Af­ter de­lay­ing its de­ci­sion ear­li­er this week, the EMA an­nounced it has for­mal­ly rec­om­mend­ed au­tho­riz­ing Mod­er­na’s Covid-19 vac­cine.

Reg­u­la­tors came to the de­ci­sion Wednes­day morn­ing, mark­ing the sec­ond vac­cine giv­en au­tho­riza­tion in Eu­rope fol­low­ing Pfiz­er and BioN­Tech. EMA had pre­vi­ous­ly sched­uled a dead­line for Jan. 12 to reach a de­ci­sion.

The ball will now head to the Eu­ro­pean Com­mis­sion’s court, which has the fi­nal say on any opin­ions giv­en by the EMA and CHMP. Should the body give it the thumbs up — a vir­tu­al cer­tain­ty — the EU would be­come the fourth to OK the vac­cine, fol­low­ing au­tho­riza­tions in the US, Cana­da and Is­rael.

Wednes­day’s de­ci­sion comes about one week af­ter Mod­er­na locked down a deal with Swedish CD­MO Re­ci­pharm for work on an undis­closed por­tion of Mod­er­na’s vac­cine sup­ply out­side of the US.

Back in De­cem­ber, the Eu­ro­pean Com­mis­sion ex­er­cised an op­tion to pur­chase 80 mil­lion ad­di­tion­al dos­es of Mod­er­na’s shot, bring­ing its com­mit­ment to 160 mil­lion dos­es. — Max Gel­man

Wood­cock back at FDA as Hahn ad­vi­sor

For­mer CDER di­rec­tor Janet Wood­cock is re­port­ed­ly back at the FDA af­ter step­ping aside to join Op­er­a­tion Warp Speed.

Janet Wood­cock

Wood­cock has joined the agency as prin­ci­pal med­ical ad­vi­sor to FDA com­mis­sion­er Stephen Hahn, ac­cord­ing to an in­ter­nal email ob­tained by Politi­co. She will still re­tain her role with OWS and re­main re­cused from de­ci­sion-mak­ing sur­round­ing Covid-19 ther­a­peu­tics.

Ad­di­tion­al­ly, Wood­cock is ex­pect­ed to work on the agency’s Covid-19 Pan­dem­ic Re­cov­ery Pre­pared­ness Plan (PREPP) ini­tia­tive with Anand Shah, deputy com­mis­sion­er for med­ical and sci­en­tif­ic Af­fairs, per a Bio­Cen­tu­ry re­port. The ini­tia­tive, which launched in Au­gust, aims to fig­ure out how Covid-19 pol­i­cy can be im­proved.

Wood­cock, along with Pe­ter Marks, re­cused her­self back in May af­ter join­ing OWS when an ad­vo­ca­cy group ar­gued their roles close to the White House could pose a con­flict of in­ter­est. Giv­en that the pair were ex­pect­ed to help meet Pres­i­dent Trump’s goal of hav­ing a vac­cine by the No­vem­ber elec­tion, crit­ics ar­gued they were not the best judges of the da­ta. — Max Gel­man

NIH, Mod­er­na study pos­si­bil­i­ty of halv­ing vac­cine dose

It may be two months be­fore Mod­er­na and the NIH can con­clude whether they can halve their vac­cine dose and pro­vide the same lev­el of pro­tec­tion, there­by dou­bling the sup­ply.

The idea was first brought to the fore by Mon­cef Slaoui, the head of Op­er­a­tion Warp Speed, who pro­posed slash­ing the Mod­er­na vac­cine dose from 100 μg to 50 μg based on da­ta from a sub­group, aged 18 to 55, who re­ceived that reg­i­men in a Phase II. But the FDA was much less en­thu­si­as­tic about it, is­su­ing a state­ment one day lat­er to say that sug­gest­ing changes to the au­tho­rized dose and sched­ule is “pre­ma­ture.”

The stakes are high be­cause with two emer­gency use au­tho­riza­tions so far, the US has or­dered enough vac­cines for on­ly 185 mil­lion Amer­i­cans out of 300 mil­lion. Vac­ci­na­tions have lagged se­ri­ous­ly be­hind fed­er­al pro­jec­tions of dis­trib­ut­ing 20 mil­lion dos­es by the end of 2020 — less than 5 mil­lion shots have been giv­en so far — but once the cur­rent batch­es are used up, short­ages could oc­cur.

John Mas­co­la

“The to­tal sup­ply of vac­cine has al­ways been a con­cern,” John Mas­co­la, di­rec­tor of the NIH’s Vac­cine Re­search Cen­ter, told the New York Times, “It’s im­por­tant to do these analy­ses that we’re do­ing, and have all that da­ta in our pock­et in the event that there’s a need to use it.”

The FDA will have to sign off on any dos­ing changes.

A few oth­er so­lu­tions have been float­ing around. Soon af­ter Pfiz­er and BioN­Tech be­gan rolling out their mR­NA vac­cine, phar­ma­cists dis­cov­ered that they could ex­tract one, or some­times two, more dos­es out of a vial even af­ter get­ting the rec­om­mend­ed 5 dos­es. The FDA quick­ly ad­vised that those ex­tra dos­es can be found as long as dif­fer­ent vials aren’t mixed to­geth­er.

Oth­ers — and the UK serves as the most no­table ex­am­ple — have ad­vo­cat­ed for pri­or­i­tiz­ing get­ting the first dos­es to more peo­ple rather than mak­ing sure peo­ple get both dos­es on time.

Pfiz­er and BioN­Tech test­ed a reg­i­men of two dos­es giv­en 21 days apart in their Phase III tri­als. The UK ini­tial­ly rec­om­mend­ed that the sec­ond shot be ad­min­is­tered 21 to 28 days af­ter the first, but it’s al­tered the guide­lines to al­low for a gap of up to 12 weeks — an ap­proach spelled out in its au­tho­riza­tion of an­oth­er vac­cine de­vel­oped by As­traZeneca and Ox­ford.

Both Pfiz­er and BioN­Tech have said that there’s no ev­i­dence to sup­port this al­ter­na­tive dos­ing sched­ule. On Tues­day, the WHO gave its rec­om­men­da­tion of keep­ing the vac­ci­na­tions with­in 21 to 28 days but added “a pro­vi­sion for coun­tries in ex­cep­tion­al cir­cum­stances of (Pfiz­er) vac­cine sup­ply con­straints to de­lay the ad­min­is­tra­tion of the sec­ond dose for a few weeks in or­der to max­imise the num­ber of in­di­vid­u­als ben­e­fit­ing from a first dose.”

“We … to­tal­ly ac­knowl­edge that coun­tries may see needs to be even more flex­i­ble in terms of ad­min­is­tra­tion of the sec­ond dose,” Joachim Hom­bach, ex­ec­u­tive of WHO’s Strate­gic Ad­vi­so­ry Group of Ex­perts on Im­mu­niza­tion, told re­porters. “But it is im­por­tant to note that there is very lit­tle … em­pir­i­cal da­ta from the tri­als that un­der­pin this type of rec­om­men­da­tion.”

I have ad­vo­cat­ed vac­ci­nat­ing more folks quick­ly, wor­ry­ing less if 2nd dose goes in a lit­tle late

Was asked twice to­day whether states should do this against FDA guid­ance

No

Ab­solute­ly not

Let's per­suade @US_FDA with de­bate, da­ta

But un­der­min­ing FDA would harm pub­lic health

— Ashish K. Jha, MD, MPH (@ashishkjha) Jan­u­ary 5, 2021

Pfiz­er/BioN­Tech score new au­tho­riza­tion in Colom­bia

Colom­bia has be­come the lat­est coun­try to au­tho­rize the Pfiz­er/BioN­Tech Covid-19 vac­cine for emer­gency use, paving the way for a roll­out in Feb­ru­ary.

It’s struck a deal to buy 10 mil­lion dos­es of the vac­cine, which would go first to those 60 or old­er with co-mor­bidi­ties and health work­ers. The coun­try has al­so se­cured shots from As­traZeneca/Ox­ford, Janssen and the CO­V­AX coali­tion led by the WHO.

Mex­i­co, Chile and Cos­ta Ri­ca were the first Latin Amer­i­can coun­tries to start mass vac­ci­na­tion with the mR­NA jab de­vel­oped by the US and Ger­man part­ners. Mean­while, Ar­genti­na opt­ed for Rus­sia’s ade­n­ovirus-based Sput­nik V for its ini­tial cam­paign and Brazil has pre-or­dered from Chi­na’s Sino­vac a vac­cine that was be­ing test­ed lo­cal­ly. — Am­ber Tong

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

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.