The approach itself is not unreasonable, said Dr. Peter Hotez, dean of the National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine. But the way it’s being communicated is scaring people, he told CNN.
“The way the message is coming out of Operation Warp Speed creates a lot of chaos and confusion. And it is enabling the anti-vaccine movement,” Hotez said.
A White House coronavirus task force source told CNN earlier this week that the Trump Administration’s Warp Speed program had chosen five companies mostly likely to produce a Covid-19 vaccine — whittled down from 14 last month when “Operation Warp Speed” was launched.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says he expects up to 100,000 doses of one vaccine, made by biotech company Moderna, to be available by the end of the year, ready to be rolled out if it is shown to work safely to protect people against coronavirus infection in clinical trials that are now under way.
He has said one of the candidates could be ready as early as January. That is a highly accelerated schedule, as vaccines typically take years to produce.
“The way they are messaging it is a little frightening because they make a point of saying how quickly it is being done,” said Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. “It makes people think there are steps being skipped.”
Hotez and Offit should know. They have both spent years fighting an organized anti-vaccination effort, and trying to educate people who have doubts and fears about vaccines. Both have written books about vaccine safety. Hotez wrote “Vaccines Did Not Cause Rachel’s Autism,” about his daughter, and Offit has written several books, including “Deadly Choices: How the Anti-Vaccine Movement Threatens Us All.”
“What does the anti-vaccine lobby allege?” Hotez asked. “They say we rush vaccines, that we don’t adequately test them for safety, and that there is this conspiratorial relationship between Big Pharma and the government.”
Lorence Kim, Moderna’s chief financial officer, exercised 241,000 options for $3 million, filings show. He then immediately sold them for $19.8 million, creating a profit of $16.8 million.
The next day, Tal Zaks, Moderna’s chief medical officer, spent $1.5 million to exercise options. He immediately sold the shares for $9.77 million, triggering a profit of $8.2 million.
It was all legal, but looked bad, Hotez said.
“They are shooting themselves in the foot,” he said.
Offit worries that companies and the federal government may actually be tempted to skip safety steps in the rush to protect people from coronavirus. That wouldn’t make the vaccine skeptics right, but it could be dangerous and further erode credibility.
“You have a president who said hydroxychloroquine was going to work. He said, ‘I heard really good things about it and how could it hurt,’ ” Offit said. “None of that was right. First, it didn’t work, and second, it did hurt. It has cardiac toxicity.”
Offit worries something even more damaging could happen with a vaccine. Currently the federal government is helping develop both vaccines and drugs to fight coronavirus.
“Do I think this administration has the capacity to perturb the process?” asked Offit. “Yes, I do.”
So far, Offit sees nothing that has gone wrong with any of the vaccines in development. He doesn’t see any indication that safety is being sacrificed.
But it’s clear to him why the administration would choose five vaccines to focus on.
“It’s because they are the fastest to make,” Offit said. All use biotechnology approaches to make vaccines using genetic sequences, as opposed to the tried-and true but slow approach of using a whole virus that has been either weakened or killed.
“As long as the phase 3 trials are done and respected, I think the speed we are witnessing will be fine,” Offit said. But the phase 3 trials, one of which is penciled in to be done in 30,000 volunteers later this year, must be taken to the end to ensure that any rare side effects from vaccination will become visible.
“That is the part that cannot be skipped,” Offit said.