Pfiz­er un­veiled the rich­es that its Covid-19 vac­cine is show­er­ing on it­self and part­ners at BioN­Tech when it pegged 2021 sales at $33.5 bil­lion. If the Ger­man biotech — which is in charge of de­sign­ing the cur­rent vac­cine and fu­ture mR­NA boost­ers — is right, it could be­come a ma­jor rev­enue pil­lar for years to come.

At its lat­est quar­ter­ly up­date, BioN­Tech fore­casts a €15.9 bil­lion ($18.6 bil­lion) cut for it­self by the end of the year, af­ter bag­ging €2.0 bil­lion ($2.4 bil­lion) in the first half.

The fu­ture BioN­Tech is out­lin­ing as a ma­jor mR­NA play­er of­fers an in­ter­est­ing con­trast with Mod­er­na, which has sig­naled it will chan­nel its overnight wealth in­to new bets on gene edit­ing and gene ther­a­py. Sure, there might be some deals to add com­bo can­di­dates, but BioN­Tech made it clear the plan is to fo­cus on in­fec­tious dis­ease and im­muno-on­col­o­gy, with a broad pipeline it’s al­ready start­ed putting in place, fea­tur­ing 15 pro­grams and 18 clin­i­cal tri­als.

Un­like Mod­er­na, BioN­Tech is al­so not shy­ing away from modal­i­ties out­side of mR­NA to get there — be it small mol­e­cule im­munomod­u­la­tors, an­ti­bod­ies, TCR cell ther­a­pies or bi­o­log­ics.

Re­it­er­at­ing what they see as a need to boost the two-dose reg­i­men with a third shot six to 12 months lat­er, ex­ecs say the best ap­proach would be to adopt the cur­rent vac­cine — which is based on the wild-type, an­ces­tral strain — for the boost­er.

Swap­ping out the strain for emerg­ing vari­ants is “tech­ni­cal­ly pos­si­ble” and would on­ly take about 100 days un­der the cur­rent set­up, CEO Uğur Şahin said. The team is al­ready run­ning a tri­al for the Be­ta vari­ant while launch­ing an­oth­er against the Delta vari­ant. But the key ques­tion is “when is the best time to change our plan” so that they don’t end up mak­ing a de­ci­sion that turns out to be wrong down the road.

He raised the ex­am­ple of in­fluen­za, where the WHO de­fines the rel­e­vant strain every year for vac­cine man­u­fac­tur­ers to fol­low in up­dat­ing their jabs.

“We do not yet have such a sit­u­a­tion for the coro­n­avirus,” he said. “And the chal­lenge at the mo­ment, the glob­al chal­lenge is that there are dif­fer­ent vari­ants on dif­fer­ent con­ti­nents. Even though the Delta vari­ant is dom­i­nat­ing North re­gion, there are oth­er re­gions like South Africa,” where the Be­ta vari­ant is more preva­lent.

Mean­while, BioN­Tech plans to keep “ac­cel­er­at­ing and broad­en­ing” the rest of the pipeline, with the re­cent ac­qui­si­tion of Gilead sub­sidiary Kite’s TCR plat­form as an ex­am­ple of how it might do that. On top of a man­u­fac­tur­ing site in Mary­land, that deal brought 50 cell ther­a­py ex­perts to BioN­Tech, in­clud­ing a cell ther­a­py pro­duc­tion crew and a per­son­al­ized neoanti­gen TCR re­search team.

When asked whether BioN­Tech would be look­ing to add a PD-1 drug to an­chor its I/O port­fo­lio — the on­ly ques­tion from an­a­lysts that was not about boost­ers — Sahin said it “could be an op­tion” if it fits the cri­te­ria.

We have, at the mo­ment, our own I/O mol­e­cules al­so with the PD-1 block­ade func­tion in de­vel­op­ment as you know, and an­ti-PD-L1 plus for the 41BB bis­pe­cif­ic is one of the pos­i­tives. And we have in­ter­nal pro­grams al­so ad­dress­ing ad­di­tion­al I/O pass­es. And in the next 12 to 18 months, we will cer­tain­ly come up with this deal, al­low­ing us to in­crease our pipeline to fur­ther gain com­bi­na­tion part­ners for the vac­cines and im­mune mod­u­la­tors that we have al­ready in placed.

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Xenotransplantation is having a moment.

Last October, a team from NYU successfully transplanted a kidney from a pig into a brain-dead patient, although observers cast doubt on the importance of the experiment. Then, earlier this month, surgeons at the University of Maryland transplanted a pig heart into a dying human, who appears to still be stable.

Now, another group is planting a flag in the xenotransplantation field. Surgeons at the University of Alabama at Birmingham said Thursday they have achieved the first kidney transplant from a pig to a brain-dead patient, publishing their peer-reviewed findings online. The team, aiming to differentiate itself from the others through the genetic modifications used, is hoping there’s now enough research to soon begin clinical xenotransplantation studies.