After application by two vaccine candidates in the EU: How does the approval process and when can vaccinations be made? </p><div> <p>The race for a corona vaccine continues: After the US company Moderna was the first company to apply for approval in the EU on Monday, Biontech and Pfizer followed suit on Tuesday. Now all eyes are on the European Medicines Agency EMA. The most important answers to the approval process at a glance.</p>
How does approval work in Europe in general?
The EMA, based in Amsterdam, is the central testing body responsible for the approval of vaccines. After a test procedure, the Committee for Medicinal Products for Human Use issues a recommendation on the approval application. This forms the basis for the final approval decision of the EU Commission.
What does the new rolling review process mean?
The approval applications for corona vaccine candidates can be evaluated in a “rolling review”. This is the case with both Moderna and the Biontech / Pfizer vaccine. The procedure serves to accelerate the EMA assessment. The evaluation of the vaccine candidate begins even before all the necessary data for a “normal” regulatory application have been submitted. The EMA already offers quick scientific advice during the development with a specially created Covid-19 task force. Despite the acceleration, the requirements for quality, safety and efficacy of the drugs in question remain high, according to the EMA.
When could the final approval be granted at the earliest?
In December, the EMA wants to decide on an approval recommendation for the corona vaccine from Biontech and Pfizer. A result of the examination should be available by December 29th at the latest. A decision on the proposal by the Moderna Group is expected by January 12th.
What exactly does the EMA check during the approval process?
According to EU drug legislation, the benefits of a corona vaccine must be far greater than any side effects or potential risks. The Committee for Medicinal Products for Human Use (CHMP), with scientists from all European regulatory authorities, is responsible for assessing the new product. Experts provide assessments of the drug’s effect and comment on the uncertainties of the data. The Pharmacovigilance Risk Assessment Committee (PRAC) assesses drug safety.
How will the EU Commission decide?
A commission spokesman said Tuesday the process could be completed in days following an EMA recommendation. Before the decision of the Commission, a panel of experts is held in which all EU countries are represented. This must approve with a qualified majority.
What does a conditional admission mean?
In the case of the Moderna vaccine, there should be conditional approval. Such approval is intended to meet urgent medical needs. The EMA writes: “In the interests of public health, applicants can be granted conditional approval for such drugs if the benefits of immediate availability outweigh the risk of less than normally required data.” The approval conditions stipulate that missing data, for example on long-term effectiveness or data in certain subgroups, must be submitted as soon as possible after approval. Conditional approval is valid for one year and can be extended.
How soon after approval can vaccinations start?
In Austria, vaccines are subject to the provisions of the Medicines Act and are approved by the Federal Office for Health Safety (BASG) and the AGES. The first safe and effective vaccines in relevant quantities could be available from the beginning of 2021, according to the Ministry of Health. Vaccination will begin where there is greatest personal and systemic risk.
What: SN, Dpa </span> </div>