Biden advisers met with Warp Speed drugmakers before election

[WASHINGTON] President-elect Joe Biden's health-care advisers have held talks with pharmaceutical-industry executives in which they discussed Operation Warp Speed, the US development programme for coronavirus vaccines and treatments, according to people familiar with the matter.

Biden advisers met with companies that have Covid-19 vaccines or therapies in late-stage clinical trials in September and October, the people said. The purpose was to gather information about the development, manufacturing and distribution of shots to ward off the novel coronavirus and therapies to treat the sick.

Operation Warp Speed has helped bankroll many companies' research efforts while forging agreements to lock in supply for the US.

The Biden administration will inherit the initiative, which is managed by the Health and Human Services and Defence departments, when it takes power in January. That timing could align with a massive effort to inoculate Americans with newly authorised vaccines.

The advisers indicated to drug-company officials that Mr Biden's administration wouldn't be interested in making changes to Warp Speed that would disrupt work in getting new drugs and vaccines to market, and that it wants to be ready to assist the companies' efforts when Mr Biden assumes office, according to the people, who asked not to be identified because the discussions were private.

Several companies could seek emergency clearance for vaccines from the US Food and Drug Administration in coming weeks.

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Regeneron Pharmaceuticals and Eli Lilly & Co have separately asked the agency for emergency-use authorisations for antibody therapies designed to fight infections.

President Donald Trump was given the experimental Regeneron drug when he was diagnosed with Covid-19 in October.

Vivek Murthy, the US Surgeon General under President Barack Obama from 2014 to 2017, and former FDA Commissioner David Kessler, who served in both the George H.W. Bush and Clinton administrations from 1990 to 1997, have been point people for Mr Biden on Warp Speed, according to one of the people.

Campaign spokesman Andrew Bates said Mr Biden is committed to helping develop a safe and effective vaccine as soon as possible and that his campaign medical advisers were briefed by companies working on vaccines to be informed about the process.

The campaign has previously criticised the Trump administration for a lack of transparency about the vaccine effort's scientific standards, oversight and distribution plans. Its website says Operation Warp Speed lacks a strategy to see its mission through and gain the trust of Americans.

In remarks in Wilmington, Delaware, on Sept 16, Mr Biden said he'd spoken with experts about how to prepare for a "swift, organised and free distribution of a safe and effective vaccine when it arrives," adding, "I trust vaccines, I trust the scientists, but I don't trust Donald Trump."

BUILDING TRUST

Led by former pharmaceutical executive Moncef Slaoui and Army General Gustave Perna, Warp Speed is the most ambitious component of the Trump administration's response to the pandemic.

It has selected promising vaccine and drug candidates; invested in research, development and manufacturing; and clinched deals assuring access to new therapies. Its budget is more than US$18 billion.

The programme has at times attracted controversy because of Mr Trump's eagerness to see new vaccines and drugs approved.

Mr Trump pushed the FDA to give emergency clearance to a shot before the election, but some trials hit scientific hurdles, and no company has yet produced late-stage study data.

A spokesperson for the Department of Health and Human Services said that Warp Speed is focused on developing and distributing safe and effective vaccines and therapeutics to the American people as fast as possible, and its process is driven by science, not politics.

Only half of US adults say they would "definitely" or "probably" get a vaccine if one were available, according to a September poll from Pew Research Center, down from 72 per cent in May. And those hardest hit by the pandemic are least likely to be willing to get a vaccine. Among black adults, only 32 per cent say they'd likely get a shot, compared with 54 per cent in May.

The Biden administration will aim to bolster trust in scientists at US health agencies, according to the people familiar with the talks between the campaign and the companies.

Some people affiliated with the Biden campaign have proposed that changing the Warp Speed moniker could increase public confidence, according to two of the people.

Some US health officials and pharmaceutical executives have suggested the name has sowed doubt in the products it is backing.

The Warp Speed name stuck after Peter Marks, director of the FDA's Centre for Biologics, Evaluation, and Research, pitched it as an homage to Star Trek. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, later said in an interview with PBS in August it was "unfortunate terminology" and "tends to subliminally suggest reckless speed."

Warp Speed officials have said that the name isn't intended to signal haste.

"We are not cutting corners on safety; we are not cutting corners on the quality of the manufactured product; those will be done to the highest standards," Matthew Hepburn, the programme's head of vaccine development, said at a talk at the Heritage Foundation last month.

Dr Slaoui, the former head of GlaxoSmithKline Plc's vaccines division, was contracted to serve as Warp Speed's chief scientific adviser in May. His contract extends through February.

The Moroccan-born Belgian-American immunologist said in an interview with Axios last month that he hasn't had contact with the Biden camp. He told Axios he would like to remain in his role until two vaccines and one or two new treatments are approved.

Biden representatives have also reached out to a group representing local health officials, who emphasised the importance of coordinating virus response through city and county health departments, instead of relying solely on elected officials.

"We asked to keep in touch if they should win the election and how we might be helpful moving forward," said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials. That help could include "taking advantage of structure already in place to do vaccine planning and distribution."

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