Moderna requests to sell its vaccine in the E.U. and USA after announcing 100% efficacy against COVID-19



The U.S. company reports that it has not detected any significant adverse effects among those vaccinated.

UNITED STATES (Times Media Mexico/El País) – The covid pandemic has reached a turning point where good news is accumulating, after nearly a year of tragedies in which the new disease has killed more than 1.3 million people worldwide.

The American company Moderna has confirmed this Monday that its experimental vaccine’s effectiveness exceeds 94% and even reaches 100% when protecting against severe covid cases, according to the first complete analysis of its clinical trial with 30,000 participants. The company, which has developed its vaccine and the U.S. National Institutes of Health (NIH), already reported similar preliminary results two weeks ago. No serious adverse effects have been detected in those vaccinated, with an average of two months of follow-up.

Moderna has announced that it will apply today for conditional marketing authorization from the European Medicines Agency, a permit that health authorities grant when considering that the public health benefit outweighs the uncertainty due to the limited data available. The company, founded ten years ago in Cambridge USA, has also announced that it will apply for an emergency use authorization from the U.S. drug regulatory agency, the FDA.

The U.S. company and the NIH started its trial with 30,000 volunteers in July. Half received two doses of the experimental vaccine, one month apart, and the other half of the participants were given two injections of water with salts as a placebo. Scientists have detected 196 cases of covid, of which 185 were in people who did not receive the actual vaccine. All severe cases of the disease-a total of 30, including one-death-have, been observed in volunteers in the placebo group.

The company assures in a press release that the observed efficacy is maintained in all “age, race, and ethnic” groups, as well as in men and women. Of the 196 volunteers infected by the coronavirus throughout the trial, 33 were people over 65 years of age, but none of them were seriously ill.

The European Commission has already signed an agreement with Moderna for an initial purchase of up to 160 million doses.
“The positive results of this analysis confirm the ability of our vaccine to prevent covid-19 with an efficacy of 94.1% and, more importantly, the ability to prevent the severe form of the disease. We believe that our vaccine will be a powerful new tool that can change the course of this pandemic and help prevent severe cases, hospitalizations, and deaths,” said Moderna’s CEO, Frenchman Stéphane Bancel, who has been singled out in recent months for earning millions of euros by selling his company’s shares following announcements such as today’s.

Moderna’s experimental vaccine is one of the three most advanced among the 48 candidates already tested on humans. The other two outstanding ones are developed by the tandem of the German biotechnology company BioNTech and the American company Pfizer -with a similar concept to Moderna’s- and the one produced by the University of Oxford together with the British pharmaceutical company AstraZeneca. The differences between them are substantial. For example, Moderna’s experimental vaccine will cost about 21 euros per dose, compared to 15 euros for Pfizer’s and barely three euros for AstraZeneca’s injection, which has assured that it will supply its product without profit during the pandemic.

Pfizer has also announced this month efficacy of 95% of its experimental vaccine, made with genetic material (RNA) of the new coronavirus, like the one from Moderna. The Oxford and AstraZeneca candidate, however, is a weakened version of a chimpanzee cold adenovirus, modified with genetic information from the covid virus to safely train the human body’s defenses. The two British entities announced a week ago that their vaccine’s effectiveness varies between 62% and 90% depending on the dose. However, the most promising results so far have been seen only in a small group of people under 55 years. The best news is that they all seem to be very safe, without significant adverse effects.

The Gamaleya Institute in Moscow also assured a week ago that its experimental vaccine, named Sputnik V and based on human cold adenovirus, has a preliminary efficacy of 95%, with a price per dose of just over eight euros. The Russian data are provisional, based on an analysis of only 39 cases of covid in a trial with 19,000 participants, figures that are still insufficient to conclude.

The European Commission approved on November 25th a contract with Moderna for an initial purchase of 80 million doses of their experimental vaccine, extendable to 160 million. The US company states that it plans to produce up to 1,000 million doses of its vaccine in 2021. In addition to the US, the company has another manufacturing chain in Europe, with a final phase of packaging in the Rovi pharmaceutical laboratories, in San Sebastian de Los Reyes, Madrid.

The European authorities have already signed six agreements to buy some 1,300 million doses of experimental vaccines. In addition to AstraZeneca, BioNTech-Pfizer, and Moderna, the European Commission has closed contracts with the German biotechnology company Curevac, with the American pharmaceutical company Johnson & Johnson, the duo formed by the French multinational Sanofi and the British company GSK.



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