[NEWS] First positive results of Moderna Therapeutics' coronavirus vaccine

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Moderna Therapeutics, one of the American laboratories that is bidding for immunization against Covid-19, gets a vaccine that generates neutralizing antibodies, the same that patients have

 

 

 

 

The first achievements are already visible in the race to obtain a coronavirus vaccine. US pharmacist Moderna Therapeutics has released the "positive" results at an early stage in its experimental SARS-CoV-2 vaccine, which "has the potential to prevent COVID-19 disease" and will continue testing.

This means that they have passed the first phase in which the vaccine has been shown to provoke activity in the immune system. At the clinical level this is called immunogenicity and what the researchers highlight is that it has been achieved at the three prescribed dose levels. This has been achieved in the 45 voluntary participants in the trial 15 days after the injection of the molecule.

"Provisional Phase 1 data, albeit early, shows that the mRNA-1273 vaccine develops an immune response of the magnitude caused by natural infection, starting with a dose as low as 25 micrograms," the director noted in the statement. company doctor, Tal Zaks.

The nearly 50 participants in the study on the candidate vaccine mRNA-1273, led by the US National Institute of Allergy and Infectious Diseases (NIAD), received two doses of 25, 100 and 250 micrograms and in all cases developed antibodies against COVID-19, as Moderna explains.

At this time, neutralizing antibody data is available only for the first four participants in each of the 25 micrograms and 100 micrograms dose-level cohorts. According to the antibody data, vaccination of mRNA-1273 caused neutralizing antibodies in up to eight participants, which was verified in the laboratory. The neutralizing antibody levels on day 43 were equal to or above the levels generally seen in convalescent sera.

In addition, it should be noted that since May 12, Moderna has been designated a 'fast-track' for the candidate vaccine. "The designation underscores the urgent need for a vaccine against the new coronavirus," says Tal Zaks. "While we await the full clinical data set from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV -2".

Getting the "fast-track" makes it easy to develop and speed up the review of therapies and vaccines for serious conditions and meet an unmet medical need. Programs with this designation can benefit from early and frequent communication with the FDA, in addition to continuous filing of the marketing application. The company previously received the designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (AP; mRNA-3927) programs.