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2020 brought us the most rapidly developed vaccine in the world, which understandably brought up a lot of questions. In Europe, the first conditional approval and the highest efficacy were achieved with a joint vaccine from Pfizer and BioNTech. How can a vaccine be developed for a new virus when there is still no cure for old diseases? Isn’t the new messenger RNA technology dangerous? Who can get vaccinated and why not give it to people under 16 years of age? What about long-term side effects? Hungarian Pfizer executives and experts have tried to answer all of our questions.
A joint vaccine against the coronavirus, Pfizer and BioNTech, a vaccine now called Comirnaty, has achieved more than 95 percent effectiveness. The two companies announced in mid-March that they would begin working together to develop a vaccine against SARS-CoV-2, and in December they launched the drug, which officially became one of the fastest-developed vaccines in the world; it took only 9 months. .
While most vaccines have yet to question the efficacy of other vaccines, apart from some blinded vaccines, the speed and epidemic closures have pushed COVID-19 to stop the vaccine, everyone wants to understand how it works, if it is safe, if it can be given and administered. to your loved ones. It doesn’t help that this is a new type of vaccine that the average person knows relatively little about, nor that a wider range of containers are slowly accepting the existence of the virus, or at least a worldwide conspiracy behind it, as a vaccine, as a medicine. . .
The reality is less dramatic, however: a long-developed engine has been outfitted with the spike protein of a well-known pathogen, which triggers our immune response and may rid us of an epidemic that scientists have been warning us about for decades. .
Magic mRNA technology
Although mRNA vaccination appears to be a new technology, in fact, the first patent was issued in 2005. The methodology covers that although conventional vaccines contain inactivated or killed virus or virus particles to elicit an immune response, the vaccine of MRNA sends a message to the cells of the body telling 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 COVID-19 spike protein. Research on the Zika virus, rabies or even the flu is also being done with mRNA vaccines.
Dr. Tibor Fabó The medical director said: Messenger RNA disappears from the body within 72 hours, from then on only the body’s natural immune response takes place, so the chances of serious long-term side effects are minimal. The big advantage of the technology is that, unlike most vaccines currently in use, it does not require a virus, so we certainly do not get COVID-19 from it, and once it has the genetic code of the pathogen, it is can produce synthetically, in large quantities, quickly and stably.
And if a mutation requires a change in the vaccine, this can also be done quickly, producing a new vaccine in six weeks.
Pfizer constantly monitors the English mutation, just like the others, for now Dr. Péter VereckeiAccording to the executive of the company, it is not necessary to modify the vaccine. If the peak protein is affected to some degree by a mutation that requires it, the vaccine can be quickly modified, already effective in 17 different strains. Therefore, it is not necessary to produce a new vaccine, but to change the current one a bit: not all mutations need a separate vaccine, but the universal vaccine will be effective against more and more viral mutations.
Clinical trials are still ongoing
The most common concern about the vaccine is rapid development; many are concerned that the Phase III clinical trials were conducted too quickly, so there was no time to observe long-term side effects. However, the follow-up, that is, the third phase itself, in addition to the authorization, is still ongoing: approximately two years before it is fully completed. No serious reaction to the vaccine was observed during the investigation, but those who had previously produced one for a drug or vaccine were not included. However, among the 44,000 subjects, there were those who had food or drug allergies.
In the first and second phases, the exact dose was determined by relatively few volunteers (there were 45 human subjects at this stage), and in the third phase, 44,000 people already participate. Pregnant women and those under the age of 16 have been excluded from the spread for the first time and will receive the vaccine at a later stage of the investigation.
“Two things are the most important in any vaccine: efficacy and safety. The joint vaccine between Pfizer and BioNTech provides 95 percent protection against coronavirus after 28 days, ”said the chief physician. No serious allergic reactions were found in clinical research and two English and six American nurses are known. The UK’s National Health Service (NHS) now wants to do research specifically on people with allergies to find out how dangerous the vaccine is for them. It is already known that the number of allergic reactions is slightly higher than with other vaccines, but how much and exactly what this means will be revealed in the future.
By the way, the number of people who received the first dose (along with the Moderna vaccine) is already approaching 3 million, and there have been very few reports of problems so far.
The duration of the vaccine protection is likely to be decided within 3 to 4 months. It is not yet clear how long natural defenses will last, time will determine how long the antibodies will be produced in the body of those infected and vaccinated. It has already been seen that the body produces 3 to 3.5 times the level of antibodies against the coronavirus vaccine in Pfizer and BioNTech compared to natural infection, and even in the oldest age group over 55 years, it is 1.8 to 2 times higher. relationship – however, this only shows the strength of the immune response, not its persistence.
It is up to each doctor to decide which diseases should not be administered to the vaccine; at the moment, it is certain that a severe allergic reaction to vaccines or an allergic reaction to their components may be a reason for exclusion. But not all diseases that affect the immune system can throw someone out of line.
You don’t have to worry if someone has already been infected with the virus or is just sick and getting the vaccine.
but the same goes for other vaccines. Therefore, there is no collision, booster with the body’s natural immune response and the immune response to vaccination.
I do, however Krisztina Zsigmond, the director of Pfizer’s vaccine business, said he could not comment on who was responsible for the side effects, as it was a joint contractual agreement between the states and the company, which was a trade secret.
Vaccine thefts and counterfeits
Pfizer representatives have drawn attention to the possibility of counterfeit vaccines appearing in the coming months. Users need to guard against this: Pfizer only delivers vaccines to vaccines, so if someone finds them online, in private clinics, or pharmacies, they may know that they are a counterfeit vaccine. Each vaccine also comes with a vaccine card, which also proves its authenticity, but this is probably not difficult to fake, so everyone should pay attention to the source.
Vaccine thefts were also discussed in the insert: Pfizer said this is a real threat, but vaccination sites need to address security. Pfizer takes care of the delivery and solves it: Since the vaccine has to be stored at -70 degrees Celsius, it is a serious logistical task, but the distribution continues without problems. Vaccines are delivered to vaccination sites in containers that are refrigerated with dry ice and delivered directly to vaccination sites so they do not have to be stored anywhere for more than 30 days. If necessary, the company can make weekly deliveries.
It is also important to know that it is not necessary to keep the vaccine at -70 degrees until use: it can be well kept in the refrigerator, that is, at a temperature of 2-8 degrees Celsius, for 120 hours. Therefore, delivery is the responsibility of Pfizer, but distribution is already a matter for regulators.
The EU has committed 200 million vaccines and another 100 million options, of which 80,000 will be delivered to Hungary this year, and we will receive a total of 4.4 million in 2020-2021, which is enough for 2.2 million people. However, the vaccination will not be commercialized in the near future because all capacity is limited by government orders.
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