It is not an understatement to say that the hopes of the entire nation are focused on what is happening in a Maryland laboratory: first step in manufacturing a potential coronavirus vaccine.
Sean Kirk, Executive Vice President of Emergent BioSolutions, explained to correspondent Martha Teichner how a bioreactor is used to create the necessary ingredients in the development and testing of a vaccine for clinical trials that are already underway in Australia. “This is where it starts, to produce the hundreds of millions of doses,” she said.
Emergent BioSolutions is preparing now, preparing 4,000-liter tanks, to have hundreds of millions of doses ready to use if and when any of its clients – Novavax, Johnson & Johnson, Vaxart and AstraZenica – reach the finish line in the race to a vaccine.
Teichner asked, “What happens to all those vaccines you are preparing to have ready the first day after approval, if it doesn’t come?”
“Yes, the federal government made it clear that they are willing to invest a substantial amount of money,” Kirk replied.
That’s $ 628 million just for Emergent to manufacture them anyway, before approval, whether they succeed or fail. “If they are considered ultimately unusable, then it is very possible that they could be discarded,” Kirk said.
President Donald Trump announced Operation Warp Speed May 15. “Their goal is to finish developing, and then manufacture and distribute, a proven coronavirus vaccine as quickly as possible,” he said. “Once again, we’d love to see if we could do it before the end of the year.”
To try to achieve that goal, the federal government has already invested more than $ 2 billion in what it is betting is the most likely to win FDA approval the fastest, of more than 120 under development. The pharmaceutical industry heavyweights are behind some of the top candidates: Pfizer, Johnson & Johnson, Merck, AstraZenica. Not so well known, modern biotech company touted promising early results for its vaccine, which uses an unconventional new approach to create immunity.
“We are desperate for a vaccine,” said Dr. Paul Offit, a member of the panel at the National Institutes of Health that oversees the accelerated development of a COVID vaccine. “As a consequence, we are looking for any kind of news that may be good. But I think what we should exercise here is humility.”
Dr. Offit fears what he calls “an October surprise,” and is co-author of an op-ed in The New York Times: “Could Trump turn a vaccine into a campaign stunt?”
“I am concerned that as we move into September and October and then on Election Day, there is pressure to get a vaccine, even if it hasn’t been tested the way it should be, which is a great phase 3 trial “, said.
What that means is giving a vaccine to at least 20,000 people, with another 10,000 receiving a placebo, and then waiting … to see who gets a disease and who doesn’t.
Those trials usually last for years, not months. It took Offit more than a quarter century to get his own rotavirus vaccine, which kills half a million babies and young children each year worldwide, more than the total number of deaths from coronavirus.
Teichner said: “People are frantic. They almost panic about living in a world until there is a vaccine. How do you handle public pressure to hurry up and reach the goal?”
“Hopefully, there will be an understanding that in order for us to prove that a vaccine is safe and effective, it needs to go through this process,” said Dr. Offit. “I go back to the days of polio. We hope, despite the fact that every year in this country as many as 30,000 children will contract polio and become permanently paralyzed or end up in iron lungs, and 1,500 died. And if you think the terror of that was different from the terror of this, you are wrong. So we could even wait then, and we can wait now. “
Abie Rohrig believes that he and others of his generation can help speed up the process. “By doing this, there is a very real and immediate possibility that a vaccine could be developed sooner,” he said. “Lives will be saved.”
Teichner asked, “Even if the cost becomes very, very sick, or even dies?”
“Yes. That cost is real.”
Rohrig is 20 years old, a university student, and a member of 1 Day Sooner, an organization that calls for controversial human challenge trials, in which healthy young volunteers between the ages of 18 and 25 would test vaccines when exposed to the virus. deliberately, without waiting. So far, more than 25,000 people worldwide say they would.
Rohrig said: “I have some history of taking this kind of calculated medical risk, because I donated my kidney last summer. And so I see this as a very similar situation. I am very willing to take this risk, because I know that COVID-19 is devastating the world. This is, I think, basically World War II of my generation. “
But with COVID, there are ethical and security issues. According to Dr. Nadine Rouphael, associate professor of medicine at Emory University, “We have multiple cases of many diseases, such as the flu, dengue, cholera, malaria, typhoid, where those human challenges have been shown to they were really able to better understand the infection, but also try therapeutics and vaccines. ”
Dr. Rouphael has worked on four human challenge trials, beginning with the decision of which virus strain to use and how large a dose to administer.
She noted: “For the human challenge of coronavirus, we don’t have a strain; we don’t have a dose. We also don’t have a good drug against COVID.”
Teichner asked, “Do diseases or viruses that have human challenge tests usually have rescue medications?”
“Normally they do,” he said. And without rescue therapy for the coronavirus, the risk escalates. He said it would take 3-6 months just to establish challenge tests in humans. But she is in favor of moving on.
Teichner asked, “Is he brave or crazy?”
“If done the right way, it really is a service to society,” replied Dr. Rouphael.
“So are you leaning towards the brave?”
“I guess so.”
For COVID vaccines, human challenge trials are still in the discussion phase, while several of the top candidates are expected to start phase 3 trials next month.
At a House Energy and Commerce Committee hearing last week on the administration’s response to the pandemic, Dr. Anthony Fauci said: “I still believe there is a reasonably good chance that by the start of 2021, if we are going to have a vaccine, we will have it by then. ”
Despite Dr. Fauci’s optimism, will that first shot allow us to remove our masks and feel safe? Will it keep us from getting COVID-19, or just getting sick or dying?
“We have to make sure that people know that it is likely to protect against moderate to severe disease, but that it may not be a mild disease associated with re-exposure,” said Dr. Offit. “So I think we need to manage expectations.”
He predicts that the first to cross the finish line may not be the final winner: “You don’t want it to be the first shot. You want it to be the best vaccine, “he said.
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Story produced by Mark Hudspeth. Publisher: Ed Givnish.
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