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All the processes that will lead humanity, for the first time in history, so quickly to a safe and effective vaccine for a contagious disease are moving rapidly. Today Wednesday, the European Union agreement with biopharmaceutical companies Pfizer and BioNTech for your supply BNT162b1 vaccine it is expected to be approved by the College of European Commissioners.
The procedure for the European approval of the vaccine.
Following the announcement of the first data from the phase 3 clinical trial, around 90% efficacy of the vaccine in 94 confirmed cases of COVID-19 infection, on Tuesday the EU Health Commissioner, Ms. Stella Kyriakidou announced the completion of negotiations with the two partners for the supply of 300 million doses of BNT162b1. The agreement is currently being considered by the College of Commissioners and will then be requestedthe approval of member countries and “then we will sign,” explained the European Commissioner.
THE European Comission had reached a preliminary agreement in early September with the Pfizer / BioNTech to preorder 200 million doses of the vaccine, with the option to supply an additional 100 million doses. According to Ms Kyriakidou, there are plan the distribution of available doses according to the population of each country, the distribution will depend on the moment of approval of the vaccine by the European Medicines Agency (EMA), which has not yet received your data. Phase 3 clinical trial.
Pfizer announced details about 94 confirmed cases of infection of the novel SARS-CoV-2 coronavirus and the efficacy of BNT162b1, but will provide competent US regulatory authorities. and the EU only when it completes the number of 164 confirmed infections. This is expected to happen in the third week of November, when two months have passed since the vaccine was administered to this number of volunteers. Coreper will consider the above information when it receives it. Committee for Medicinal Products for Human Use (CHMP) who will be called upon to express a positive opinion. This decision will be sent to the European Commission, which will decide on the marketing authorization of the vaccine.
COVID-19 vaccine in 2021 in Europe
With the exact launch date of the COVID-19 vaccine, both in Europe and the United States, it is currently not possible to determine precisely, sources in the European Union say that “A vaccine will be available in early 2021.” The European Union has already signed pre-order contracts for COVID-19 vaccines with AstraZeneca, Johnson & Johnson, up to 400 million doses each, as well as with Sanofi / GSK for 300 million doses. Preliminary agreements have also been concluded with CureVac and Moderna.
According to the European Commissioner for Health, the EU is creating a portfolio of six vaccines for COVID-19, ensuring that member states eventually have access to an effective and safe vaccine.
What Pfizer’s Competitors Are Doing
Therefore, Pfizer / BioNTech is preparing to provide all the details to the Food and Drug Administration (FDA) from the USA and like all shows, they will be the first to “cut” the thread in the vaccine race. THE Modern, who on October 22 administered the second dose of his vaccine to 26,000 volunteers Of the final sample of 33,000 people who participated in the phase 3 clinical trials, you will have to wait two months from the second infusion. Only then can you provide proof of its safety and efficacy to the FDA. This practically means that you will not be able to apply for an urgent license before the end of December or the beginning of January 2021.
On the other hand AstraZeneca It has already stated that it expects its own final results from phase 3 clinical trials by the end of 2020, which means it will be late to apply for a license from the European Medicines Agency, compared to Pfizer. It is recalled that AstraZeneca went out after hours due to the side effects of two volunteers who participated in clinical trials of their vaccine.
Kikilias: Greece will have the vaccine at the same time as the rest of Europe
The Greek Minister of Health Mr. Vassilis Kikilias Commenting on these pleasant advances in the field of vaccines, he stated in yesterday’s press conference on the preparation of the Health System that “Greece participates in the European effort to supply vaccines.” It will have the vaccine as long as the rest of Europe has it. “
Confirming Sunday SUBJECT’s report, Mr. Kikilias explained that “Firstly, health and vulnerable groups will be vaccinated, according to the instructions of the National Vaccination Committee, and then everyone else. “This will allow us to achieve partial regularity and is a hopeful message.”
While the lady Anastasia Kotanidou, Professor of Pneumology-Intensive Care at the EKPA Faculty of Medicine, President of the Hellenic Society for Intensive Care and head of the Scientific Committee for the design of new ICU beds at NSS Hospitals, added that “The vaccine will be available to everyone in Greece.” There will simply be a priority for medical personnel, then vulnerable groups and then in turn all people who voluntarily want to be vaccinated. “
And he emphasized that, “The vaccines to come are considered completely safe and there is no reason to spread various false news that vaccines are dangerous and we should not apply them.”
Next week, the Minister of Health is expected to present the complete plan for vaccination centers for COVID-19, part of which was first described by THEMA on Sunday, November 8.
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