The Biden administration has stood by Johnson & Johnson as the vaccine maker struggled to deliver promised doses of its Covid-19 vaccine — but privately, frustrated senior health officials have largely written off the shot, according to seven people with knowledge of the matter, Politico learns.
Johnson & Johnson, which has a long history of successful vaccine development, was one of the government’s first and biggest bets in the coronavirus vaccine race. But the company has faced an unrelenting series of setbacks, including a contractor mix-up that ruined 15 million doses and revealed serious safety and hygiene lapses, and concerns that the vaccine may be linked to recent reports of rare, severe blood clots among recipients.
A Centers for Disease Control and Prevention vaccine advisory committee will meet Friday for the second time to review the possible blood clot link, and federal health officials are expected to update their current recommendation to pause use of the shot.
But the Biden administration is bracing for yet another potential complication: If ongoing tests of remaining vaccine batches made by J&J’s contractor Emergent BioSolutions reveal further contamination, it could take the vaccine maker up to four months to replace those doses through manufacturing at alternate facilities, according to two people with direct knowledge of the situation.
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.
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 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.
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.
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