The Johnson & Johnson vaccine is bringing a new glimmer of hope to a pandemic-weary public, but the number of doses that will initially be delivered in the United States is lower than originally expected. Why?
In the company’s $1 billion contract with the federal government in August, the company 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.
Now, instead of 12 million doses by the end of February, the company is expected to deliver 3.9 million, all the doses it currently has on hand, over the first few days of March.
Another 16 million doses is expected from the company by the end of the month. “We know that J & J distribution and delivery, will be uneven across these early weeks in March. And the company expects the delivery to be predominantly in the back half of the month,” said Jeff Zients, White House coordinator of pandemic responses, at a news briefing on Monday.
The total of 20 million doses by the end of March is 17 million less than the company’s federal contract envisioned.
The company’s chief executive acknowledged Monday that J&J had hit supply snags in its efforts to ramp up production. “In my more than 30 years in the industry, what I can tell you is this kind of a ramp-up is never -- or rarely -- what I would call a linear shot,” Alex Gorsky told Bloomberg News. “There are almost always going to be unanticipated challenges along the way.”
“We are doing everything we can partnering with the US government and other external manufacturers to see what we can do to accelerate and increase” the number of doses, Gorsky said. Company officials have said they are still shooting for 100 million or more by the end of June.
Gorsky said in an interview last month on CNBC that the company has a “very extensive and robust network of partners,” including companies that make the vaccine substance itself and other “fill-finish” companies that fill the vaccine vials and finish the packaging.
“We’re learning every step of the way. Our partners are learning as they go along,” he said.
The Financial Times reported this weekend that one of the company’s partners had to resort to checking vaccine vials by hand for two weeks. Catalent, a New Jersey-based contract manufacturer, suffered a setback when tuning up its automated visual verification line, which makes checks on vials, people familiar with the matter told the Financial Times.
“Short-term variations are normal when initiating new production processes to rapidly increase the supply of safe, high-quality vaccines,” Mike Riley, president of Catalent Biologics, North America, told the Financial Times.
Fill-finish capacity is limited, Gorsky told Bloomberg Monday, and as result, the company is looking to increase it in the future. “We’re leaving no stone unturned in terms of partnerships,” he said. “One of the most important lessons of the pandemic is the power of collaboration.”
The Financial Times also reported that some delays may have arisen in scaling up production of the vaccine substance itself.
Maryland-based Emergent Biosolutions is one of Johnson & Johnson’s partners that makes the vaccine substance. Last month, the company admitted it faced obstacles in ramping up production.
“We took a two-plus year, you know, typical timeline and compressed into seven months, so of course we’re going to have challenges. But nothing that was or is insurmountable,” Sean Kirk, executive vice president of manufacturing and technical operations, told CBS News.
“This is not making corn flakes,” he emphasized. “This is an extremely difficult and extremely complicated process, and it has to be such because it is a highly regulated, appropriately so, manufacturing process in need of a high level of control.”
In congressional testimony last week, Dr. Richard Nettles, vice president of U.S. medical affairs at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, said, “The production of our vaccine is a highly complex process that requires very particular capabilities and experiences. As a result, there are significant challenges inherent in scaling manufacturing output and accelerating the timeline needed for a COVID-19 vaccine.”
He also said, “We are working around the clock to develop and broadly scale our manufacturing capabilities to supply the United States, and we are appreciative of the ongoing and extensive collaboration and partnership with the U.S. government.”
Zients, the White House official, said at a briefing last week that the new administration, when it arrived on Jan. 20, “learned that J&J was behind on manufacturing, and our team has been working with them since. You know, I think they’re in a better place now.”
“We’ve helped them with equipment and raw materials, which I think is helping to increase greater capacity and accelerate,” he said. “I think the progress is real, and we look forward to continuing to work with the company to accelerate their delivery and their capacity.”
Dr. Bruce Y. Lee, a professor of health policy and management at the City University of New York, said in an interview that he and other experts had been concerned that not enough attention had been paid to the details of production, supply chain, and distribution.
Once a vaccine is developed, “it has to be produced and it actually has to get to people and get into the arms of people” to make a difference, he said.
“It’s certainly a complicated process, but, of course, there should have been anticipation in terms of the production,” he said.
At a news conference Monday, Massachusetts Governor Charlie Baker said he was optimistic the new vaccine would help to speed the pace of vaccinations in the state.
Baker said the Biden administration informed him the state will initially receive thousands of doses and, after that, will face a “pause” until later in March.
“It is likely that we will get, for next week, a shipment,” Baker said. “That shipment will probably be distributed pretty evenly across what we think of the vaccinating community here in Massachusetts, but the message that’s come from the feds at this point is, ‘Yep, they’ve made some, we will distribute those through our own channels and to you, and then you should expect there will be a bit of a pause as they ramp up production.’”
Jeremiah Manion of the Globe staff contributed to this report. Material from Globe wire services was used in this report.
Martin Finucane can be reached at firstname.lastname@example.org.