As chil­dren re­turn to school and youth Covid-19 hos­pi­tal­iza­tions hit a new high, BioN­Tech is re­port­ed­ly prep­ping a launch for its mR­NA vac­cine de­vel­oped with Pfiz­er in those be­tween 5 and 11 years old.

BioN­Tech CMO Özlem Türe­ci told the week­ly Ger­man mag­a­zine Der Spiegel that the com­pa­ny will file the re­sults of its tri­al in 5- to 11-year-olds with reg­u­la­tors across the world “over the next few weeks,” and that fi­nal pro­duc­tion steps are be­ing ad­just­ed to bot­tle a low­er-dose pe­di­atric ver­sion of the vac­cine.

“Things are look­ing good, every­thing is go­ing ac­cord­ing to plan,” CEO Ugur Sahin told Der Spiegel.

The Pfiz­er/BioN­Tech vac­cine is cur­rent­ly au­tho­rized for chil­dren as young as 12 years old, and back in Au­gust be­came the first Covid-19 vac­cine ful­ly ap­proved in the US for peo­ple 16 years and old­er.

Mod­er­na’s vac­cine is au­tho­rized for those 18 years and old­er. The com­pa­ny be­gan re­cruit­ing in March for a tri­al test­ing the mR­NA jab in kids younger than 12, and said it would en­roll in three age brack­ets: 6 to 11 years old; 2 to 5 years old; and 6 months to 1 year old.

Sino­vac weighs vac­cine pro­duc­tion site in South Africa — re­port

Chi­na’s Sino­vac is re­port­ed­ly con­sid­er­ing a new vac­cine pro­duc­tion site in South Africa, where its Covid-19 vac­cine Coro­n­aVac is cur­rent­ly in a Phase III tri­al in chil­dren and ado­les­cents.

“This clin­i­cal tri­al is a pre­cur­sor to the es­tab­lish­ment of a South African vac­cine man­u­fac­tur­ing fa­cil­i­ty part­nered by Sino­vac and Nu­molux Group that will cov­er the en­tire spec­trum of vac­ci­na­tions be­yond just the COVID-19 re­sponse,” Hilton Klein, CEO of Sino­vac’s South Africa-based part­ner Nu­molux, said per Reuters. 

South Africa’s reg­u­la­to­ry au­thor­i­ty, SAH­PRA, gave con­di­tion­al au­tho­riza­tion to Sino­vac’s vac­cine back in Ju­ly for those be­tween 18 and 59 years old.

Sino­vac’s vac­cine — which was just ef­fec­tive enough to meet reg­u­la­to­ry stan­dards — was au­tho­rized in Chi­na last sum­mer and be­came the first Chi­nese Covid-19 vac­cine to be con­sid­ered by the Eu­ro­pean Med­i­cines Agency back in May. How­ev­er, the EMA said yes­ter­day that it needs more da­ta on both the Sino­vac and Rus­sia’s Sput­nik V vac­cines be­fore it can progress rolling re­views, ac­cord­ing to Reuters.

Sino­vac and Nu­molux are cur­rent­ly en­rolling 2,000 par­tic­i­pants be­tween the ages of 6 months and 17 years in the South Africa co­hort of their glob­al tri­al.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.