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Thursday 17 December 2020
EMA prefers the decision
The Moderna vaccine could be approved on January 6
The Biontech vaccine has not yet been approved in the EU, as the European Medicines Agency has already announced the next important date: the use of the Moderna vaccine is expected to be allowed in Europe in the first week of January.
The European Medicines Agency EMA wants to decide on the approval of another crown vaccine on January 6. It is about the preparation of the American manufacturer Moderna, as announced by the authority in Amsterdam. The corresponding deliberations had been advanced just under a week. The Moderna vaccine could therefore be the second most likely to hit the EU market. In studies relevant to approval, Moderna achieved about 95 percent effectiveness with its vaccines after two doses of vaccine.
The EMA wants to decide on the approval of the vaccine by the manufacturers Pfizer and Biontech as of next Monday. As soon as the EU Commission gives the green light, vaccinations could take place in the EU in December. The approval of the Commission is a matter of form. Germany prepares to start vaccinations on December 27.
Moderna vaccine can be stored in the refrigerator for 30 days.
Originally, the EMA wanted to decide on the Moderna vaccine on January 12. The pharmaceutical company had already sent the latest data packet on Thursday, earlier than expected. This contains information specific to production for the EU market ”, announced the authority. In the scientific evaluation of all the data and studies, however, no compromises are made in terms of safety and efficacy.
The EU Commission has already contractually insured six vaccines for EU states. In addition to the Biontech / Pfizer vaccine, agents are from Astrazeneca, Sanofi-GSK, Janssen Pharmaceutica, Curevac, and Moderna. In total, the supply contracts amount to a good 1.3 billion cans. In addition, options were agreed for 660 million more cans.
In the case of the vaccine from the Mainz-based company Biontech and its US partner Pfizer, the commission has already made use of this option and has requested 100 million more doses in addition to the previous 200 million doses. At Moderna he also took his option and increased his firm order from 80 million to 160 million cans. Moderna expects its vaccine to be stable for 30 days at refrigerator temperature and to store for up to six months at minus 20 degrees Celsius.
The Biontech and Moderna vaccines, on the other hand, are based on so-called messenger RNA (mRNA), which is supposed to transmit information to human cells about the production of proteins and, therefore, about the fight against pathogens.
Approval in the US may be imminent
Meanwhile, an advisory group to the US FDA has discussed the request for emergency approval for the Moderna vaccine. Scientists, doctors and employees of authorities and pharmaceutical companies discussed various aspects of the preparation, its effectiveness and side effects for different population groups through a video link.
At the end of the full-day session, a recommendation to the FDA was expected on whether the vaccine should receive emergency approval in the US The final decision is then left to the FDA and expected shortly after the meeting ended . US government officials had already announced that vaccines could begin early next week after an emergency approval.
