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US Nears Emergency Approval of Second COVID-19 Vaccine

FILE - Biotechnology company Moderna protocol files for COVID-19 vaccinations are kept at the Research Centers of America in Hollywood, Florida, Aug. 13, 2020.

The United States is on the cusp of getting a second COVID-19 vaccine.

Regulators with the Food and Drug Administration announced Tuesday that its preliminary analysis of a vaccine developed by Moderna and the National Institutes of Health confirmed its safety and effectiveness.

The report did reveal that four volunteers in the late-stage clinical trial developed Bell’s palsy, a condition that involves temporary paralysis or weakness in a person’s facial muscles. Three of those participants had received the vaccine, while the other was given a placebo, or a false version of the vaccine.

The approval process of the two-dose vaccine is now in the hands of the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Thursday. If the committee gives its stamp of approval, the FDA would then grant an emergency use of authorization for the Moderna vaccine.

White House spokesperson Kayleigh McEnany told reporters Tuesday 6 million doses of the Moderna vaccine could be shipped out to the public by next week after the FDA grants approval. The first doses of the COVID-19 vaccine developed jointly by U.S. drugmaker Pfizer and Germany’s BioNTech were administered to health care workers across the U.S. this week.

Ahead of a final decision on the Moderna vaccine, the FDA granted emergency approval Tuesday of an over-the-counter COVID-19 test developed by Ellume, an Australian-based health care technology company. The self-administered home kit returns the test results within 15-20 minutes through a smartphone application.

As the United States, Britain and other nations escalate their efforts to vaccinate their citizens against a virus that has sickened over 73.5 million people worldwide, including over 1.6 million deaths, a new study says at least a fifth of the world’s population may not have access to a COVID-19 vaccine until 2022, as wealthier nations buy more than half of next year's potential doses.

The study by the Johns Hopkins Bloomberg School of Public Health comes just days after United Nations Secretary-General Antonio Guterres warned about the rise of “vaccine nationalism” among the world’s richest nations at the expense of much poorer nations.

Two of the world’s biggest annual New Year’s celebrations are either being curtailed or cancelled due to the pandemic. New York City is banning visitors from the city’s historic Times Square to witness the iconic “ball drop” that counts down the final seconds of the previous year. In Brazil, officials in Rio de Janeiro announced Tuesday that it is calling off its annual New Year’s Eve beach party, which normally attracts hundreds of thousands of people with live music and a spectacular fireworks display.

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