Pfiz­er and BioN­Tech have done the fi­nal ef­fi­ca­cy analy­sis for their Phase III Covid-19 tri­al, and the re­sults con­firm the head­line-grab­bing re­lease from last week: Their vac­cine is 95% ef­fec­tive at pre­vent­ing Covid-19.

They al­so said the vac­cine was 94.5% ef­fec­tive in old­er adults, mit­i­gat­ing con­cerns that the first Covid-19 vac­cines might not work as well in one of the pop­u­la­tions most sus­cep­ti­ble to se­vere dis­ease.

The two com­pa­nies said they have al­so crossed the FDA’s key safe­ty thresh­old of two-months fol­low-up and will sub­mit for an emer­gency use au­tho­riza­tion “with­in days.” Al­though the agency will con­vene an ad­vi­so­ry com­mit­tee be­fore mak­ing a de­ci­sion, the an­nounce­ment like­ly sets up the Big Phar­ma and their biotech part­ner to ob­tain the first FDA OK for a Covid-19 vac­cine.

Pfiz­er CEO Al­bert Bourla said at dif­fer­ent con­fer­ences yes­ter­day af­ter­noon that they had passed the safe­ty thresh­old and would soon sub­mit to reg­u­la­tors. The com­pa­nies an­nounced last week that their vac­cine was “over 90% ef­fec­tive” in an in­ter­im analy­sis.

Mod­er­na, which an­nounced Mon­day that their vac­cine was 94.5% ef­fec­tive at an in­ter­im analy­sis, is al­so ex­pect­ed to re­lease fi­nal ef­fi­ca­cy da­ta and head to reg­u­la­tors soon. CEO Stéphane Ban­cel pre­dict­ed the first ad­vi­so­ry com­mit­tee hear­ings for any vac­cine to come Dec. 7th or Dec. 14th. The two vac­cines both use mR­NA and are high­ly sim­i­lar.

To­day’s ef­fi­ca­cy da­ta came from an analy­sis of 170 Covid-19 cas­es in their 44,000-per­son tri­al — 162 cas­es in the place­bo group and 8 cas­es in the vac­cine group. It al­so in­clud­ed Pfiz­er’s first safe­ty re­sults; the most se­vere side ef­fects were fa­tigue, which oc­curred in 3.8% of re­cip­i­ents, and headache, which oc­curred in 2% of re­cip­i­ents.

Pfiz­er said they saw 9 cas­es of se­vere dis­ease in the place­bo group and 1 in the vac­cine group, in­di­cat­ing the vac­cine can help pre­vent hos­pi­tal­iza­tion and death. Mod­er­na’s first analy­sis had shown 11 se­vere cas­es on place­bo and 0 in the vac­cine group.

Key ques­tions, how­ev­er, still re­main on how durable the vac­cine will be.

Al­though oth­er ques­tions re­main about how ef­fec­tive­ly Pfiz­er will be able to dis­trib­ute its vac­cine, which re­quires stor­age at -70 de­grees Cel­sius (-94 Fahren­heit), Bourla ex­pressed con­fi­dence yes­ter­day that roll­out would go far more smooth­ly than out­side ex­perts have feared.

The com­pa­ny has in­vest­ed in freez­er box­es to ship and store their vac­cines on dry ice. State health of­fi­cials have raised con­cerns about how well these will work for get­ting the vac­cine to rur­al ar­eas. Mod­er­na has less strin­gent cold-chain re­quire­ments.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.