Covid-19 roundup: Novavax finally receives the go-ahead in Europe for its vaccine; CDC struggles to track Omicron

The long wait for No­vavax’s promis­ing Covid-19 vac­cine will soon be over for Eu­ro­peans.

The Eu­ro­pean Med­i­cines Agency on Mon­day rec­om­mend­ed grant­i­ng a con­di­tion­al mar­ket­ing au­tho­riza­tion for No­vavax’s shot, to be known as Nu­vax­ovid, to pre­vent Covid-19 for all those over the age of 18. And lat­er Mon­day morn­ing, the Eu­ro­pean Com­mis­sion grant­ed that au­tho­riza­tion.

Clin­i­cal tri­als of the two-shot vac­cine, with each jab tak­en three weeks apart, showed it was safe and of­fered strong ef­fi­ca­cy, but the EMA warned that the vac­cine has not been test­ed against some vari­ants of con­cern like Omi­cron.

‘Tak­en to­geth­er, the re­sults of the two stud­ies show a vac­cine ef­fi­ca­cy for Nu­vax­ovid of around 90%. The orig­i­nal strain of SARS-CoV-2 and some vari­ants of con­cern such as Al­pha and Be­ta were the most com­mon vi­ral strains cir­cu­lat­ing when the stud­ies were on­go­ing. There is cur­rent­ly lim­it­ed da­ta on the ef­fi­ca­cy of Nu­vax­ovid against oth­er vari­ants of con­cern, in­clud­ing Omi­cron,’ the EMA said.

No­vavax and the Eu­ro­pean Com­mis­sion an­nounced an agree­ment in Au­gust to sup­ply up to 200 mil­lion dos­es of No­vavax’s vac­cine. The Serum In­sti­tute of In­dia will sup­ply ini­tial dos­es for the EU.

The vac­cine is al­so cur­rent­ly un­der re­view by mul­ti­ple reg­u­la­to­ry agen­cies world­wide, and the com­pa­ny ex­pects to sub­mit its com­plete chem­istry, man­u­fac­tur­ing and con­trols (CMC) da­ta pack­age to the US FDA by the end of the year.

Mean­while, the head of the EMA warned on Mon­day that the avail­able vac­cines, in­clud­ing the mR­NA and ade­n­ovirus-based ones, are los­ing their ef­fi­ca­cy with the new vari­ant.

‘The da­ta com­ing in . . . it’s not at all de­fin­i­tive, there are very small num­bers, [but] it’s clear that there is a drop in ef­fec­tive­ness,’ Emer Cooke, ex­ec­u­tive di­rec­tor of EMA, told the Fi­nan­cial Times.

CDC da­ta strug­gles con­tin­ue with Omi­cron

With Omi­cron emerg­ing, the US con­tin­ues to re­ly on in­ter­na­tion­al da­ta for a lot of its de­ci­sions, and pub­lic health of­fi­cials told POLITI­CO that the cur­rent lev­el of in­vest­ment by the fed­er­al gov­ern­ment to im­prove the coun­try’s da­ta sys­tems is not enough to over­haul their ex­ist­ing sur­veil­lance sys­tems if there’s an­oth­er mas­sive surge, like with Omi­cron, or an­oth­er pan­dem­ic.

‘We’re re­ly­ing on every­one else’s da­ta. We should be pro­vid­ing da­ta to the world and we are not,’ said Zeke Emanuel, a bioethi­cist and for­mer mem­ber of Pres­i­dent Biden’s tran­si­tion Covid-19 ad­vi­so­ry board. ‘We start­ed [the pan­dem­ic] with a se­ri­ous prob­lem of not enough da­ta and bad da­ta in­fra­struc­ture. We have not made the struc­tur­al in­vest­ments we need. The ide­al is that we have re­al time da­ta. And we don’t have that. We’re not even close to that.’

And with the Build Back Bet­ter bill now floun­der­ing, the $7 bil­lion to sup­port the im­prove­ment of pub­lic health in­fra­struc­ture across the coun­try is al­so on the ropes.
https://endpts.com/covid-19-roundup-novavax-finally-receives-a-thumbs-up-from-the-ema-for-its-vaccine-cdc-struggles-to-track-omicron