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(Photo = Getty Image Bank)
The United States Food and Drug Administration (FDA) announced on the 15th (local time) that a new vaccine against coronavirus infection (Corona 19) developed by the pharmaceutical company Modena was effective.
If the FDA advisory body’s Vaccines and Biological Medicines Advisory Committee (VRBPAC) recommends urgent use of modders or vaccines at a meeting on the 17th, the FDA is expected to approve the final approval on the 18th. This is the first case of approval for emergency use of modders or vaccines.
In a review report, the FDA stated that the Modena vaccine is very effective in preventing COVID-19 and that no special safety concerns have been observed when the vaccine is administered to adults 18 years of age and older. The report was prepared in preparation for the advisory committee meeting on the 17th.
If the FDA approves the Moderna vaccine for emergency use, it will be the second vaccine available in the United States after last week’s Pfizer-Bioentech.
Modena’s vaccine, like Pfizer, requires two doses to ensure normal immunity. In clinical trials involving 30,000 people, 94.1% of the preventive effects were found. By age groups, the prevention effect was 95.6% for those aged 18 to 65 and 86.4% for those over 65.
In an interim analysis on the 7th of last month, the FDA said that participants who received only one dose of the vaccine showed an efficacy of 80.2%. The FDA said no serious allergic reactions were found in the modder or study, and hypersensitivity reactions were found in 1.5% of vaccine recipients and 1.1% of fake drug users.
The FDA determined that serious adverse events that occurred in clinical trials were similar to the frequency of occurrence in the general population.
However, the possibility of facial paralysis in clinical trial participants like Pfizer was also seen for modder and vaccines. Over the course of the clinical trial, symptoms of facial paralysis were reported in all 4 patients, including 3 recipients of the vaccine and 1 of the fake drugs (placebo). All three recipients of the vaccine healed naturally.
The Washington Post predicted approval would take place this week, as the Moderna vaccine produced similar test results to Pfizer’s and was based on the same technology called messenger ribonucleic acid (mRNA). The New York Times cited a source and said that the FDA approval would be issued on the 18th.
The United States plans to begin vaccinating as soon as the modder or vaccine is approved. Along with the Pfizer vaccine, which has already been inoculated, it is expected to help fight COVID-19 in the United States.
The first vaccination of the Pfizer vaccine took place on day 14 after the FDA and the Centers for Disease Control and Prevention (CDC) completed the review process on day 13 and final approval for emergency use. .
Monsef Slawi, executive director of the team responsible for vaccine development, Super-Fast Operations, said he plans to distribute 40 million doses of vaccines in the United States by the end of the year, including the Pfizer and Modena vaccines. These vaccines must be vaccinated twice to generate normal immunity, so 20 million people can be vaccinated.
Slawi expected the United States to reach herd immunity level in May-June next year, and said 100 million people will have immunity by the end of March next year. In addition to these two vaccines, the Johnson & Johnson vaccine is expected to be approved for emergency use in the United States in late January or early February, and the AstraZeneca vaccine in late February.
Eunbit Go, Reporter Hankyung.com [email protected]
