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

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. 

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.