Health

FDA ordered Johnson & Johnson to throw out 60 million COVID-19 vaccine doses

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, which a source told Reuters will be 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 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

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

It’s unclear if the ruined shots were meant to be distributed in the U.S. or to other countries.

Several hard-hit nations around the world have been asking America to send them the government’s stockpile of vaccines, and the blunder means shipments could be delayed even further.

Among those countries is India, which has been facing a devastating second wave of the COVID-19 pandemic, which reporting more than 6,000 deaths on Thursday – the highest number recorded in the world.   

The Biden administration had been under intense pressure to send excess doses of vaccines to nations like India, which was hit by raw material shortages, limiting the number of people who could get vaccinated.

Additionally Latin America is a region in desperate need of vaccines, with eight of the 10 countries with the highest COVID-19 deaths per capita in Latin America and the Caribbean, according to The Times.

Only about two million have been vaccinated in Central America and and three million have been in the Caribbean, which is home to 44 million 34 million, respectively.

‘Today we’re seeing the emergence of two worlds, one quickly returning to normal and another where recovery remains a distant future,’ said Dr Carissa Etienne, director of the Pan American Health Organization – part of the WHO – said at a virtual news conference on Wednesday.

‘Unfortunately, vaccine supply is concentrated in a few nations while most of the world waits for doses to trickle down.’

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.

FDA ordered Johnson & Johnson to throw out 60 million COVID-19 vaccine doses

The bungle means doses can't be sent to India, which is facing a shortage of vaccines and a surge of COVID-19 cases and deaths

The bungle means doses can’t be sent to India, which is facing a shortage of vaccines and a surge of COVID-19 cases and deaths

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.’

FDA ordered Johnson & Johnson to throw out 60 million COVID-19 vaccine doses

FDA ordered Johnson & Johnson to throw out 60 million COVID-19 vaccine doses

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. 

FDA ordered Johnson & Johnson to throw out 60 million COVID-19 vaccine doses

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