The European Medicines Agency did not name the company it expects to file the application. However, EU leaders hope a vaccine will be available before the end of the year.
The first application for marketing approval of a COVID-19 vaccine in the European Union should arrive in the next few days, according to the European Medicines Agency (EMA).
The drug watchdog did not identify the drugmaker expected to file, however partners Pfizer and BioNTEch are the most advanced in the regulatory approval process. A total of three drugmakers have published late-stage trial data for their respective coronavirus vaccine candidates, including US firm Moderna, and a British partnership between AstraZeneca and Oxford University.
The Pfizer-BioNTech collaboration has already applied for approval in the US, and the UK has asked its medical regulator to assess the vaccine.
Researchers on the US-German vaccine should enjoy a speedy approval process, as they have been allowed to submit data in real-time to the EMA, without waiting for studies to conclude.
The EMA earlier acknowledged it was trying “to speed up” the evaluation process, but said it was “ensuring the same high regulatory standards for quality, safety and efficacy” as for any other drug.
EMA told the AFP news agency that it could approve the first COVID-19 vaccines by the end of the year. Many European countries, including France, Spain and Italy, have based their immunization plans on that basis.
German Chancellor Angela Merkel told lawmakers Thursday that a vaccine may become available before the end of the year.
In the US, if the Food and Drug Administration (FDA) approves accelarated rollout, vaccination efforts may start as early as mid-December.
In China, medical authorities have already begun immunizing high-risk patients. In Russia, two vaccines have been validated for use before the final phase of clinical trials had started.
The candidates that have passed trials all claim more than 90% effiacy, but their results have not yet been backed up by by publication in peer-reviewed journals, which can usually take months.
Price and logistics will also factor in the success of the vaccines. AstraZeneca’s double dose is the cheapest, costing about €2.5 ($3) per dose and requires just a normal fridge temperature. Moderna’s vaccine must be kept at -20 degrees Celsius (-4 Farenheit), while Pfizer’s must be kept at -70C (-94 Farenheit).
Source: Deutsche Welle