A coronavirus vaccine is the desire of many on the planet. But the truth is that the development of this immunization can take a long time. We tell you in this article what phase is experimentation.
The race to get a coronavirus vaccine started in the same month of January 2020, when SARS-CoV-2 left its native China to spread to other countries. Given the existence of the pandemic, some companies and institutes began the search.
One of the initial breakthroughs came from the United States. Where the National Institute of Allergy and Infectious Diseases (NIAID) and the company Moderna joined. Using a ribonucleic acid (RNA) replication technique. They made a vaccine with only genetic information.
This means that, as we will see later, the physical presence of viral particles not required. But rather the laboratory SARS-CoV-2 genome emulated. Hence the speed with which the doses were prepared.
Now, the United States government has authorized to go to phase 2 of experimentation on the coronavirus vaccine. This implies a larger human test. Before reading this full article we invite you to know that What Is Coronavirus? Symptoms, Treatment, And Prevention.
The history of the coronavirus vaccine
The modern biotechnology company had the first doses of vaccines prepared at the beginning of 2020. Already on February 7 of this year, it had manufactured the first vials to inject.
This is a very rapid technological advance, considering that the onset of COVID-19 infections was between November and December 2019, in China. It has been genetic engineering that has accelerated the process. This coronavirus vaccine is based on a biotechnological methodology called mRNA. In basic terms, it is a sequencing of the RNA of the viruses without their presence in the laboratory.
The company recreated the genetic information from SARS-CoV-2 with the data obtained from Chinese scientists. Who first isolated the genome. It is an almost theoretical process in its entirety.
On March 4, the Food and Drug Administration (FDA) gave the start guarantee to phase 1 of the experimentation. The company placed the first vials in humans on March 16, 2020, and thus began the first phase of the coronavirus vaccine.
From phase 1 to phase 2
Phase 1 testing of the coronavirus vaccine established as an open-label trial. In this type of experiment, both the investigated subjects and the researchers are aware of all the information.
The injected groups divided into three. Which received doses of 25, 100, and 250 micrograms, respectively. The minimum waiting time was 6 weeks to have the preliminary results. That interval was met in late April.
The vaccine tested in healthy adults between the ages of 18 and 55. As with phase 1 experiments, what intended to establish is the safety of the product. That it does not generate unwanted adverse effects or life-threatening events.
By April 27, the company Moderna submitted the papers to the FDA to request authorization for phase 2 of the coronavirus vaccine. A few days ago, on May 7, 2020, this phase authorized.
What are phase 2 tests?
The substantial difference between phase 1 and phase 2 of experimentation: the objective pursued. While the first focuses on the safety of the material to be analyzed. The second phase aims to establish efficacy.
During phase 1 the question of adverse effects raised. Many subjects do not usually participate. Only a matter of establishing that no collateral damage due to the product investigated.
Instead, the question in phase 2 is whether the substance works or not. Larger participation of subjects usually carried out than in the previous stage. And lasts a little longer, to collect data that support efficacy.
The next steps in the coronavirus vaccine
Once the safety and efficacy of the coronavirus vaccine established, the next step is phase 3. The Modern company calculates to be ready for this development in the early summer, for July or August.
Phase 3 of experimentation is almost always to compare the product with other options available, to establish whether it is worth its release. In this case, the determining data will be whether the vaccine is capable of generating a positive and protective effect in the world or would not contribute anything.
The truth is that we should not be anxious about this investigation. The development of a reliable pharmacological product is slow and not always successful.
Although times have accelerated due to the contingency of COVID-19, the weeks required to test the vaccine remain the same. It is illusory to pretend that in a few weeks we have doses all over the planet to vaccinate.
It is necessary to wait and carefully follow the preliminary reports released. Then there will be the distribution and application stage, which will vary according to geographical areas. The studies continue, you have to be patient.