More than 18 months af­ter adults were able to start re­ceiv­ing Pfiz­er-BioN­Tech’s and Mod­er­na’s Covid-19 vac­cines, kids as young as six months are on the verge of be­ing able to get in­oc­u­lat­ed against the pan­dem­ic virus.

The FDA au­tho­rized the Pfiz­er-BioN­Tech and Mod­er­na vac­cines Fri­day morn­ing un­der EUA af­ter the agency’s out­side ad­vi­sors unan­i­mous­ly fa­vored (21-0) ad­min­is­ter­ing the shots. Par­ents and care­givers just have to wait for the CDC to sign off be­fore the youngest of Amer­i­ca’s kids can get the vac­cine.

Un­like the orig­i­nal adult emer­gency green­light, kids will take a three-dose pri­ma­ry se­ries of the Pfiz­er-BioN­Tech shot. Mod­er­na’s shot will be de­liv­ered as two dos­es. The vac­cines have reaped bil­lions of dol­lars for the com­pa­nies in the past year and a half and have helped ce­ment mR­NA tech­nol­o­gy in bio­phar­ma R&D.

All states but Flori­da have al­ready or­dered the Covid-19 vac­cine for chil­dren, ac­cord­ing to news re­ports.

“We are grate­ful to all the par­ents and care­givers who made to­day’s au­tho­riza­tion pos­si­ble by choos­ing to en­roll their chil­dren in our COVID-19 vac­cine clin­i­cal tri­al,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

Ef­fi­ca­cy of Pfiz­er’s three-dose se­ries was de­ter­mined by 376 kids who re­ceived the vac­cine and 179 who re­ceived place­bo in a group of chil­dren aged 6 to 23 months. One Covid-19 case oc­curred in the vac­cine arm and two in the place­bo arm. In the 2- to 4-year age range, 589 re­ceived the Pfiz­er vac­cine and 271 kids got the place­bo. Two cas­es oc­curred in the vac­cine group and five in the place­bo group.

Dur­ing the ad­vi­so­ry com­mit­tee meet­ing on Wednes­day, ad­vi­sors had a few reser­va­tions giv­en the two-dose da­ta ap­peared to show lit­tle ef­fi­ca­cy, but the ex­perts sup­port­ed the over­all risk-ben­e­fit ra­tio.

Paul Of­fit

One ad­vi­sor, Paul Of­fit, di­rec­tor of the vac­cine ed­u­ca­tion cen­ter at the Chil­dren’s Hos­pi­tal of Philadel­phia, said those low lev­els of ef­fi­ca­cy af­ter the sec­ond vac­cine dose were con­cern­ing, and not­ed the vac­cine may end up be­ing a four-dose se­ries.

Ef­fi­ca­cy of Mod­er­na’s vac­cine se­ries was 36.8% for the 2 to 5 age group and 50.6% for kids 6 to 23 months of age. Those re­spons­es oc­curred when Omi­cron was pre­dom­i­nant. In the 2 to 5 age group, 4.6% of kids with the vac­cine end­ed up get­ting the pan­dem­ic dis­ease af­ter the sec­ond dose, com­pared to 7.1% of the kids on place­bo.

A Kaiser Fam­i­ly Foun­da­tion sur­vey in May found that just 18% of par­ents with chil­dren un­der age 5 were “ea­ger” to get their kid vac­ci­nat­ed right away. About 38% of par­ents said they would wait to see how the vac­cine is work­ing for oth­er peo­ple, and 27% of par­ents said they will “def­i­nite­ly not” take their kids to get vac­ci­nat­ed against SARS-CoV-2. And just over one in 10 said they would on­ly get their child vac­ci­nat­ed if they were re­quired to do so.

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.