As the first company — Moderna wants to apply for EU approval for Corona vaccine — - today

The race for the first coro­na vac­cine con­tin­ues at record speed. The US com­pa­ny Mod­er­na wants to apply for approval in the EU and emer­gency approval in the USA today. This means that the start of vac­ci­na­tions is get­ting clos­er this year. The US phar­ma­ceu­ti­cal com­pa­ny Mod­er­na wants to be the first com­pa­ny to apply for approval for a coro­na vac­cine in the EU. The com­pa­ny announced that the appli­ca­tion for con­di­tion­al approval should be sub­mit­ted to the Euro­pean Med­i­cines Agency Ema on Mon­day. At the same time, an appli­ca­tion for emer­gency approval is to be sub­mit­ted to the US FDA.

Bion­tech, Mod­er­na, Astrazeneca The three top coro­na vac­cines in comparison

With the appli­ca­tion for approval at Ema, a coro­na vac­ci­na­tion is also approach­ing in Ger­many. Last week, EU Com­mis­sion chief Ursu­la von der Leyen announced that a frame­work con­tract for up to 160 mil­lion vac­cine dos­es had been con­clud­ed with Mod­er­na. Accord­ing­ly, 80 mil­lion cans are to be deliv­ered ini­tial­ly, with the option of 80 mil­lion more units. Accord­ing to Mod­er­na, the prod­uct could be deliv­ered in the EU as ear­ly as Decem­ber, pro­vid­ed it receives approval. A so-called rolling review process is already run­ning at Ema for the RNA vac­cine from Mod­er­na, which is intend­ed to accel­er­ate the approval process. Man­u­fac­tur­ers can sub­mit indi­vid­ual parts on the qual­i­ty, safe­ty and effec­tive­ness of a prepa­ra­tion even before the com­plete appli­ca­tion for approval. The Mainz-based man­u­fac­tur­er Bion­tech has also run such a pro­ce­dure togeth­er with the US com­pa­ny Pfiz­er. Bion­tech and Pfiz­er have already applied for emer­gency approval in the USA, but not yet in the EU. Moderna’s prepa­ra­tion is com­par­a­tive­ly sim­i­lar to the Bion­tech / Pfiz­er vac­cine in terms of its mode of action and its effec­tive­ness. In the case of con­di­tion­al mar­ket­ing autho­riza­tion, the Ema can, under cer­tain con­di­tions, autho­rize a prod­uct on the basis of less com­pre­hen­sive data if the prod­uct is urgent­ly needed.

120 peo­ple per hour This is how vac­ci­na­tion works in a vac­ci­na­tion center

The Mod­er­na vac­cine mRNA-1273 has an effec­tive­ness of 94.1 per­cent, as the com­pa­ny announced. This emerges from the lat­est analy­sis of data from the Phase III clin­i­cal tri­al, in which 30,000 peo­ple in the Unit­ed States are par­tic­i­pat­ing. Half of the par­tic­i­pants receive the vac­cine, the oth­er half a placebo.

Two dos­es for full vac­ci­na­tion protection

For full vac­ci­na­tion pro­tec­tion, two dos­es are nec­es­sary at inter­vals. A total of 196 cas­es of the Covid-19 dis­ease have been con­firmed among the test sub­jects. 11 of these cas­es were in the vac­cine group and 185 in the place­bo group. This results in an effec­tive­ness of 94.1 per­cent. The new results rough­ly cor­re­spond to the pre­lim­i­nary data that Mod­er­na pub­lished in mid-Novem­ber. In addi­tion, Mod­er­na announced that the total of 30 severe Covid-19 cours­es in the study only affect­ed the place­bo group. The effec­tive­ness of mRNA-1273 was sim­i­lar across all age groups, accord­ing to Moderna.

Rejec­tion by one in five Barmer: only a small major­i­ty of those will­ing to vaccinate

Like that from Pfiz­er and Bion­tech, the Mod­er­na prepa­ra­tion is a so-called RNA vac­cine. It con­tains genet­ic infor­ma­tion about the pathogen, from which the body then pro­duces a virus pro­tein. The aim of the vac­ci­na­tion is to stim­u­late the immune sys­tem to pro­duce anti­bod­ies in order to inter­cept the virus­es. There is still no approved vac­cine of this type. Coun­tries such as Rus­sia, Chi­na and recent­ly Bahrain have already released vac­cines with restric­tions and are already vac­ci­nat­ing parts of the pop­u­la­tion with them. But how well these vac­ci­na­tions actu­al­ly pro­tect and what side effects they can have is cur­rent­ly large­ly open.

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