December 6, 2020

Trump’s Operation Warp Speed promised a flood of covid vaccines. Instead, states are expecting a trickle.

 




The administration pledged several hundred million doses in 2020. Companies will actually ship about 10 percent of that.


Coronavirus continues to devastate the country, with official deaths topping 281,000 today, but it turns out that the Trump administration did not actually have a plan for distribution of vaccines. Federal officials have drastically slashed the amount of vaccine they promised to states before the election. Instead of the 300 million doses the administration had promised before the end of 2020, the plan is currently to distribute 35 to 40 million doses. Even those, though, are plagued by bottlenecks in parts of the production process, as well as manufacturing issues. This means a longer struggle with the disease than many had come to expect.


WASHINGTON POST

Federal officials have slashed the amount of coronavirus vaccine they plan to ship to states in December because of constraints on supply, sending local officials into a scramble to adjust vaccination plans and highlighting how early promises of a vast stockpile before the end of 2020 have fallen short.

Instead of the delivery of 300 million or so doses of vaccine immediately after emergency-use approval and before the end of 2020 as the Trump administration had originally promised, current plans call for availability of around a tenth of that, or 35 to 40 million doses.

Two vaccines, from manufacturers Pfizer and Moderna, which both use a novel form of mRNA to help trigger immune response, are on the verge of winning Food and Drug Administration clearance this month. Approval would cap an unprecedented sprint by government and drug companies to develop, test and manufacture a defense against the worst pandemic in a century — part of the Operation Warp Speed initiative that promised six companies advance purchase orders totaling $9.3 billion.

As planning accelerated for distributing supplies, the government began to further lower expectations. To make sure supplies don’t run out and leave some people only partially immunized, the government said it would stagger deliveries to ensure that states have enough supply for the second shot, required 21 days later for the Pfizer vaccine, which is expected to be first to gain approval.

Lower-than-anticipated allocations have caused widespread confusion and concern in states, which are beginning to grasp the level of vaccine scarcity they will confront in the early going of the massive vaccination campaign.

The gap reflects the disconnect between Trump’s campaign promises, as well as the optimistic estimates from some drug companies, and scientific and manufacturing realities.

The drop-off is a product of manufacturing problems, bottlenecks in the supply of raw materials and other hurdles in ramping up clinical-trial production of 5 liters of protein-based vaccine at a time to commercial-scale fermentation of 2,000-liter batches, the companies and the Trump administration said.

The flow is expected to accelerate in January and February but still will not meet the bold predictions of Trump and the leader of Operation Warp Speed, pharmaceutical executive Moncef Slaoui, who said in the White House Rose Garden in May that he was confident “several hundred million” doses of vaccine would be ready by the end of December.

Instead, Slaoui said this past week that officials are now planning to ship 35 to 40 million doses by the end of the year, enough for up to 20 million people under a two-shot regimen.

Experts agreed the administration’s plan to pay companies billions of dollars in advance to spur manufacturing in parallel to the initiation of clinical trials — a strategy never attempted on such a massive scale — must still be considered a success. The advance payments eliminated or reduced financial risk for the companies, which have raced to ramp up production of doses that are still in the pipeline, if coming slower than originally pledged.

“They have done better than I could have imagined they could have done,” said Barry Bloom, a professor and expert in immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.