15 million doses of J&J vaccine ruined by ingredient mix-up

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.

Emergent BioSolutons, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the U.S. by the end of May. 

But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold 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.

Johnson & Johnson said Wednesday that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, can’t be used because employees accidentally swapped in an ingredient meant for a different vaccine into the J&J shot, the New York Times reported Wednesday. 

The Emergent BioSolutions plant is also manufacturing doses for AstraZeneca, and apparently used an ingredient for the UK firm’s vaccine in a batch of J&J’s. 

The gaff occurred two weeks ago and will delay tens of millions doses of J&J’s shot slated to ship next month while the FDA investigates. 

J&J blamed the mix-up on human error and says that 11 million doses that shipped this week were not affected. 

Johnson & Johnson will meet its goal of delivering 20 million doses of its one-dose COVID-19 vaccine to the U.S. by the end of March, with a whopping 11 million doses shipping next week

Johnson & Johnson will meet its goal of delivering 20 million doses of its one-dose COVID-19 vaccine to the U.S. by the end of March, with a whopping 11 million doses shipping next week

Some 15 million doses of Johnson & Johnson’s one-shot coronavirus vaccine have been ruined after employees at a Baltimore manufacturing plant accidentally swapped two ingredients

White House officials told the Times that the J&J fiasco will not prevent the U.S. from reaching President Biden’s goal of having enough COVID-19 vaccine doses in the national stockpile to inoculate every American adult by the end of May.   

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. 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 that 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´s 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 the company 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, Johnson & Johnson, 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.

Other problems cited by the FDA during the April 2020 inspection included failures by the Bayview plant ‘to ensure that electronically held data generated during analytical testing’ of material ‘was protected from deletion or manipulation.’ The FDA´s lead investigator, Marcellinus Dordunoo, wrote that Emergent hadn´t investigated what he described as ‘data integrity concerns.’

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 hadn´t corrected ‘continued low level mold and yeast isolates’ found in the facility. Nearly a year later, 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 is filled into vials.

Emergent´s revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone.

 Because Johnson & Johnson’s vaccine is authorized by the FDA to provide protection against COVID-19 with a single dose, a delay in its shipments is an even larger dent in the U.S. vaccination campaign than the loss of doses made by another firm would have been. 

Fifteen million doses of the J&J shot would have been enough to fully vaccinate 15 million Americans. 

The same number of shot made by Moderna or Pfizer would only have been enough to fully vaccinate 7.5 million people.

FDA officials are currently investigating the monumental mistake made at the plant. 

Shipments from Moderna and Pfizer remain on track, and Pfizer is prepared to expedite doses that re ready to ship earlier than expected. 

But the loss of 15 million doses of Johnson & Johnson’s one-dose vaccine will be a major blow to the U.S. rollout in the coming weeks. 

Worse yet, the affected plant was supposed to be responsible for next month’s entire U.S. supply of J&J’s vaccine. 

The last batches came from a facility in the Netherlands. 

In light of the error, regulators will refuse to give clearance to the plant to make and distribute the vaccine. 

Emergent’s massive plant is responsible for manufacturing the actual vaccine serum that goes into J&J’s vials. 

A second plant located in Indiana and owned by Catalent does the ‘fill and finish’ or final stages of getting vaccine into vials.  

Having just one relatively small vaccine-making facility likely contributed to the disappointing first shipment of just four million doses of J&J’s precious vaccine, rather than tens of millions. 

That first embarrassing shortfall was revealed days before J&J’s shot was authorized by the FDA. 

Impressively, the firm made it just under the wire to meet its goal of providing the U.S. with 20 million doses of its vaccine by the end of March by shipping a massive 11 million doses this week. 

But now J&J is headed for more delays. 

The U.S. purchased a second hundred million doses from J&J earlier this month. 

Moderna will soon be able to ramp up its shipments of vaccine doses by filling each vial with 15 doses, and Pfizer is currently ahead of its production schedule. 

The U.S. is giving an average of 2.8 million COVID-19 shots a day, and with the steady supply of Moderna’s and Pfizer’s vaccines, Biden’s goals of 200 million doses given in the first 100 days of his term. 

President Joe Biden has pledged to have enough vaccines for all U.S. adults by the end of May. The U.S. 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 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, and the Centers for Disease Control and Prevention´s online vaccine tracker showed J&J had provided about 6.8 million doses to the U.S. vaccine effort. J&J has been shipping finished vaccines from its factory in the Netherlands to the U.S.

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.

HOW DO THE THREE COVID-19 VACCINES AUTHORIZED IN THE US COMPARE?

PFIZER

WHEN WAS IT APPROVED? December 11, 2020 

WHO CAN GET IT? Anyone 16 or older

DOSAGE: 2 doses, given 21 days apart 

HOW DOES IT WORK? Uses messenger RNA to deliver a tiny bit of genetic code from the virus to ‘teach’ the body to make a protein that provoke antibody production  

HOW EFFECTIVE IS IT… 

AFTER 2 DOSES: 95% effective at preventing illness; 100% effective at preventing COVID-19 death; 87% effective at preventing hospitalization

AFTER FIRST DOSE: (not recommended) ~46% effective at preventing infection seven to 20 days later; 57% effective against against symptomatic illness; 72% effective at preventing death; 74% effective against hospitalization; 62% effective against severe illness (based on real-world data from Israel) 

AGAINST VARIANTS FROM…  

UK – B117: No significant impact 

South Africa – B135110% less effective; still protective 

Brazil  – P1: 10.4-fold weaker antibodies; still protective 

MODERNA 

WHEN WAS IT APPROVED? December 18, 2020 

WHO CAN GET IT? Anyone 18 or older

DOSAGE: 2 doses, given 28 days apart 

HOW DOES IT WORK? Uses messenger RNA to deliver a tiny bit of genetic code from the virus to ‘teach’ the body to make a protein that provoke antibody production  

HOW EFFECTIVE IS IT… 

AFTER 2 DOSES: 94% effective at preventing illness; 100% effective at preventing COVID-19 death; 89% effective at preventing hospitalization

AFTER FIRST DOSE: (not recommended) ~80% effective, based on trial data 

AGAINST VARIANTS FROM…  

UK – B117: No significant impact 

South Africa – B1351: 10% less effective; still protective 

Brazil  – P1: More data needed 

JOHNSON & JOHNSON 

WHEN WAS IT APPROVED? February 27, 2021

WHO CAN GET IT? Anyone 18 or older

DOSAGE: 1 dose

HOW DOES IT WORK? Uses a harmless, inactivated cold virus to carry piece of spike protein into body to teach it to fight SARS-CoV-2 

HOW EFFECTIVE IS IT… 

AFTER SINGLE DOSE: 72% worldwide; 86% in the US  

AGAINST VARIANTS FROM…  

UK – B117: No significant impact 

South Africa – B1351: 64% effective

Brazil  – P1: 85% effective 

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