[ad_1]
The American biotechnology firm Moderna announced that it has initiated practices in the United States and Europe to obtain emergency authorization for its coronavirus vaccine. A few days ago, Pfizer-BioNTech had done the same, following the very promising results of its solution. Therefore, the use of two vaccines to curb the pandemic could be approved by the end of the year, less than a year after the start of their development and testing.
Moderna announced the initiation of the application by reporting the final results of its clinical trials, which were 94.1 percent effective, in line with the 94.5 percent estimated a few weeks ago in a ‘preliminary analysis based in part the 30 thousand volunteers who had participated in the experiment. There were 196 cases of COVID-19: 185 occurred in the group that had received a substance that does nothing (placebo), while the remaining 11 in the group that had received the actual vaccine.
The study also identified 30 cases with severe COVID-19 symptoms in the placebo group, while no severe cases were detected among the vaccinated volunteers. This circumstance seems to indicate a high efficacy of the vaccine in reducing the risk of developing even severe forms of the disease, which in subjects at higher risk can lead to various complications and sometimes death.
Moderna found no particular differences in effectiveness since the age of the volunteers or their geographical origin varied. Among the 196 cases of COVID-19, 33 occurred in the elderly, among those most at risk.
– Read also: What is “the efficacy of a vaccine”?
The new data did not reveal any particular adverse effects related to the administration of the vaccine. The most common were pain at the injection site and headache, which were temporary and disappeared in a short time, as often occurs after receiving a dose of a vaccine.
Both Moderna and Pfizer-BioNTech believe they have collected enough material to apply for an emergency authorization from the Food and Drug Administration, the U.S. federal drug agency. Initiating these practices allows you to obtain approval faster than usual. usual, still maintaining some steps for the control and analysis of the data by the agency managers.
The Pfizer-BioNTech vaccine will be reviewed by a first panel of experts on December 10, while Moderna’s vaccine is due to be reviewed on December 17. The commission is tasked with evaluating data from clinical trials and recommending or not the use of new vaccines, starting with health professionals and population groups at highest risk.
Barring unforeseen circumstances, the FDA is expected to grant emergency authorization for both vaccines later this year. Pfizer-BioNTech and Moderna are also working to obtain the necessary authorizations in the European Union, which should allow the doses to be distributed before the end of December.
Initially, the available doses will be limited due to the technical time required to produce them. Pfizer-BioNTech expects to provide at least 25 million doses of the vaccine in the United States by the end of the year for 12.5 million vaccines (two doses per person one month apart). Moderna has announced that it will be able to produce up to 15 million doses by the end of the year, while it claims that it should produce up to one billion doses during the next.
As for Europe, the European Commission has reserved 80 million doses of Moderna vaccines, with the option to buy another 80 million. The Commission also reserved 200 million doses of Pfizer-BioNTech, reserving the right to add a second order for 100 million doses. To these are added the doses reserved by other pharmaceutical companies that are still working on their vaccines, such as Sanofi-GSK and AstraZeneca.
The Moderna and Pfizer-BioNTech vaccines are expected to be the first messenger RNA (mRNA) -based vaccines to be deployed for large-scale use, which is why there is also a lot of interest surrounding their solutions. The mRNA is the molecule that codes and transports the instructions contained in the DNA to the cells to produce proteins. Simply put, the vaccine uses synthetic forms of mRNA, made in the laboratory, that contain instructions for making some specific coronavirus proteins. In this way, the immune system learns to recognize and fight them, but without the risks that would occur in the case of a real coronavirus infection. The immune system can use the knowledge gained to counteract these proteins to counteract any actual infection.
Clinical tests have revealed this ability, in addition to confirming the safety of the two solutions, both to be administered with two doses one month apart. This circumstance and the fact that the vials must be kept at -70 ° C for Pfizer-BioNTech and -20 ° C for Moderna will pose a significant logistical challenge. Moderna’s vaccine could have some advantages because, once thawed, it remains stable in the refrigerator for about a month, so there is no need to use very powerful (and expensive) freezers in pharmacies and hospitals.
News of the imminent approval of the two vaccines is positive, but experts urge you not to get too caught up in the hype. Only after its use in millions of people will we know how effective the vaccine is in the community, compared to that estimated in clinical trials with a limited (albeit fairly large) number of individuals. In addition, the two vaccines have only been around for a short time and therefore it is not possible to establish to what extent they guarantee protection, a particular closely related to the ability of the immune system to develop long-term immunity.
[ad_2]
