The drugmaker Moderna will file documents with the US Food and Drug Administration today to obtain an emergency use of the vaccine.
The updated results of the third phase of trials of the anti-coronavirus two-component vaccine mRNA-1273 from the American biotechnology company Moderna confirmed that its effectiveness is 94.1%. Moreover, in the case of a severe course of Covid-19, this figure rises to 100%, follows from a press release.
In total, more than 30 thousand people took part in the tests. Of these, 196 people who received a placebo and 11 people who received the vaccine fell ill with the coronavirus. In this case, the company concludes, the effectiveness of the vaccine was 94.1%
“The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. Vaccine efficacy has been demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy. Today’s primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group”the company said in the press release.
Trials also involved 7,000 people over 65 and more than 5,000 young people with chronic conditions such as diabetes, obesity and cardiovascular disease. 11 thousand volunteers (37%, similar to the share of the US population) were from ethnic minorities (blacks or African Americans, Hispanics and Asians). No serious side effects were found in any of the subjects. The effectiveness of the drug was independent of age, race or gender.
The company today plans to transfer the data to the US Food and Drug Administration (FDA) to obtain permission for an emergency use of the vaccine. The application should be considered at a meeting on December 17.
Moderna has received $ 2.48 billion in the US federal funds, so the United States will be the first to access mRNA-1273, with 20 million doses expected by the end of the year. In 2021, they plan to release from 500 million to one billion doses (including for other countries).
In the development of the vaccine from Moderna, as well as the drug from the Pfizer and BioNTech, mRNA technology was used: it is based on a virus that cannot multiply, which carries a messenger RNA inside to encode specific SARS-CoV-2 proteins. However, the cost of the drug is high compared to other analogues: from $ 32 to $ 27 per dose (the Oxford vaccine from AstraZeneca will cost less than three pounds, that is, about $ 4.
But the effectiveness of the British vaccine AZD1222, developed by Oxford University and the drugmaker company AstraZeneca, was estimated at 70.4%. According to scientists, this is the average value: this result was obtained after combining the results of two different dosage (when 2741 participants were administered to the study participant, first half the dose, and then the full effectiveness was 90%, and when two full doses were administered (also in two stages) 8895 participants – only 62%). On other hand, Experts from the US criticized this data and accused the developers of testing fraud.