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May 18, 2020

New details: Trump's effort to produce 'hundreds of millions' of coronavirus vaccine doses by 2021

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    President Trump and officials in his administration on Friday outlined new details of Trump's ambitious effort to develop and manufacture hundreds of millions of doses of a vaccine against the new coronavirus by the end of this year, which, if successful, would significantly undercut the average time it's typically taken to develop and approve new vaccines.

    Covid-19 weekly webinar: What health care leaders need to know

    US Covid-19 cases near 1.5M, death toll tops 89K—but growth rates start to slow

    The effort comes as U.S. officials as of Monday morning had reported 1,493,600 cases of Covid-19, disease caused by the new coronavirus—up from 1,424,700 cases as of Friday morning.

    According to the New York Times, the number of newly reported cases of Covid-19 in the United States began to grow at a slower rate over the past few days. The daily rates of newly reported cases have begun to plateaued in 28 states, decrease in 19 states, and increase in three states, the Times reports.

    Epidemiologists have credited the slowdown to widespread social distancing measures that had been in place throughout America, the Times reports. However, public health experts expect to see a resurgence of Covid-19 cases in coming weeks at states across the country reopen nonessential businesses and ease social distancing measures intended to curb the new coronavirus' spread.

    There has also been a slowdown in the rate of newly reported deaths linked to the new coronavirus, the Times reports. But despite that slowdown, the country's cumulative death rate tied to the new coronavirus is estimated to reach nearly 113,000 by June, according to a consolidated model developed by Nicholas Reich, a biostatistician at University of Massachusetts Amherst.

    As of Monday morning, officials had reported a total of 89,504 U.S. deaths linked to the new coronavirus—up from 85,843 deaths reported as of Friday morning.

    Trump admin unveils new details of 'Operation Warp Speed'

    Meanwhile, Trump and administration officials during a White House press conference on Friday announced new details on "Operation Warp Speed," which is the administration's project to speed up development of a vaccine against the new coronavirus and get millions of Americans vaccinated by the end of this year.

    Officials said the project's goal is to develop and manufacture hundreds of millions of doses of a vaccine against the new coronavirus by the end of this year—an objective that Trump said is "risky" and "expensive."

    "[W]e're looking to get it by the end of the year if we can, maybe before," Trump said. He noted, "It's risky, it's expensive, but we'll be saving massive amounts of time."

    Trump said the project represents "a massive scientific industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project."

    HHS Secretary Alex Azar said the initiative will streamline the federal government's efforts to develop a vaccine against the virus. Under the plan, drug manufacturers with promising vaccine candidates will scale up their production of the potential vaccines during clinical trials and before receiving FDA's approval for the immunizations. That means drugmakers would be accelerating production of the potential vaccines before their effectiveness is validated by FDA.

    Azar on Friday told Fox Business Network that there currently are "over 100 vaccine candidates that have been discovered." He said, "What we're doing now is we're narrowing those down to the core group that we're going to place huge multi-hundred million dollar bets on and scale massive vaccine domestic production." Azar said the goal is to have "hundreds of millions of doses" of at least one safe and effective vaccine by the end of the year.

    Trump during Friday's White House press briefing said the administration eventually will chose a group of 14 promising vaccine candidates to focus under Operation Warp Speed. In addition, he said the administration is considering making the eventual vaccine available to Americans at no cost.

    Public health experts have noted that the administration's goal of developing and producing hundreds of millions of doses of a vaccine against the new coronavirus runs counter to conventional timelines for vaccine development. For instance, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said, under the best of circumstances, researchers could develop a vaccine within 12 to 18 months.

    However, former GlaxoSmithKline executive Moncef Slaoui, who Trump has tapped to serve as Operation Warp Speed's chief adviser, during the press briefing said, "I have very recently seen early data from a clinical trial with a coronavirus vaccine. These data make me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020."

    House approves $3T coronavirus relief package—but its prospects in the Senate are dim

    Meanwhile, the House on Friday voted 208-199 to approve a $3 trillion coronavirus relief package (HR 6800) that includes nearly $1 trillion to help states, cities, and Native American tribes affected by the country's new coronavirus epidemic, as well as funding to pay unemployed Americans' health insurance premiums.

    The bill, called the Heroes Act, also includes funding intended to help states increase their testing capacity for the new coronavirus. In addition, the measure would require the HHS secretary to update the nation's strategic testing plan with new benchmarks and timelines. Under the bill, public health departments would receive $75 billion in grants to cover costs related to Covid-19 contact tracing, containment activities, testing, and surveillance. The bill would require public health departments to use culturally responsive and multilingual contact tracing strategies and public awareness campaigns.

    The bill also includes $100 billion in grants to help hospitals and health care providers cover expenses related to the Covid-19 public health emergency. Further, the bill would provide $500 billion to help states address the financial impacts of the country's new coronavirus epidemic and includes $345 billion for local governments and $20 billion for tribal governments.

    The bill also seeks to help public health departments by establishing a loan repayment program for the departments to recruit and retain employees, and by authorizing grants for public health departments to obtain technology-based learning tools.

    The bill now heads to the Senate, where it is unlikely to advance. Nearly all Republicans in the Senate have said they oppose the bill as it's currently written and Trump has promised to veto the bill if it reaches his desk (Bosman, New York Times, 5/16; Chalfant [1], The Hill, 5/15; Chalfant [2], The Hill, 5/15; Facher, STAT News, 5/15; Johnson et al., Washington Post, 5/15; Reuters, 5/15; New York Times, 5/17; Brady, Modern Healthcare, 5/15; Taylor/Fram, Associated Press, 5/15; New York Times, 5/18).

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