WASHINGTON—The Food and Drug Administration and vaccine maker Johnson & Johnson are expected to announce as early as Friday Friday that contamination problems at the COVID-19 vaccine plant have been reported. In Baltimore it has been fixed. This will increase the dosage by millions of doses.
Production of the vaccine in a facility operated by contract manufacturer Emergent BioSolutions Inc. was suspended after unsanitary conditions led to contamination of the J&J vaccine. The facility produces vaccine compounds and ready-to-use vaccine doses for J&J and AstraZeneca. PLC
Emergency chief Robert Kramer told a council panel last week that The company has produced enough active ingredients to produce more than 100 million doses of the J&J vaccine.
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The company has taken remedial measures and is negotiating with the FDA and J&J about the steps necessary to reopen the plant.
Johnson & Johnson says it is working with Emerrgent to keep it safe. “Emergency Substance Abuse Authorization in the United States for Covid-19 Drugs Made in Emerrgent Bayview ASAP”
Emergency declined to comment for this article.
U.S. officials said emergency permits for factories to produce the COVID-19 vaccine could be done as early as Friday. That could help fulfill President Biden’s pledge to share 20 million doses of the drug from J&J, Pfizer Inc. and Moderna Inc. with the rest of the world by the end of June.
The Baltimore facility is producing millions of doses that are in inventory pending approval. But most of them were unfinished and were put in bottles. officials said And added that it may take several months for all the drugs to be available.
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One official said part of the deal to keep the factory online was The United States and J&J Co. have roughly agreed that about 60 million doses of the J&J vaccine are now being made at the Baltimore facility. will be cleared for use in the US or abroad.
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AstraZeneca is still testing approximately 60 million doses, which are also produced at the Baltimore emergency facility. This could be the subject of another deal with the FDA in the coming weeks, or it could still be part of the deal. Another official said AstraZeneca declined to comment for this article.
J&J’s quantity when it’s done It would be enough to vaccinate about 60 million people with the company’s single injection. AstraZeneca dosage, if available, is a two-dose regimen. and can vaccinate about half of most people.
An accident occurred at a factory in Baltimore. material contamination That can yield up to 15 million doses during January and February.
An emergency factory FDA audit in April concluded that the plant was unable to maintain clean and hygienic conditions. and not taking appropriate measures to avoid cross-contamination between the two vaccine lines.
Under a deal with the U.S. government, the U.S. pays an emergency booking fee of $271 million per month to prepare the vaccine. But the government suspended some payments after becoming aware of the contamination. According to a memorandum from the staff of the House of Representatives of the House of Representatives Coronavirus Crisis Subcommittee.
At a subcommittee meeting last week, Emergent executives blamed some problems at the Baltimore vaccine plant that had to produce the two vaccines in large quantities at once.
Mr Kramer said “Increasing production of two new vaccines at a very large scale in the same facility is unprecedented.
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In an April 30 response to the FDA review report, Emergent said it had discontinued the AstraZeneca portion of the plant in Baltimore’s Bayview section and had taken a number of steps to avoid contamination of J&J vaccine ingredients.
The company said it plans to take a number of remedial steps, such as repairing, cleaning and disinfecting its production facilities. and improve the training of personnel at the job site
The company has pledged to take a number of corrective actions during May and June. All of this had to be accomplished before a full re-production could be started on site.