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


BREAKING NEWS: Shipments of 15 MILLION doses of Johnson & Johnson’s one dose Covid vaccine will be halted after ingredient mix-up at Baltimore plant

  • Workers at an Emergent BioSolutions plant swapped two ingredients in Johnson & Johnson’s one-dose vaccine 
  • The mix-up happened about two weeks ago but does not affect shipments that went out this week 
  • About 15 million doses due to ship next month were ruined by the ‘human error’ 
  • All of next months J&J doses were set to come from the Baltimore plant and will be halted indefinitely during an FDA investigation
  • White House officials say there will still be enough Covid vaccine doses to inoculate all American adults by May  

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

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. 

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

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. 

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. 

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. 

The Emergent plant only received FDA authorization to make J&J’s vaccine substance on March 23, weeks after the shot’s February 21 authorization. 

Authorization of the large U.S. facility was expected to dramatically speed up the production and rollout of J&J’s doses. 

When it received authorization, only a small plant in the Netherlands had been authorized to produce the J&J shot.  

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. 

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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