Some of the problems J&J has faced are failures of management or oversight; others appear to be pure bad luck. But the chaos has disappointed the Biden team, which once argued that the company’s one-dose vaccine would be central to turning the tide of the pandemic. Instead, the administration has concluded that the company can’t be counted on for any significant production until it gets the green light from regulators to resume vaccination, according to two sources.
Federal officials say they have enough doses from Pfizer and Moderna to vaccinate all American adults. But officials are hopeful that J&J can iron out its problems and still be of use for booster shots down the line, and for immunization in other countries as the U.S. ramps up its vaccine diplomacy.
“I think if J&J’s vaccine were the first vaccine available, the conversation would be different,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia who sits on FDA’s advisory panel. “What I worry about is by giving this vaccine a scarlet letter … we may do harm,” he added, pointing to vaccine hesitancy issues that could emanate far outside of the U.S. as well.
“What we do in this country does affect how other countries view vaccines.”
An HHS spokesperson praised J&J’s move to take greater control over the Emergent plant in recent weeks, saying the department has seen improvement since the company boosted its oversight at the direction of the Biden administration.
But J&J’s broader troubles represent an extraordinary turn of events for a company with deep experience making and marketing vaccines. The Biomedical Advanced Research and Development Authority — an arm of the federal health department — partnered with Johnson & Johnson in March 2020, when human trials were months away, to put more than $1 billion into research, development and eventual manufacturing of its Covid-19 shot.
Unlike other vaccine makers employing brand-new technology, J&J said it would rely on an adenovirus approach it used successfully in an Ebola shot just a few years earlier. The strategy was seen as relatively reliable: After all, no one knew yet whether the messenger RNA technology used by Moderna and Pfizer would actually work, and the former had never before brought a product to market.
Flash forward a little more than a year, and Pfizer and Moderna are steadily increasing their deliveries to the U.S., while J&J is unlikely to hit its goal of supplying 100 million doses by the end of May. Biden officials have said they’re holding off on forecasting what the company might be able to contribute over the long term until the CDC and FDA conclude their investigations into the shot’s potential link to the rare blood clots, known as cerebral venous sinus thrombosis, and low platelet levels.
The health agencies cited six known instances of the clots among women 18-48 when they recommended last week that use of the J&J vaccine be paused nationwide. Two other cases have been identified among participants in clinical trials of the vaccine, and regulators are continuing to look for other cases.
The European Medicines Agency has already weighed in, saying on Tuesday that it saw a possible link between the shot and the blood clots but the benefits of the vaccine outweighed any risk. The EMA recommended adding a warning to the vaccine’s label. U.S. regulators are considering issuing a similar warning or restricting the vaccine’s use by age or sex.
“My hope is that the pause will be lifted tomorrow and that there will be a suitable recommendation,” said Rajeev Venkayya, president of the global vaccine business unit at Takeda Pharmaceutical Company. “Then I think the public health community, the scientific community and then world leaders will have to have a strong set of messages, reassuring people everywhere and decision makers everywhere that this J&J vaccine is a very, very important and valuable tool to help us to mitigate the pandemic.”
In the meantime, FDA is continuing to test all existing batches of J&J vaccine produced by Emergent to determine if they are safe for use. But it will take J&J at least two more weeks to address safety and hygiene concerns raised by FDA after its recent inspection of Emergent’s Bayview plant in Baltimore. The agency said Monday that the Bayview facility is not large or sanitary enough for vaccine production and that the company has not fixed the problems that led to the ruined doses.
With Emergent’s woes setting the company up for months of repairs, the administration has sought to accelerate J&J vaccine production at a separate facility run by Merck, which agreed in March to help churn out doses. But the pharmaceutical giant’s vaccine facility will not be ready until September, according to a senior administration official.
The Biden administration is still on track to have enough vaccine between Moderna and Pfizer to vaccinate every American adult by the end of May. But the outsize attention paid to J&J’s stumbles have frustrated officials who lamented that it’s distracted from the White House’s broader vaccination campaign — and specifically, overshadowed what should have been a triumphant week as the administration hit its goal of 200 million administered shots in fewer than 100 days.
The administration still has a small amount of J&J doses that were not manufactured by Emergent, and thus could be distributed as soon as the pause is lifted. But officials have cautioned state leaders that it’s a limited supply, and shifted much of their focus to ramping up the availability of Moderna and Pfizer’s vaccines.
“It is all a little surprising that it happened because J&J is so experienced on this,” said Ashish Jha, dean of Brown University’s School of Public Health. “My assumption is that they’re going to fix it. This is going to get back on track. We’re gonna have a lot of single-dose vaccines from J&J in the weeks and months ahead. I really believe that J&J remains a really critical part of the path to herd immunity in the U.S.”