•   
  •   
  •   

US J&J COVID-19 vaccine manufacturing halted at U.S. plant that had contamination issue

19:15  19 april  2021
19:15  19 april  2021 Source:   reuters.com

As the US races to vaccinate the country, J&J vaccine distribution will slow down 84% next week

  As the US races to vaccinate the country, J&J vaccine distribution will slow down 84% next week Just as the Biden administration is moving up its deadline to make vaccine eligibility available to all adults by April 19, the supply of at least one of the vaccines, Johnson & Johnson's, is slowing down, and with some of its manufacturing challenges at an independent plant that has had problems in the past, it's unclear exactly when it will pick back up again. © U.S. Air Force Tech. Sgt. Anthony Nelson Jr./Department of Defense via AP In this Feb. 9, 2021 photo provided by the Department of Defense, Hickam 15th Medical Group host the first COVID-19 mass vaccination on Joint Base Pearl Harbor-Hickam. By the thousands, U.S.

By Manas Mishra

logo: FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland © Reuters/ANDREW KELLY FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) -Production of Johnson & Johnson's COVID-19 vaccine at a U.S. manufacturing plant was halted by the U.S. Food and Drug Administration while the agency investigates an error that led to millions of doses being ruined last month.

Emergent BioSolutions Inc, the company that owns and runs the Baltimore plant that had been making the J&J vaccine, said in a regulatory filing that the FDA requested a pause on April 16 in production of new drug substance for the shot pending completion of the inspection.

Ramadan rules, Flags of Hope, zoo overnights: News from around our 50 states

  Ramadan rules, Flags of Hope, zoo overnights: News from around our 50 states How the COVID-19 pandemic is affecting every stateStart the day smarter. Get all the news you need in your inbox each morning.

Johnson & Johnson said it would work with Emergent and the FDA to address any findings at the end of the inspection.

J&J was put in charge of manufacturing at the plant in early April by the U.S. government after it disclosed the error in which ingredients from AstraZeneca's shot also being produced at the plant at that time contaminated a batch of the J&J vaccine.

The request to pause manufacturing is the latest setback to J&J's vaccine, which has been paused for use by U.S. regulators as they review reports of rare but serious brain blood clots in people who took the one-dose shot.

The Baltimore plant had been seeking authorization from the FDA for the J&J vaccine when the error occurred. J&J has authorization to make doses in the Netherlands and finish them in the U.S. plant of Catalent Inc..

What to Do if You Have an Appointment for the Johnson & Johnson COVID Vaccine

  What to Do if You Have an Appointment for the Johnson & Johnson COVID Vaccine Those who have already made appointments for the J&J vaccine should consider rescheduling options that may be available to them. © Michael M. Santiago/Getty Images A dose of the Johnson & Johnson coronavirus (COVID-19) vaccine is seen on a table at the Northwell Health pop-up coronavirus (COVID-19) vaccination site at the Albanian Islamic Cultural Center in Staten Island on April 08, 2021 in New York City. NYC continues to have a 6.55 percent coronavirus (COVID-19) cases on a seven-day rolling average as the city continues to ramp up vaccinations.

"At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries," J&J said. The company has previously said it would deliver 100 million doses of its vaccine to the United States during the first half of 2021 and has so far delivered about 18 million.

J&J said in a statement it was focused on securing emergency use authorization for the Emergent plant.

Emergent said on Monday in a regulatory filing that the FDA started its review on April 12. The company said it would quarantine existing material manufactured at the Baltimore facility until the review is complete.(https://bit.ly/32oEg7A)

"We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes," Emergent said in an emailed statement.

In March, J&J said it had found a problem with a batch of the drug substance for its COVID-19 vaccine being produced by Emergent.

J&J did not say how many vaccine doses the spoiled batch would have produced, but the New York Times, without citing a source, reported that about 15 million doses were ruined.

(Reporting by Manas Mishra and Ankur Banerjee in Bengaluru; Editing Sriraj Kalluvila , Caroline Humer and Bill Berkrot)

From scarcity to abundance: US faces calls to share vaccines .
TEGUCIGALPA, Honduras (AP) — Victor Guevara knows people his age have been vaccinated against COVID-19 in many countries. His own relatives in Houston have been inoculated. But the 72-year-old Honduran lawyer, like so many others in his country, is still waiting. And increasingly, he is wondering why the United States is not doing more to help, particularly as the American vaccine supply begins to outpace demand and doses that have been approved for use elsewhere in the world, but not in the U.S., sit idle. “We live in a state of defenselessness on every level,” Guevara said of the situation in his Central American homeland.

usr: 3
This is interesting!