COVID-19 VACCINES: US announces it will release J&J vaccine from closed down factory in Baltimore. Could Jamaica receive any?

According to the Associated Press (AP), US regulators will allow the release of 10 million doses of Johnson & Johnson's COVID-19 vaccine from the closed down vaccine factory in Baltimore. Unfortunately, millions of other doses will have to be discarded. 

They said that the Food and Drug Administration on Friday had announced that it had determined that two batches of the J&J vaccine could be released, from a plant that has been shuttered for several weeks. The plant called Bayview, is owned by Emergent BioSolutions. The FDA however noted that a significant number of batch were not "suitable for use" and that additional batches are currently under review.  

The agency wouldn't specify why those batches can't be used, but a person familiar with the decision told The Associated Press that it was due to possible contamination. The person wasn't authorised to release details about the decision and spoke to the AP on condition of anonymity.

The FDA's decision means that the two batches from the factory can be used in the US or exported to other countries. They will be the first J&J vaccines from Bayview approved for use.

The agency said the vaccines are "critically needed," given the current public health emergency. It also said it made the decisions after reviewing records and the results of the manufacturer's quality testing.

"This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA's" manufacturing requirements, Dr Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

The FDA, however, stopped short of allowing the plant to restart vaccine production. The agency said it was working through issues there with J&J and Emergent BioSolutions management.

Emergent is one of several J&J contractors that produce its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.

Roughly 100 million doses made from bulk vaccine produced at Emergent's factory, including those just approved for use, had been set aside for additional review by FDA staff after factory employees accidentally contaminated an earlier batch.

That contamination led the FDA to shut down the factory in mid-April and send in a team of inspectors. They spent a week going through the factory and reviewing security camera footage that showed employees carelessly handling vaccine materials. The inspectors reported unsanitary conditions, poorly trained employees and other problems.

The lapses have hampered J&J's efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it's the only drugmaker with an authorised vaccine that only requires one dose and standard refrigeration. It's also cheaper than some other vaccines.

The productions problems have forced J&J to import millions of doses from its factory in the Netherlands to the US and to miss supply commitments.

Emergent's factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, yet it was given a huge role in COVID-19 vaccine production by the Trump administration. Emergent was handed a lucrative contract to make many millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.

Emergent's chief executive has blamed the contamination and other problems on the complexity of scaling up the factory in just months to make two different vaccines.

The Biden administration is working to find a different American manufacturing partner for the British drugmaker, which has yet to request authorisation to distribute it in the US.

Meanwhile in Jamaica, Minister of Health and Wellness, Dr. Christopher Tufton, said he and his team are expecting to receive the island's first shipment of the Johnson & Johnson COVID-19 vaccine in August.

The Minister gave this update during the COVID Conversations and digital press conference, held virtually on Thursday (June 10).

“We continue to work to get additional vaccines. You may have heard that we have paid down a fairly substantial sum, just over $350 million for 1.9 million doses of Johnson & Johnson vaccine, with first shipment to arrive in August,” Dr. Tufton said.

“That Johnson and Johnson delivery will take place over several months and, of course, that is a single-jab vaccine,” he pointed out.

It has not been indicated whether the doses the country will receive comes from the ill-fated factory in Baltimore.

Could Jamaica receive any of the doses? 

On Monday, May 17, US president Biden had pledged to share over 20 million of its extra doses of Covid-19 vaccines to the rest of the world. He announced that the super power will share millions of supplies of Pfizer, Moderna, Johnson & Johnson and the not yet authorized AstraZeneca batches to poorer countries. 

According to National Public Radio (NPR) News, Biden told reporters at a press briefing on the country's progress in fighting the disease: "We need to help fight the disease around the world. It's the right thing to do, it's the smart thing to do, it's the strong thing to do."

So yes, it could be a possibility. We'll find out more as the time comes closer. And we'll post details here on this blog.

*Current COVID-19 Stats:

According to the Ministry of Health as at June 12, Jamaica now has 49,232 confirmed cases of COVID-19. Fifty-three (53) new cases have been recorded within the last 24 hours.

 The death toll for the disease has risen to 969 up by 6 new casualties of the virus. There are currently 20,499 active cases and 27,365 persons who have recovered from the virus.

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References:

Johnson, Linda A. & Zeke Miller. Some J&J vaccine doses can be used, but many must be tossed. The Associated Press. Published June 11, 2021.  https://apnews.com/article/government-and-politics-coronavirus-pandemic-business-health-d67646ba072e5eb4e574005174d1c184

Morris, Ainsworth. First Shipment Of Johnson & Johnson Vaccine In August. The Jamaica Information Service. Published June 11, 2021. https://jis.gov.jm/first-shipment-of-johnson-johnson-vaccine-in-august/

*Covid-19 stats: COVID-19 Clinical Management Summary for Friday, June 11, 2021. Ministry of Health & Wellness. Published June 12, 2021. https://www.moh.gov.jm/covid-19-clinical-management-summary-for-friday-june-11-2021/

National Public Radio. U.S. To Ship 20 Million Additional COVID Vaccine Doses Overseas. The Coronavirus Crisis. Published May 17, 2021. https://www.npr.org/2021/05/17/997575473/u-s-to-ship-20-million-additional-covid-vaccine-doses-overseas