Johnson & Johnson asked the US government on Thursday to clear its one-shot coronavirus vaccine for emergency use, the first step in a regulatory process that could lead to the rollout of the third vaccine within a few weeks.
The giant health care company, which licensed technology pioneered by Beth Israel Deaconess Medical Center, has promised to deliver 100 million doses in the United States by the end of June. Because the vaccine can be administered in one shot ― unlike the other vaccines, which require two ― that would mean full coverage for 100 million people.
Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer, said in a statement that the emergency use application to the Food and Drug Administration is a “pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”
Johnson & Johnson filed the application six days after the New Brunswick, N.J.-based firm announced encouraging results from its late-stage global clinical trial on 43,783 volunteers. The data showed that a single shot prevented 66 percent of moderate and severe cases globally, and 72 percent in the United States.
The FDA will now assemble a packet of material, including data from the trial, that will be scrutinized by a panel of outside experts in a public hearing. A member of the advisory panel, Dr. Eric Rubin, an immunologist at the Harvard T.H. Chan School of Public Health, said he expects the committee will consider the application within two weeks. If the committee recommends authorization, the FDA is likely to act swiftly.
Dr. Anthony Fauci, President Biden’s top medical adviser on the pandemic, said in a tweet Thursday that if the FDA agrees with the committee, the vaccine “could be available in March.”
The 66 percent global effectiveness rate for the one-shot vaccine fell significantly short of the performances of the two-shot vaccines from Pfizer-BioNTech and Moderna that the FDA cleared for emergency use in December. Those vaccines prevented more than 90 percent of coronavirus cases in large trials, a remarkable showing considering that they were the first to successfully use new technology called synthetic messenger RNA.
But Dr. Dan Barouch, who runs the Center for Virology and Vaccine Research at Beth Israel, which developed different technology for the vaccine, said the pandemic has evolved, with the emergence of more resistant variants, in particular a worrisome South African strain that was detected in the United States for the first time last week.
Several vaccine experts agreed and highlighted a particularly encouraging finding in Johnson & Johnson’s announcement last week: The one-shot vaccine was highly protective against the worst cases of COVID-19. Worldwide, the shot prevented 85 percent of severe cases, and none of the vaccinated people needed hospitalization or died from COVID-19.
Fauci acknowledged last week that public health officials will likely face a “messaging challenge” to persuade people to take a vaccine that prevented 66 percent of symptomatic cases compared with roughly 95 percent.
But, he said, “If you can prevent severe disease in a high percentage of individuals [as the Johnson & Johnson vaccine did], that will alleviate so much of the stress and human suffering and death.”
He and other officials also said the Pfizer and Moderna vaccines would likely get lower efficacy results now, given the emergence of the South African strain, which appears to be more resistant to immunization.
The FDA said last summer that a vaccine that was safe and at least 50 percent effective would likely be cleared for use. The annual flu vaccine is typically 40 to 60 percent effective at preventing influenza cases, according to the Centers for Disease Control and Prevention.
The Johnson & Johnson coronavirus vaccine relies on a design that Barouch pioneered nearly 20 years ago for two experimental vaccines that have shown promise against HIV and Zika, and a third vaccine that won approval from the European Union in July to prevent Ebola.
It uses a harmless and relatively rare cold virus, adenovirus serotype 26 ― or Ad26 ― as a Trojan horse to deliver part of the distinctive spike protein on the coronavirus surface into cells to trigger an immune response without making people sick.
Despite its lower performance in preventing all COVID-19 cases, the Johnson & Johnson vaccine has major advantages over its Pfizer-BioNTech and Moderna rivals. By requiring only one shot, it would simplify and speed the vaccine campaign. In addition, it is stable at refrigerated temperatures, unlike the other vaccines, which must be frozen at ultracold temperatures when shipped and stored before use.
The FDA cleared the Pfizer-BioNTech vaccine on Dec. 11 and the Moderna vaccine a week later. But their rollout has been frustratingly slow and cumbersome, and public health officials want more vaccines from other drug makers to bolster the supply. As of Thursday, the government has distributed more than 57.4 million vaccine doses, and 27.9 million people have gotten one or more shots, according to the CDC.
Rubin, of the FDA advisory panel, said Thursday that “it’s been frustrating how long it’s taken to roll out vaccines, but if everything were perfect and we had a perfect distribution system, we’d run out of vaccines really fast. We just don’t have enough supply.”
Jonathan Saltzman can be reached at firstname.lastname@example.org.