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- The US government’s coronavirus vaccine program aimed to back eight candidates and has inked deals with six programs.
- Moncef Slaoui, the co-leader of Operation Warp Speed, told Business Insider the strategy was to have two vaccine candidates across four types of technologies.
- Lawmakers, industry watchdogs, and vaccine experts have expressed concerns about how Warp Speed picked its vaccine candidates.
- Slaoui said he is “extremely aware of and very worried about” the perception of Warp Speed as not transparent.
- Visit Business Insider’s homepage for more stories.
The US government’s ambitious program to accelerate coronavirus vaccine development has signed major deals for six candidates and is eyeing two additional vaccines, the co-leader of the initiative told Business Insider.
The Trump administration unveiled Operation Warp Speed in mid-May as an effort to speed up vaccine research, testing, manufacturing and distribution. But details about Warp Speed’s strategy and how it makes decisions have been shrouded in secrecy, alarming Democratic lawmakers, drug industry watchdogs, and vaccine experts.
So too have Slaoui’s ties with the pharmaceutical industry. Slaoui spent three decades working at the British vaccine giant GlaxoSmithKline, retiring in 2017. He was a board member of Moderna, which has a leading coronavirus vaccine candidate, until he was appointed to Warp Speed.
In a rare interview with Business Insider, Warp Speed’s chief adviser Moncef Slaoui pushed back against those criticisms and revealed the initiative’s strategy in how it came to select its six vaccine programs.
Coronavirus stock Warp Speed wanted to back 8 programs across 4 types of vaccine technologies
Before Slaoui stepped into his Warp Speed role, US government scientists were already winnowing down a sprawling field of vaccine candidates.
Slaoui said a team led by Peter Marks, a top regulator at the US Food and Drug Administration, reviewed nearly 100 vaccine programs and narrowed it to 14 and then 10 potential shots.
“When I joined, of those 10, we as a team in the operation selected eight to pay careful attention to,” Slaoui said. “As time goes by, I will be very happy to explain those that were not selected, why they were not selected, and those that were selected, why they were selected.”
Warp Speed wanted to back eight programs in total that represent four different vaccine technologies:
- Nucleic acids, which are genetically based vaccines: This is an unproven but promising technology that delivers genetic code, either DNA or RNA, to human cells to defend against a virus. There are no DNA- or RNA-based vaccines on the market.
- Non-replicating viral platforms: These shots use a killed version of another type of virus, often the adenovirus, to deliver genes of the targeted virus. In 2019, the FDA approved a smallpox and monkeypox vaccine that used a non-replicating platform.
- Protein adjuvants: These vaccines use a fragment of the virus to induce an immune response along with an adjuvant that can boost the immune response. Pertussis, diphtheria and tetanus vaccines are protein-based shots.
- Live attenuated virus vectors: Scientists use the entire virus but weaken it, so it doesn’t lead to infection. The oral polio vaccine uses this approach.
These technologies “are validated enough to enable making vaccines quite quickly,” Slaoui said. Warp Speed sought two vaccines for each platform.
So far, six spots haven been filled and announced:
- Moderna and Pfizer/BioNTech are both in the final stage of clinical trials with messenger RNA vaccine candidates.
- AstraZeneca and Johnson & Johnson both are advancing vaccines that use the adenovirus as a delivery tool for the shot.
- Novavax and Sanofi/GlaxoSmithKline have filled the slots for shots based on delivering proteins with an adjuvant.
The US government has secured 800 million initial doses of these vaccine candidates through agreements that total more than $10 billion. For many of these programs, Warp Speed is also funding the cost of running massive clinical trials and scaling up manufacturing.
The final two spots for live-attenuated vaccines have yet to be filled. Slaoui said they have not met Warp Speed’s criteria for safety, efficacy and timeline.
“There is still the possibility for two slots. Frankly, today, they are unlikely to be filled,” Slaoui said, “but I would love to be surprised positively by one of the candidates we are carefully looking at.”
A vaccine based on a live sample of the virus works by delivering the right amount of virus to induce an immune response but not lead to illness. “Finding that right balance is time-consuming and very difficult to predict in animal models,” Slaoui said.
Coronavirus stock Slaoui said Warp Speed was secretive about its vaccine process to curb speculation
Warp Speed been subject to criticism and scrutiny since it was unveiled in May, especially in how the initiative picked vaccine candidates.
Lawmakers and pharmaceutical industry watchdogs have highlighted Slaoui’s connections to the drug industry.
Slaoui still holds roughly $10 million in GlaxoSmithKline stock, and held more than $10 million in Moderna stock when he was tapped to lead Warp Speed. Slaoui has since he divested his Moderna shares and pledged to donate realize profits to cancer research.
He has held onto his GSK holdings, saying his retirement is funded by the dividend payments. Lawmakers and watchdog groups characterized these ties as a troublesome conflict of interest that could hurt public trust in the process.
“I am concerned that the selection of candidate vaccines for Operation Warp Speed lacked transparency and excluded many vaccine experts,” South Carolina’s Democratic Rep. James Clyburn wrote in an August 12 letter.
Slaoui has pledged to donate any gains from his GSK shares while he runs Warp Speed to cancer research as well. Clyburn noted there is no legal mechanism requiring he does so.
Slaoui said he is “extremely aware of and very worried about” the perception of Warp Speed as not transparent. He said he wished Warp Speed could have been more open on the process, but couldn’t when negotiations were ongoing.
If the program had announced it was seeking eight vaccines with these types of technologies, dozens of companies would have seen shares jump and dive based on speculation, Slaoui said.
Now, with the deals in place, Slaoui said he can be more transparent with the public.
“It’s not a shift,” he said. “It’s a natural progression.”