Tons of mon­ey, re­sources and con­struc­tion projects have been dumped in­to the pro­duc­tion of Covid-19 vac­cines, and when the Serum In­sti­tute of In­dia stepped up and pledged to pro­vide dos­es to low- and mid­dle-in­come coun­tries, it re­ceived praise from around the world.

But now, the CEO of the world’s largest vac­cine man­u­fac­tur­er said Fri­day that pro­duc­tion of the vac­cine has been halt­ed since De­cem­ber, when the com­pa­ny’s stock­pile hit the 200 mil­lion mark.

“I have even of­fered to give free do­na­tions to who­ev­er want­ed to take it,” Adar Poon­awal­la said at the In­dia Eco­nom­ic Con­clave Fri­day, Bloomberg re­port­ed.

Poon­awal­la al­so blamed the In­di­an gov­ern­ment for the de­lay in the avail­abil­i­ty of Cov­o­vax, the Serum Covid-19 vac­cine, in its home coun­try. The vac­cine has been sold in Eu­rope and Aus­tralia, but said that the gov­ern­ment is tak­ing its time on how to im­ple­ment the vac­cine in­to its pro­gram.

When the num­ber of pos­i­tive Covid-19 cas­es sky­rock­et­ed in In­dia, the gov­ern­ment put a hold on ex­ports of vac­cines. That start­ed with the As­traZeneca jab, which Serum col­lab­o­rat­ed on. Though the ban has been lift­ed, the coun­try has been stuck with a stock­pile. CO­V­AX, the vac­cine shar­ing pro­gram, has an op­tion to buy 550 mil­lion dos­es of the shot, but is no longer re­liant on Serum as it has looked else­where amidst the ban.

In­dia now al­lows for all those above the age of 18 to get a boost­er, though Poon­awal­la called for more ex­pan­sion.

The past month has seen Serum make moves look­ing past the pan­dem­ic, as it signed a deal with UK-based biotech Wock­hardt to cre­ate a glob­al vac­cine pro­gram and build a new fa­cil­i­ty in North Wales to help build up long-term ca­pac­i­ty. It en­tered a li­cens­ing deal with Green­Light Bio­sciences, a Mass­a­chu­setts biotech, for three vac­cines, in­clud­ing one for shin­gles. On top of that, Serum’s new drug dis­cov­ery pro­gram has fo­cused on the un­met need for an­tibac­te­r­i­al drugs that can bat­tle “un­treat­able su­per­bugs.”

British Prime Min­is­ter Boris John­son was in Del­hi Fri­day, talk­ing about the ex­pan­sion of col­lab­o­ra­tion be­tween the two coun­tries. He high­light­ed the work that As­traZeneca and the Serum In­sti­tute have done to­geth­er on the vac­cine, and even men­tioned that he had the col­lab­o­ra­tive jab in his own arm right now.

“Which vac­ci­nat­ed more than a bil­lion peo­ple against Covid, in­clud­ing, I’m proud to say, me. I have the In­di­an jab in my arm, and a pow­er of good it did me,” John­son said. “That has helped In­dia be­come … the phar­ma­cy of the world.”

Mean­while, Reuters re­port­ed that low-in­come coun­tries de­clined 35 mil­lion of the As­traZeneca/Serum In­sti­tute jabs, in fa­vor of jabs made by J&J, Mod­er­na and Pfiz­er/BioN­Tech, cit­ing a longer shelf life as the rea­son be­hind the pref­er­ence.

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.