The U.S. Food and Drug Administration (FDA) ordered Johnson & Johnson on Friday to dispose of 60 million COVID-19 vaccine doses.
The shots were made at a Baltimore facility that exhibited multiple health injuries and destroyed millions of doses of the J&J vaccine during an ingredient mix-up.
The contract that J&J signed with the U.S. government last year cost roughly $ 10 each dose, which means $ 600 million worth of cans will be discarded – but federal officials are not believed to be the company for pay those stitches.
Earlier in the day, the FDA allowed the distribution of 10 million cans that a source told Reuters would be given to other countries, but with the caveat that there is no guarantee that the J&J shots were made under good manufacturing practices were manufactured.
It has not yet been decided whether the facility operated by Emergent BioSolutions will not be allowed to reopen after it was closed two months ago.
Officials say there is no need to worry that Americans received ruined shots because all of the J&J doses administered in the US to date have been made at the Janssen plant in the Netherlands rather than the Baltimore plant.
Critics say this is a colossal mistake by everyone – the FDA, Johnson & Johnson, and Emergent – in efforts to distribute vaccines to countries suffering from shortages.
The FDA has ordered that 60 million doses of Johnson & Johnson’s coronavirus vaccine be discarded on Friday Pictured: Johnson & Johnson COVID-19 vaccine vials on a table in Los Angeles, Jan.
The shots were made at an Emergent BioSolutions-operated facility in Baltimore (above) that has come under fire after multiple violations
The FDA has been working on a solution for weeks after it was discovered that the Emergent BioSolutions facility ruined millions of J&J vaccines.
They became unusable after workers mistakenly mixed up ingredients for the J&J shot with those for the AstraZeneca jab.
A report released by the US House of Representatives Committee last month found that workers making the vaccine were often unable to shower or change.
Although J&J commissioned Emergent to manufacture the vaccine in April 2020, the Baltimore facility was not designed to produce millions of doses, according to an FDA inspection last year.
The FDA records – released as part of the House report – described the facility as a contract testing laboratory that “did not make products for sale”.
The inspection also found there was “mold, poor disinfection of plant equipment and insufficient training of staff”.
After the news of the discarded cans, J & J’s shares fell 1.6 percent.
J&J has shipped 21.4 million doses of its COVID-19 vaccine to the US, but only half have been given, compared to 129 million people who were fully vaccinated with Pfizer and Moderna vaccinations
It is unclear whether the destroyed recordings should be distributed in the USA or in other countries.
Several hard-hit nations around the world have asked America to send them government vaccine supplies and the mistake means deliveries could be delayed even further.
Those countries include India, which has faced a devastating second wave of the COVID-19 pandemic and reported more than 6,000 deaths on Thursday – the highest number recorded in the world.
The Biden government was under heavy pressure to send vaccine overdoses to countries like India, which was suffering from raw material shortages, which limited the number of people who could be vaccinated.
Additionally, Latin America is a region in dire need of vaccines, according to The Times, with eight of the 10 countries with the highest COVID-19 deaths per capita in Latin America and the Caribbean.
Only about two million have been vaccinated in Central America and three million in the Caribbean, where 44 million and 34 million live respectively.
“Today we see the emergence of two worlds, one quickly returning to normal and another where recreation remains a distant future,” said Dr. Carissa Etienne, Director of the Pan American Health Organization – part of WHO – at a virtual news conference on Wednesday.
“Unfortunately, vaccine supply is concentrated in a few nations while most of the world is waiting for the doses to trickle down.”
It was announced on Thursday that the US government has stopped all new shipments of the J&J vaccine this allows injection sites to clear a jam of unused cans before they expire.
The botch means doses cannot be sent to India, which is facing a shortage of vaccines and an increase in COVID-19 cases and deaths
State and federal health officials told the Wall Street Journal that the single-dose vaccine will not be available for several weeks, but the suspension is considered temporary.
Officials in Arkansas, Illinois, Maryland, Michigan, and Oklahoma said they had not been able to order new J&J vaccines for several days, even weeks.
“It just didn’t get on our weekly federal allotments, which means it can’t be ordered,” Oklahoma 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 cans a few weeks ago.
When he and his team tried to order more, the government informed them that the vaccine was not available and did not give a date when it would be.
“We ran out of inventory in the state,” Mroz said.
“We definitely have more supply than demand.”
J & J’s vaccine was considered a game changer in the fight against the coronavirus because it only needs one and doesn’t need to be stored at freezing temperatures.
It was expected that it should be used to vaccinate hard-to-care populations such as those in rural areas and the home-bound seniors.
However, as of Friday, Pfizer and Moderna had fully vaccinated more than 129 million Americans with their two-dose vaccinations and had agreements with the US government on enough vaccinations to vaccinate all adults.
By comparison, only 11 million Americans were vaccinated with the J&J shot.
The loss of the 60 million doses means the US is even less likely to hit Biden’s target of 70 percent of Americans with at least one COVID-19 vaccine dose by July 4th.