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Moderna announced that it had submitted to the Food and Drug Administration (FDA) a formal application for the emergency use of the coronavirus vaccine in the United States. According to the pharmaceutical company, the data from the clinical studies was sent for analysis of the organ, which will decide whether the immunizer can be applied to the population.
Previously, the company had reported that its vaccine was 94.1% effective in phase 3 studies: of the 196 volunteers who had COVID-19, 185 of them received the placebo, while 11 received the active immunizer. The vaccine is also 100% successful in preventing severe cases of the disease, as the vaccinated infected had only mild symptoms.
Efficacy remained consistent across all age groups, as well as race and ethnicity. The 196 participants with covid-19 included 33 adults over the age of 65 and 42 who identified as Hispanic, Black, asian american or multiraciais.
Before phase 3, the modern vaccine, called MRNA-1273, also proved to be safe. So far, the immunizer has only caused mild side effects in most recipients, usually fever and pain that lasted a day or two.
Moderna, which also plans to seek approval in Europe, is expected to be the second company to apply for the use of emergency vaccines in the United States. The first was Pfizer, last week, which also started proceedings in the UK, where vaccination should start next week.
Americans scheduled the final announcement of the Pfizer vaccine evaluation for the next 10. The analysis of Moderna’s vaccine is due to be submitted by the FDA the following week, December 17.
Moderna president Stephen Hoge highlighted the speed of production of the vaccine, with “really exciting” data. Now the drugmaker will need to make the promised number of doses: 20 million in the United States alone next month and at least 80 million more next year.
Outlook for Brazil
Brazil has yet to purchase doses of Moderna’s vaccine, but company representatives recently met with the Ministry of Health to address the problem. The federal government has a prior agreement only with AstraZeneca, which develops a vaccine in partnership with the University of Oxford.
In the state of São Paulo, Governor João Doria (PSDB) signed an agreement with the pharmaceutical company SinoVac Life Science and promises 46 million doses of CoronaVac, as it is called, in the coming months. The immunizer is also in phase 3 testing.
(With Estadão Content and Reuters)
