The U.S. Food and Drug Administration’s advisory panel voted Thursday in favor of Moderna inc. ‘s Wuhan Pneumonia vaccine, clearing the way for FDA leaders to approve an emergency mass distribution of the vaccine. The outbreak has seen a surge in infections across the United States.
According to Foxnews, the committee voted on the following question: “Based on all available scientific evidence, do the benefits of the Moderna vaccine outweigh the risks for Moderna age 18 and older?” The vote was 20 to 0, with one member abstaining.
The highly anticipated meeting included members of the ADVISORY committee for the FDA’s Center for Biologics Evaluation and Research, outside vaccine experts and Moderna representatives.
Although significant, the committee’s vote in favor of emergency Use Authorization is not final. FDA officials also attended the meeting. The officials will use the vote to decide whether to grant emergency use authority. About a week ago, the F.D.A. approved Pfizer inc. ‘s vaccine for individuals 16 and older. U.S. states began offering the vaccine to health care workers this week.
A similar process will follow after a vote by an independent panel of experts at America’s Centres for Disease Control and Prevention (CDC). Front-line health care workers and workers in long-term care facilities will be the first to receive the long-awaited vaccine against the virus. The decision still requires the approval of Dr. Robert Redfield, director of the CENTERS for Disease Control and Prevention.
The FDA panel’s vote to approve the Moderna vaccine for emergency use did not come as a surprise. Documents released before the agency’s Dec. 17 meeting showed that the candidate vaccine met the FDA’s requirements for emergency use.
Food and drug supervision and administration commission of the emergency use authorization to apply for a review of Moderna vaccine, in according to age, race, nationality, medical complications or always infected with SARS – CoV – 2 (the communist party of China (virus) subgroup analysis, “found no special safety problems”, this may be for the full second vaccine immunization paved the way.
The team also found that the vaccine reduced the risk of COVID-19 infection after the first injection and a second injection at least 14 days later.
At the same time, the committee cautions that there is not enough data to assess the duration of protection in humans, effectiveness in certain high-risk groups (such as immunocompromised individuals), effectiveness in individuals previously infected with SARS-COV-2 (coV-2), and effectiveness in pediatric populations. The Committee also does not have sufficient data to assess the future effectiveness of the vaccine, including the impact of possible viral mutations, effectiveness against asymptomatic infections, long-term effectiveness against COVID-19, effectiveness against mortality, and effectiveness against SARS-COV-2 (coV-2) transmission.
Unlike Pfizer and BioNTech’s vaccines, Moderna vaccine injections can cause less severe side effects such as injection site pain, fatigue, headache, muscle pain, joint pain and chills. The level of adverse reactions is generally mild to moderate.
Three other serious side effects can occur, including nausea, vomiting and facial swelling, the FDA said. One vaccinated person also developed Bell’s Palsy, but “it’s not clear that this is cause-and-effect with vaccination.”
For its benefit, Moderna vaccine has proven to be more than 90 percent effective in late-stage clinical trials and requires two injections spaced a few weeks apart, without the need for ultra-cold storage. And the doses in each batch are smaller than the 975 doses in the Pfizer-Biontech vaccine.
If officially approved by the FDA, it would mark the first time Moderna has received such approval, so Americans will see the initial 6 million doses of Moderna vaccine distributed next week.
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