J&J Provides Updates of COVID-19 VaccineBy
Johnson & Johnson (J&J) has provided updates on the manufacturing of its COVID-19 vaccine as well as on its rollout in the US and Europe.
On the manufacturing front, J&J reported that it is working closely with the US government, including the US Food and Drug Administration (FDA), concerning the FDA’s inspection, which concluded on April 20, 2021 of the Bayview facility in Baltimore, Maryland of one of its manufacturing partners, Emergent BioSolutions.
During the inspection of the facility, the FDA cited a number of observations concerning whether the facility’s processes met requirements and standards and issued a Form 483, an inspection close-out report. To date (as of April 21, 2021), the FDA has not authorized the facility to manufacture or distribute any of J&J’s COVID-19 vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the US.
At the FDA’s request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues. For the vaccines already manufactured, the products will undergo additional testing and will be evaluated to ensure their quality before any potential distribution.
J&J had previously announced on April 3, 2021 that it would increase its oversight of drug-substance manufacturing at Emergent BioSolutions’ Bayview facility, including additional controls and personnel, to ensure quality standards are met. Following the FDA’s inspection, J&J said it “will exercise its oversight authority to ensure that all of FDA’s observations with respect to the Emergent facility are addressed promptly and comprehensively.” The company added that it will also continue to work toward securing emergency use authorization in the US for drug-substance manufactured at the Emergent Bayview facility.
J&J reports it is establishing a global vaccine supply network, where, in addition to its internal manufacturing site in Leiden, the Netherlands, 10 manufacturing sites will be involved in the production of the vaccine across different facilities globally.
J&J provides update on COVID-19 vaccine for very rare, adverse event
Separately, J&J reports it will resume shipment of its COVID-19 vaccine in the European Union (EU), Norway, and Iceland following a pause in the rollout of the vaccine pending a review from the European Medicines Agency (EMA) of a very small number of cases of blood clots with low blood platelets in individuals after receiving the vaccine.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) provided updated guidance that a warning about unusual blood clots with low blood platelets, a very rare adverse event, should be added to the vaccine’s product information. PRAC reported that the combination of blood clots and low blood platelets is very rare, and the overall benefits of J&J’s COVID-19 vaccine in preventing COVID-19 outweigh the risks of side effects. The updated EMA and Healthcare Professionals guidance will be available to national healthcare authorities. J&J will also update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet.
J&J’s vaccine received conditional marketing authorization in the EU on March 11, 2021. The rollout of the vaccine in the EU was temporarily paused by the company as the cases were evaluated. In an April 20, 2021 statement, the company says it remains committed to supplying 200 million doses of its COVID-19 vaccine to the EU, Norway and Iceland.
In the US, the Centers for Disease Control and Prevention (CDC) and the FDA currently are reviewing these same cases. On April 14, 2021, the CDC convened a meeting of the Advisory Committee on Immunization Practices (ACIP) to review these cases and assess their potential significance. The ACIP plans to reconvene on April 23, 2021, for further discussion.