SOURCE: As­so­ci­at­ed Press

THE HAGUE, Nether­lands (AP) — The Eu­ro­pean Union drug reg­u­la­tor said Thurs­day it has start­ed a rolling re­view of a new coro­n­avirus vac­cine made by French start­up Val­ne­va, the first step to­ward giv­ing the vac­cine the green light to be used in the 27-na­tion EU.

Ap­proval by the Eu­ro­pean Med­i­cines Agency would add an­oth­er vac­cine to the EU’s ar­mory against COVID-19 as the bloc ramps up ad­min­is­ter­ing boost­er shots and some coun­tries are prepar­ing to de­liv­er shots of Pfiz­er’s vac­cine to chil­dren ages 5 to 11.

Last month, the EU’s ex­ec­u­tive com­mis­sion ap­proved a con­tract with Val­ne­va for mem­ber na­tions to buy al­most 27 mil­lion dos­es in 2022. The con­tract al­so in­clud­ed the pos­si­bil­i­ty to adapt the vac­cine to new vari­ants of the coro­n­avirus and to pur­chase up to 33 mil­lion more dos­es in 2023.

A rolling re­view is an ac­cel­er­at­ed way of as­sess­ing new drugs that al­lows Eu­ro­pean Med­i­cine Agency ex­perts to look at da­ta from on­go­ing stud­ies as they be­come avail­able. Once suf­fi­cient da­ta is avail­able, the com­pa­ny can sub­mit a for­mal ap­pli­ca­tion for EMA mar­ket­ing au­tho­riza­tion.

The Am­s­ter­dam-based agency did not give a time frame for pos­si­ble ap­proval of the Val­ne­va vac­cine.

In Sep­tem­ber, the U.K. gov­ern­ment can­celled an agree­ment with Val­ne­va, part­ly be­cause it was clear the com­pa­ny’s COVID-19 vac­cine wouldn’t be ap­proved by British reg­u­la­tors, the U.K. health sec­re­tary said.

The EMA is now car­ry­ing out rolling re­views of four COVID-19 vac­cines, in­clud­ing Rus­sia’s Sput­nik shot and Chi­na’s Sino­vac.