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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 City of Columbus took down a Christopher Columbus statue from in front of City of Hall on Wednesday, removing what Mayor Andrew Ginther called a symbol of “patriarchy, oppression and divisiveness.”Ginther announced the decision to remove the statue on June 18."That does not represent our great city, and we will no longer live in the shadow of our ugly past,” Ginther said. “Now is the right time to replace this statue with artwork that demonstrates our enduring fight to end racism and celebrate the themes of diversity and inclusion.”The statue, which was a gift from the people of Genoa, Italy, in 1955, will be placed in safekeeping at a secure city facility. The city asked the Columbus Art Commission to launch a community-driven process that embraces diversity. This process would determine how to best replace the statue while evaluating other monuments and art installations on their diversity and inclusiveness.The Arts Commission will also help determine the final disposition for the statue, working with the community to determine, in the proper context, if it should be displayed elsewhere to help future generations understand the ongoing conversations about racism and why leaders ultimately decided on its removal.“By replacing the statue, we are removing one more barrier to meaningful and lasting change to end systemic racism,” said Ginther. “Its removal will allow us to remain focused on critical police reforms and increasing equity in housing, health outcomes, education and employment.”This story originally reported by Kaylyn Hlavaty on news5cleveland.com. 1597

The engine came roaring back to life, despite the vehicle being partially burned and melted. And though their car may not look pretty, Christina Lopez and her husband concluded the fire-damaged Honda Civic was safe enough to drive.Lopez said she was anxious to have her car so she could drive to work and take her 18-month-old son to day care. Her husband's car was lost in the fire.A locksmith had to make a new key because the previous one was lost, along with everything else they owned, inside their now-destroyed home. 531
The Federal Communications Commission voted and approved Thursday that the new National Suicide Hotline number beginning in July 2022 will be 988. 154
The FDA's Vaccines and Related Biological Products Advisory Committee panel has endorsed a second COVID-19 vaccine in the United States.Now the FDA is expected to act quickly to authorize the Moderna vaccine for emergency use and keep it on schedule to be distributed to patients across the country as early next week.The panel voted 20 yeses and one abstain.WATCH RECAP:With the panel recommending EUA, the FDA as a whole would then need to file its own EUA approval. The final step would be a formal recommendation from the Centers for Disease Control and Prevention that Americans should receive the vaccine.Last Thursday, the committee voted in favor of granting EUA to Pfizer's COVID-19 vaccine. By Monday, it was being administered across the country.The panel's meeting comes days after a key FDA report upheld the safety and efficacy results of the Moderna vaccine's Phase III trials. Those statistics showed that the vaccine was 95% effective with no severe side-effects."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 said.An approval of Moderna's vaccine would immediately boost the supply levels of COVID-19 vaccines in the U.S. Millions of doses are ready to be shipped across the country as soon as approval is granted.The arrival of COVID-19 vaccines comes amid the bleakest stretch to date in the COVID-19 pandemic. The U.S. is currently seeing the highest level of new cases (213.000) and deaths (2,500) each day, according to seven-day rolling averages totaled by the COVID Tracking Project. More Americans than ever are also battling the virus in a hospital (113,000). 1725
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