Results expected soon on single-shot product
Johnson & Johnson expects to release critical results from its COVID-19 vaccine trial in as little as two weeks — a potential boon in the effort to protect Americans from the coronavirus — but likely won’t be able to provide as many doses this spring as it promised the federal government because of unanticipated manufacturing delays.
If the vaccine can strongly protect people against COVID-19, as some outside scientists expect, it would offer big advantages over the two vaccines now authorized in the U.S.
Unlike those products, which require two doses, Johnson & Johnson’s could need just one, greatly simplifying logistics for local health departments and clinics struggling to get shots in arms. What’s more, its vaccine can stay stable in a refrigerator for months, whereas the others have to be frozen.
But the encouraging prospect of a third effective vaccine is tempered by apparent lags in the company’s production. In the company’s $1 billion contract signed with the federal government in August, Johnson & Johnson pledged to have 12 million doses of its vaccine ready by the end of February, ramping up to a total of 100 million doses by the end of June.
Federal officials have been told that the company has fallen as much as two months behind the original production schedule and won’t catch up until the end of April, when it was supposed to have delivered more than 60 million doses, according to two people familiar with the situation.
Carlo de Notaristefani, lead manufacturing adviser for Operation Warp Speed, the federal vaccine development program, acknowledged a delay but said the company might be able to catch up with initial production goals by March.
“I agree there was a problem,” de Notaristefani said. But he added, “Manufacturing of pharmaceuticals is not a black box where you turn the key and start counting.”
Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer, said he expected to see clinical trial data showing whether his company’s vaccine is safe and effective in late January or early February.
If the data is positive and the Food and Drug Administration authorizes the vaccine for emergency use, he added, “hopefully somewhere in March we’ll be able to contribute” to the nation’s vaccination drive.