Johnson & Johnson JNJ announced that it is taking full responsibility of manufacturing partner, Emergent BioSolutions’ EBS Baltimore Bayview facility that ruined its COVID-19 vaccine doses due to some employee blunder several weeks ago. J&J said that it will supervise and direct all critical manufacturing operations at the plant by increasing the number of manufacturing, quality and technical operations personnel at the facility.
J&J’s stock has risen 3.4% so far this year against 0.5% decrease of the industry.
Last week, J&J issued a statement that a batch of drug substance for its COVID-19 vaccine manufactured at Emergent’s Bayview facility had failed to meet quality standards. Reportedly, workers at Emergent's Bayview facility had mixed up vaccine ingredients of J&J’s and AstraZeneca’s AZN vaccines. Emergent has partnered with both J&J and AstraZeneca to help in manufacturing of their respective COVID-19 vaccines. The incident reportedly ruined 15 million doses of J&J’s vaccine. The facility is not yet authorized to manufacture the drug substance for J&J’s vaccine, which means that the ruined doses were not used for vaccinations. Nonetheless, J&J is working closely with the FDA to get Emergency Use Authorization (EUA) for the Emergent Bayview facility.
U.S. health officials have now put J&J incharge of the facility, implying that the plant will now only make J&J’s vaccine to rule out any future mix ups. AstraZeneca will work with President Joe Biden’s administration to find an alternative site to manufacture its vaccine. Please note that AstraZeneca’s vaccine has not yet been granted EUA in the United States by the FDA.
Despite the potential delay in shipments due to the Bayview blunder, J&J targets to deliver 24 million doses to the U.S. government in April and 100 million doses by the end of May. Meanwhile, the U.S. Department of Health & Human Services has increased Emergent’s task order by $23 million to support manufacturing of J&J’s COVID-19 vaccines.
J&J’s single-dose COVID-19 vaccine was granted EUA by the FDA in February. Its vaccine is the only COVID-19 vaccine to be approved for single administration. Other approved vaccines globally, including Pfizer PFE/BioNTech’s BNT162b2, Moderna’s mRNA-1273 and AstraZeneca’s C19VAZ are approved as two-dose dosing regimens separated by three/four weeks. A single dose will require lesser production, which is a key when vaccines are in short supply. A single-dose vaccine also ensures patient convenience.
J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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