The u.s. government is committed to invest up to nearly a billion dollars for the development of this potential vaccine against the Covid-19, which enters the final phase of its clinical trials this Monday.
The biotech american Moderna between this Monday in the final phase of its clinical trials for a vaccine against the Covid-19, in order to test the effectiveness of the latter in real-world conditions. The u.s. government is committed to the opportunity to bring up to 472 million additional dollars to the firm, in addition to 483 million already announced.
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While the race for the vaccine is raging between several laboratories throughout the world, one of Moderna is in the head of the pack by entering in the final phase of clinical trials determines whether it is effective and safe. The Express makes the point.
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Why is this vaccine raises hope?
last may, Moderna, the first biotechnology company to have tested a vaccine on the man, had made public the “interim results” of phase 1 of the test, according to which the vaccine had induced an immune response in eight patients. According to the article published in the New England Journal of Medicine in mid-July, the 45 participants in phase 1 were divided into three groups of 15, to which doses of 25 micrograms, 100 micrograms, and 250 micrograms were administered. They have received a second dose, in the same amounts, 28 days later.
After the first administration, it was found that the antibody levels were higher with the higher doses ; after the second, the participants had higher levels of antibodies that most of the patients who had the Covid-19, and having generated their own antibodies. On the other hand, more than half of the participants experienced any side effects mild or moderate, this is considered normal. Among these side effects include fatigue, chills, headaches and pain where the vaccine was injected.
While a vaccine classic is to inoculate the individual a part of the virus, weakened or dead, in order to stimulate the immune defences of the organism, the vaccine messenger RNA tested by Moderna, is to inoculate a part of the genetic code of the virus and not the virus itself. A technology that has to this day never proven to be effective against other viruses.
How will unfold the last phase of testing?
Pivotal, phase 3 trial, which is thus launched from this Monday, will appeal to 30,000 people in the United States. Half of them will receive a dose of 100 micrograms, the other a placebo.
The researchers will then follow for two years to determine if they are protected against infection by SARS-CoV-2. Or, if they are still infected, if the vaccine can prevent the progression to symptoms. The study is expected to last until 27 October 2022, but the preliminary results should be communicated before that date.
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Even if symptoms are recognized, the vaccine can be considered a success if it prevents serious cases of Covid-19. It is also possible, according to the researchers, the vaccine does not prevent to be infected but block the development of symptoms of the Covid-19. This last step should also ensure that the vaccine does not generate serious adverse effects.
When to expect a bet on the market ?
If the vaccine gets positive results, the firm hopes to launch on the market before the end of the year 2020 explains with 20 Minutes professor Daniel Floret, chairman of the technical committee of the vaccinations to the High Authority of health.
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If proven, it will be necessary for the firm to obtain the authorisation of the placing on the market. In the United States, that burden comes back to the FDA. As for Europe, the european medicines Agency should review the results of the trial to grant or not an authorisation for the placing on the market. And the final decision will then be recognised by the european commission. It is likely that if successful, the permission is only temporary, the time to assess the longer term effectiveness of the vaccine and its tolerance by humans.
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“Covid-19”, the new coronavirus
in The United States, 80% of the companies intend to continue teleworking after the crisis, A vaccine tested on a large scale, the Latin America going through the grieving process… The point on the pandemic in the Washington double its investment in a potential vaccine against the coronavirus
once the last steps of the past, the american laboratory hopes to produce a considerable stock of vaccines. Moderna was expected to be able to produce 500 million doses per year, and “possibly up to $ 1 billion”, says the AFP.
