As­traZeneca and Ox­ford have land­ed the first au­tho­riza­tion for their Covid-19 vac­cine. And with this par­tic­u­lar shot, the UK may be much fur­ther ahead than the rest of the world.

The MHRA rec­om­mend­ed an emer­gency OK to the UK gov­ern­ment al­most two months af­ter it start­ed a rolling re­view — al­though the de­vel­op­ers on­ly sub­mit­ted the full ap­pli­ca­tion last week. Reg­u­la­tors have de­ter­mined that “the vac­cine has met its strict stan­dards of safe­ty, qual­i­ty and ef­fec­tive­ness,” ac­cord­ing to a state­ment, even though ex­perts in oth­er coun­tries have raised ques­tions.

While da­ta from a sub­group sug­gest­ed that a reg­i­men in which peo­ple first re­ceive a half dose, fol­lowed by a full dose has a high­er ef­fi­ca­cy fig­ure at 90%, the MHRA gave the thumbs up to the 62% ef­fec­tive full-full dose reg­i­men, which is sup­port­ed by more ev­i­dence from two tri­als con­duct­ed in the UK and South Africa.

Hav­ing be­come the first coun­try to au­tho­rize and start ad­min­is­ter­ing the Pfiz­er/BioN­Tech vac­cine, the UK has or­dered enough of that mR­NA jab for 20 mil­lion peo­ple. Its deal with As­traZeneca now gives it ac­cess to an­oth­er 50 mil­lion ade­n­ovirus-based vac­cines, more than enough to vac­ci­nate a pop­u­la­tion of 66 mil­lion-plus.

The OK trig­gers an im­me­di­ate re­lease of its batch­es, As­traZeneca said, and mil­lions of dos­es will be ready for vac­ci­na­tion ear­ly in the new year.

No­tably, the two dos­es of its vac­cine — dubbed ChA­dOx1 nCoV-19 and AZD1222 at var­i­ous points of its short life — can be giv­en four to 12 weeks apart. Ac­cord­ing to ear­li­er com­ments by Adar Poon­awal­la, CEO of the Serum In­sti­tute of In­dia, giv­ing them 2 to 3 months apart boosts the ef­fi­ca­cy to 95% (his com­pa­ny is mass-man­u­fac­tur­ing the vac­cine). By com­par­i­son, doc­tors are rec­om­mend­ed to give the sec­ond dose of Pfiz­er/BioN­Tech’s BNT162b2, now chris­tened Comir­naty, 21 days af­ter the first.

UK au­thor­i­ties made no ref­er­ence to that claim but said that means they can pri­or­i­tize giv­ing one, par­tial­ly pro­tec­tive As­traZeneca/Ox­ford vac­cine to as many peo­ple as pos­si­ble, with­out hav­ing to rush to the next shot.

Matt Han­cock, the Sec­re­tary of State for Health and So­cial Care, called it “a mo­ment to cel­e­brate British in­no­va­tion.”

Oth­er coun­tries, though, haven’t been as en­thu­si­as­tic. Mon­cef Slaoui, the sci­en­tif­ic chief of Op­er­a­tion Warp Speed, has re­marked that As­traZeneca would like­ly need the re­sults from its US tri­al to file for an emer­gency use au­tho­riza­tion with the FDA. In­dia had passed on grant­i­ng an ear­ly OK to As­traZeneca. Ear­li­er this week, a top EMA of­fi­cial not­ed that Eu­ro­pean au­thor­i­ties have yet to re­ceive the non-clin­i­cal da­ta nec­es­sary to con­firm vac­cine “qual­i­ty” for au­tho­riza­tion, mean­ing they like­ly can’t make a de­ci­sion any time soon.

For its part, As­traZeneca has been tout­ing the sta­bil­i­ty — it can be stored, trans­port­ed and han­dled at nor­mal re­frig­er­a­tor tem­per­a­tures of 2-8 de­grees Cel­sius — and the low cost of its vac­cine as it makes plans to sup­ply bil­lions of vac­cines to less de­vel­oped re­gions.

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The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.