U.S. President-elect Joe Biden will be facing a daunting challenge in taking over what is now a dysfunctional system of distributing COVID-19 vaccines once they are cleared for the U.S. market, philanthropist Bill Gates said.

Gates said he was concerned about the "cacophonous" nature of the Trump administration's strategy for distributing the vaccine, in which states were charged with crafting their own plans.

"I don't see it coming together in a rational fashion," he said Nov. 17 at a virtual forum hosted by Stat News. "Wow, it is a dysfunctional set of people right at the moment."

But Gates said he had faith Biden could get the situation under control, given he has shown more willingness to listen to scientific and public health advisers than his predecessor.

"He's going to overdo it on listening to science, which is a wonderful thing," Gates said about Biden.

Biden is "off to a very good start" on putting together his scientific team of advisers, he added.

President Donald Trump has blocked officials at the U.S. Department of Health and Human Services and members of his White House Coronavirus Task Force from speaking with Biden's transition team.

"If we have to wait until Jan. 20 to start that planning, it puts us behind," Biden told reporters Nov. 16. "More people may die if we don't coordinate."

In a Nov. 17 letter, the American Medical Association, American Hospital Association and American Nurses Association called on Trump to work with Biden and his transition team.

Science guy

Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, or NIAID, praised Biden as having a "considerable, in fact, if not profound" grasp and appreciation for science.

During the 2013-16 Ebola outbreak in West Africa, Biden would frequently attend meetings with the White House's scientific advisers and "sit down and listen and contribute in the discussions," Fauci said at the Stat Summit.

"Clearly he was engaged there," he said.

Biden also oversaw former President Barack Obama's Cancer Moonshot initiative.

"So he got very much involved in talking to scientists," Fauci said. "That was just the reality of what went on."

Fauci said he fully anticipates remaining on the job at NIAID during the Biden administration despite turning 80 years old in December.

"The thought about quitting is not even in my DNA," Fauci said. "I'm a public health official. I'm a scientist. I've devoted my entire professional career to fighting outbreaks, as well as established diseases, like HIV, malaria."

Durability unknown

Even though there are now two experimental vaccines that have shown over 90% efficacy in preventing symptomatic COVID-19 — products from Pfizer Inc. and Moderna Inc. — the durability of that protection is not yet known.

"You have to be honest and say that that is a question," Fauci said. "That's the reason why you have trials that go on for the durability."

Study participants will be followed over at least two years, he told S&P Global Market Intelligence. If people start getting reinfected with COVID-19, that will "give you a real insight into what the durability of the immunity is," Fauci said.

Both Pfizer and Moderna are on the verge of submitting applications to the U.S. Food and Drug Administration to obtain emergency use authorization, or EUA — a regulatory mechanism created by Congress in 2004 to permit preapproval marketing of medical products during public health crises, such as COVID-19.

The FDA on Nov. 17 said it planned to publicly post its reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs for all products, including COVID-19 vaccines, in an effort to be transparent.

At the Stat Summit, Pfizer CEO Albert Bourla said his company was "very close" to submitting its EUA after reaching the FDA's threshold of a median of two months of safety data.

The interim results from Pfizer's and Moderna's phase 3 trials is a "light at the end of the tunnel," Fauci said. "Help is coming."

He urged Americans to "hang in there a bit longer" until the shots are authorized by the FDA and available — though Fauci acknowledged widescale vaccination is not expected in the U.S. until spring or summer 2021.

Fauci's agency, which he has led since 1984, is partnering with Moderna on its vaccine, which is based on a messenger RNA platform.

The NIAID's research on mRNA was initiated and initially funded by the Obama administration. NIAID and Moderna were initially pursuing a vaccine against Middle East Respiratory Syndrome — a member of the coronavirus family — but were able to adapt their platform in January to pursue a shot for COVID-19.

Pfizer and its partner BioNTech SE are also using an mRNA platform for their product.

While the mRNA platform is "fantastic," the technology is not as mature as others and therefore the high-volume factories are not set up to manufacture those products, Gates said. The cold-chain requirements and scalability is also not as attractive as other approaches, he added.

But in another five years, the mRNA platform "is going to be great" not only for infectious diseases but cancer and other conditions, Gates said.

Vaccinations save lives

The overall effectiveness of the COVID-19 vaccines will depend on "what proportion of the people in society take the vaccine," Fauci said at the virtual conference, adding that number must be "substantial."

"A vaccine has never saved anyone. It's the vaccination," Caitlin Rivers, senior scholar at the Johns Hopkins University Center for Health Security, said during a Nov. 16 session at the Stat Summit. "Just having a product available does not mean anything if we cannot get it to people and that people do not feel comfortable taking it."

Logistics and community engagement will be critical for making the COVID-19 vaccine distribution successful, Rivers said.