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Tuesday, March 18, 2025

Af­ter US fac­to­ry or­dered to de­stroy 60 mil­lion vac­cines

Deyalsingh: Difficult to assess impact on J&J delivery to T&T

by

1370 days ago
20210617

There is now con­cern over the pos­si­ble ef­fects on the 800,000 John­son and John­son vac­cine or­der T&T is ear­marked to re­ceive from the African Med­ical Sup­plies Plat­form, af­ter man­u­fac­tur­ers John­son and John­son (J&J) was re­cent­ly or­dered by the US Food and Drug Ad­min­is­tra­tion (FDA) to dis­pose of 60 mil­lion vac­cine dos­es due to pos­si­ble con­t­a­m­i­na­tion at a fac­to­ry.

How­ev­er, Health Min­is­ter Ter­rence Deyals­ingh has said it is dif­fi­cult to an­tic­i­pate the pos­si­ble ef­fects at this time.

Deyals­ingh in­di­cat­ed the dif­fi­cul­ty in Par­lia­ment yes­ter­day, while re­ply­ing to a query from the UNC’s Rod­ney Charles. The lat­ter asked how the move in the US would im­pact the 800,000 J&J vac­cines T&T is ex­pect­ing.

Re­ports in the US press five days ago stat­ed John­son & John­son must de­stroy 60 mil­lion dos­es of its COVID-19 vac­cine be­cause they may be con­t­a­m­i­nat­ed.

How­ev­er, mil­lions of its un­used dos­es were giv­en ex­tra shelf life by reg­u­la­tors.

The FDA an­nounced it had ap­proved two batch­es of vac­cine from the plant for use in the US or abroad, but that they are “not yet ready” to al­low the plant to re­open to make new dos­es of the vac­cine. The two batch­es are es­ti­mat­ed to be about ten mil­lion dos­es.

The New York Times re­port­ed the ap­proved dos­es will come with a warn­ing that the FDA does not know if Emer­gent BioSo­lu­tions, which made the vac­cines, “fol­lowed good man­u­fac­tur­ing prac­tices.”

The US re­port stat­ed the Emer­gent BioSo­lu­tions was cit­ed in 2020 for de­fi­cien­cies in safe­ty and test­ing and was shut down by the FDA in April for mak­ing J&J’s COVID-19 vac­cines “with poor­ly trained work­ers in un­san­i­tary con­di­tions that al­low cross-con­t­a­m­i­na­tion of bulk drug sub­stances.”

In April al­so, the FDA and the Cen­tre for Dis­ease Con­trol called for a pause of the vac­cine’s use while it “in­ves­ti­gat­ed ex­treme­ly rare but se­ri­ous blood clots in some women who re­ceived the vac­cine.”

It was lift­ed ten days lat­er. But the ar­ti­cle stat­ed fear of side ef­fects “ap­pears to have hurt de­mand for the vac­cine.”

The Dai­ly News stat­ed the man­u­fac­tur­ing prob­lems “put J&J in a pre­car­i­ous sit­u­a­tion where they’ve failed to make good on sev­er­al con­tracts and made up for short­ages by im­port­ing mil­lions of dos­es” from its Nether­lands fac­to­ry.

Re­ply­ing to Charles’ con­cern yes­ter­day, Deyals­ingh said, “The J&J vac­cines are pro­duced at mul­ti­ple sites in the US. The af­fect­ed site is called Emer­gent.”

He said J&J vac­cines are al­so pro­duced in South Africa un­der a tech­nol­o­gy trans­fer agree­men­tand in Italy, the Nether­lands, Spain, France and al­so in In­dia.

“For these rea­sons, it is dif­fi­cult to an­tic­i­pate the pos­si­ble ef­fects of this so, there­fore, no opin­ion could be put for­ward at this time,” the Min­is­ter said.

Deyals­ingh de­nied Charles’ view that er­rors were made with vac­cine sup­plies.

He point­ed to bi­lat­er­al talks which have “borne abun­dant fruit in the past few months.”

He cit­ed 300,000 dos­es in T&T and oth­er dos­es from Co­v­ax. He said talks are al­so on with oth­er man­u­fac­tur­ers.

He added, “While this (J&J is­sue) is some­thing to un­doubt­ed­ly take note of, as in­di­cat­ed, there are sev­en oth­er coun­tries cur­rent­ly man­u­fac­tur­ing J&J vac­cines in ad­di­tion to mul­ti­ple sites with­in the US. So it is very dif­fi­cult, as I said, at this time to try to pre­dict what the im­pact of this is go­ing to have.”


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