In a sign of its grow­ing com­mit­ment to the con­ti­nent, Mod­er­na will sup­ply up to 110 mil­lion dos­es of its Covid-19 vac­cine to the African Union, the com­pa­ny an­nounced Tues­day. And CEO Stéphane Ban­cel said it’s just the first step.

“We be­lieve our vac­cine can play an im­por­tant role in ad­dress­ing the needs of low-in­come coun­tries giv­en its com­bi­na­tion of high Phase 3 ef­fi­ca­cy against COVID-19, strong dura­bil­i­ty in the re­al-world ev­i­dence, and su­pe­ri­or stor­age and han­dling con­di­tions. We rec­og­nize that ac­cess to COVID-19 vac­cines con­tin­ues to be a chal­lenge in many parts of the world and we re­main com­mit­ted to help­ing to pro­tect as many peo­ple as pos­si­ble around the globe,” Ban­cel said in a state­ment.

The first 15 mil­lion dos­es will come in Q4 of 2021, with an­oth­er 35 mil­lion in Q1 2022 and up to 60 mil­lion in Q2 2022. All of those dos­es will be of­fered at the com­pa­ny’s low­est tiered price. It is al­so work­ing on plans to al­low it­self to fill dos­es in Africa as ear­ly as 2023, in a mem­o­ran­dum of un­der­stand­ing that would add an ad­di­tion­al 500 mil­lion dos­es in ad­di­tion to pre­vi­ous deals with Co­v­ax through 2022.

The move comes as Mod­er­na is un­der im­mense pres­sure from the White House and pub­lic health ad­vo­cates. The com­pa­ny has large­ly ex­port­ed its shots to wealth­i­er coun­tries so far, at a time when few­er than 6% of Africa’s en­tire pop­u­la­tion has been ful­ly vac­ci­nat­ed. Just 4% of the world’s dos­es have been ad­min­is­tered in Africa.

“It’s a drop in the ocean for what the needs are,” Fa­ti­ma Has­san, the head of the Health Jus­tice Ini­tia­tive in South Africa, said of Mod­er­na’s an­nounce­ment to the New York Times. “It’s up to 110 mil­lion for a pop­u­la­tion and a con­ti­nent of 1.3 bil­lion.”

In an in­ter­view with End­points News, Ban­cel said that the vi­sion for an African man­u­fac­tur­ing site stemmed from a de­sire to treat trop­i­cal dis­eases that arose dur­ing the time he lived in Asia. Now, as the CEO of a com­pa­ny that’s dou­bled its work­force in the past year, Ban­cel says it seems dif­fi­cult to imag­ine the next 10 years of Mod­er­na with­out a pres­ence in Africa.

Ad­vo­ca­cy groups, such as Pub­lic Cit­i­zen, have called for the com­pa­ny to share its vac­cine’s in­tel­lec­tu­al prop­er­ty. Mean­while, US Pres­i­dent Joe Biden’s ad­min­is­tra­tion has ques­tioned why the num­ber of dos­es pledged to low­er- and mid­dle-in­come coun­tries are much low­er than oth­er com­pa­nies. The Times found 1 mil­lion of Mod­er­na’s dos­es have gone to coun­tries clas­si­fied as low-in­come by the World Bank, com­pared with 8.4 mil­lion from Pfiz­er and 25 mil­lion from J&J.

But Ban­cel said that among oth­er rea­sons, sup­ply con­tracts and ex­port con­trols with the US and Eu­rope are to blame for the slow ex­ports, and the size of Mod­er­na’s staff — 1,500 to­tal em­ploy­ees, com­pared with Pfiz­er’s 29,400 in the US alone — has been a con­tribut­ing fac­tor.

The con­ti­nent now has two di­rect vac­cine sup­ply deals, as it al­so has agreed to 220 mil­lion dos­es of J&J’s sin­gle-shot vac­cine, with an op­tion for 180 mil­lion more.

The com­pa­ny’s boost­er dose was al­so giv­en ap­proval by Swissmedic Tues­day for in­di­vid­u­als 12 years and old­er in pa­tients with a weak­ened im­mune sys­tem. That is to be ad­min­is­tered at least 28 days af­ter the sec­ond dose.

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.

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.

The chikungunya virus met its match in Valneva’s vaccine candidate, VLA1553, according to data from an antibody persistence trial released today.

The trial found that 99% of 363 participants retained neutralizing antibodies 12 months after a single dose of vaccine in the company’s earlier, larger Phase III trial, called VLA1553-301. The participants from the long-term study will continue to be monitored for at least five years.