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.

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.