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Following the marketing authorization of the European Medicines Agency (EMA) and the European Commission for the covid-19 vaccine developed by Pfizer and BioNTech, Comirnaty became the first conditionally authorized covid-19 vaccine in the European Union.
How the vaccine works
Comirnaty is a so-called mRNA vaccine. This means that, while conventional vaccines contain inactivated or killed virus or virus particles to elicit an immune response, the mRNA vaccine sends a message to the cells of the body instructing the cells to form the spike protein. This protein is found on the surface of the coronavirus and is responsible for the development of infection in human cells. The production of spike protein by cells elicits an immune response in the body, including the production of antibodies specific to the spike protein covid-19. For maximum protection (95% vaccination efficacy), each person needs two doses.
The mRNA research is linked to a Hungarian scientist, Katalin Karikó and her team has been developing the technology for more than 30 years, in 2005 the first patent was registered.
The great advantage of technology is that you can react quickly. If the genetic code of the coronavirus is available, it can be produced synthetically, carrying the information so that the same sequences can be produced quickly and reliably. If the genome of the virus changes, the new vaccine can be produced in just 6 weeks, said Péter Vereckei, Pfizer’s Hungarian managing director.
In clinical trials, the antibody produced by Pfizer’s vaccine was effective against 17 viruses, so no separate vaccines are needed for the strains, and the 17 currently known strains were effective.
In response to questions about long-term effects, Tibor Fabó, Pfizer’s chief medical officer in Hungary, said it was not yet possible to say how long the vaccine would provide immunity, but that they would follow the vaccine for 2 years.
The mRNA itself disappears from the body within 72 hours.
To address the global health crisis, the entire vaccine stock is currently being distributed under government delivery agreements that will run through at least the end of 2021. Globally, Pfizer and BioNtech will produce 50 million vaccines this year and 1,300 million doses by the end of 2021 from their pooled vaccine. The European Commission has immobilized 200 million vaccines and has an option for another 100 million for 2020-2021. Projected in Hungary, this year 80,000 doses will be delivered, which is enough to vaccinate 40,000 people.
and a total of 4.4 million vaccines were committed for the period 2020-2021 under a contract with the European Commission.
Full vaccine stocks will be distributed through government contracts, the vaccine will not be marketed. The relevant regulatory authority will identify the groups to ensure that vaccination is carried out. The vaccination will only be available at state designated vaccination points and will not be marketed. If someone doesn’t try to take detours, they can avoid counterfeiting, Pfizer said at a news conference today.
Anyone who receives a Pfizer vaccine will receive a vaccination card with the Pfizer logo.
According to Péter Vereckei, we are witnessing a breakthrough, in mid-March Pfizer and BioNTech announced the joint development of the vaccine and on December 26 the first dose of the vaccine arrived in Hungary. There has never been a more urgent need for this. Speed can not be at the expense of quality and safety, the company has not made concessions. The development of the vaccine has been transparent throughout and there has been constant publication, he added.
Vaccine development requires development programs and then clinical trials. After that, the product must be produced, for which all raw materials must be obtained and then manufactured. If we have this, we need proper cooperation with governments and regulators. Once everything is created, the topic of global distribution moves to the next step, which is not easy during a pandemic when everyone wants the product at once.
To ensure the quality of the vaccine, Pfizer has developed specially designed and insulated shipping containers,
where dry ice can provide recommended transport conditions for a longer period of time (-90ºC to -60ºC). The thermally insulated transport box, if not opened, can maintain this temperature for 10 days, allowing transport to any country in the world. After reconstitution, the vaccine vial can be safely stored for up to 5 days (up to 120 hours) in a refrigerated environment (2-8 ° C).
The company’s delivery is based on a flexible, just-in-time system that delivers quick frozen vials to the designated inoculation point, when needed, minimizing the need for long-term storage at the inoculation point.
Cover image: Pfizer
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