Page 12 THE REVERE ADVOCATE – FRIDAY, NOVEMBER 20, 2020 Congresswoman Clark elected Assistant Majority Speaker in U.S. House Becomes second-highest ranking woman ever nationally in Democratic Party history By Steve Freker C ongresswoman Katherine N. Clark, D-5th Middlesex, was elected as Assistant Speaker in the U.S. House of Representatives Wednesday, making her the fourth-ranked Democrat in the nation and the second-highest ranked women in party history. U.S. Rep. Clark, a Melrose resident, will serve a key, pivotal role on the Congressional leadership team and Democratic caucus under longtime House Speaker Nancy Pelosi, 80, if Pelosi is reelected as House Speaker. Pelosi was nominated for Speaker by voice vote Wednesday, but will have to win by a fl oor vote in January to return for another term. U.S. Rep. Clark has represented Malden, Revere and Winthrop, as well 23 other greater Boston and MetroWest communities in the 5th Middlesex District nationally since 2013. She formerly represented Malden as a state Senator before that for a term and part of Malden as state representative for three terms in the 2000s. “I am honored and humbled to join the leadership team in this new role as assistant speaker,” Clark said Wednesday at a press conference in Washington, D.C. following the election. She went on to talk about change and the need to help Americans who are suff ering in this pandemic and other divides across our nation. “We are going to see and help the American people with the pain they’re suff ering, through the loss of life and livelihood from this pandemic, and the racial and economic injustices that they are facing," Rep. Clark said. "We are the guardians of peoples’ hopes and aspirations, and we are going to be the unifi ed engine for change." U.S. Rep. Clark defeated Rhode Island Rep. David Cicilline, the outgoing chairman of the Democratic Policy and Communications Committee, in a 135-92 vote. Rep. Cicilline congratulated Clark, noting in a statement released by rollcall.com, that the race was a “hard fought campaign” but that Democrats would come together to deliver on their policy promises. “I look forward to being a part of those eff orts and doing whatState by President Obama. The Assistant Speaker spot was open because the current occupant, New Mexico Rep. Ben Ray Lujбn, is moving to the Senate. According to national political U.S. REP. KATHERINE CLARK ELECTED ASST. HOUSE SPEAKER ever I can to make real progress for the people we serve,” he said. In the present term, Rep. Clark had been serving as the ViceChair of the Democratic Caucus, which is the #6-ranked spot in Congressional leadership. She has represented Malden nationally since 2013, and formerly as a state Senator before that for a term. Rep. Clark was fi rst elected to Congress in 2013 in a special election to fill the unexpired term of now U.S. Sen. Ed Markey, D-Mass., who left Congress after 40 years to run for the U.S. Senate. The Senate seat opened in 2013 when then Sen. John Kerry was appointed U.S. Secretary of watchers, "Clark is now in prime position to ascend to a higher role — potentially even one day becoming the second female speaker — after Pelosi and her top lieutenants retire." Rep. Clark, at age 57, is decades younger than the Democratic leadership team. On Wednesday, The caucus also reelected the #2 spot, Majority Leader Steny H. Hoyer, 81, and #3 spot, Majority Whip James E. Clyburn, 80, by acclamation. House Democratic Caucus Chairman Hakeem Jeff ries, 50, who was reelected to the #5 position Wednesday by acclamation, and was unopposed, is also considered a potential Pelosi successor and could be the fi rst Black Speaker. Wednesday’s leadership election was held virtually, with Democrats gathered over a video call. The vote for Assistant Speaker was conducted using secret ballot. Moderna announces COVID-19 vaccine candidate with 94 percent efficacy CAMBRIDGE – Biotechnology company Moderna, Inc. recently announced the Phase 3 study of mRNA-1273, a vaccine candidate against COVID-19. The Coronavirus Effi cacy and Safety Study (COVE) has enrolled more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confi rmed and adjudicated starting two weeks following the second dose of vaccine. This fi rst interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus fi ve cases observed in the mRNA-1273 group, resulting in an efficacy rate of 94.5 percent. A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases in this fi rst interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. The 95 COVID-19 cases included 15 adults over the age of 65 and 20 participants from diverse communities. The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the Data Safety Monitoring Board (DSMB), which did not report any signifi cant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated; most adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to two percent in frequency after the fi rst dose included injection site pain (2.7 percent), and after the second dose included fatigue (9.7 percent), myalgia (8.9 percent), arthralgia (5.2 percent), headache (4.5 percent), pain (4.1 percent) and erythema/redness at the injection site (two percent). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and fi nal analysis. Preliminary analysis suggests a broadly consistent safety and effi cacy profi le across all evaluated subgroups. As more cases accrue leading up to the fi nal analysis, Moderna expects the point estimate for vaccine effi cacy might change. The company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication. “This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the fi rst clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Moderna CEO Stéphane Bancel. “This milestone is only possible because of the hard work and sacrifi ces of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fi ght against the virus. They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. We look forward to the next milestones of submitting for an EUA [Emergency Use Authorization] in the U.S. and regulatory fi lings in countries around the world, while we continue to collect data on the safety and effi cacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.” Based on these interim safety and effi cacy data, Moderna intends to submit for an EUA with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the fi nal safety and effi cacy data (with a median duration of at least two months). Moderna also plans to submit applications for authorizations to global regulatory agencies. Moderna is working with the Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson – a COVID-19 vaccine distributor contracted by the federal government – as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations. By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA-1273 ready to ship in the United States. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273. Moderna recently announced that further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.
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