J&J’s US Vaccine Rollout may Resume Apr. 23

FDA Shuts Emergent Biotech’s Baltimore Plant

20.04.2021 - The rollout of Johnson & Johnson’s Covid-19 vaccine could be resumed starting Apr. 23, Anthony Fauci, the top US infectious-disease expert and chief advisor to US president Joe Biden on pandemic-related issues, has told US media.

On Apr. 13, the US  Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) called for a pause in the rollout of the single-dose vaccine after six cases of rare blood clots were observed in recipients.

Fauci suggested that a warning label or some restrictions could potentially be mandated. At present, however, he said there is not enough data to determine whether the suspected adverse reaction affected only women in the age group 18 to 48 as initially seen. This is what federal health officials have been trying to determine over the past week.

The FDA said last week it was recommending the pause in part “to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment this type of blood clot requires.”

FDA Shuts Emergent Biotech’s Baltimore Plant

Meanwhile, at the request of the FDA, production of J&J’s vaccine’ at the Baltimore, Maryland, plant of US biotech Emergent Biosolutions has been shut down. Two weeks earlier, the US had handed over control of the facility to the New Jersey healthcare company and mandated that AstraZeneca find a new CDMO supplier.

The first action came after workers at the plant apparently mixed the ingredients of the two companies’ vaccines that were being made there simultaneously. The second is said to reflect persistent quality issues similar to those the FDA found during an April 2020 inspection of the CDMO's contract testing laboratory

US press reports said the health agency, among other things, had noted in last April’s inspection that the company’s separate or defined areas to prevent contamination or mix-ups were deficient. What’s more, FDA inspectors were unable to find records proving that workers in the biochemistry lab had been trained on Emergent's written procedures or test methods.

The 2020 inspection took place before the Baltimore facility had begun manufacturing Covid vaccines. After the recent ingredient mix-up, it emerged that it had not yet been FDA-certified for the purpose. Nevertheless, the plant received $23 million to boost production of the J&J shot.

Author: Dede Williams, Freelance Journalist