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“A great day for science and humanity,” as the Pfizer director described it Dr. Albert Burla, was yesterday, as the first results of the Phase 3 clinical trial of the Pfizer / BioNtech show that BNT162b1 has 90% efficiency.
This is well above the expectations of both scientists and regulators, who have set the bar much lower, at 50-60%. In addition to the seasonal flu vaccine, it is rarely more than 70% effective.
A respite before approval
So we are literally a few days apart from when Pfizer submits your request to United States Food and Drug Administration (FDA), in the third week of November, for the urgent license of BNT162b1.
The first results of Phase 3 of the clinical trial of the vaccine in 94 confirmed cases of volunteers with COVID-19 infection, where the vaccine proved to be effective in 90% of them 28 days after the first injection and an efficacy greater than 90% seven days after the second dose.
The clinical trial is ongoing until Pfizer collects data from at least a total 164 confirmed cases of COVID-19 infection of the sample of 43,538 volunteers who participated in Phase 3 in five countries. This is expected to happen in the coming days, when the drug company can finally apply for an urgent license from the FDA.
“As we understand it, the news is very encouraging. However, the challenges we face are still enormous and we have a long way to go.”commented during yesterday’s periodic briefing, Mr. Gikas Majorkinis, Adjunct Professor of the EKPA School of Medicine and member of the Expert Committee of the Ministry of Health for the new coronavirus.
How many quotas will the EU and Greece receive?
Pfizer and BioNTech are expected to produce up to 50 million doses of the vaccine by the end of 2020 and up to 1.3 billion doses in 2021.
The European Commission will conclude a supply agreement up to 300 million doses of BNT162b1 for its member countries, with the President of the Commission, Mrs. Ursula von der Leyen to declare ourselves satisfied with the encouraging results.
Asked yesterday about the doses of the specific vaccine corresponding to Hellas, the Vice Minister of Health Mr. Vassilis Kontozamanis He noted that this is the fourth agreement on new coronavirus vaccines. “Our country participates in the four agreements. We will have the Pfizer vaccine. The agreement between the company and the European Union will be ratified in the coming days. The vaccine, as Majorkinis said, is in the approval process. Once it has been approved by the competent regulatory authorities of the European Union, it will be available. It is very important that we achieve at the same time that the vaccine will be available in Europe and also in Greece. “
In any case the wide distribution by BNT162b1 is a challenge. Since the vaccine uses messenger RNA technology, a basic condition is to keep the final product at low temperatures so as not to alter its composition. However, Pfizer has already developed a special refrigeration system for vaccine administration, equipped with thermal sensors and GPS.
When, where and who will get vaccinated first in Greece
The Ministry of Health, closely following developments in the field of vaccines, has already drawn up the vaccination plan for the population against COVID-19. Greece as a member of the European Union and based on a special algorithm expected to receive partial doses of the vaccine previously licensed by Coreper.
The EU has agreed on behalf of its member states to buy first 300 million doses of AstraZeneca and an additional 100 million doses in the second phase, from Pfizer / BioNTech 200 million doses and an additional 100 million, from Moderna 80 million doses and an additional 80 million in the second phase, from Johnson & Johnson 200 million doses and another 200 million, while Sanofi / GSK 300 million doses and CureVac 225 million doses.
Greece in two months January February will have at your disposal 1.6 million doses of vaccine for COVID-19 infection to be administered free to all citizens in two doses with a difference of approximately 28 days between injections.
How he wrote it SUNDAY SUBJECT, which citizens will be vaccinated in the new year first in our country has been decided after the relevant scientific recommendations of the Expert Committee of the Ministry of Health for the new coronavirus but also based on statistics from the National Organization of Health Services (EOPYN) and the Government of Social Security SA (IDIKA SA).
Therefore, tthe first two months of 2021 will be the first to be vaccinated against SARS-CoV-2 Health workers and in particular those with a higher risk of contact with suspicious and positive cases, security forces, then vulnerable groups of the population, such as people over 65 and children and finally other citizens of the country.
In the coming years you will be administered the new coronavirus vaccine as in your case seasonal fluIn other words, the vaccine will be included in the electronic prescription and will be made in a specific time interval in order to create the immune wall in time. Coronaviruses, to which the SARS-CoV-2 family belongs, have one long period of circulation in the community, from October to April of the following year. So, theoretically, vaccination should take place at least 1.5 months before the start of the coronavirus circulation period, that is, around mid-August.
For 2021, the first year of the new vaccine, the Ministry of Health has drawn up a special “map” of vaccination centers for the COVID-19 disease, the burden of which falls on the structures of Primary Health Care. In particular, the Health Regions have requested the Health Centers and Regional Clinics to guarantee the adequate building infrastructure as well as the suitability of the medical personnel, in proportion to the local population, for the proper development of vaccination. Each vaccination center should have a special refrigerated storage area for doses.
Regarding the personnel, initially at least one doctor and one nurse will be trained both in the process of administering the vaccine and in the detailed record of the health evolution of the vaccinated people for the timely detection of side effects. Relevant information will be provided to each vaccinated person so that, either at the local vaccination center or in contact with the National Medicines Agency (EOF) to thoroughly record any side effects.
Positive outlook for Moderna and Astrazeneca
Pfizer’s encouraging results create optimism and by the expected results of the other candidate vaccines.
THE Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, commenting on the effectiveness of BNT162b1 described it “Just great” stressing that it will have a “great impact” in the fight against the pandemic.
He estimated that the mRNA-1273 vaccine that Moderna is developing may have similar efficacy to the Pfizer vaccine because it is based on messenger RNA (mRNA) technology.
THE Modern has stated that it will be able to send bi-monthly data to the FDA on the safety and efficacy of the vaccine, requesting urgent authorization for its administration to high-risk groups at the end of November. Its production capacity is up to 20 million doses of mRNA-1273 by the end of 2020 and 500 million with 1 billion doses in 2021.
With regard to the European COVID-19 vaccine, c Ruud dober since his administration AstraZeneca Referring yesterday to the success of “rival” Pfizer, he called the results “incredibly promising” and added that he is full of optimism that his own company’s results will be positive.
AstraZeneca with its partner, the Oxford University, Results from Phase 3 of AZD1222 are expected in the coming weeks, and the biopharmaceutical company has stated that the vaccine could be ready by Christmas. The British National Health Service (NHS) is already in the process of preparing its health structures to vaccinate the population against COVID-19.
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