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.

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Axsome’s on-and-off quest to obtain an FDA approval for their depression drug AXS-05 is back on again.

After the markets closed on Monday, the biotech issued a short, simple alert in an SEC filing saying the team had “received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.”

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.