Can you now get the J&J vaccine in the US?
The Johnson & Johnson one-shot vaccination was supposed to make distibution easier, but a small number of blood clots forced the CDC to reassess its use.
The United States has resumed use of the Johnson & Johnson covid-19 vaccination after health regulators lifted an 11-day pause. The vaccination’s use was temporarily suspended at the start of this month after reports of recipients suffering from rare blood clots.
Around eight million doses of the J&J vaccine had been administered before the pause and the Centers for Disease Control and Prevention (CDC) have so far found 15 cases of the rare disorder known as cerebral venous sinus thrombosis.
But despite now getting the green light from the CDC, manufacturing issues in one of the factories producing the one-shot vaccination threaten to delay the distribution process.
US lifts J&J pause after CDC verdict
After conducting their own research into the scale of the problem, the CDC and the Food and Drug Administration (FDA) decided that the benefits outweighed the small risk of blood clots.
The J&J vaccine is the only on-shot vaccination currently approved for use in the United States and it offers a much easier way to get individuals in isolated communities immunised against the virus. The highest rate of blood clots was found amongst women aged between 18 and 49, with a frequency of seven instances of thrombosis per million shots administered.
The CDC has learned of 15 cases of the rare blood clot condition linked with Johnson & Johnson’s coronavirus vaccine, per CDC’s Dr. Tom Shimabukuro.— Kaitlan Collins (@kaitlancollins) April 23, 2021
— All have been women
— 13 were women under the age of 50
— 3 died and 7 are hospitalized
Dr. Janet Woodcock, acting commissioner of the FDA, said: "Both agencies have full confidence that this vaccine's known and potential benefits outweigh its known and potential risks in individuals 18 years and older.”
Manufacturing issues plague Johnson & Johnson distribution
Aside from the concern over the rare side effect, the rollout of the J&J vaccine has been complicated by issues in the manufacturing process. To speed up the production Johnson & Johnson have licensed around ten other companies to make the one-shot vaccine in their own facilities.
However that has caused additional problems with a factory in Baltimore blamed with the contamination of millions of vaccine doses. It is reported that workers at a plant ran by emergent BioSolutions mixed up the ingredients for the Johnson & Johnson and AstraZeneca vaccines, both of which are made on site. The human error is thought to have rendered up to 15 million doses unusable, and has delayed shipments of the J&J vaccine.
FDA’s @DrWoodcockFDA & Peter Marks add in statement that Emergent’s production of J&J vaccine will be paused, no product released until issues at plant are resolved.— Meg Tirrell (@megtirrell) April 21, 2021
This is the only U.S. plant making J&J #covid19 vaccine drug substance at the moment, until Merck comes on board. pic.twitter.com/Bd1ob3wCtX
That mix-up sparked an FDA investigation into the Baltimore factory which found that the facility was not suitable for producing the vaccines. The support outlines nine areas of concern, from peeling paint and damaged floors to insufficient training for staff members.
The FDA found that the site was not in a “clean and sanitary condition” and the manufacturing process left the doses produced there susceptible to cross-contamination. An unknown brown residue was found on both the floors and the walls in the room in which vials are filled with vaccine doses.
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