The FDA and CDC have joint­ly de­cid­ed to stop ad­min­is­ter­ing J&J’s Covid-19 vac­cine af­ter re­view­ing da­ta in­volv­ing six re­port­ed US cas­es of a rare and se­vere type of blood clot in in­di­vid­u­als af­ter re­ceiv­ing the vac­cine.

CDC will con­vene a meet­ing of its Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices on Wednes­day to fur­ther re­view these cas­es and as­sess their po­ten­tial sig­nif­i­cance. “FDA will re­view that analy­sis as it al­so in­ves­ti­gates these cas­es. Un­til that process is com­plete, we are rec­om­mend­ing a pause in the use of this vac­cine out of an abun­dance of cau­tion,” Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search and Anne Schuchat, Prin­ci­pal Deputy Di­rec­tor of the CDC, said in a joint state­ment Tues­day morn­ing.

Marks said in a me­dia call that the prob­a­ble cause may be a sim­i­lar mech­a­nism seen in oth­er ade­n­ovirus vec­tor vac­cines, like the As­traZeneca Covid-19 vac­cine, which un­der­went a sim­i­lar safe­ty re­view in Eu­rope. He said one per­son has died and one per­son is in crit­i­cal con­di­tion from the blood clots. FDA act­ing com­mis­sion­er Janet Wood­cock added that the time­frame for this re­view of the J&J vac­cine “will be a mat­ter of days.”

J&J said in a state­ment on Tues­day that it has made the de­ci­sion to proac­tive­ly de­lay the roll­out of its vac­cine in Eu­rope. “The safe­ty and well-be­ing of the peo­ple who use our prod­ucts is our num­ber one pri­or­i­ty,” the com­pa­ny said.

“All six cas­es oc­curred among women be­tween the ages of 18 and 48, and symp­toms oc­curred 6 to 13 days af­ter vac­ci­na­tion,” they not­ed, adding that al­most 7 mil­lion dos­es of the vac­cine have now been ad­min­is­tered in the US. The CDC and FDA said that peo­ple who have re­ceived the J&J vac­cine and who de­vel­op se­vere headache, ab­dom­i­nal pain, leg pain, or short­ness of breath 3 weeks af­ter vac­ci­na­tion should con­tact their health care provider.

Treat­ment of this spe­cif­ic type of blood clot is dif­fer­ent from he­parin, which is the treat­ment that might typ­i­cal­ly be ad­min­is­tered, as in this set­ting, CDC and FDA said, “ad­min­is­tra­tion of he­parin may be dan­ger­ous, and al­ter­na­tive treat­ments need to be giv­en.”

Sen­a­tors on Tues­day be­gan weigh­ing in on what the FDA should do with its re­view.

I re­spect the in­de­pen­dence of the FDA and their need to eval­u­ate risk. But 6 out of 6.8 mil­lion is not a lot, and if they are go­ing to land on “we re­viewed the da­ta and every­thing is fine,” they need to be clear and quick and un­equiv­o­cal.

— Bri­an Schatz (@bri­an­schatz) April 13, 2021

Jeff Zients, White House Covid-19 re­sponse co­or­di­na­tor, said in a state­ment that the Biden ad­min­is­tra­tion is work­ing with states to resched­ule J&J ap­point­ments for Morder­na or Pfiz­er vac­cines. New York said all ap­point­ments for J&J vac­cines to­day at New York State mass vac­ci­na­tion sites will be hon­ored with the Pfiz­er vac­cine.

The news comes as the Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee said last Fri­day that it has ini­ti­at­ed a re­view of four “se­ri­ous cas­es of un­usu­al blood clots with low blood platelets,” in­clud­ing one death, re­port­ed af­ter peo­ple re­ceived the J&J vac­cine in the US.

As of April 4, EMA said a to­tal of 169 cas­es of cere­bral ve­nous si­nus throm­bo­sis (CVST) and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed to the data­base, among 34 mil­lion peo­ple who have been vac­ci­nat­ed with the As­traZeneca vac­cine in the EEA and UK. By com­par­i­son, the agency not­ed that for the J&J vac­cine, 3 CVST cas­es were found among 4.5 mil­lion vac­ci­nat­ed world­wide, for Pfiz­er, 35 CVST cas­es world­wide were found and 54 mil­lion re­ceived the vac­cine in the EEA, and for Mod­er­na, 5 CVST cas­es world­wide were among 4 mil­lion vac­ci­nat­ed in the EEA.

Mod­er­na said in a state­ment on Tues­day that more than 64.5 mil­lion dos­es of its vac­cine have been ad­min­is­tered glob­al­ly and its as­sess­ment of the da­ta “does not sug­gest an as­so­ci­a­tion with cere­bral ve­nous si­nus throm­bo­sis (CVST) or throm­bot­ic events.”

Anne Schuchat, prin­ci­pal deputy di­rec­tor at the CDC, al­so said on the me­dia call that they are not see­ing con­cerns with these clot­ting events for the Mod­er­na or Pfiz­er vac­cines.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.