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By this weekend, the United States may have two COVID-19 vaccines. A detailed data review by scientists from the Food and Drug Administration (FDA) confirmed that the vaccine developed by Moderna appears to be ready for regulatory approval. The company's two-dose vaccine program is 94% effective in clinical trials and has no serious safety issues. According to an unnamed person familiar with the matter, the FDA may approve the Moderna vaccine on Friday. General Gustave Perna, who oversees the distribution of vaccines by the federal government, said on Monday that the United States is preparing to ship nearly 6 million doses of Moderna vaccine to 3,285 locations in the first week.
In the 54-page document released by the US Food and Drug Administration on Tuesday morning, the Moderna vaccine follows the same approach as the Pfizer-BioNTech vaccine. After the agency gave a positive review of the Pfizer-BioNTech vaccines a week ago, an external panel of experts approved the vaccines on Thursday and was approved by the regulatory agency a day later. The first dose of the vaccine provided to health care workers began on Monday. Regulators say that the two-dose Moderna vaccine treatment regimen is particularly effective for serious diseases. In the trial, there were 30 cases of severe new coronary pneumonia caused by the virus, but none of them were in the vaccinated group.
They also confirmed that the Moderna vaccine works well in people of all ages, races and genders. Side effects are common in most vaccine recipients, but they usually last for a short time and include fatigue, headache, muscle pain, and pain at the injection site. Moderna is only seeking to approve its vaccine for people 18 years of age and older, so controversy about the Pfizer-BioNTech vaccine (whether it should be authorized for use in teenagers aged 16 and 17) may be avoided; last week the company started testing it in teenagers vaccine. Moderna's vaccine will be reviewed by an independent panel of experts who recommended the Pfizer-BioNTech vaccine last week. Moderna cooperated with the National Institute of Allergy and Infectious Diseases to develop a vaccine, and the government underwritten the research and development of the vaccine, and purchased 200 million doses of vaccine in advance, bringing taxpayers' investment to 4.1 billion US dollars.
In Moderna’s trial, 30,000 people were randomly assigned to receive two doses of the vaccine, or two saline injections within four weeks; neither the participants nor the people conducting the trial knew who was vaccinated. Investigators then waited for volunteers to be exposed to the new crown pneumonia virus in their daily lives to see if there were more new crown pneumonia virus infections in the placebo-vaccinated group. They calculated cases of new coronary pneumonia that started two weeks after the second dose of vaccination to measure the degree of protection of the vaccine to volunteers after a full immune system response. In the experiment, there were 196 cases. Except for 11 people who received the real vaccine, everyone else received a placebo. In the trial, there were 30 severe cases of new coronary pneumonia and 1 death from new coronary pneumonia, all of which were in the group receiving placebo injections.
One of the main open questions about this vaccine and other coronavirus vaccines is whether they prevent infection. Since most cases of new coronary pneumonia are asymptomatic, how to best use the vaccine and whether people need to continue to wear masks and maintain social distancing after vaccination has a major impact. In an addendum submitted to the FDA, the company stated that after receiving the second dose of the vaccine, 52 people tested positive for new coronary pneumonia but were asymptomatic. Most of these people are in the placebo group, indicating that those who administer the vaccine may be protected by the vaccine.Infected by patients without symptoms of new coronary pneumonia.
There were three cases of Bell’s palsy (Bell’s palsy,) in the group receiving the Moderna vaccine: a temporary facial palsy; and one case in the placebo group. People with Bell's Palsy have other risk factors, and this ratio is similar to what the general population expects. However, the FDA concluded that the potential risk of the vaccine to the manifestations of these facial nerve palsy events cannot be ruled out. Swelling of the vaccinated arm and lymphadenopathy are more common in the vaccinated group. 16% of the participants developed symptoms after the second injection, but did not have a serious allergic reaction; and after the first injection of the Pfizer-BioNTech vaccine in the United Kingdom, there were two cases.
This summer, as scientists worried that the vaccine lacks sufficient ethnic diversity to be sure whether it really protects those at the highest risk of the disease, Moderna's testing speed has slowed down. Finally, one-fifth of the participants were Hispanic; 10% were black; 4% were Asian. More than 40% of participants were 65 years of age or older, or had medical conditions that increased their risk of serious illness.
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