Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Sign up for our Retail & E-Commerce newsletter
You must correct or enter the following before you can sign up:
Thank You!
Law360 (November 18, 2020, 8:38 PM EST ) The Trump administration said Wednesday that 40 million doses of COVID-19 vaccines are likely to be distributed across the U.S. within a month, after Moderna and Pfizer announced that their vaccine candidates are about 95% effective.
Vaccines could be available for distribution to 20 million of the "most vulnerable Americans" by December if the U.S. Food and Drug Administration provides emergency use authorization to the two candidates announced by Pfizer and Moderna, Department of Health and Human Services Secretary Alex Azar said during a press conference.
Azar credited that success to Trump's vaccine program Operation Warp Speed.
"Operation Warp Speed has accelerated the timelines for delivering an eventual safe and effective vaccine," Azar said, noting the program's investments in five vaccines and pre-purchasing agreements with six other manufacturers.
On Monday, the independent Data and Safety Monitoring Board said that Moderna's candidate is 94.5% effective. On Wednesday, Pfizer said that its vaccine candidate is 95% effective. Those developments are the product of the public-private partnerships backed by Operation Warp Speed, said Dr. Moncef Slaoui, the program's chief science adviser.
"What we've done was to leverage the decades of discovery and research that was done in identifying and optimizing platform technologies, like cassette players that are able to play cassettes with different music, [to] make vaccines against different viruses," Slaoui said. "We used a perfected set of cassette players to put in them the COVID-19 information and they played that music."
Distribution of the vaccine has been months in the making, and the stage is now fully set, said General Gustave Perna, the program's chief operating officer.
The first doses of the vaccine candidates will be distributed to 64 U.S. jurisdictions — which include the 50 states, eight territories and six major metropolitan cities — based on their individual plans, Perna said. Those plans took shape in September, when HHS, along with the Department of Defense and the Centers for Disease Control and Prevention, issued their distribution report to state and local governments.
"Governors and the states will figure out the plan and we are ready to execute in collaboration with their plan," Perna said, urging states to sign data use agreements and track vaccine administration. "We must be able to see who got their first dose, where they got their first dose and what vaccine did they receive as their first dose."
Within the first 24 hours after the FDA authorization, Perna said the administration expects a national, equitable distribution where no one is left out.
"There [are] no have and have nots," he said.
The officials also addressed lingering concerns about refrigeration as Pfizer's vaccine requires storage at a lower temperature than the Moderna vaccine and can't be maintained for the same length of time as Moderna's vaccine.
"Don't be afraid of the constraints because of the vaccine and the temperature requirements," Perna said.
"Everything is planned to the minute," Slaoui said of the temperature concerns. "I'm learning about how the Army wins wars."
Azar also fended off questions about how the vaccine distribution will be affected by a transition of power to President-Elect Joe Biden.
"In the event of a transition, there's really total continuity that would occur," Azar said, adding that his primary focus is distributing a vaccine.
"Our mission at Operation Warp Speed is about saving lives," he said. "Every hour, every day matters."
--Editing by Emily Kokoll.
For a reprint of this article, please contact reprints@law360.com.