By Alex M. Azar II | Fox News
Trump's Operation Warp Speed is credited with helping
race for COVID-19 vaccine.
With about 3 million doses on the way, this means that
health care workers and residents of long-term care facilities across America
will begin receiving vaccines in the coming days.
Americans who may fall into these categories—the exact
allocations are done by states and public health jurisdictions—can find out
more about where they will receive a vaccine from their state or local
governments, such as through the state’s COVID-19 webpage.
This spring, experts predicted that a vaccine
was at least a year or year and a half away. Yet, within a year, we have one
vaccine authorized, millions of doses being shipped, and another vaccine under
review by the FDA.
We’ll easily beat the experts’ expectations not by luck,
but because of deliberate planning by President Trump’s administration through
Operation Warp Speed (OWS).
American researchers and partners around the world began
research and development on COVID-19 vaccines back in January.
Work on the Moderna vaccine began the morning after the
viral sequence was shared by Chinese researchers. While this work progressed,
the Trump administration identified the potential challenges that could slow
access to vaccines.
First, vaccines are complex and scaling up manufacturing
takes time.
Second, rapidly distributing and administering vaccines
to every American is an unprecedented logistical project.
Back in April, with the president’s support, I started
working with the Department of Health and Human Services’ scientific leaders
and our colleagues across the administration to tackle these problems,
recruiting world-class leaders to execute on OWS’s bold goals.
First, beginning production as soon as possible would
accelerate the process without compromising safety or efficacy. Vaccines are
one of the most complex products made by modern industry, some are grown in
chicken eggs or with other specialized living media. Drugmakers almost never
invest in large-scale manufacturing upfront, lest the investment go to waste if
a drug isn’t approved.
To solve these challenges, we enlisted
Moncef Slaoui, a scientist who has led the development of numerous major
vaccines.
Together, we built a portfolio of promising candidates,
investing more than $10 billion to give companies confidence, and worked
closely with them to ensure they had what they needed to begin manufacturing.
HHS has deep experience working with researchers and
innovators, but supporting a manufacturing endeavor of this scale required
enlisting expert drug makers and another government partner: the Department of
Defense.
Every day, the Pentagon ensures that manufacturing
supplies go where they need to go, including between private-sector companies,
so that the guns, bullets, food and everything else the military needs are
produced and shipped where they need to go.
DOD uniformed and civilian experts have now done the same
thing for vaccine manufacturing, through the Defense Production Act and other
informal actions to prioritize supplies. When one manufacturer needed
particular parts to bring a new bioreactor online, for instance, OWS staff
ensured that the parts maker prioritized the order.
Second, safe and effective vaccines are only as good as
the plan we have for distributing and administering them. Coordinating with
public health authorities and private sector partners would require the finest
logistics experts in the world.
When I met with the Secretary of Defense and the Chairman
of the Joint Chiefs back in April, they immediately had a name for just such an
expert: Gen. Gustave Perna, who runs the U.S. Army’s logistics command.
Working with the private sector, on the same evening of
the authorization, we began shipping vaccines to administration sites in all 50
states and other public-health jurisdictions. Through a military-style battle
rhythm, OWS has been working to mitigate potential problems and setbacks,
planning with a precision that marks the U.S. military.
Americans can have confidence that these vaccines are
safe and effective because they’ve gone through an incredibly rigorous process.
OWS vaccines are proceeding through the typical three
phases of clinical trials. Then, trial data is reviewed by an independent data
safety and monitoring board, which makes its own statistical assessments, and
then by the drug maker.
The data is then submitted to the FDA, which publicly
consults with its outside panel of vaccine experts. Then, FDA’s career
scientists review the data and the experts’ recommendations, and make a final
decision—as they
now have with Pfizer’s vaccine. It’s the same process Americans know and
trust for any other drug authorized or approved by the FDA.
We all owe a debt of gratitude to the public servants who
have made this progress possible, and to every American who’s sacrificed to get
us to this point.
Soon enough, it will be time for each of us to do our
part and encourage our family and friends to go out and get a safe and
effective vaccine—as I plan to do the first day I can.
Operation Warp Speed will go down as one of the great
scientific achievements in our country’s history, and it offers all the more
encouragement to double down on the sacrifices we’re making now to slow the
spread of the virus. As Americans get vaccinated, we need to continue taking
steps like washing our hands, social distancing, and wearing face masks to
protect ourselves, our loved ones, and our communities.
https://nypost.com/2020/12/12/how-operation-warp-speed-delivered-a-covid-19-vaccine/
