At least 10 MILLION AstraZenaca vaccine doses were tossed at US plant

At least 10 MILLION AstraZenaca COVID-19 vaccine doses had to be thrown away last year at the same Baltimore production plant that ruined 15M Johnson & Johnson doses last week

  • Emergent BioSolutions in Baltimore discarded 15 million doses of Johnson & Johnson vaccine last week due to contamination with AstraZeneca vaccine 
  • Since then, it has been learned that the plant was cited for several lapses in upholding standard industry safety regulations, according to New York Times 
  • Last fall, plant threw out between 10 million and 15 million doses of the AstraZeneca vaccine due to suspected contamination, Times reported 
  • Last year, Emergent received a combined $1.5billion from the federal government, J&J, and AstraZeneca to mass produce COVID-19 vaccines 
  • Since then, it has manufactured 150 million doses of COVID-19 vaccines, but so far none have made it into the arms of Americans due to safety concerns 
  • Federal government last week ordered J&J to take over operations at the plant after it was forced to discard the 15 million doses of vaccine 
  • Biden administration also ordered the plant to work exclusively on the J&J vaccine and to halt manufacturing of the AstraZeneca shot 

The Baltimore plant that discarded 15 million doses of Johnson & Johnson’s COVID-19 vaccine last week threw away up to 15 million doses of the AstraZeneca vaccine last year.

And it may have to scrap up to 120 million more due to shoddy factory conditions, according to the New York Times: Included would be 62 million of possibly bad J&J doses and around 58 million AstraZeneca doses.

Emergent BioSolutions, the factory, announced last week that it was forced to throw out 15 million doses of the J&J vaccine due to fears that the vaccine was contaminated with elements of the AstraZeneca vaccine.

The loss of the 15 million doses came just months after the same Baltimore plant had to discard between 10 and 15 million doses of the AstraZeneca vaccine due to suspected contamination, according to The New York Times.

The mishaps took place after Emergent received a $628million contract from the federal government to improve the plant and prepare to manufacture a high volume of vaccine. 

It then struck deals with J&J and AstraZeneca for a combined $875million. In total, Emergent received $1.5billion to churn out hundreds of millions of doses of COVID-19 vaccine – though so far none of have been administered, according to the Times. 

Of the 150 million doses produced at the plant, none have made it into Americans’ arms as of Tuesday. 

After the latest mishap, the Biden administration ordered J&J to take over operations at the Emergent plant, which will now solely be devoted to manufacturing the J&J vaccine. 

The Emergent BioSolutions plant in Baltimore, Maryland is pictured above on Thursday. Last fall, the plant discarded between 10 million and 15 million doses of the AstraZeneca vaccine due to suspected contamination. Last week, 15 million doses of the Johnson & Johnson vaccine were thrown out

The Times, citing internal logs, also quoted former employees who said that the plant’s management placed little emphasis on basic safety procedures and regulations.

A spokesperson for Emergent, Matt Hartwig, told ‘No one, including employees at Emergent, wants to see vaccines that cannot be used. 

‘We empathize with everyone’s desire to see the pandemic come to an end. 

‘We are laser-focused on supporting Johnson & Johnson’s goal of establishing a strong global supply chain for their COVID-19 vaccine.

‘Unfortunately, a batch of drug substance can fail to meet rigorous quality standards especially during the early part of the manufacturing process. 

‘Importantly, our quality control systems are working as designed to detect and isolate any batch that fails to meet quality standards for any reason. 

‘Emergent has rigorous safety, quality, and compliance processes that allow early identification of issues and means to address them when they arise. 

‘Any allegation that our safety, quality, and compliance systems are not working or that we do not take these responsibilities seriously is unequivocally false.

‘We remain exceedingly proud of the role the Emergent team is playing in support of the response to COVID-19 to help stem this pandemic. 

‘While being unfairly attacked, more than 400 Emergent employees continue to work literally around the clock to manufacture the drug substance for hundreds of millions of vaccinations.’ 

A medical worker holds a vial of AstraZeneca COVID-19 vaccine at a vaccination center in Belgium on Tuesday. The White House says that the decision to halt production of the vaccine at the Baltimore plant is not a reflection of the vaccine’s efficacy or safety

But former officials at the company told the Times that management was lax in enforcing industry safety standards.

When one senior manufacturing supervisor was told about repeated quality errors at the plant, they responded: ‘Do you want me to make drugs or fix issues? I don’t have time to do both.’

J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal funding.

Emergent was a key to J&J’s plan to deliver 100 million doses of its single-shot vaccine to the United States by the end of May.

But the Food and Drug Administration repeatedly has cited Emergent for problems such as poorly trained employees, cracked vials and problems managing mold and other contamination around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act.

The records cover inspections at Emergent facilities since 2017.

J&J said last week that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, cannot be used because it did not meet quality standards.

It was unclear how the problem would affect future deliveries of J&J’s vaccine.

The company said in a statement it was still planning to deliver 100 million doses by the end of June and was ‘aiming to deliver those doses by the end of May.’

White House press secretary Jen Psaki said Thursday that none of the J&J vaccine doses on the market are affected and the company was on track to deliver 24 million doses in April and 100 million doses by the end of May.

‘These are doses that the US government has purchased, but we also have plenty of doses from Pfizer and Moderna, regardless, Psaki said.’

J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal money.

At the time, Emergent’s Bayview facility wasn’t scaled for making millions of doses of a potential COVID-19 vaccine, according to the FDA records, which describe the plant as a contract testing laboratory that ‘did not manufacture products for distribution.’

Upgrades in technology and personnel were required before Bayview could begin making what is known as ‘drug substance’ material for the vaccine, a two-month process during which the required biological cells are grown.

The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced.

The federal agency criticized Emergent for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP.

The FDA’s lead investigator cited the company for failing to train employees ‘in the particular operations they perform as part of their function and current good manufacturing practices.’

On the same day, J&, in a separate news release, heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of the vaccine globally by the end of 2021.

But the FDA’s inspection of Emergent’s Bayview plant had faulted the company for a series of quality control shortcomings, according to the records. Although the inspection was not triggered by work on a COVID-19 vaccine, the issues listed by agency inspectors stand out due to the large role Emergent would soon have to combat the pandemic.

The FDA criticized the Bayview plant for failing to ensure that electronic data generated through testing of drug ingredients ‘was protected from deletion or manipulation.’

A closer review found 202 deletions and 543 reprocessed files, yet the company had not investigated how those alterations had occurred or their possible impact, according to the records.

The FDA’s lead investigator, Marcellinus Dordunoo, wrote that Emergent had not investigated what he described as ‘data integrity concerns.’

Emergent was paid $1.5billion by the federal government as well as Johnson & Johnson and AstraZeneca to mass produce the COVID-19 vaccine. The image above shows a vial of the Johnson & Johnson vaccine in Lakewood, California on March 31

Emergent also did not follow proper testing and lab procedures at Bayview, the FDA said, noting that ‘deviations from test methods are not investigated, and are manually corrected days after performance, with no supporting data or documented justification.’

The FDA also criticized Emergent for carelessness in the handling of rejected materials in the Bayview plant.

An inspector observed items in a ‘reject cage’ that did not have reject labels, and wrote that ‘separate or defined areas to prevent contamination or mix-ups are deficient.’

The inspection was the most recent in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a plant in Canton, Massachusetts, in which the FDA said the company had not corrected ‘continued low level mold and yeast isolates’ found in the facility.

Halting AstraZeneca vaccine at Baltimore plant is not a reflection of its safety, White House official says 

A US government decision to end production of AstraZeneca’s COVID-19 vaccine at Emergent BioSolutions Inc’s Baltimore manufacturing facility is not an indication of concerns about its safety or effectiveness and will not impact the output of doses, a White House official said on Monday.

The US Department of Health and Human Services (HHS) ordered Johnson & Johnson to take charge of production at the plant that was being used to produce both vaccines. 

Emergent was told to stop making AstraZeneca’s shot after the contract manufacturer made an error that ruined 15 million J&J COVID-19 vaccine doses.

‘This is not a decision that in any way has anything to do with any concerns about the AstraZeneca vaccine,’ White House COVID-19 adviser Andy Slavitt told reporters during a virtual news conference.

The AstraZeneca shot, which is being used in dozens of countries, has been under increased scrutiny over reports of extremely rare but serious blood clots in the brain in some people who received the vaccine.

The US manufacturing mistake occurred several weeks ago, when it was discovered that a batch of J&J vaccine had been contaminated with ingredients from AstraZeneca’s vaccine, The New York Times reported last week.

J&J on Saturday reiterated that it will deliver 100 million doses to the government by the end of May.

Emergent said on Sunday would ramp down production of AstraZeneca´s COVID-19 vaccine at the Baltimore plant.

AstraZeneca, whose vaccine has not yet been authorized for use in the United States, said it will work with the Biden administration to find an alternative production site.

‘This is a decision that HHS made with Johnson & Johnson and AstraZeneca in complete collaboration,’ Slavitt said.

Slavitt also said during Monday’s briefing that nearly one-in-three Americans have had at least one COVID-19 shot and more than 55 per cent of seniors have been fully vaccinated.

However, average daily coronavirus infections have increased 7 per cent over the previous seven-day period to around 64,000 daily, Dr. Rochelle Walensky, head of the US Centers for Disease Control and Prevention, told reporters on Monday.

The United States has shipped out nearly 208 million COVID-19 shots and administered more than 165 million, according to federal data last updated on Sunday. 

In September 2018, agency investigators questioned why Emergent had ‘an unwritten policy of not conducting routine compliance audits’ at a separate plant in Baltimore, known as Camden, where an anthrax vaccine, BioThrax, is filled into vials.

A few months earlier, FDA inspectors noted that the company’s processes there were flawed.

‘Your firm received 3 complaints for residue on the outside of the vials for 3 different lots,’ the FDA’s inspection report said.

Tests on that residue confirmed it was vaccine, according to the June 2018 report.

The agency, in another finding from that inspection, noted Emergent’s ongoing problems managing contamination at the Camden facility: ‘Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequately established and followed.’

FDA’s inspectors also noted that Emergent staff filling vials of vaccine held ‘their hands directly above open vials’ in a way that violated sterility safeguards.

The FDA declined repeated requests to discuss the inspections at Emergent’s facilities.

A spokesman said the agency ‘cannot comment on any particular company or any potential or ongoing compliance matters.’

In an emailed statement, Hartwig told AP the company’s ‘rigorous quality checks’ identified a batch of drug substance that did not meet its standards.

‘Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,’ he said.

Emergent’s revenues skyrocketed during the Trump administration, from about $523million in 2015 to more than $1.5billion in 2020.

Emergent has invested heavily in lobbying the federal government, according to disclosure records that show the company spent $3.6million on lobbying in 2020 alone.

Emergent is one of about eight companies that J&J is using to speed up manufacturing of its recently approved coronavirus vaccine, the company said.

The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected.

President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May.

The US government has ordered enough two-dose shots from Pfizer and Moderna to vaccinate 200 million people to be delivered by late May, plus the 100 million single-dose shots from J&J.

A federal official said Wednesday evening that the administration’s goal can be met without additional J&J doses.

A J&J spokesman said earlier Wednesday that the company met the end-of-March goal.

The Centers for Disease Control and Prevention’s online vaccine tracker showed J&J had provided more than 12 million doses to the US vaccine effort.

J&J has been shipping finished vaccines from its factory in the Netherlands to the US.

J&J said it was putting more of its manufacturing and quality experts inside Emergent’s factory to supervise production of the COVID-19 vaccine, a move meant to enable delivery of an additional 24 million vaccine doses through April.

J&J said it still expects to deliver more than 1 billion vaccine doses globally by the end of the year.

The J&J vaccine has been viewed as crucial for vaccination campaigns around the world because only one shot is required and it can be shipped and stored at standard refrigeration temperatures, unlike some other vials that must be kept frozen.

The company also has pledged to sell the vaccine without a profit, but only during the pandemic emergency.

The problem with the vaccine batch was first reported by The New York Times.

The FDA said it was aware of the situation but declined further comment. 

After the Biden administration ordered J&J to be put in charge of the plant, it also placed a halt on the shipment of between 120 million and 130 million doses of COVID-19 vaccines.

Of those 62 million doses are of the J&J vaccine while some 58 million are from AstraZeneca. Federal inspectors must give final approval before allowing those doses to be released to the public.

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