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After applying the experimental new coronavirus vaccine to volunteers in Germany, Pfizer and the German pharmaceutical company Biontech SE announced that they also began testing doses in the United States yesterday (4).
The plan now is to give the vaccine to 360 American volunteers ages 18 to 55 for the first stage of the study, with a total of 8,000 volunteers, including seniors up to 85 years old, at the end of the second stage.
The researchers already administered five doses on Monday, four of which were placebo. The procedure should be the same in the coming days.
The analysis is performed at New York University, the University of Maryland School of Medicine, the University of Rochester Medical Center, and the Cincinnati Children’s Hospital Medical Center.
According to the companies, if the vaccine proves to be safe and effective in testing, it could be ready for wide distribution in the US. USA In mid-September, significantly shortening the time it usually takes for immunization drug approval.
How the vaccine works
The development of the drug is based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. By injecting a specifically designed messenger RNA into the body, it could tell cells how to make the spike protein (which allows Sars-CoV-2 to infect our cells) without making a person sick.
For testing, participants will divide into groups to compare four variations of the vaccine, each representing a messenger RNA format with instructions to create a different version of the spike protein. Doctors will closely monitor participants’ antibody levels, liver enzymes, and other indicators of possible side effects.
Why is the availability date not guaranteed?
According to the WHO (World Health Organization) there are more than 100 vaccines under development in the world, with at least eight already tested on humans.
With scientists working around the clock looking for the right combination, the chances of launching doses to the general public are high, but the speed with which this will happen is still questionable for many experts.
Developing, testing, and reviewing any potential vaccine is a long, complex, and expensive task that generally takes months or even years.
Due to the emergency situation, companies like Pfizer and BioNTech are using techniques to speed up the process.
Testing multiple candidates in parallel, as they are doing, is one of the ways that companies hope to shorten the time it takes to gather enough evidence to request approval of emergency use by the US Food and Drug Administration. United States (FDA). .
Once the pharmaceutical companies show that the vaccine is effective and does not present any serious risk, it is possible to request approval. However, the results of more detailed studies may still be necessary to convince American regulators to approve immunization for the general public.
