Current outbreaks help speed up vaccine research

Michael Wilner, Tribune News Service

Surging coronavirus cases across the United States may offer one upside, increasing the chances of a vaccine breakthrough before November, Dr. Anthony Fauci, the leading infectious disease expert on the White House coronavirus task force, told McClatchy in an interview on Friday.

That could be a silver lining for President Donald Trump, who has been pushing for the discovery of a COVID-19 vaccine before the November 3 election amid sinking poll numbers over his handling of the pandemic.

The sheer scope of the current outbreak could speed up clinical trials currently underway for potential vaccines, Fauci said, by generating data on their effectiveness more quickly from volunteers located in coronavirus hot spots.

“The more infections you have in the community, the quicker you get an answer,” Fauci said. “We don’t want there to be a lot of infections in our country. But on the other hand, if there are, we get an answer regarding the efficacy of the vaccine sooner.”

Phase III clinical trials for two potential vaccines — from Moderna, a biotechnology company, and Pfizer, a pharmaceutical giant — began on July 27. Advanced trials for other vaccine candidates from companies such as Johnson & Johnson and AstraZeneca are set to begin within weeks.

Fauci said he expects those first two trials will be fully set up, with roughly 30,000 individuals recruited as volunteers for each study, within six weeks, by mid-September.

“If everyone has their full scale immunization by October or so, you should get some results by November or December,” Fauci said. “If we have a large number of infections, we could get an answer sooner than November, December. But my projection, and that of almost everybody who’s involved in this, is that it is more likely — though not definitive — that it is more likely that it will be November and December. But it is possible that it could be earlier.”

Trump administration officials have made it a top priority to declare a vaccine discovery by November, launching Operation Warp Speed — a federal programme to discover, produce and deliver 300 million doses of a coronavirus vaccine by January — to coordinate the all-of-government push.

The president’s focus on that programme has led some scientists to express concern that the administration may rush a vaccine to market before it is fully ready.

Trump told reporters at the White House on Thursday that the discovery of a vaccine before the November vote could help his election prospects. “It wouldn’t hurt. It wouldn’t hurt,” Trump said. “I’m doing it, not for the election. I want it fast because I want to save a lot of lives.”

Fauci would not directly respond to the president’s remarks. But he echoed his pledge made in a previous interview with McClatchy to speak out against any premature announcements on vaccine development.

“I’m just going to tell you that I have always, am doing it now and will always make recommendations and make policy and give advice based on science, data and evidence,” Fauci said Friday.

The vaccines that emerge may require two doses for the initial vaccine — a prime and a boost — or may require a booster shot further down the line, Fauci said.

The Moderna vaccine candidate, for example, already requires an initial shot, followed by a secondary shot 28 days later to reach what’s called “optimal immunity.”

That requirement is already extending the trials by a month, which factored into Fauci’s timeline for expecting results. But he is unconcerned that the need of multiple doses will complicate the production and distribution process.

“I don’t see the production issue that I’m hearing about,” Fauci said. “That has all been factored into the needs of production. So it isn’t as if it’s a surprise that, maybe it’s going to require two shots. We are assuming it’s requiring two shots, and the protocol is written to allow for a prime and a boost.”

Fauci noted that multiple existing vaccines — for tetanus, for shingles and for influenza in children — require two shots over time to optimize their effect.

But the science remains unclear on how long the protection of a vaccine might last.

“I think it’s important to say we do not know,” Fauci said. “We are only six months into this outbreak. And we need to be a few years down the pike to determine the durability of protection against natural infection, and the durability of protection from a vaccine.”

Since the coronavirus outbreak became apparent in March, Fauci has become a prominent national figure, serving as a voice of scientific authority throughout the once-in-a-century pandemic. But he has also been subjected to searing attacks from those critical of his persistent warnings over the dangers of the outbreak.

Trump has criticised Fauci publicly, repeatedly characterizing his assessments as “wrong” and accusing him of making “a lot of mistakes.”

Fauci pushed back against those criticisms. Science, he said, requires humility and flexibility in a dynamic situation like a global pandemic. “I wouldn’t talk about failures, because I followed the science, and the science isn’t failure,” Fauci said. “I think I will be known by the fact that I have always, always spoken the truth, and have always made any kind of recommendation or decision based on the data that was available at the time that I was making the decision.”

“Science stays the same. The data changes,” he continued. “But when you’re dealing with an evolving situation, where every week and every month you learn something new, science helps you to accumulate the correct evidence and the correct data. And that’s what I do. That’s what I’ve always done, and that’s what I’ll continue to do.”

In that spirit, he offered advice to Dr. Deborah Birx, the coordinator of the White House coronavirus task force and a lifelong HIV-AIDS researcher.

Birx has come under fire from all sides in recent weeks. Long time colleagues in the public health community and critics from inside the White House have accused her of presenting overly rosy projections to Trump throughout the crisis, providing him with a sense of false optimism, while the president himself has called her “pathetic” on Twitter for describing the pandemic as extraordinarily widespread.

“My advice to her is the same advice that I give myself: Don’t get distracted by all that stuff. Just focus like a laser beam on what your job is and what your mission is,” Fauci said.

“I have been criticised a thousand times more than she has, as you well know,” he added. “At least she hasn’t had editorials written by White House staff against her.”