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Three EU member states, including Hungary, deviated from the EU protocol, so the vaccination started yesterday:
In its vaccination strategy adopted in mid-June, the European Commission asked member states to start vaccination on the same day and for the first doses to be delivered on Saturday. EU countries can start vaccinating on Sunday, but can also choose to do it on the 28th or 29th.
The European Commission on Monday granted a conditional marketing authorization for the use in Europe of a vaccine developed by the German company BioNTech and the US pharmaceutical company Pfizer. The vaccine is the first coronavirus vaccine approved in the EU.
The EU committee authorized the vaccine after the European Medicines Agency (EMA) issued a favorable scientific recommendation on the same day, based on an evaluation of the vaccine’s safety, efficacy and quality.
The delivery of the authorized vaccine will continue until the end of December and weekly in the following months. BioNTech and Pfizer will have until September distribution of their full vaccine inventory.
The European Commission so far
- AstraZeneca (400 million doses),
- Sanofi-GSK (300 million doses),
- Johnson & Johnson (400 million doses),
- BioNTech-Pfizer (300 million doses),
- CureVac (405 million doses) and
- Modern (160 million servings)
signed contracts for the supply of vaccines with companies.
According to the EU vaccine strategy, each vaccine will be available to Member States at the same time and under the same conditions after authorization and production. As there will not be enough doses in the first months to vaccinate all adults, the first doses will be administered to priority groups defined by the Member States, such as health workers and those over 60 years of age.
Delivery to national distribution centers is the responsibility of the manufacturers. The greater distribution among vaccination centers is the responsibility of the Member States, which are also responsible for immunizing the population.
Everyone who receives the vaccine will receive a vaccination certificate as proof. This document can be useful for travel, among other things. You can allow testing or quarantine to be required when you arrive in another country.
BioNTech and Pfizer submitted a formal application for a conditional marketing authorization on December 1. The EMA had previously analyzed the relevant data in a continuous evaluation since October 6, which allowed it to evaluate the application in a short time. Following the favorable opinion of the EMA, the European Commission examined all the factors supporting the marketing authorization and also consulted the Member States before granting the conditional marketing authorization.
BioNTech and Pfizer’s vaccine technology is based on messenger RNA (mRNA) molecules. They are used to produce harmless viral protein fragments in the human body, creating an immune response to prevent or fight subsequent natural infections.
When a person is vaccinated, their cells read the genetic instructions and produce smaller elements called glycoprotein spikes on the outer surface of the virus. The live virus uses them to enter the cells of the body, replicate, and therefore cause disease. The human immune system then treats this protein as a foreign substance and, as a natural defense, produces antibodies and T cells belonging to the group of white blood cells against it.
In the case of a conditional marketing authorization, the medicine is authorized on the basis of less complete data than in the normal procedure. A conditional marketing authorization may be considered if the benefits of the immediate availability of the medicine clearly outweigh the risks.
Following the granting of a conditional marketing authorization, companies must provide additional data, including new or ongoing studies, within a specified time frame to confirm that the benefits continue to outweigh the risks.
The European Commission also approved another contract with the American pharmaceutical company Moderna in early November to buy 80 million doses of the vaccine in the first round. The vaccine known as Moderna mRNA-1273 may be the second to receive a conditional marketing authorization in the EU. The EMA will be able to decide on a recommendation for the use of the vaccine in the EU on January 6.
To date, no other vaccine manufacturer has formally applied for a marketing authorization from the European Medicines Agency. However, to speed up the process, the EMA has initiated ongoing evaluations of the vaccines manufactured by Johnson & Johnson and AstraZeneca.
Cover image: Getty Images
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