WASHINGTON – The supply of the vaccine against Johnson and Johnson’s coronavirus vaccine will be extremely limited until federal regulators approve production at a production plant in Baltimore with a pattern of quality control, the White House coordinator’s response to pandemic Said Friday.
© Ricardo Arduengo / Agence France-Presse – Getty Images
A mass vaccination site in San Juan, PR, in March. Johnson & Johnson was a latecomer to the conquest of federal emergency use, after Pfizer and Moderna.
With the company’s vaccine awarded 86 percent next week, governors across the country warned that the loss of supplies they were counting on would put their vaccinations back.
Federal officials said Moderna and Pfizer-BioNTech, the other two federally authorized vaccine manufacturers, could be part of the shortfall. They also pointed out that some states currently do not use all of the vaccine assigned to them.
But the increase in Moderna and Pfizer will not, at least in the short term, compensate for the rise in the Johnson & Johnson offering. California will receive 400,000 fewer total doses next week than this week, a 15 percent drop, even with slight increases from Pfizer and Moderna. That will be followed next week by another 5 percent decline, government officials said Friday. Officials in a broad group of states said the sudden decline in Johnson & Johnson’s supply would significantly delay the vaccination.
© Jim Lo Scalzo / EPA, via Shutterstock
The decrease in Johnson & Johnson doses is directly linked to quality control issues at the 112,000-square-foot facility in southeast Baltimore, which is managed by Emergent BioSolutions.
“The last thing we wanted to hear about was getting fewer vaccines,” Gov. Larry Hogan of Maryland, a Republican, told reporters Friday. “We were hoping to rush as they promised.”
In a statement, New York Gov. Andrew M. Cuomo, a Democrat, said: “We will not be able to get as many shots into the arms of New Yorkers as we would like.” He added: “As has been the case since the beginning of our vaccination effort, the X-factor is supply, supply, supply.”
Some state health officials have hoped to use the easily stored vaccine from Johnson & Johnson to target university students and other passing groups. Others offered it at mass vaccination sites or led it to rural areas.
Instead, delivery of Johnson & Johnson doses will drop sharply in states next week: California will drop from 572,700 to 67,600 doses, Texas from 392,100 to 46,300, Florida from 31,3200 to 37,000 and Virginia from 253,400 to 27 900.
In Virginia, which will broaden vaccine admission to its entire adult population in nine days, the impact will be “huge”, said Dr. Danny Avula, the state vaccination coordinator, said. He said officials would have to warn people that although they are eligible to report for shots, appointments can be difficult.
© Chang W. Lee / The New York Times
Johnson & Johnson’s single-dose shot, which has become a popular weapon for state health officials across the country, could come close to temporary disappearance.
Johnson & Johnson was a latecomer to the conquest of federal emergency use, after Pfizer and Moderna. But recently in February, federal officials projected weekly deliveries of more than four million doses of the company’s vaccine in April, a significant increase in the country’s vaccine supply. Only a quarter of these doses are expected at best this month – all from the Netherlands – while federal regulators traverse the Baltimore plant that was supposed to take over for the Dutch plants.
The precipitation comes as new, more contagious variants of the coronavirus infection rates skyrocket in some parts of the country. In Michigan, Democrat Gretchen Whitmer, a Democrat, said Friday that she’s Mr. Biden urged to allow vaccines to her state, where an outbreak, the worst in the country, filled hospitals and forced some schools to close.
But the White House is reluctant to change the allocation formula for states, which distributes doses evenly based on the population. White House coronavirus coordinator Jeff Zients said Friday that the government does not plan to shift additional vaccine doses to hard-hit countries, such as Michigan.
“At this point, it’s not being deployed, but I’m not giving up,” Whitmer said, describing a call Thursday night with the president. “Today it’s Michigan and the Middle East. Tomorrow it could be another part of our country. ‘
The decrease in Johnson & Johnson doses is directly linked to quality control issues at the 112,000-square-foot factory in southeast Baltimore, which is managed by Emergent BioSolutions, a subcontractor of Johnson & Johnson. Johnson & Johnson discovered last month that emerging workers have infected a vaccine and are being forced to discard the equivalent of 13 million to 15 million doses.
The FDA has now begun launching a causal inspection. Such queries are usually prompted by specific complaints. A separate team will likely review the plant to determine whether the FDA’s authorization for the Johnson & Johnson vaccine should be extended to doses manufactured there, according to people familiar with the agency’s procedures.
The New York Times reported this week that a series of confidential audits and investigations revealed a pattern of problems in the factory, including a persistent mold problem, failure to properly disinfect for pollution, frequent use of raw materials without it fully test and issues with data integrity. Former supervisors who spoke on condition of anonymity said that when the factory managers complained about the failure to solve problems, the fast deadlines for production were to blame.
As regulators of the Food and Drug Administration have so far not certified the plant, none of the other 62 million Johnson & Johnson doses already produced there can be distributed to the public. About 15 million of the doses have already been bottled and can be distributed quickly if regulators give the plant the green light.
Mr. Zients said Johnson & Johnson is installing a new senior leadership and that AstraZeneca, another vaccine that has not been federally approved for use in the United States, will no longer be manufactured there. Production of new groups of Johnson & Johnson vaccines is halted until federal regulators conduct their inspections.
Mr. Zients said Johnson & Johnson would eventually expect to deliver as many as eight million doses a week from the Baltimore plant. He first suggested that the FDA could certify the plant by the end of the month. Then he stepped back and said he did not know and that he could not speculate on what federal regulators could do.
“Johnson & Johnson expects a relatively low level of weekly dose delivery until the company obtains FDA approval,” he said.
In a subsequent interview with The Times, Zients said that by the end of next month, the federal government will still have enough doses for all adults in the country.
“You know, it’s wartime. We will always have sufficient stock, ”he said. “We always plan for contingencies. And we do not know what specific things are going to happen, but we will have stock at the end of May. ”
Federal officials said Moderna and Pfizer-BioNTech could jointly ship up to two and a half million doses a week. But it will still fall short of the more than four million doses per week that the Johnson & Johnson government expected. The overall effect is already clear.
Los Angeles County, whose population is about 10 million more than that of some states, expects to receive 74,000 fewer doses next week, even with increases from Moderna and Pfizer. “We are concerned about the award,” said Dr. Paul Simon, the chief scientific officer of the Los Angeles County Department of Public Health, said.
Government Mike DeWine of Ohio, a Republican, said health officials used the Johnson & Johnson vaccine primarily to vaccinate university students and for its mass vaccination sites, but was surprised to learn that a large number of residents at the vaccine names requested. .
“That’s really the problem,” he said in a telephone interview. ‘We will have enough to finish our college students, we will not need so much for mass vaccination sites, and the real downside is that there are people who really want it and who hold it back, and that’s a concern. ”
The Pentagon on Thursday blamed the problems at the Baltimore factory for the slow progress of the military in vaccinating troops and their families stationed abroad.
“The recent event that caused the loss of approximately 15 million doses of Johnson & Johnson vaccine has affected the DOD awards,” said Lt.Gen. Ronald J. Place, the director of the Defense Agency, said with reference to the Department of Defense. .
He said the vaccine was an important resource to use abroad because it did not require the cold storage for the Pfizer vaccine, which the military commonly uses domestically. Laura Ochoa, spokeswoman for the Department of Defense, said Friday that the military would move to Moderna and still hopes to have at least one dose injected into each service member abroad by mid-May.
Easier to store and transport – Johnson & Johnson’s vaccine can be kept at normal cooling temperatures for three months – states relied on the vaccine to fill important gaps in their vaccination campaigns and pass it on to homeless people, migrant workers and rural and tribal communities take. at mobile vaccination units.
In Louisiana, the vaccine was surprisingly popular during community vaccine events, more so than Moderna’s and Pfizer’s, said Dr. Joseph Kanter, the state’s top health official, said. He said the drop in supply to 8,000 doses next week from 67,000 this week was a blow to the state’s momentum.
“There are now exactly two things we can do here to prevent a varying upswing, and that is increasing the mitigation measures and increasing the vaccination,” he said. “And we’d rather do the latter.”
Dr. Kanter said White House officials did not link the fault in the Baltimore plant to the decline in supply next week. But he said the dip fits into a pattern of volatility in the availability of the vaccine – something White House officials have said will continue until April.
“We have not received a real confident message about J & J’s offer since it became available,” he said.
Apoorva Mandavilli and Remy Tumin reported from New York, Sheryl Gay Stolberg and Eileen Sullivan from Washington, and Mitch Smith and Julie Bosman from Chicago.
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