Johnson & Johnson’s easy to deliver Covid-19 shot is the preferred vaccine for much of developing countries.
Yet the American company, which has already fallen far behind its own deliveries to poorer countriesLate last year, the only plant that manufactures usable batches of the vaccine quietly shut down, according to people familiar with the decision.
The facility in the Dutch city of Leiden has instead made an experimental but potentially more cost-effective vaccine to protect against an unrelated virus.
The halt is temporary – the Leiden plant is expected to start cutting the Covid vaccine again after a break of a few months – and it is not clear if it has affected vaccine supplies yet, thanks to stocks.
But over the next many months, the disruption has the potential to reduce supply Johnson & Johnson’s Covid vaccine with a few hundred million doses, according to one of the people familiar with the decision. Other facilities have been hired to produce the vaccine, but they are either not up and running yet or have not received regulatory approval to send what they are doing for bottling.
Inside Johnson & Johnson’s executive suites, the decision to suspend production in Leiden raised concerns that it would impair the company’s ability to meet its vaccine obligations to developing countries.
Johnson & Johnson’s moves also blinded officials at two of the company’s key customers: the African Union and Covax, the clearing house responsible for getting vaccines to poor countries. Leaders of these organizations heard about the halt in production from New York Times reporters.
“This is not the time to change production line for anything when the lives of people across developing countries are in balance,” said Dr. Ayoade Alakija, Co-Leader of the African Union Vaccine Delivery Program.
Jake Sargent, a spokesman for Johnson & Johnson, said in an email that the company was “focused on ensuring that our vaccine is available where people are in need” and that its global production network “works day and night” to help fight the pandemic.
He said the company continued to supply batches of the vaccine to facilities that bottled and packaged doses. He also said Johnson & Johnson had millions of finished doses in stock.
Johnson & Johnson’s Covid vaccine, originally considered a single shot, fell out of favor in the United States and other affluent countries in part because of its link to a rare but dangerous blood coagulation disorder. Studies have found that it performs worse at some targets than the shots from Pfizer and Moderna.
But poorer countries remain dependent on Johnson & Johnson’s vaccine, which does not require ultra – cold cooling. It has been shown to provide strong and long-lasting protection against serious illness across variants, including Omicron, when given as a two-shot cure. As a single shotthe vaccine is cheaper and relatively easy to give to hard-to-reach populations.
“In many low- and middle-income countries, our vaccine is the most important and sometimes the only option,” Dr. Penny Heaton, a Johnson & Johnson director, said in December at a meeting of experts advising the US government on vaccines. She added: “The world depends on us.”
Countries with lower incomes now have more vaccine options than at any earlier point in the pandemic, and the impact of stopping production at the factory in Leiden is therefore less serious than it could have been earlier. Some African governments have asked vaccine manufacturers to suspend shipments until the countries use what they have on hand. Companies have mentioned this as proof that they supply lots of vaccines to poorer countries.
But the reality is more complicated.
Only about 11 percent of Africans have been fully vaccinated (and few have received boosters). Many countries lack the infrastructure – medical staff, storage facilities and transport – to quickly inoculate their populations. They do not need a huge pile of vaccines at once; they need a stable and predictable supply over many months.
Mr. Sargent said the company continued to fulfill its contractual obligations to the African Union, which has ordered vaccines on behalf of dozens of countries in Africa and the Caribbean, and to Covax, which buys vaccines for dozens of low-income governments.
But Johnson & Johnson failed to deliver near as many doses to Covax as planned. The company said in May that it “aimed to deliver” up to 200 million vaccine doses to Covax by the end of last year. Covax got only four million; another 151,000 arrived last month, according to Gavi, the main nonprofit organization that operates Covax. (Rich countries supplemented it with donations.)
The African Union, which ordered 220 million doses, has fared better. It has received doses on or before the schedule, with the majority of the order due within the next eight months.
Dr. Seth Berkley, who helps run Covax as CEO of Gavi, said the Johnson & Johnson vaccine had been at the heart of the program’s strategy to fight Covid last year. However, due to Johnson & Johnson’s delay in delivering doses, Covax has increasingly sought out other vaccine providers.
“We really needed their doses in 2021, and we were counting on them,” said Dr. Berkley. “They did not deliver. So we had to find other doses to meet the needs of the countries.”
An African Union official said the bloc was also concerned about the decision to halt production at the Leiden plant because it had been assured that all its vaccine would come from this facility. The official said Johnson & Johnson’s initiatives raised doubts as to whether the bloc would exercise an option to purchase an additional 180 million Johnson & Johnson doses.
Johnson & Johnson has already been criticized for not prioritizing people in developing countries for their Covid vaccine. Last summer he was the leader of the World Health Organization reprimanded the company after The Times reported that millions of doses that had been bottled in South Africa were exported for distribution in Europe.
To make its Covid vaccine, Johnson & Johnson relies on an extensive international network. In addition to the company-run Leiden plant, factories in India, Baltimore and North Carolina have been hired to manufacture the substance in the vaccine. Others, including a factory in South Africa, handle the so-called fill-finish process of bottling and packaging doses.
From the outset, Johnson & Johnson executives told U.S. officials that they eventually planned to pull the Leiden plant out of rotation so it could manufacture other products, according to current and former U.S. officials.
That was before Johnson & Johnson’s network was overrun with problems.
Johnson & Johnson hired a contractor, Emergent BioSolutions, to produce its vaccine at a Baltimore plant that is large enough to make the equivalent of up to a billion doses a year. However, Emergent did not meet federal production standards, and regulators forced the plant to stop production in April last year.
The factory restarted in August, but regulators with the Food and Drug Administration have not yet determined that it can consistently operate in accordance with production standards, officials said.
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As a result, the FDA has insisted on reviewing individual batches of vaccines before they are shipped. Regulators have not cleared any batches made since the factory reopened, said Matt Hartwig, a spokesman for Emergent.
Plans are underway for two other facilities – one a Merck plant in North Carolina, the other operated by Biological E in India – to begin contributing batches of the Johnson & Johnson vaccine. However, these plants do not yet produce usable vaccine substance and are not expected to do so until late spring.
The Merck factory – whose participation in vaccine production The White House last year was hailed as a “historicBreakthrough – should produce batches as early as last fall. That timeline has since been pushed back to late spring, federal officials said.
The delays at Merck and Emergent increased the importance of the Leiden plant. Following a renovation last year, the facility had the capacity to produce the equivalent of well over 50 million Covid vaccine doses per month, said two people familiar with the matter.
Unlike companies like Pfizer and Moderna, which have reaped billions of dollars in profits, Johnson & Johnson did not find the Covid vaccine a great money maker.
Since the production of the Covid vaccine was stopped at the end of last year, the Dutch factory has produced an experimental vaccine against respiratory syncytial virus or RSV, which will be used for a clinical trial with older adults in wealthy countries, a person with knowledge of the case said. Although effective, the vaccine is not expected to be available until several years from now.
Mr. Sargent, a spokesman for Johnson & Johnson, said the company’s manufacturing sites “produce more products as we have a commitment to deliver life-changing medicine to patients worldwide.”
Johnson & Johnson is among several companies that are in a race to develop the first vaccine against RSV that kills one estimated 14,000 older adults in the United States annually.
As with other medical products, the company that wins the first approval is ready to have an advantage in conquering a large share of a market that some analysts believe may be worth $ 10 billion annually by 2030.
The vaccine is likely to be targeted at humans in affluent countries, as adults in developing countries are rarely tested for RSV.
Even with the Leiden plant no longer producing the Covid vaccine, Mr. Sargent that Johnson & Johnson continued to supply batches to all the places that handled bottling.
One of them is Aspen Pharmacare in South Africa. Stephen Saad, Aspen’s CEO, said the Leiden shutdown had not interrupted the delivery of the vaccine to Aspen’s factory.
Johnson & Johnson is preparing to return the Leiden plant to make the Covid vaccine next month.
But it will not result in an immediate wave of new doses. The plant’s production will undergo tests and inspections. Doses made from the restarted Leiden production will most likely not be shipped until May or June.