The European Union is next to suspend the use of an American-made Covid-19 vaccine.
The EU’s drug regulator made the announcement Friday, saying that they will not use the Johnson & Johnson Covid-19 vaccines that were made at a Baltimore, Maryland plant.
Allegedly, manufacturing problems were reported at the facility around the same time the vaccines were handled.
The plant in Maryland, Emergent Biosolutions, is one of Johnson & Johnson’s vaccine contractors.
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The European Medicines Agency (EMA) claims the Johnson & Johnson vaccines were not contaminated.
Rather, the move to suspend the vaccines was done out of “an abundance of caution.”
Once announced, the news broke worldwide:
Is this suspension due to the manufacturing incident?
Or perhaps due to safety concerns with Johnson & Johnson’s vaccine?
Back in April, the EMA continued to back Johnson & Johnson vaccines even after it heard of the blood clot issues!
The EMA had believed the vaccine’s benefits outweighed the risks.
Why the sudden flip-flop from the EU?
We have a video from Reuters on Rumble discussing how the EU backed Johnson & Johnson despite the risks.
Left-leaning Washington Post emphasizes the manufacturing error as the reason for the suspension:
The Food and Drug Administration has decided at least 60 million doses of Johnson & Johnson’s coronavirus vaccine made at the problem-plagued Emergent BioSolutions plant must be discarded, according to an individual familiar with the situation.
The agency, after an extensive safety review, also is releasing 10 million doses for use, according to the individual and a statement released by the agency on Friday. The statement said “several other batches are not suitable for use, but additional batches are still under review.”
The 60 million doses that must be discarded are in addition to the 15 million already thrown out that were contaminated by the AstraZeneca vaccine at the plant earlier this year, according to the knowledgeable person who spoke on the condition of anonymity because the individual was not authorized to discuss details. The person said the 60 million doses were made before and after the 15 million previously discarded and that the agency could not determine whether they were safe to use.
The decision about the 60 million doses being discarded was first reported by the New York Times.
The 10 million doses being released are expected to be sent overseas as part of President Biden’s effort to share vaccines with other nations. Millions of other doses that were made at the plant are still under review. The FDA has not yet authorized the facility to resume production of the single-shot Johnson & Johnson vaccine.
Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said in the statement, “These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product. This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements.”
Europe’s drug regulator said Friday that batches of Johnson & Johnson’s coronavirus vaccine made for the region about the time when contamination issues were revealed at a U.S. manufacturing site would, as a precaution, not be used, according to Reuters.
South Africa’s Aspen Pharmacare, which was performing finish and fill of Johnson & Johnson vaccine, also was waiting for word on which of its doses would be cleared for use and which might have to be discarded, according to a local media report.
“This may pose another huge blow to African vaccine distribution,” said Zain Rizvi, law and policy researcher at the advocacy group Public Citizen.
The decision brings Johnson & Johnson closer to a resolution over a crisis that has frozen domestic production and distribution of its vaccine for months.
“Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities,” Kathy Wengel, Johnson & Johnson’s executive vice president and chief global supply chain officer, said in a statement released by the company.
The company’s statement confirmed two batches of vaccine had been authorized for release. It did not address the question of the shots that were earmarked for disposal. Emergent also did not address the discarded doses. It said in a brief emailed statement it was pleased about the release of some doses but did not confirm the amount.
U.S. officials learned in April that up to 15 million doses of the Johnson & Johnson vaccine had been contaminated with the vaccine developed by Oxford and AstraZeneca, which was also being made at the facility. Federal authorities halted plant operations and directed Johnson & Johnson to assume a larger role in fixing the plant’s problems and managing it.
The Baltimore facility acted as a contract manufacturer for the Johnson & Johnson and AstraZeneca vaccines before the shutdown.
The release of the Johnson & Johnson doses comes as the White House responds to criticisms that it has not done enough to share vaccines with other countries. This week, the Biden administration said it is buying 500 million doses of the coronavirus vaccine developed by Pfizer, with German partner BioNTech, to donate to the world. Last week, the Biden administration announced details of a plan to share 25 million doses of vaccines globally in what officials described as a down payment on 80 million vaccines to be sent abroad by the end of the month.
A scathing FDA inspection report on the Emergent plant in April cited unsanitary conditions at the plant and a lack of adherence to basic protocols intended to prevent contamination of the vaccine.
The supply of the Johnson & Johnson vaccine has fluctuated. About 21 million doses have been delivered throughout the United States, of which about 11 million have been administered, according to the Centers for Disease Control and Prevention data. They were imported from the company’s operation in the Netherlands. No shots from the Emergent plant have been distributed.
With the Emergent plant failing to come online, supplies of Johnson & Johnson vaccine eventually began running short. The Biden administration in May stopped making new doses available to states. Even so, state officials still had the option of claiming unordered doses already allocated to them, in addition to using the millions of doses already delivered but not yet administered.
Over the weekend, the federal government began moving unclaimed doses to a stock for international donation, according to an administration official familiar with the developments who spoke on the condition of anonymity to discuss internal matters. The expectation is that new Johnson & Johnson vaccines will be available for states by next week, the official said.
About 100 million doses manufactured at Emergent before it was closed had been awaiting FDA clearance, according to Emergent.
Johnson & Johnson’s contract with the federal government had called for the company to have delivered 87 million doses by the end of May, worth $870 million in payments. A remaining 13 million doses were scheduled to be delivered by June 30.
After Emergent suspended vaccine production in April, Johnson & Johnson assumed a bigger role in managing the facility — a change dictated by the Biden administration. Officials also decided the facility would no longer make the AstraZeneca product when it resumed operations.
The House Oversight select subcommittee on the coronavirus crisis recently released a staff report that provided additional details about the Emergent debacle and how the Johnson & Johnson product was contaminated.
The panel also released an Emergent report saying a harmless virus from the AstraZeneca vaccine that is used to trigger immunity against the coronavirus was detected in a large batch of the Johnson & Johnson vaccine. The cross-contamination was detected by Johnson & Johnson on March 5 in a batch of vaccine manufactured between Jan. 19 and Feb. 21.
Emergent officials said the most likely route of contamination was during preparation of a growth medium for the Johnson & Johnson vaccine, which came into contact with the “waste path” from an area used to make the AstraZeneca vaccine.
During a hearing of the House subcommittee, Emergent officials were attacked for taking huge bonuses at the same time the factory failed to produce any vaccine that could be used in the United States or elsewhere.
Emergent’s CEO, Robert Kramer, told the House Oversight select subcommittee in testimony May 19 that Emergent has retained an independent quality oversight firm to monitor its performance. He said the company has performed cleaning, disinfection and repairs throughout the facility; improved waste-handling procedures; and boosted training for workers at the site.
Funny how the media is quick to point the finger at the vendor, Emergent, instead of looking into Johnson & Johnson.
Another case of nothing to see here!
Except, there’s no hiding what the side effects of the Johnson & Johnson Covid vaccine have done.
We have a clip from KTNV on Rumble discussing the Johnson & Johnson vaccine side effects, including life-threatening blood clots.
It seems the media has been hard at work trying to brush the blood clot side effects under the rug.
Twitter is definitely waking up to the vaccine’s risks:
The Epoch Times has more on the story:
The European Union’s drug regulator announced Friday it will not use batches of the Johnson & Johnson COVID-19 vaccine that were made at a Baltimore, Maryland-based plant around the time that manufacturing problems were reported at the facility.
The European Medicines Agency (EMA) said that vaccines that it obtained from the Emergent Biosolutions plant weren’t affected by any contamination. The move on Friday to suspend using the vaccines is being done out of an abundance of caution, the agency said.
“Authorities in the EU are aware that a batch of the active substance for COVID-19 Vaccine Janssen had been contaminated with materials for another vaccine manufactured at the same site,” the statement said, adding that the “batch concerned was not intended for the EU market.”
“Based on available information, batches of the vaccine released in the EU are not affected by the cross-contamination,” the EMA said. “However, as a precaution and to safeguard the quality of vaccines, the supervisory authorities have recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred.”
It’s not clear how many J&J doses would be affected by the EU decision.
The decision came amid reports, citing anonymous sources, that claimed that up to 60 million doses were tossed out due to the decision, although spokespersons for the Food and Drug Administration (FDA) or Johnson & Johnson did not respond for comment after The Epoch Times’ inquiries about the doses.
A Johnson & Johnson spokesperson, in an email to The Epoch Times, pointed to a news release from Kathy Wengel, a vice president, who said that the recent actions “represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities.” A spokesperson for the FDA, in an email, referred to J&J.
The FDA, in a news release on Thursday, said that two batches manufactured at the Baltimore plant can be used under the emergency use authorization.
“The FDA’s decision to include these two batches of vaccine drug substance in the [emergency use authorization] for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries,” the FDA said.
But the FDA said it has discovered that “several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed.” The agency not make any mention of how many Johnson & Johnson single-shot vaccine doses, known as the Janssen vaccine, would be affected—if any.
“Additionally,” the news release said, “the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months.”
Emergent Biosolutions is one of several J&J contractors that make the vaccine in bulk, which is then shipped to other factories to finalize. In April, there were reports that a human error caused millions of doses to be ruined.
Manufacturing error or not, this suspension of vaccines may very well save lives.