The US Food and Drug Administration, known as FDA, has informed Johnson & Johnson of canceling about 60 million doses of vaccines it is working on against the Corona virus (Covid-19). Especially those manufactured in the company’s factories in Baltimore, Maryland, due to potential contamination and industrial defects.
And the American media reported this news, which Johnson & Johnson refused to comment on, at a time when the Food and Drug Administration plans to allow the distribution of about 10 million doses in the United States from the company’s manufacture, or send them to other countries, but with a warning that the regulators They cannot guarantee that the company has followed good manufacturing practices.
Some officials told the New York Times that the Food and Drug Administration has not yet decided whether it can allow the Baltimore plant, which has been closed for two months due to regulatory concerns, to reopen. Now at the company’s plant in the Netherlands, the Food and Drug Administration has tried to figure out what to do about at least 170 million doses of the vaccine, which were left in limbo after a major production accident involving two vaccines made at the Baltimore plant was discovered.
More than 100 million doses of Johnson & Johnson were previously suspended, and at least 70 million doses of the “AstraZeneca” vaccine were discovered after batches of the two vaccines manufactured by a third company were discovered to be contaminated, Emergent Bio Solutions, which operates the Baltimore plant. Federal officials then ordered the factory to halt production temporarily, stripping the company of its responsibility to produce the “AstraZeneca” vaccine, but in return allowing them to work on the Johnson & Johnson vaccine. The Johnson & Johnson vaccine was promising and could change the way vaccines work in the country, because it requires only one injection, and was particularly useful in at-risk communities, but the federal government now has an abundant supply of vaccines from Pfizer and Moderna. The two federally licensed developers of vaccines no longer need additional supplies from Johnson, and regulators also continue to question whether the company, which has received hundreds of millions of dollars from the federal government to manufacture coronavirus vaccines, is adhering to manufacturing standards.
However, the loss of 60 million doses of “Johnson & Johnson” limits the Biden administration’s plan to distribute vaccines to other countries, which are still in the grip of the epidemic, and the administration was reliant on sharing doses of “Johnson & Johnson” and “AstraZeneca” in Distribute it to needy countries.
After arriving in Britain to attend the G7 summit this week, US President Joe Biden announced that he had found another source of donations, as Pfizer agreed to sell its administration 500 million doses at the cost of donating to low and middle-income countries over the next year, while The World Health Organization estimates that 11 billion doses are needed globally to stem the epidemic.
Experts said the agency’s plan to allow 10 million doses to be used in the United States or abroad, with the caveat, is somewhat unusual, for a product issued under an emergency permit, and said regulators have the discretion to take this action if there is an urgent need. to medicines and supplies shortages.
In a statement, the US Food and Drug Administration said that, before making its decision, it “conducted a comprehensive review of the facility’s records, and the results of quality tests conducted by the manufacturer,” and considered the ongoing public health emergency, stressing that it continues to “work by looking into the issues.” at the Baltimore factory.