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The “green light” for approval of the Pfizer / BioNTech vaccine was given by the European Medicines Agency (EMA) at noon on Monday (12/21).
In its statement, the European regulator ensures that its first priority was to evaluate the safety of the vaccine.
“I am very pleased to announce that the EMA Scientific Committee has made a positive decision to approve the conditional release within the EU of the vaccine developed by Pfizer and BioNTech,” said EMA CEO Emer Cook. online press conference.
“This is a crucial moment in our efforts to distribute vaccines safely and effectively to European citizens,” Commission President Ursula von der Leyen said in a Twitter post. Indicative of the immediacy of the procedures is that, following the decision of the European Medicines Agency, the Commission is expected to make a decision today, to start the process.
“This is the time for the EU,” said EU Health Commissioner Stella Kyriakidou.
In particular, Ms. Kyriakidou stated:
“Now is the time for the European Union: we are one step closer to a safe and effective vaccine for COVID19. The European Health Agency has established a conditional marketing authorization for the Pfizer / BioNtech vaccine. The European Commission and Member States urgently move now. “
Acceleration by … pressures
The EMA decided to speed up the coronavirus vaccination approval meeting as it came under considerable pressure from Germany. In particular, the services of Chancellor Angela Merkel and the German Health Minister were pressing the European Medicines Agency and the EU to allow the vaccine from the American pharmaceutical industry Pfizer and the German biotechnology laboratory BionNTech to obtain the most urgent .
Vaccines will begin in Greece and across Europe on December 27 and is expected to be the beginning of the end of the nightmare, even if the road is long and even with various obstacles.
What countries have approved the use of the Pfizer vaccine?
Authorities in the United States, Great Britain, Canada, Bahrain, Mexico, Saudi Arabia, Singapore, Switzerland and Costa Rica have already issued permits for the emergency use of the drug.
Serbia also approved the Pfizer vaccine, and Health Minister Zlatibor Loncar announced that a small quantity of 5,000 doses of the vaccine will arrive in the country on Tuesday and will be used immediately to vaccinate nursing homes. As he pointed out, Serbia prepaid 1.8 million installments. He will receive 340,000 installments in the first quarter of 2021 and the remaining installments at the end of the same year.
At the same time, the Chinese pharmaceutical company FosunPharma announced that it will purchase at least 100 million doses of the coronavirus vaccine from Pfizer / BioNTech to administer to people from mainland China at that time, although Chinese companies are producing their own 19 vaccines. c.
The colossal vaccination campaign in the United States began earlier this month, but the government of outgoing Republican President Donald Trump is in talks with Pfizer to reach an agreement to buy at least 100 million additional doses of the virus vaccine. 2021.
The 10 ingredients in the vaccine
The ingredients of the Pfizer vaccine were published a few days ago by the New York Times, putting an end to conspiracy theories about the presence of chips in the vaccine.
The vaccine contains a unique active ingredient, a molecule called messenger RNA (mRNA) and contains only genetic instructions, so that the body of the vaccinated person produces the protein that protrudes (spike) on the surface of the coronavirus, which infects human cells .
The mRNA directs human cells to produce this coronavirus protein. Thus, the human body is deliberately exposed not to the virus itself in an inactivated form (as is the case with more traditional vaccines), but to the predominantly artificially recognizable characteristic of the virus, which activates the immune system to produce antibodies and cells. . memory.
MRNA breaks down quickly, leaves no traces in the body, and does not integrate into human DNA, as conspiracy theorists wrongly claim. All that is left is the desired molecular memory of the coronavirus, so that the body can activate its defenses in time, when it really is against SARS-CoV-2.
The Pfizer / BioNTech vaccine also contains nine other excipients.
Four of them are lipids with complex chemical names:
- (4-hydroxybutyl) azanodiyl) bis (hexane-6,1-diyl) bis (ALC-3015),
- (2-hexyldecanoate),
- 2-[(polyethylene glycol)-2000]-N, N-ditetradecylacetamide (ALC-0159),
- 1,2-distearoyl-sglycero-3-phosphocholine (DPSC)
- Cholesterol.
These lipids together form a protective coating around the mRNA, which is very fragile and would break down quickly if it were introduced into the body on its own. Protected within the little pearl of fat, genetic instructions are more likely to reach human cells to do their work programmed there.
The vaccine also contains the sugar sucrose, which prevents the above nanoparticles from sticking together when the vaccine is stored in deep refrigeration. The other four components of the vaccine are four salts: potassium chloride, monobasic potassium phosphate, basic sodium phosphate dihydrate, and sodium chloride (the latter is the known salt).
These common ingredients have been around in many drugs and vaccines for many years. The salts help the other components of the coronavirus vaccine better adapt to the environment of the human body, which contains its own mixture of natural salts. Finally, the vaccine is diluted with water and salt before it is injected into the body.
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