Vaccinations against coronavirus-induced covid-19 disease are progressing at varying rates around the world.
The European Commission has so far granted marketing authorizations for Pfizer and BioNTech as well as Moderna, and a vaccine developed by AstraZeneca and the University of Oxford is expected in the near future.
In the video above, THL's chief physician Taneli Puumalainen talks about virus variants and vaccinations at a press conference on Thursday.
Once the European Commission has granted a marketing authorization, the manufacturer can sell its product in all EU countries.
However, before a marketing authorization can be granted, the product must be approved by the European Medicines Agency (EMA).
The European Medicines Agency (EMA) recently moved from London to Amsterdam due to brexit. Photo: PIROSCHKA VAN DE WOUW / REUTERS
The EMA is responsible for the scientific evaluation, control and safety monitoring of medicinal products for human and veterinary use in the EU.
The agency recently moved from London to Amsterdam as a result of a Brexit.
Manufacturers of coronary vaccines apply for a marketing authorization for their products through a centralized procedure, which allows them to be authorized throughout the EU at once.
AstraZeneca submitted its application to the EMA on 12 January.
Applications for marketing authorizations for coronary vaccines have been and will be processed by the EMA on an accelerated basis.
This is possible because the Agency has already processed ingredient data related to the quality of vaccines and their production methods, laboratory studies and the results of clinical trials.
On 12 January, the pharmaceutical company AstraZeneca submitted an application for authorization to the EMA for a vaccine it has developed in collaboration with the University of Oxford.
The marketing authorization is expected to expire possibly on January 29.Picture: NurPhoto / Zuma / MVPhotos
Marketing authorizations granted on an accelerated schedule are conditional.
This means that the manufacturer will have to provide more research information on the vaccine within a pre-determined timeframe, so that the greater benefits outweigh the risks.
The applications were scientifically evaluated by the EMA's Committee for Medicinal Products for Human Use (CHMP), which is responsible for medicines for human use.
The CHMP's recommendation to the European Commission will ultimately decide whether or not the vaccine can be authorized.
If the application meets the criteria, AstraZeneca will be authorized on 29 January, when the CHMP will meet to decide.
The French queued at the coron vaccination center in Marseille on Monday. Photo: Denis Thaust / Zuma / MVPhotos
The CHMP is made up of members and alternates nominated by each EU country.
Member countries decide on their appointments after consulting the EMA Management Group, which also consists of, among other things, representatives elected by the member countries.
Representatives of non-EU countries Iceland and Norway are also involved in the CHMP.
In addition, the Committee shall be composed of a maximum of five invited members selected by experts, whose task shall be to provide, where appropriate, more specialized expertise in the various fields of science.
Timo Suonsyrjä, Chief Physician of HUS's Haartman Hospital Acute Department, received the first dose of Pfizer and BioNTech's coronary vaccine on December 27. Photo: Antti Aimo-Koivisto / STT-Lehtikuva
The members of the Committee shall serve for a renewable period of three years.
The CHMP is currently chaired by Harald Enzmann, a representative of the German Medicines Agency's BfArm.
Finland's representative in the CHMP is Outi Mäki-Ikola, Chief Physician of the Finnish Pharmaceutical Safety and Development Center Fimea.
The Committee's work is based on a comprehensive evaluation of scientific data.
The Committee shall determine, inter alia, on the basis of information from clinical trials, whether the product meets the requirements as to quality, safety and efficacy and whether the balance of risks and benefits associated with its use is positive.
The Committee is supported and under the auspices of the EMA Special Pandemic Task Force (Covid-ETF), composed of experts from the European Pharmacovigilance Network.
Fimea Finland is also involved in the assessment work of the pandemic working group.
The main purpose of the working group is to bring in more expertise and to ensure that the corona pandemic can be responded to quickly and in a coordinated manner.
It is hoped that the vaccines will provide a solution to the coronary crisis that has been going on for days.
Photo from Dublin, Ireland last week. Photo: Artur Widak / Zuma / MVPhotos
As the corona situation has worsened in recent months, the EMA has been criticized for its slow approval of vaccines, as in Britain, for example, the process has been much faster.
However, the British Medicines and Medicines Agency (MHRA) has granted exemptions for vaccines on a very accelerated schedule, as the infection situation in the country has been very alarming and there has been a desire for vaccinations to progress rapidly.
The EMA criticized Britain’s speed in early December when the country announced it was the first in the world to grant a marketing authorization for the Pfizer and BioNTech vaccine.
In a statement, the agency described its own, longer process as more appropriate, as it is based on a larger amount of information and requires more reassurance than the British emergency procedure.
German Health Minister Jens Spahn commented at a press conference at the time that EU countries wanted a more comprehensive licensing process so that public confidence in the vaccine would not erode.
- The idea is not to be the first, but to get a safe and effective vaccine, Spahn said.
Sources: Europa.eu, Fimea.fi, Reuters