WASHINGTON. – Following a review of the troubled Baltimore plant, federal regulators have decided that about 60 million doses of the Son Onson և John Onson coronavirus vaccine produced there should be discontinued due to possible contamination, people familiar with the situation say.
The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or shipped to other countries, but warned that regulators could not guarantee that plant-based company Emergent BioSolutions had recovered from good manufacturing experience. The agency has not yet decided whether Emergent can restart the plant, which was closed for two months due to regulatory issues, people say.
For weeks, the FDA has been trying to figure out what to do about at least 170 million doses of the vaccine, which were left in limbo after the discovery of a major production crash involving two locally produced vaccines.
Son Onson և Over 100 Million Doses of John Onson Vaccines առնվազն At least 70 million doses of AstraZeneca vaccine have been discontinued after Emergent discovered in March that its employees had contaminated a batch of Johnson & Johnson vaccines used to make AstraZeneca, the main ingredient in AstraZeneca. Federal officials then ordered the plant to cease production, stripping Emergent of responsibility for producing the AstraZeneca vaccine and instructing John Onson and John Onson to take direct control of vaccine production there.
The Son Onson և Son Onson vaccine was once considered a potential game changer in the country’s vaccine stockpile because it required only one shot and was especially useful in vulnerable communities. But the federal government now has an abundant supply of vaccines from Pfizer-BioNTech, Moderna, two other federally licensed vaccine developers, and no longer needs Johnson & Johnson.
However, the loss of 60 million shares of Johnson & Johnson hurts the Biden administration to distribute vaccines to other countries that are still plagued by the epidemic. The government had hoped to split both Johnson & Johnson and AstraZeneca, but was forced to postpone its plan until the FDA completed its review of the facility.
Arriving in Britain this week for the G7 summit, President Biden announced that he had found another source of donations. Pfizer-BioNTech has now agreed to sell 500 million doses to its administration to donate to low- and middle-income countries next year. The World Health Organization estimates that 11 billion doses are needed worldwide to eradicate the epidemic.
The FDA action is disappointing news for Emergent և Johnson & Johnson, who have hired the company as a subcontractor. Inspectors are still reviewing the plant, do not expect the company to restart it by the end of this month, say people familiar with the situation. Regulators continue to question whether the company, which was paid hundreds of millions of dollars by the federal government to produce coronavirus vaccines, is adhering to production standards.
A Johnson & Johnson spokesman declined to comment.