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The British Medicines Agency approved on Tuesday the marketing of a vaccine developed jointly by Pfizer and BioNTech against a new type of coronavirus. The United Kingdom is the first country in the world to approve the Pfizer-BioNTech coronavirus vaccine for widespread use. This step paved the way for the widespread use of next-generation vaccines, RNA vaccines. The European Medicines Agency, EMA, undertakes to issue the license before December 29.
The British regulator, the MHRA, says that vaccination of the population could start next week. First, healthcare workers are vaccinated, as well as those most at risk, such as residents of nursing homes.
The UK has already ordered 40 million doses of the vaccine, enough to vaccinate 20 million people. About 10 million servings will be available soon, with the first 800,000 servings arriving in the country in a matter of days. The vaccines will be manufactured at Pfizer’s plants in the US and Europe, but BioNTech’s plants in Germany will also be involved in production. The actions destined for the United Kingdom will come from Belgium.
The vaccine was completed at a record speed in just 10 months.
How could the vaccine be made so quickly?
Pfizer-BioNTech is based on a completely new technology; An RNA-based vaccine, which means that not all of the virus is needed to make the vaccine, is enough to introduce a genetic segment into the body.
When the coronavirus first appeared, a Chinese research team quickly mapped the entire genome of the pathogen and the information thus obtained was immediately released to pharmaceutical manufacturers around the world.
Because various companies are researching RNA vaccines, they have been able to respond relatively quickly to developments.
In addition to the Pfizer-BioNTech pair, Moderna, among others, obtained a genetic blueprint for the virus, so they made a very similar vaccine.
What does an RNA vaccine know and how is it different from a conventional one?
The working principle of traditional and RNA vaccines is essentially the same: they cause the body to produce antibodies by eliciting an immune response.
The main difference is that while conventional vaccines immunize with killed or attenuated viruses, Until then, our body produces RNA vaccines to produce viral proteins that then make the body fight back.
This requires the genetic material of the virus, called messenger RNA (mRNA for short). The mRNA carries information about the protein spike in the virus, in fact it is produced by our cells. The protein spikes that appear are noticed by the immune system and begin to produce neutralizing antibodies and T cells against them.
The coronavirus spike alone is not harmful and there is no fear that the mRNA will leave a trace in our gene pool (this would require parts of the virus that are not in the vaccine).
RNA-based vaccines can be prepared quickly, easily, and cheaper than conventional ones.
The RNA vaccine does not contain the entire gene pool of the pathogen, so it cannot cause an infection even with a weakened immune system.
The only downside to the RNA vaccine is that it requires extremely low storage temperatures, which are -70 degrees Celsius for the Pfizer-BioNTech formulation. Moderna RNA vaccine can be stored at a slightly higher temperature, – 20 degrees Celsius. Experts do not yet know the reason for this difference.
How can it be transported at such low temperatures?
The vaccines are placed in special containers that resemble pizza boxes, in which the extreme cold is provided by dry ice, that is, solid carbon dioxide. The vaccines are then shipped to vaccination centers where they are stored in a refrigerator.
Temperatures are controlled at each stage of transport so that the vaccine does not become unstable and unusable. By continually replenishing dry ice, Pfizer says the vaccine can be stored in cans for up to 30 days.
Its 95 percent efficacy is outstanding among vaccines.
The final phase of a clinical trial investigating the efficacy and safety of the Pfizer-BioNTech vaccine involved 44,000 volunteers.
Of the people in the study, 170 were infected with a coronavirus. Of these, 162 received placebo and eight received regular vaccinations. The vaccine had to be administered twice, 28 days apart.
According to the final results, the vaccine protected 95 percent of people from the coronavirus. It is very important to note that the preparation was well tested in the elderly, immunizing 94 percent of those over 65 years of age.
According to the United States Food and Drug Administration (FDA) regulations, a vaccine can be approved if it reduces the chance of developing the disease by at least 50 percent, in light of which the effectiveness of the vaccine Pfizer-BioNTech is outstanding.
Most researchers believe that protein spikes can elicit a sustained immune response from the body.
According to Pfizer, 1.3 billion doses of vaccine could be available in 2021
Albert Bourla, Pfizer CEO, says the company is ready to ship the first 20 million ready-to-use batches immediately to countries whose authorities are giving consent.
The company plans to produce 50 million doses of coronavirus vaccine by the end of this year and 1.3 billion in 2021.
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