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After Pfizer-Biontech also Modern announced in a statement that its Covid vaccine is 90% more effective. Precisely, the American pharmaceutical company affirmed that the effectiveness is equal to 94.5%. Both candidates were developed with an innovative technique of bioengineering or in the technology ofmRna, the molecule used to make the Sars Cov 2 Spike protein that allows the virus to infect human cells. “These are obviously very exciting results – says scientist Anthony Fauci, quoted by CNN – It’s the best you can think of: 94.5% is truly exceptional.”
The vaccine says the US company can be distributed “using the widely available vaccine storage and administration infrastructure no dilution required prior to vaccination. We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our Covid 19 candidate vaccine at temperatures commonly found in readily available pharmaceutical freezers and refrigerators“Said Juan Andrés, Technical Head of Operations and Quality. “We are pleased to present these extended stability conditions for mRNA-1273 to the authorities for approval. Lthe possibility of storing our vaccine for up to 6 months at -20 ° C, including up to 30 days under normal refrigerator conditions after thawing, it is an important advance and would allow for simpler distribution and greater flexibility to facilitate vaccination on a larger scale in the United States and other parts of the world. Once out of the refrigerator, Moderna vaccine can be stored at room temperature for 12 hours.
The compound transmits genetic instructions to cells to produce the virus-specific Spike protein antigens, the cells follow the instructions for making proteins or antigens, which can then be visualized on the cell surface and recognized by the vaccinated individual’s immune system, generating an immune response to the vaccine antigen.
Meanwhile, the EMA (European Medicines Agency) has started to analyze the data on the Moderna vaccine. It was decided to leave, the agency said, with the procedure of continuous review, first step of the approval process, based on preliminary results from non-clinical studies and the first clinical studies in adults, which appear to indicate that the vaccine stimulates the production of antibodies and immune T cells against the SarsCov2 virus. The EMA’s Committee for Medicinal Products for Human Use (CHMP) began to evaluate the first batch of vaccine data from Moderna Biotech Spain, which come from laboratory tests.
All available data on the safety of the vaccine and its quality (ingredients, production method, stability and storage conditions) will be reviewed by the EMA as soon as they are available. Ongoing review will continue until there is sufficient data to support an application for authorization to sell the vaccine. The EMA, specifies in a note, will evaluate the vaccine according to the usual standards of efficacy, safety and quality but the process should be shorter than normal thanks to the time gained from continuous review. The European Agency had already activated this procedure at the beginning of October for the anti-Covid-19 vaccine developed by AstraZeneca and from the university of Oxford And, of course, from Pfizer.
The first preliminary analysis has seen 95 participants with confirmed cases of Covid-19. The news comes on the day of the launch of the accelerated review of the vaccine by EMA, the European Medicines Agency. The work illustrated today also analyzed serious cases of Covid-19: they were included in particular 11 severe cases (as defined in the study protocol) in this first interim analysis. “All 11 cases occurred in the placebo group and none in the mRna-1273 group.” The 95 cases of Covid-19 included 15 over 65s and 20 minority participants. Based on these data, Moderna intends to submit an emergency use authorization request to the US Food and Drug Administration “in the coming weeks.” “This is a crucial moment for the development of our Covid-19 vaccine candidate. Since the beginning of January, we have been chasing this virus with the intention of protecting as many people as possible around the world. We have always known that every day is important. This preliminary analysis of our phase 3 study gave us the first clinical confirmation that our vaccine can prevent Covid-19, including the severe forms, ”said Stéphane Bancel, CEO of Moderna.
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