US government moves AstraZeneca out of Covid vaccine plant that suffered contamination
3 years, 8 months ago

US government moves AstraZeneca out of Covid vaccine plant that suffered contamination

CNN  

CNN — The federal government has moved to stop any further risk of contamination at a Baltimore contract vaccine manufacturer where 15 million potential doses of Johnson & Johnson vaccine were spoiled last month, telling rival drugmaker AstraZeneca it must move its production from the plant and find somewhere else to make its vaccine. The Emergent BioSolutions plant, which had been making doses of both Johnson & Johnson’s vaccine as well as a vaccine made for AstraZeneca, will now only produce J&J vaccines, the official said. “Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Bayview facility,” the company said in a statement emailed to CNN. And another source told CNN that Johnson & Johnson had successfully produced 115 million other doses of its vaccine at the Emergent plant.

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History of this topic

J&J COVID vaccine factory forced to trash even more doses
2 years, 4 months ago

J&J COVID vaccine factory forced to trash even more doses

Associated Press  

WASHINGTON — About 135 million more doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory will have to be destroyed due to quality problems, Congressional panel leaders said Thursday. The announcement follows a report in May that detailed how more than 400 million vaccine doses made at an Emergent BioSolutions plant had to be trashed. Johnson & …

House panel alleges cover-up by contract vaccine maker
2 years, 7 months ago

House panel alleges cover-up by contract vaccine maker

Associated Press  

WASHINGTON — Executives at contract vaccine manufacturer Emergent BioSolutions covered up quality control problems that led to more than 400 million doses of coronavirus vaccines needing to be trashed, congressional investigators said in a report Tuesday. “Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars,” …

Canada authorises first plant-based COVID-19 vaccine
2 years, 9 months ago

Canada authorises first plant-based COVID-19 vaccine

India Today  

Canadian regulators said Thursday Medicago's two-dose vaccine can be given to adults ages 18 to 64, but said there's too little data on the shots in people 65 and older. The decision was based on a study of 24,000 adults that found the vaccine was 71% effective at preventing COVID-19 — although that was before the omicron variant emerged. While …

EU to return millions of doses of J&J’s Covid-19 vaccine imported from Africa
3 years, 3 months ago

EU to return millions of doses of J&J’s Covid-19 vaccine imported from Africa

Live Mint  

The European Union will return to Africa millions of doses of Johnson & Johnson’s Covid-19 vaccine that it received from a plant in South Africa, following criticism by health activists that the bloc was taking away shots from a continent that has the lowest immunization rate in the world. Strive Masiyiwa, who heads the African Union’s Vaccine Acquisition Task Team, …

Shut-down Baltimore vaccine plant cleared to return to operation
3 years, 4 months ago

Shut-down Baltimore vaccine plant cleared to return to operation

Daily Mail  

A Baltimore factory that had to be shut down by the U.S. Food and Drug Administration in April will return to operation soon. A Baltimore factory that was forced to close after producing contaminated doses of the Johnson & Johnson vaccine is slated to reopen soon The plant forced to close after Johnson & Johnson vaccines were contaminated with AstraZeneca …

FDA is letting troubled COVID vaccine factory restart, company says
3 years, 4 months ago

FDA is letting troubled COVID vaccine factory restart, company says

LA Times  

A vial of Johnson & Johnson’s COVID-19 vaccine is used at a pop-up clinic in the Staten Island. The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine, the company said Thursday. The lapses at the Bayview factory have hampered J&J’s efforts to be a major player in …

US Looking at Joint Production of Johnson and Johnson's Covid Vaccine in India
3 years, 7 months ago

US Looking at Joint Production of Johnson and Johnson's Covid Vaccine in India

News 18  

The US is looking at joint production of Johnson and Johnson's COVID-19 vaccine in India and ways to help manufacturers like the Serum Institute of India to boost production, Daniel B Smith, the Charge D'Affaires of the US embassy, said on Tuesday. Last month, the White House said that the US plans to share 60 million doses of AstraZeneca's vaccine …

US to share AstraZeneca shots with world after safety check
3 years, 7 months ago

US to share AstraZeneca shots with world after safety check

Associated Press  

WASHINGTON — The U.S. will begin sharing its entire stock of AstraZeneca COVID-19 vaccines with the world once it clears federal safety reviews, the White House said Monday, with as many as 60 million doses expected to be available for export in the coming months. “Given the strong portfolio of vaccines that the U.S. already has and that have been …

US will share AstraZeneca vaccines with world
3 years, 7 months ago

US will share AstraZeneca vaccines with world

India Today  

The US will begin sharing its entire pipeline of vaccines from AstraZeneca once the Covid-19 vaccine clears federal safety reviews, the White House told The Associated Press on Monday, with as many as 60 million doses expected to be available for export in the coming months. Full list here “Given the strong portfolio of vaccines that the US already has …

FDA inspection found problems at factory making J&J vaccine
3 years, 8 months ago

FDA inspection found problems at factory making J&J vaccine

Associated Press  

The Baltimore factory hired to help make Johnson & Johnson’s COVID-19 vaccine was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material going into a batch of shots, U.S. regulators said Wednesday. Agency inspectors said a batch of bulk drug substance for J&J’s single-shot vaccine was contaminated with material used to make COVID-19 …

FDA Inspection Finds Numerous Problems At Facility Intended To Make J&J Vaccine
3 years, 8 months ago

FDA Inspection Finds Numerous Problems At Facility Intended To Make J&J Vaccine

NPR  

FDA Inspection Finds Numerous Problems At Facility Intended To Make J&J Vaccine Enlarge this image toggle caption Tasos Katopodis/Getty Images Tasos Katopodis/Getty Images Peeling paint. All of these were problems noted by U.S. Food and Drug Administration inspectors at the Emergent BioSolutions factory in Baltimore – a facility that is intended to produce materials for the Johnson & Johnson COVID-19 …

Opinion: An abundance of caution and good science are the right way to build trust in vaccines
3 years, 8 months ago

Opinion: An abundance of caution and good science are the right way to build trust in vaccines

CNN  

Editor’s Note: Céline Gounder, MD, ScM, FIDSA is an internist, infectious disease specialist, and epidemiologist. The blood clots observed among these six women who received the J&J vaccine are similar to those seen among patients in Europe after receiving the AstraZeneca Covid-19 vaccine. Many of us in the medical and public health community now wonder whether the altered adenovirus could …

White House says a pause in US rollout of Johnson & Johnson coronavirus vaccine won't delay plan
3 years, 8 months ago

White House says a pause in US rollout of Johnson & Johnson coronavirus vaccine won't delay plan

ABC  

White House COVID-19 response coordinator Jeff Zients says a recommended pause in the use of the Johnson & Johnson coronavirus vaccine will not have a significant impact on the country's vaccination plan and was taken out of "an abundance of caution". Earlier on Tuesday, US federal health agencies recommended pausing the use of Johnson & Johnson's COVID-19 vaccine after six …

US shuts Johnson & Johnson vaccine sites after adverse reactions reported
3 years, 8 months ago

US shuts Johnson & Johnson vaccine sites after adverse reactions reported

India TV News  

Several states in the United States have temporarily shut down some vaccine sites after people suffered adverse reactions to the shot. Georgia was the third US state to temporarily shut down a vaccine site following North Carolina and Colorado after eight people suffered adverse reactions following vaccination. The supply of Johnson & Johnson's Covid-19 vaccine is expected to drop by …

How AstraZeneca’s latest vaccine troubles could slow the global recovery
3 years, 8 months ago

How AstraZeneca’s latest vaccine troubles could slow the global recovery

CNN  

London CNN Business — AstraZeneca’s vaccine is key to ending the global economic slump caused by the coronavirus. The World Health Organization said in a statement Wednesday that “based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed.” AstraZeneca said that nearly 200 million …

April 1, 2021 coronavirus news
3 years, 8 months ago

April 1, 2021 coronavirus news

CNN  

Johnson & Johnson said Thursday it still expects to meet its commitments for the promised delivery of an additional 24 million doses of its Covid-19 vaccine in April, even after a quality problem at one of the company’s contract manufacturers. Emergent told CNN the problem affected a single batch of “bulk drug substance” used to make vaccine. In an emailed …

Company producing J&J vaccine had history of violations
3 years, 8 months ago

Company producing J&J vaccine had history of violations

Associated Press  

The company at the center of quality problems that led Johnson & Johnson to discard 15 million doses of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems. As I mentioned, that’s the reason nothing from that plant has gone into anyone that we’ve administered to.” White House press secretary Jen Psaki said …

Johnson & Johnson COVID-19 vaccine batch fails quality check
3 years, 8 months ago

Johnson & Johnson COVID-19 vaccine batch fails quality check

Associated Press  

A batch of Johnson & Johnson’s COVID-19 vaccine failed quality standards and can’t be used, the drug giant said Wednesday. As of Wednesday, J&J had provided about 6.8 million doses to the U.S. vaccine effort, according to the Centers for Disease Control and Prevention’s online vaccine tracker. Some additional doses may not yet have been recorded as delivered, and federal …

US Plant Ruins 15 Million Johnson & Johnson Coronavirus Vaccine Doses, Says Report
3 years, 8 months ago

US Plant Ruins 15 Million Johnson & Johnson Coronavirus Vaccine Doses, Says Report

News 18  

About 15 million doses of the single-shot coronavirus vaccine made by Johnson & Johnson were ruined in a factory error in the United States, The New York Times reported — a blow to the company’s efforts to quickly boost production. When contacted by AFP, the pharmaceutical giant said it had identified a batch of doses at a plant in Baltimore …

March 31, 2021 coronavirus news
3 years, 8 months ago

March 31, 2021 coronavirus news

CNN  

Employees work in a lab at Emergent Biosolutions, which is manufacturing vaccines for AstraZeneca and Johnson & Johnson on February 8, in Baltimore, Maryland. Michael Robinson Chavez/The Washington Post/Getty Images/FILE Drugmaker Johnson & Johnson said Wednesday it had found a quality problem at a Baltimore plant helping manufacture its coronavirus vaccine under contract. The New York Times reported Wednesday that …

Johnson & Johnson vaccine: Quality issue at Baltimore plant delays some of the J&J supply
3 years, 8 months ago

Johnson & Johnson vaccine: Quality issue at Baltimore plant delays some of the J&J supply

CNN  

CNN — Drugmaker Johnson & Johnson said Wednesday it had found a quality problem at a Baltimore plant helping manufacture its single-dose coronavirus vaccine under contract. Johnson & Johnson said in a statement to CNN Wednesday that the quality control process at the plant identified “one batch” of drug substance that did not meet quality standards. On Wednesday evening, Biden …

Millions of J&J COVID vaccines ruined due to human error: NYT
3 years, 8 months ago

Millions of J&J COVID vaccines ruined due to human error: NYT

Al Jazeera  

About 15 million Johnson & Johnson doses ruined due to a mix-up at a plant in Maryland, the New York Times reports. About 15 million doses of Johnson & Johnson’s COVID-19 vaccine have been ruined due to a mix-up at a United States production facility, the New York Times newspaper reported on Wednesday, delaying future shipments. In a statement later …

Johnson & Johnson: The race to manufacture Covid-19 vaccines at record speed
3 years, 9 months ago

Johnson & Johnson: The race to manufacture Covid-19 vaccines at record speed

CNN  

CNN — Before the pandemic, Anne Leonard’s friends and family had only a cursory interest in her two decades of work manufacturing pharmaceuticals. But as President Joe Biden said Tuesday, “it simply wasn’t coming fast enough.” Biden announced that drugmaker Merck will help manufacture the Johnson & Johnson vaccine – a decision made after it became clear that J&J would …

February 25, 2021 coronavirus news
3 years, 9 months ago

February 25, 2021 coronavirus news

CNN  

US Food and Drug Administration vaccine advisers are scheduled to meet Friday to discuss the potential emergency authorization of a third coronavirus vaccine for the US, this one made by Johnson & Johnson’s vaccine arm Janssen Biotech. The CDC then takes the ACIP vote into consideration and the CDC director – who is currently Dr. Rochelle Walensky – will decide …

Johnson & Johnson asks FDA to OK Covid-19 vaccine
3 years, 10 months ago

Johnson & Johnson asks FDA to OK Covid-19 vaccine

CNN  

CNN — Johnson & Johnson officially asked the US Food and Drug Administration for an emergency use authorization of its Covid-19 vaccine Thursday, taking forward the possibility of a third coronavirus vaccine for the US market. “Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people …

Coronavirus vaccine: AstraZeneca resumes Phase-3 trial in US, J&J prepares for the same
4 years, 1 month ago

Coronavirus vaccine: AstraZeneca resumes Phase-3 trial in US, J&J prepares for the same

Live Mint  

AstraZeneca has resumed the Phase-3 trial of its experimental coronavirus vaccine in US, said the US Food and Drug Administration, putting research into two of the leading candidates for a Covid-19 inoculation back on track. "As this trial resumes, I am hoping the message communicated to the public is that we are following procedures to highest ethical standard and not …

Coronavirus vaccine update: AstraZeneca resumes US vaccine trial, J&J to start next week
4 years, 2 months ago

Coronavirus vaccine update: AstraZeneca resumes US vaccine trial, J&J to start next week

India Today  

After being paused for over a month, AstraZeneca Plc has resumed the US trial of its experimental coronavirus vaccine after approval by regulators. AstraZeneca vaccine trials were paused in September AstraZeneca, one of the leading vaccine developers, paused its US trial on September 6 after a report of a serious neurological illness, believed to be transverse myelitis, in a participant …

Column: Drugmaker AstraZeneca teaches Trump why the virus hunt can’t be rushed
4 years, 3 months ago

Column: Drugmaker AstraZeneca teaches Trump why the virus hunt can’t be rushed

LA Times  

Donald Trump’s effort to force science into serving his reelection campaign ran into a pothole Tuesday. These things take time, and one or two months to have all that happen seems not even feasible.” Trump’s preferred timeline assumes that the existing trials proceed perfectly. Those who defend Trump’s cheerleading for a vaccine sometimes argue that the public needs some good …

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