Pfizer CEO Albert Bourla, BioNTech CEO Ugur Sahin

UK grants Pfiz­er, BioN­Tech his­toric first OK for mR­NA vac­cine, ex­pects mil­lions of dos­es by year end

Pfiz­er and BioN­Tech have scored a his­toric OK for their Covid-19 vac­cine in the UK, where the first dos­es are ex­pect­ed to be de­liv­ered with­in days.

Days af­ter the British gov­ern­ment au­tho­rized its Med­i­cines & Health­care Prod­ucts Reg­u­la­to­ry Agency to make a call in­de­pen­dent of the Eu­ro­pean Union — from which it’s in the process of ex­it­ing — the reg­u­la­tors gave the green light for emer­gency use of BNT162b2.

It marks the first time an mR­NA vac­cine has been sanc­tioned for wide­spread dis­tri­b­u­tion.

While Rus­sia and Chi­na have each start­ed ad­min­is­ter­ing home­grown vac­cines, they all lack the late-stage da­ta that Pfiz­er and Mod­er­na have of­fered to prove their shot works: In a 44,000-per­son tri­al, in­ves­ti­ga­tors record­ed 170 cas­es of Covid-19, of which on­ly 8 were in the vac­cine group. That trans­lat­ed to a 95% ef­fi­ca­cy for the 2-dose reg­i­men, bol­stered by pos­i­tive safe­ty re­sults with 2 months of me­di­an fol­low-up.

“We be­lieve that the roll-out of the vac­ci­na­tion pro­gram in the U.K. will re­duce the num­ber of peo­ple in the high-risk pop­u­la­tion be­ing hos­pi­tal­ized,” BioN­Tech CEO and co-founder Ugur Sahin said in a state­ment, adding:”The da­ta sub­mit­ted to reg­u­la­to­ry agen­cies around the world are the re­sult of a sci­en­tif­i­cal­ly rig­or­ous and high­ly eth­i­cal re­search and de­vel­op­ment pro­gram.”

FDA and EMA de­ci­sions are ex­pect­ed lat­er in De­cem­ber. The US agency like­ly won’t have a fi­nal ver­dict be­fore Dec 10, when an ad­vi­so­ry com­mit­tee is con­ven­ing to dis­cuss the emer­gency use au­tho­riza­tion.

Eu­ro­pean reg­u­la­tors and law­mak­ers ap­par­ent­ly aren’t im­pressed with the speed, crit­i­ciz­ing the move as “hasty.” In a state­ment to Reuters, the EMA said it has a more ap­pro­pri­ate pro­ce­dure that is longer be­cause it takes more ev­i­dence in­to ac­count and in­volves more checks. It ex­pects to de­cide by Dec 29.

But the MHRA stood by its process, and BioN­Tech ex­ecs said the UK agency had asked ques­tions to the same lev­el of de­tail as their in­ter­na­tion­al coun­ter­pars. Hav­ing first teamed up on the un­prece­dent­ed de­vel­op­ment ef­fort, Pfiz­er and BioN­Tech start­ed a rolling sub­mis­sion at the MHRA in late Oc­to­ber, lat­er than they went to the EMA.

In a state­ment, they em­pha­sized that ob­served ef­fi­ca­cy in adults age 65 or over — a key, vul­ner­a­ble group that will al­so like­ly be pri­or­i­tized for vac­ci­na­tion — is more than 94%. UK reg­u­la­tors al­so re­viewed chem­istry, man­u­fac­tur­ing and con­trol da­ta be­fore giv­ing out the OK.

In a state­ment, Pfiz­er CEO Al­bert Bourla ap­plaud­ed the MHRA “for their abil­i­ty to con­duct a care­ful as­sess­ment and take time­ly ac­tion to help pro­tect the peo­ple of the U.K.”

The next chal­lenge will be get­ting the vac­cines to hos­pi­tals and clin­ics ef­fi­cient­ly. Ex­perts and an­a­lysts have ex­pressed con­cerns about rolling out a vac­cine that re­quires stor­age at -70 de­grees Cel­sius (-94 Fahren­heit), but Pfiz­er and BioN­Tech say they have in­vest­ed in the in­fra­struc­ture, from freez­er box­es to char­ter flights, to get them where they need to be.

Each vial, BioN­Tech COO Sean Marett added in a press con­fer­ence, con­tains 5 dos­es that need to be di­lut­ed with saline so­lu­tion at the point of ad­min­is­tra­tion. Trans­port stud­ies they have con­duct­ed with Pfiz­er sug­gest­ed that the vac­cine can re­tain sta­bil­i­ty in trans­port at 2-8 de­grees Cel­sius for up to 6 hours, for de­liv­ery from vac­ci­na­tion hubs to satel­lite sites such as care homes.

When asked why their shot re­quires tougher cold chain con­di­tions than Mod­er­na’s, Sahin not­ed that sta­bil­i­ty stud­ies are still on­go­ing and they’re ex­pect­ing more da­ta in Jan­u­ary or Feb­ru­ary that might sup­port up­dat­ing the re­quire­ments.

“So there should be no big dif­fer­ences be­tween the dif­fer­ent mes­sen­ger RNA vac­cines, but the da­ta needs to be gen­er­at­ed,” he said. “We have just to un­der­stand that our can­di­date was se­lect­ed end of Ju­ly for this clin­i­cal tri­al — we had mul­ti­ple can­di­dates and we want­ed to iden­ti­fy the best can­di­date — So the sta­bil­i­ty stud­ies for this can­di­date start­ed sig­nif­i­cant­ly lat­er than the da­ta that were al­ready avail­able for oth­er can­di­dates.”

With a sup­ply deal al­ready in place for 40 mil­lion dos­es, the UK au­tho­riza­tion opens the door to phased de­liv­ery through­out 2020 and 2021. The com­pa­nies say the first dos­es should ar­rive from Pfiz­er’s fa­cil­i­ty in Bel­gium with­in a few days, whether by lor­ry or plane. Health Sec­re­tary Matt Han­cock said on BBC Ra­dio 4 that he ex­pects “a mat­ter of mil­lions of dos­es for the whole of the UK by the end of the year.”

Based on a pri­or­i­ti­za­tion guid­ance pre­pared by the Joint Com­mit­tee on Vac­ci­na­tion and Im­mu­ni­sa­tion, the 66 mil­lion-plus UK res­i­dents should re­ceive the vac­cine in the fol­low­ing or­der:

  • old­er adults’ res­i­dent in a care home and care home work­ers
  • all those 80 years of age and over and health and so­cial care work­er
  • all those 75 years of age and over­all those 70 years of age and over
  • all those 65 years of age and over­high-risk adults un­der 65 years of age
  • mod­er­ate-risk adults un­der 65 years of age
  • all those 60 years of age and over
  • all those 55 years of age and over
  • all those 50 years of age and over
  • rest of the pop­u­la­tion (pri­or­i­ty to be de­ter­mined)

So how does it feel to have the first vac­cine emer­gency ap­proval backed by Phase III da­ta?

“Ac­tu­al­ly I don’t think we’ve had time to think about it be­cause we’re too busy pack­ing vials for ship­ping to the UK with our col­leagues at Pfiz­er,” Marett said.

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