[ad_1]
Second Vaccination Option in the US … Final FDA Decision Imminent
The US Food and Drug Administration (FDA) advisory committee recommended urgent approval of the Corona 19 messenger RNA (mRNA) vaccine from the US biotechnology company Modena.
Moderna on the 17th (local time) of the Vaccines and Related Biologicals Advisory Committee of the US Food and Drug Administration (VRBPAC) approved the emergency use approval (EUA) of the mRNA-1273 of the Corona vaccine 19 candidate (20 votes, 0 negative votes, 1 abstention) She announced that she was recommended by vote.
The advisory committee made recommendations based on all of the scientific evidence shared by Modena, including analysis of data from the pivotal phase 3 clinical trial of COVE announced last month 30.
The COVE trial was conducted in more than 30,000 participants in the United States.
As a result of performing a primary efficacy analysis based on 196 confirmed corona cases, 19 the vaccine efficacy rate was 94.1%.
The most common adverse reactions reported after two vaccinations are injection site reactions, erythema, swelling, and ipsilateral lymphadenopathy. Most adverse reactions were mild (Grade 1) or moderate (Grade 2), but the incidence of serious reactions (Grade 3) was higher after the second dose of mRNA-1273. Locally described adverse reactions occurred within 1 to 2 days after vaccination and lasted 1 to 2 days.
Safety data for vaccines continues to be collected, and clinical trials continue to be overseen by the Independent Data Safety Monitoring Committee (DSMB) appointed by the National Institutes of Health (NIH).
All COVE study participants will be followed for two years after the second dose for a prophylactic and long-term safety evaluation.
The FDA considers the recommendations of the Advisory Committee and makes the final decision on approval. According to foreign reports, the FDA is expected to decide on the 18th to approve the emergency use of modder or vaccines.
“We are working with the US Centers for Disease Control and Prevention and the High Speed Operations team to prepare for the distribution of mRNA-1273 if the FDA decides to approve emergency use,” said the director. Modena executive Stefan Bancell. “We hope to vaccinate Americans with our vaccine to resolve the situation.”
Unlike the previously approved Pfizer and Bioentech vaccines, the Modena vaccine does not require special cryocoolers or large amounts of dry ice.
Previously, Modena said that mRNA-1273 was stable for 30 days at the standard refrigeration temperature of 2-8 degrees Celsius.
At the same time that the results of the Advisory Committee meeting were being announced this time, Modena announced that it had expanded the vaccine handling guidelines so that mRNA-1273 can be transported in a liquid state at 2 to 8 degrees Celsius.
In some cases, this may be the only practical way to deliver vaccines to hospitals or remote locations, management explained.
The United States government estimates that 20 million people in the United States will be vaccinated through the Pfizer and Bioentech vaccine and the Modena vaccine by the end of this year. The first dose of the vaccine was assigned to medical workers, nursing home residents, and staff.
Copyright © Medical News Unauthorized reproduction and redistribution prohibited
