J&J has run in­to a snag in pro­duc­tion of its Covid-19 vac­cine af­ter its qual­i­ty pa­trol spot­ted prob­lems with one batch of drug sub­stance.

The is­sue — which the New York Times re­port­ed was due to a mix-up be­tween the vec­tors used in J&J and As­traZeneca’s vac­cines — sent J&J in­to trou­ble-shoot­ing mode. The com­pa­ny said it’s send­ing ad­di­tion­al ex­perts in man­u­fac­tur­ing, tech­ni­cal op­er­a­tions and qual­i­ty to su­per­vise on­site at Emer­gent’s Bayview fa­cil­i­ty, which was once tout­ed for its ca­pac­i­ty to rapid­ly scale man­u­fac­tur­ing.

In a state­ment, J&J didn’t con­firm whether the batch would in­deed trans­late to 15 mil­lion dos­es, as the Times re­port­ed. It in­stead em­pha­sized that the Emer­gent site has not yet been au­tho­rized by the FDA to make the ac­tive in­gre­di­ents of its one-shot, ade­n­ovirus vec­tor-based vac­cine, and that it’s on track to de­liv­er a to­tal of 1 bil­lion dos­es by 2021.

But while a board mem­ber has pre­vi­ous­ly pre­dict­ed they would de­liv­er a to­tal of 100 mil­lion dos­es to the US by April, J&J is now push­ing that goal to the end of May. Through April, they ex­pect to have 24 mil­lion dos­es, on top of the 20 mil­lion al­ready in arms.

“This batch was nev­er ad­vanced to the fill­ing and fin­ish­ing stages of our man­u­fac­tur­ing process,” the com­pa­ny added. “This is an ex­am­ple of the rig­or­ous qual­i­ty con­trol ap­plied to each batch of drug sub­stance.”

Emer­gent, which had inked a $480 mil­lion deal to sup­ply J&J’s Covid vac­cine for the next two years, had been known as the mak­er of an an­thrax vac­cine pri­or to the pan­dem­ic.

Billed as a cen­ter for in­no­va­tion in ad­vanced de­vel­op­ment and man­u­fac­tur­ing (CIADM), the Bayview site was built as part of a part­ner­ship with BAR­DA to speed de­vel­op­ment and pro­duc­tion of vac­cines or treat­ments for pan­dem­ic re­sponse.

Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

The Eu­ro­pean Union has seen a short­age in Covid-19 vac­cine avail­abil­i­ty, and Pfiz­er head Dan­ny Hen­drikse wants it to be known that new EU re­stric­tions won’t make end­ing that short­age any eas­i­er.

The VP of glob­al sup­ply spoke out against new EU rules about the free move­ment of goods across bor­ders, say­ing that it made it more dif­fi­cult for the com­pa­ny to ex­port the vac­cine.

“Ul­ti­mate­ly what we would like our col­leagues to do is to fo­cus on mak­ing and dis­trib­ut­ing the vac­cine,” he told the UK’s Tele­graph. “The com­po­nents don’t just come from Eu­rope, but from all over the world.”

Pfiz­er told EU lead­ers that the amount of time it takes to make the vac­cine has been cut in half from 110 days to 60, thanks to an in­crease of pro­duc­tion at its Bel­gium plant. But that batch is start­ed in the US, with DNA plas­mids.

The news comes on the back of Ger­many’s sus­pen­sion of the As­traZeneca vac­cine for pa­tients un­der the age of 40 due to a rare, but fa­tal, blood clot called ve­nous throm­bo­sis. The clot was par­tic­u­lar­ly present in young women, a re­port said. EU’s med­ical reg­u­la­tor said that there was no ev­i­dence to sup­port the de­ci­sion to stop us­ing the vac­cine, how­ev­er.

Pfiz­er and BioN­Tech con­firm high ef­fi­ca­cy, no se­ri­ous safe­ty con­cerns af­ter sec­ond Covid-19 vac­cine dose

Six months af­ter Pfiz­er and BioN­Tech’s Phase III clin­i­cal tri­al par­tic­i­pants re­ceived the sec­ond dose of their Covid-19 vac­cine, the com­pa­nies have an­nounced that there are no se­ri­ous safe­ty con­cerns.

Of the 927 con­firmed symp­to­matic cas­es, 850 of the cas­es were in the place­bo group and 77 were in the group giv­en BNT162b2, good for a vac­cine ef­fi­ca­cy of 91.3%, ac­cord­ing to a re­lease. Six-month re­sults al­so showed 100% ef­fi­ca­cy in pre­vent­ing se­vere dis­ease.

Vac­cine safe­ty has now been eval­u­at­ed in 44,000 par­tic­i­pants ages 16 and up. Sci­en­tists have deemed the vac­cine 100% ef­fec­tive in South Africa, where the B.1.351 vari­a­tion is preva­lent.

“The high vac­cine ef­fi­ca­cy ob­served through up to six months fol­low­ing a sec­ond dose and against the vari­ant preva­lent in South Africa pro­vides fur­ther con­fi­dence in our vac­cine’s over­all ef­fec­tive­ness,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.