The U.S. Food and Drug Administration (FDA) ordered Johnson & Johnson to discard 60 million COVID-19 vaccine doses on Friday.
The shots were made at a plant in Baltimore that had several health violations and ruined million of doses of J&J vaccine during an ingredient mix-up.
People familiar with the situation told The New York Times that the FDA said the shots have to be thrown away due to potential contamination.
The contract J&J signed with the U.S. government last year priced each dose at roughly $10, meaning $600 million worth of doses are being tossed out – but it’s not believed federal officials with pay the company for these jab.
Earlier in the day, the FDA allowed 10 million doses to be distributed in the U.S. and to other countries, but with a caveat that there is no guarantee the J&J shots were made under good manufacturing practices.
It has not been decided yet whether not the plant, run by Emergent BioSolutions, will be allowed to reopen after closing two months ago.
Officials say there is no cause for concern that Americans received ruined shots because all J&J doses administered in the U.S. so far were manufactured at the firm’s Janssen plant in the Netherlands, not at the Baltimore plant.
Critics say this represents a colossal blunder by all parties involved – the FDA, Johnson & Johnson and Emergent – in the effort to get vaccines distributed to countries that are suffering from a shortage.
The FDA has ordered 60 million doses of Johnson & Johnson’s coronavirus vaccine to be discarded on Friday Pictured: Johnson & Johnson COVID-19 vaccine vials on a table in Los Angeles, May 7
The shots were made at a Baltimore plant run by Emergent BioSolutions (above), which has come under fire after receiving several violations
The FDA has been working for weeks to come up with a solution after it was discovered that Emergent BioSolutions’ plant ruined millions of J&J vaccines.
They were left unusable after workers accidentally mixed-up ingredients for the J&J shot with that of the AstraZeneca jab.
A report released by the U.S. House Oversight Committee last month found that workers producing the vaccine often failed to shower or change clothes.
What’s more, despite J&J contracting Emergent in April 2020 to manufacture the vaccine, the Baltimore facility wasn’t scaled for making millions of doses, according to an FDA inspection which was conducted last year.
The FDA records – released as part of the House report – described the plant as a contract testing laboratory that ‘did not manufacture products for distribution.’
Further, the inspection also noted there was ‘mold, poor disinfection of plant equipment and inadequate training of employees.’
Upon news of the discarded doses, shares of J&J were down 1.6 percent.
J&J has delivered 21.4 million doses of its COVID-19 vaccine to the U.S., but only half have been administered compared to 129 million people fully vaccinated with Pfizer and Moderna shots
On Thursday, it was revealed that the U.S. government had stopped all new shipments of the J&J inoculation so vaccination sites can clear a logjam of unused doses before they expire.
State and federal health officials told The Wall Street Journal that the one-dose vaccine won’t be made available for several weeks but the cessation is believed to be temporary.
Officials in Arkansas, Illinois, Maryland, Michigan and Oklahoma say they have not been able to order new J&J vaccine supplies for several days, even weeks.
‘It just hasn’t been included in our weekly allocations, from the feds, which means it is not available to order,’ Oklahoma State Department of Health Deputy Commissioner Keith Reed told the newspaper
Maryland Department of Health Assistant Secretary Bryan Mroz told The Journal that the state last ordered a shipment of doses several weeks ago.
When he and his team tried to order more, the government told them the vaccine was not available, and did not give a day for when it would be,
‘We’ve been using up our inventory in the state,’ Mroz said.
‘We definitely have more supply than demand.’
J&J’s vaccine was believed to be a game-changer in the fight against coronavirus because it only require one and does not need to be store at freezing temperatures.
It was expected to be used to inoculate hard-to-serve populations such as people living in rural areas and home bound seniors.
However, as of Friday, Pfizer and Moderna have fully vaccinated more than 129 million Americans with their two-dose shots and have made agreements with the U.S. government for enough does to vaccinate all Adults.
Comparatively, just 11 million Americans have been vaccinated with the J&J shot.
The loss of the 60 million doses means the U.S. is even more unlikely to reach Biden’s goal of 70 percent of Americans with at least one COVID-19 vaccine dose by July 4.