Dr. Steven Zeichner warns about the dangers of rushing out a vaccine
CHARLOTTESVILLE-When will it be ready? That’s the big question when it comes to a COVID-19 vaccine. Everyone seemingly has an opinion about when it should or will be available. As of Sept. 25, there were 57 vaccines in some form of testing, with 42 beginning clinical trials.
While there are many hurdles to consider in creating a safe vaccine, an additional burden has been the race’s politics. President Trump said a vaccine would possibly be ready in October or at least before the election. Other Republican members of Congress have doubled down on that. However, some of the researchers see things differently.
“I think the October projection is unrealistic,” said Dr. Steven Zeichner, an infectious diseases specialist at the University of Virginia. Zeichner is part of the university’s team working on a potential COVID-19 vaccine. “The thing about vaccines is first you need to check for safety and second, you need to test for efficacy. A vaccine that protects you from a virus, but causes a lot of side effects, is nothing to be happy about.”
That’s what researchers at AstraZeneca found out. American trials on the company’s COVID-19 vaccine were put on hold this month, after multiple volunteer test subjects started developing a variety of illnesses. The company’s test subject recruitment form said “volunteers in the trials developed unexplained neurological symptoms including changed sensation or limb weakness.”
After that, the company suspended trials across the world. In order to start them back up in Europe, the EU agreed to give AstraZeneca partial immunity against claims related to side effects. Under the deal, EU governments would share the compensation costs if unexpected side effects develop after the vaccine’s approval.
You Need Time to Study Side Effects
The potential for side effects is why a vaccine can’t be rushed out, Zeichner said. This isn’t like taking an antibiotic. In that case, if you have a bad reaction, just stop taking the pills. You can’t stop a vaccine.
“With vaccines, the entire goal is to essentially make a permanent change in the immune system, and because it is a permanent change, you want to be extra careful that it is not a harmful change,” he explained.
The problem right now, Zeichner said, is that groups are trying to push through a vaccine by combining phases. Vaccines go through four steps before being submitted for approval. The first involves testing with animals. The second is a small study with people, to record responses. This is where the AstraZeneca vaccine is at. The third step involves a larger group of test subjects and the fourth is mass testing, where you see if the vaccine actually works. By combining steps, it’s easy to make a mistake.
“Some people are going to have a bad reaction,” Zeichner said. “Now if that was one in one hundred million people, that is probably acceptable, but one in 100, that is not acceptable. We have to understand that with everything, there are risk and risk benefits, and nothing is risk-free.”
And you have to weigh those risks against the current situation. The Virginia Health Department just reported the first teenage death as a result of the virus. The overall death toll also keeps climbing in the Commonwealth.
Why Should People Have to Die?
Zeichner also disagrees with the ‘herd immunity’ concept being pitched. In that argument, people encourage others to go out and get infected. Once enough people recover from COVID-19 and build up their immunity, the ‘herd’ concept argues the entire community would then be protected, as the illness would have fewer potential hosts. The problem, Zeichner said, is that the price of such a plan is too high.
“Sweden pursued a policy of herd immunity and they had infection rates and death rates 10 times that of its neighbor Norway,” Zeichner said. “To think that [way], to obtain herd immunity, we’d be willing to have a death rate and infection rate 10 times higher than needed. I find that irresponsible and ethically unacceptable.”
Sweden’s seen 90,923 cases and 5,580 deaths. Norway on the other hand practiced quarantine and isolation. It’s had a total of 13,660 cases and 270 deaths. By comparison, the United States has recorded 7.14 million cases in the same timeframe, with 205,000 deaths as of Sept. 27. This is first in the world, with India coming up second at 5.99 million cases and 94,503 deaths.
Also unacceptable to Zeichner is the money issue he believes will soon pop up.
“The prices for the vaccines that are in advanced stages of development will probably cost in the order of $100 to $200,” Zeichner explains. “That would obviously be way too much for much of the world.”
As part of the partial immunity deal with AstraZeneca, the EU already paid the company a non-refundable first payment of 336 million euros. That payment covers 400 million doses of the vaccine. Then they turned around and gave the Sanofi company 324 million euros, in exchange for 300 doses of its product.
You Only Get One Chance to Release
It’s important to make sure the vaccine is safe before introducing it, Zeichner said. You very rarely get a chance to pull something back once it’s been released. A look back in history shows that there are some cases of vaccine recalls because of safety concerns. According to the Center for Disease Control, an example of a recall was in 1998. The US Federal Drug Administration approved the RotaShield vaccine. Some infants developed intussusception after taking it. The CDC immediately suspended the use of the vaccine and quickly started two emergency investigations.
However, recalls of that nature are rare, and the FDA monitors vaccine creation. The agency has certain restrictions in place to stop any harmful vaccine from coming on the market too soon. They can be overridden, however. In a recent press conference, President Trump said the White House might override the FDA if the agency released stricter standards that slowed the authorization of a Covid-19 vaccine.
Politics aside, he does not believe any vaccine will be ready for the public before 2021. Even that would be somewhat of a record. Currently the quickest step from vaccine development to approval took four years and that was with the mumps. While things have greatly changed since the 1960s when that happened, Zeichner wants to be clear that it’s still a lengthy process.
When asked how to convince others to take the vaccine when it is ready, Zeichner says that others can use empathy and understanding to lead by example.
“We live in a world that has become so safe, and we don’t see the consequences of the diseases that the vaccines are designed to prevent, so we lose sight of how bad it can be,” he said.
Erica Turman is a freelance reporter for Dogwood. You can reach her at [email protected].