CDC committee votes to restart J&J vaccinations – Endpoints News

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A CDC ad­vi­so­ry com­mit­tee on Fri­day vot­ed to restart vac­ci­na­tions with J&J’s Covid-19 vac­cine but stopped short of re­strict­ing its use to spe­cif­ic pop­u­la­tions or spec­i­fy­ing a new warn­ing for rare but some­times fa­tal side ef­fects of blood clot with low platelets linked to the vac­cine.

The vote in fa­vor of restart­ing the vac­ci­na­tions for any­one over the age of 18 fol­lows J&J com­ments on Fri­day that it has agreed with the FDA to add a warn­ing to the la­bel re­gard­ing the risks.

“Most cas­es of throm­bo­sis with throm­bo­cy­tope­nia re­port­ed fol­low­ing the Janssen COVID-19 Vac­cine have oc­curred in fe­males ages 18 through 49 years; some have been fa­tal,” the warn­ing says, ac­cord­ing to J&J’s pre­sen­ta­tion Fri­day, af­ter cau­tion­ing the com­mit­tee against re­strict­ing use of the vac­cine. “Based on cur­rent­ly avail­able ev­i­dence, a causal re­la­tion­ship be­tween throm­bo­sis with throm­bo­cy­tope­nia and the Janssen COVID-19 Vac­cine is plau­si­ble.”

The CDC said Fri­day that it has now spot­ted 15 cas­es of the blood clots with low platelets, al­so known as throm­bo­sis with throm­bo­cy­tope­nia syn­drome (TTS), among about 8 mil­lion re­ceiv­ing the vac­cine. Those 15 cas­es in­clude three deaths (up from one death from last week), sev­en peo­ple hos­pi­tal­ized, four of whom are in in­ten­sive care, and five peo­ple dis­charged.

Tom Shimabukuro, deputy di­rec­tor of the CDC’s Im­mu­niza­tion Safe­ty Of­fice, al­so not­ed about 10 oth­er pos­si­ble cas­es of TTS are un­der in­ves­ti­ga­tion.

The fea­tures of TTS ap­pear sim­i­lar to what is be­ing ob­served in rare in­stances fol­low­ing the As­traZeneca Covid-19 vac­cine in Eu­rope, Shimabukuro added, echo­ing com­ments made ear­li­er this week when the Eu­ro­pean Med­i­cines Agency added a warn­ing to its J&J Covid vac­cine la­bel.

But un­like the EU, the US cur­rent­ly has plen­ti­ful and avail­able quan­ti­ties of both of the mR­NA vac­cines from Mod­er­na and Pfiz­er, which may change the ben­e­fit-risk sce­nario for J&J vac­cines in the US.

CDC mod­el­ing on Fri­day showed that even if the FDA restart­ed vac­ci­na­tions with the J&J shot in all age cat­e­gories im­me­di­ate­ly, the avail­able dos­es would on­ly speed up US vac­ci­na­tions for all in­tend­ing to do so by about two weeks (from 74 days to 88 days af­ter Fri­day).

But physi­cians at the meet­ing Fri­day al­so not­ed the im­por­tance of hav­ing a sin­gle shot in their ar­ma­men­tar­i­um for unique pop­u­la­tions like those who are home­less, home-bound or mi­grant and sea­son­al com­mu­ni­ties.



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