By Paul Mango
Tuesday, May 04, 2021
Millions of people across the United States have
already received doses of vaccines against coronavirus — vaccines developed as
part of Operation Warp Speed (OWS), the project conceived, initiated,
resourced, and largely executed under Trump administration leadership. Daily,
millions more join their ranks. But listening to members of the liberal media
and the Biden administration, one could be forgiven for not clearly
understanding the pivotal role leaders within the Trump administration, along
with private-sector partners, played in developing, manufacturing, and
delivering over 300 million safe and effective vaccines in less than
one year to the American people.
After President Biden’s address to the nation last week,
Nicole Wallace of MSNBC commented that OWS “didn’t do anything to get a needle
into the arm” of any American. In February, Vice President Harris commented
that the Biden administration was in many ways “starting from scratch.” And,
Jeff Zients, from the administration’s COVID-19 task force, commented recently
that the Trump administration had “no plan” to vaccinate Americans. The Biden
administration’s overall COVID-19 response performance in its first 100 days,
averaging over 75,000 cases per day and over 1,700 fatalities per day, has been
less effective than the year during which the Trump administration was
overseeing the response (~60,000 and ~1,100, per day, respectively). On January
20, 2021, there were approximately 24.5 million total COVID cases and 405,000
fatalities in the U.S. This was one year into the pandemic. In the first 100
days of the Biden administration, we added 7.8 million cases (32.3 million
total) and 170,000 fatalities (575,000 total). So much for extinguishing the
virus. Also, as of May 1, close to 70 million of the 310 million vaccine doses
distributed are sitting idle in U.S. vaccination sites. We were criticized for
having less than one-tenth this number of vaccines sitting idle. These are
inconvenient facts, so one will not likely hear them from MSNBC or CNN.
Clearly, President Biden is learning that governing is more difficult than
campaigning.
Many in the media attribute the success of OWS to some
sort of miracle, a deus ex machina introduced to unravel the mysteries of
vaccine development and manufacturing. In fact, the success of OWS was a
function of exceptional leadership, a deliberate strategy, and exacting
execution.
OWS was conceived in the spring of 2020 by Department of
Health and Human Services secretary Alex Azar, a former pharmaceutical company
executive who deeply understood the motivations, risk tolerance, and
complexities of drug development, manufacturing, and distribution. It was
immediately embraced by President Trump, who ensured we had the financial
resources, attention, talent, and government support required for success.
Shortly thereafter, we added a number of other exceptional leaders: Dr. Moncef
Slaoui, the most accomplished vaccine developer of our generation, Generals
Perna, Ostrowski, and Sharpsten from the Army Logistics Command, and Carlo de
Notaristefani, a distinguished pharmaceutical manufacturing expert, Dr. Francis
Collins of the National Institutes of Health, who oversaw the clinical trials,
and Jared Kushner as our White House liaison. This country owes the vaccines we
have to this team of leaders.
The OWS strategy required the U.S. government to assume
the financial risk for manufacturing the vaccines. Normally, manufacturing
vaccines at scale only occurs after its developer receives approval from the
FDA. In the middle of a global pandemic, this was unacceptable. So, beginning
in the summer of 2020, we financed the manufacturing of up to 3 billion
vaccines, many months before any vaccine was granted an Emergency Use
Authorization (EUA). When the Biden administration “secures” more doses, it is
simply pushing the “reorder button” on options in contracts we established last
year. The OWS strategy also involved selecting a small “portfolio” of the very
best vaccines from among 114 vaccine candidates. Could the candidate get
through phase-three clinical trials quickly enough? Would it be effective in
persons over age 65? Could it be manufactured at scale such that we would have
tens of millions of doses prior to the first half of 2021? Dr. Slaoui chose six
candidates across three technology platforms, five of which have, or will
shortly, meet all of these criteria.
However, simply selecting vaccines was insufficient.
Success required leaders such as Dr. Collins, who shepherded multiple clinical
trials, composed of tens of thousands of Americans, allowing them to be
completed in record time and with sufficient experimental diversity. Because of
the disproportionate impact of COVID on the elderly and some minorities, we
wanted to ensure the vaccine was valid in these groups. Thus, we aimed for 25
percent participants over age 65, 10 percent black, and 10 percent Hispanic.
Carlo de Notaristefani and his teams had to stand up, or expand, 23 separate
manufacturing facilities in seven months’ time. This included obtaining
equipment, raw materials, and labor. Dr. Bob Kadlec, the assistant secretary
for Preparedness and Response, had to secure a billion needles and syringes, as
well as tens of millions of vials, and began doing so in March of 2020. We
utilized the Defense Production Act 18 times to ensure proper priority was
assigned to these vital tasks. When the Biden administration claimed its use of
this authority would be something different, it was simply not true. It has
only used the DPA once in the first 100 days.
When the Biden administration asserts we had no plan to
vaccinate Americans, it is insulting every career official in the CDC, every
governor and mayor of the 64 public-health jurisdictions we devised, and every
public-health official at the state, county, and city level in the U.S. In
conjunction with these professionals, we developed a national operating plan
and 64 micro-plans. Each was reviewed, evaluated, and scored.
Distribution and administration of vaccines was another
area of exceptional execution, for which Generals Perna, Ostrowski, and
Sharpsten, along with CDC leaders such as Dr. Anita Patel, organized the very
best of the private sector. McKesson, UPS, FedEx, CVS Health, and Walgreens
were among our first partners. We eventually enrolled, and electronically
linked, over 40,000 pharmacy locations, thousands of Community Health Centers,
and thousands of hospitals, all of which are being well-utilized today. We
developed Tiberius, the most sophisticated vaccine-tracking system ever used.
Before the end of February 2021, only two months into the rollout, nearly every
one of America’s 15,000-plus nursing-home residents had had the opportunity to
receive two doses of vaccines. UPS and FedEx have maintained a 99.99
percent-plus record of on-time deliveries, to the right destinations, without
compromising extraordinarily stringent storage and delivery requirements. On
our last day in office alone, the CDC reported over 1.5 million newly
vaccinated Americans.
To be sure, there were uncertainties during the first
several weeks of administering vaccines. We were entering the holiday season
(the Pfizer and Moderna EUAs were granted on December 14 and 21, respectively).
We could not have anticipated that around 30 percent of frontline health-care
workers, and around 50 percent of nursing-home employees, would refuse
vaccination. But we adapted quickly, and on January 12, Secretary Azar and Dr.
Robert Redfield from the CDC announced we would be expanding criteria for
eligibility and expanding access sites for vaccine administration.
Despite the Biden administration’s comments suggesting we
“had no plan,” we are flattered the Biden administration has actually embraced
nearly 100 percent of the Trump administration’s plan. The only difference is
FEMA-led mass-vaccination sites, which have administered less than 2 percent of
our vaccines. The Biden folks snub their noses at the Trump dog food at night,
but the bowl is always empty in the morning.
Biden administration personnel have done an outstanding
job of fulfilling the OWS mission. We “handed them the baton” and they ran with
it. No one is more pleased about this success than President Trump and his OWS
team. One has to ask, however, why the Biden folks and the media so vigorously
and disingenuously disparage our achievements, while withholding credit to
those few leaders who came together under President Trump’s leadership on
behalf of the many. This behavior represents the worst of politics, a lack of
executive presence, and most important, a missed opportunity to unify
Americans. If we cannot celebrate this example of American exceptionalism as a
united people, then what can possibly bring us together?
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