goal of producing 1 billion doses globally before the end of the year.
The J&J candidate was among six vaccines used for the Trump administration’s Operation Warp Speed program, receiving about $ 1.5 billion in support from the United States government. The company plans to set a price for the nonprofit vaccine that does not exceed $ 10 per injection, said Wolk.
The Centers for Disease Control and Prevention is reading data from Johnson & Johnson “as soon as possible,” said John Brooks, medical director of the CDC Covid-19 response, on a call to the Infectious Diseases Society of America.
“Any vaccine is better than no vaccine,” as long as it meets FDA standards for emergency use authorization, Brooks said. He added that he would encourage anyone who received a vaccine who received an emergency authorization to take it.
While reading the essay marks the beginning of a new phase in responding to the pandemic, it is also the end of an anxious chapter in the lives of those who developed it. Mammen said he was in his basement office in New York. Hope, Pennsylvania, when he learned of the results.
“I’ve been in it for about a year, every day, from morning to night,” he said. “When I was not blind, there was an enormous, I mean, enormous sense of relief. And a lot of joy. I could finally sleep. “
– With the help of Emma Court and Josh Wingrove
(Updates with comments from the White House in the eighth paragraph)