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The Food and Drug Administration (FDA) released a key report Tuesday that said a COVID-19 vaccine made by Moderna is safe and effective — the latest in a series of rubber stamp approvals that could allow the vaccine to be distributed by the end of the month.The FDA report on Tuesday upheld the clinical trials, which have shown the vaccine to be 95% effective with no severe side-effects. The FDA report says that the data is "consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.""FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the report reads.The next step in approval for the Moderna vaccine will come on Thursday when the FDA's Vaccines and Related Biological Products Advisory Committee will meet and vote on whether to approve the Moderna vaccine for Emergency Use Authorization.The vaccine would then need approval from the FDA as a whole, and then a recommendation from the CDC before health care professionals can begin injections.The release of the FDA report comes a day after the first Americans received initial doses of a COVID-19 vaccine made by Pfizer.Should Moderna's vaccine follow the same approval schedule as the Pfizer vaccine, health care professionals should begin injections by Monday.The U.S. purchased 100 million doses of the Moderna vaccine earlier this year, and Moderna will have millions of doses ready to ship as soon as it receives Emergency Use Authorization.Late last week, the federal government purchased an additional 100 million doses of the vaccine, meaning it expects to have 200 million doses by spring 2021.The decision to purchase more doses of Moderna's vaccine came days after the New York Times reported that the U.S. government chose not to purchase more doses of the Pfizer vaccine when it had the chance earlier this year. 1977
The CEOs of T-Mobile and Sprint are confident that their proposed merger will get approval from US regulators and create jobs — and that it won't raise prices for wireless subscribers.T-Mobile's John Legere and Sprint's Marcelo Claure told CNN's Richard Quest on Monday that the merger of the two companies would make it easier for them to build out a national, high-speed 5G network before their rivals Verizon and AT&T do."The country needs 5G," Claure said. He said the United States can't fall further behind China and South Korea, which are ahead in deploying 5G technology. 591
The Food and Drug Administration approved on Wednesday a treatment for the Ebola virus. This is the first FDA-approved treatment for Zaire ebolavirus infection in adults and kids.Zaire ebolavirus is one of four Ebola virus species that can cause potentially deadly infections. It is transmitted through direct contact with blood, tissue or body fluids of an infected person or wild animal.The treatment, Inmazeb, is a mixture of three monoclonal antibodies and was created by Regeneron Pharmaceuticals. The three antibodies work together to bind to the glycoprotein on the surface of the Ebola virus and block it from entry into the body’s cells.Inmazeb was tested in the Democratic Republic of the Congo during an Ebola virus outbreak in 2018-2019 through a partnership between the local government and the National Institutes of Health.A vaccine for Ebola virus was approved by the FDA in December 2019.Regeneron is also the company behind an experimental antibody cocktail that was given to President Donald Trump following his diagnosis of COVID-19, and which he said “cured” him. Trump was also prescribed the antiviral drug remdesivir and the steroid dexamethasone at the time.Regeneron’s COVID-19 treatment is a mix of two powerful antibodies that are believed to boost the immune response to the coronavirus. Early results seem promising, according to initial tests and a press release from the company.The company has submitted an application to the FDA to get emergency approval of their COVID-19 treatment. 1525
The deaths of 22 more children from flu-related causes were reported Friday by the US Centers for Disease Control and Prevention in its weekly surveillance report.Those deaths bring the total number of children reported to have died to 84 since October, when the current flu season began. Three out of four children who died from the flu had not gotten a flu vaccine, the acting director of the CDC said in a Thursday news conference. "We continue to recommend parents get their children vaccinated even though it's late in the season," Dr. Anne Schuchat said. The season may continue for several more weeks, she added. 633
The Confederate-themed Mississippi flag is drawing criticism from two big forces in the culturally conservative state. Walmart says it will no longer display the state flag because it includes the Confederate battle emblem. Displaying state flags inside stores is a common practice. “We know the design of the Mississippi state flag is being discussed by various stakeholders. While the issue continues to be discussed, we’ve made the decision to remove the Mississippi state flag from display in its current form from our stores," Walmart spokesperson Anne Hatfield said in an email statement.“We believe it’s the right thing to do, and is consistent with Walmart’s position to not sell merchandise with the confederate flag from stores and online sites, as part of our commitment to provide a welcoming and inclusive experience for all of our customers in the communities we serve," Hatfield continued. The Mississippi Baptist Convention is calling on lawmakers to remove the Confederate symbol from the flag because many people are “hurt and shamed” by it. The governing body for college athletics and other influential groups are calling for Mississippi to change its flag. Republican Gov. Tate Reeves says if the flag is going to be redesigned, it should be done in a statewide election. 1300