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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
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
The city of Philadelphia has settled with two black men arrested at a Starbucks in the city. Rashon Nelson and Donte Robinson settled for apiece while the city committed 0,000 for young entrepreneurs, according to the New York Daily News. The two men were arrested after sitting down at the Starbucks without ordering anything. Starbucks also reached a settlement with the two men, the company said in a statement. The deal includes a financial settlement. "I want to thank Donte and Rashon for their willingness to reconcile," Starbucks CEO Kevin Johnson said in the statement. "I welcome the opportunity to begin a relationship with them to share learnings and experiences. And Starbucks will continue to take actions that stem from this incident to repair and reaffirm our values and vision for the kind of company we want to be." 889
The death toll from Sunday's devastating earthquake on the Indonesian island of Lombok has risen to 347, according to the state-run Antara news agency.The majority of people died in Kayangan, on the north side of the island, Antara reported. Another 1,447 people were injured and 165,003 were displaced by the 6.9 magnitude quake, National Disaster Management Agency spokesman Sutopo Purwo Nugroho told the news agency earlier.Around 200,000 people live in northern Lombok, a mountainous region, according to the 2010 census. On Tuesday, the government estimated 20,000 people are in need of assistance, with around 80% of buildings destroyed, as aid workers struggled to reach those affected by the disaster. 717
The CDC is recommending restaurants, cafes and places where people eat and drink, and likely are not wearing a mask while they do so, should consider all efforts to limit possible COVID-19 exposure and community spread, following the publication of a study looking at where coronavirus patients visited.Adults in the study with positive COVID-19 test results were "twice as likely to have reported dining at a restaurant than those with negative test results", according to the Centers for Disease Control and Prevention.The study looked at people who had coronavirus symptoms and sought testing and care from 11 health care facilities around the country. It found two situations were connected to a higher rate of positive COVID-19 test results compared to negative results; going to locations offering on-site eating and drinking options, and having close contact with persons known to have COVID-19.“Exposures and activities where mask use and social distancing are difficult to maintain, including going to places that offer on-site eating or drinking, might be important risk factors for acquiring COVID-19. As communities reopen, efforts to reduce possible exposures at locations that offer on-site eating and drinking options should be considered to protect customers, employees, and communities,” the study states.CDC personnel conducted interviews with more than 300 study participants, asking them about their mask-wearing habits, attending community gatherings, and activities in the last two weeks; including going to an office, salon, gym, bar/coffee shop, church, eating at a restaurant, or using public transportation. Participants answered using a five-point scale to indicate how often they did these activities.“Reports of exposures in restaurants have been linked to air circulation. Direction, ventilation, and intensity of airflow might affect virus transmission, even if social distancing measures and mask use are implemented according to current guidance. Masks cannot be effectively worn while eating and drinking, whereas shopping and numerous other indoor activities do not preclude mask use,” the report says.The responses indicated around 42 percent of those who had positive COVID-19 test results had close contact with one or more people with known positive cases. The majority of those “close contacts” were family members. Only 14 percent of those who had symptoms but had negative COVID-19 test results reported having close contact with a person known to have the virus.The CDC recommends that if a family member or member of a household becomes sick and it is possibly COVID-19, additional prevention measures should be taken. This includes isolating the sick person as much as possible in the home, reducing shared meals and common spaces, wearing gloves and masks inside the home, and cleaning and disinfecting the home often.The study was completed during July and the results were released September 10. 2952