US Health Authorities End J&J Rollout Pause
The US Centers for Disease Control and Prevention (CDC) and the Food & Drug Administration (FDA) announced on Apr. 23 that they would lift the two-week pause on administration of the Johnson & Johnson Covid-19 vaccine for all adults and require a warning label about the possibility of a rare but dangerous blood clotting disorder combined with a low level of platelets.
"In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women aged 18-49, and this vaccine could prevent over 4,700 hospitalizations and nearly 600 deaths among women over 50," said CDC director Rochelle Walensky.
The panel’s recommendation to resume the vaccinations followed a presentation of the health authority’s scientists about the potential associated risks. This included information about nine new confirmed cases of the clotting disorder, which brings the total number of reported cases to 15. All of the adverse events have been seen in women, all but two aged 18 to 49 years. Three have died from the clots, and reports said seven remained hospitalized as of Friday, including four in the intensive care unit.
J&J meanwhile is still facing supply issues due to repercussions from the mix-up of 10 to 15 million doses of its vaccine with AstraZeneca’s at the Baltimore, Maryland, plant of Emergent BioSolutions. Emergent’s plant was closed by the FDA last week and will remain shut for an undetermined time as reports of earlier incidents are investigated.
It emerged late last week that most if not all of the AstraZeneca doses released by the US – and shipped by the Anglo-Swedish drugmaker to Canada and Mexico – came from the Baltimore plant. Although authorities have suggested that not all of the mixed doses may have been identified, Canadian and Mexican leaders have assured their populations that the doses received are safe.
In statement, AstraZeneca said the quality information from the plants involved was properly submitted to the relevant regulatory agencies in each country to support authorization and approval of shipments. The drugmaker’s vaccine has still not been approved in the US, but it has said it will apply to the US Food and Drug Administration for an Emergency Use Authorization as soon as the regulatory body has given the green light.
Author: Dede Williams, Freelance Journalist
