Thursday, May 6, 2021

The Truth about Trump’s Operation Warp Speed

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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