Companies Move to Late-Stage COVID-19 Vaccine Trials
August 21, 2020 | Coronavirus
Executives from Pfizer and Moderna say they are on track to have a COVID-19 vaccine on the shelves by the end of 2020.
With these two trials which will have about 30,000 patients each, Moderna and Pfizer established a sizable lead in the race to develop a vaccine.
Some 150 firms currently have COVID-19 vaccines in various stages of development.
AstraZeneca said it hoped to begin late-stage trials this summer, and Johnson & Johnson predicted it would reach this stage by September.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal,” admitted National Institutes of Health (NIH) Director Francis Collins. However, “it’s the right goal for the American people,” he added.
Will a Vaccine End the Pandemic?
An effective vaccine might help bring the pandemic to an earlier end.
Virus vaccines usually reduce the infection rate by about 50 percent. If such a tool is available and safe, it must be used.
Additionally, vaccines reduce symptoms.
When vaccinated patients are infected, they usually do not get as sick. That symptom reduction helps reduce the infection rate even further.
Moreover, symptom reduction is especially important among older adults, people with certain pre-existing respiratory conditions, and others for whom COVID-19 is life-threatening.
Finally, vaccines typically have a substantial placebo effect.
COVID-19 Vaccine Safety Issues
U.S. infectious disease doctor Anthony Fauci said he was “not particularly concerned” about a potential vaccine’s safety.
That’s not exactly a ringing endorsement.
Moderna has never made any sort of vaccine before, and Pfizer has never relied on the unproven synthetic messenger RNA platform.
Typically, vaccines inject a tiny amount of a virus into the body, so the body produces natural immunity.
mRNA is different. This extremely complex process alters cell DNA and moves particles to the outside of the cell. Once the revised DNA strand enters the cell’s cytoplasm, it triggers the production of certain proteins which substitute for disease antibodies.
This process has many moving parts. As a result, there are many things which can go wrong.
Some observers are concerned about the breakneck speed of this process. More on this below.
Furthermore, as a rule, altering cell DNA is a very risky proposition. That’s the way various environmental toxins, most notably asbestos, cause cancer and other serious illnesses.
In an accelerated development timeline, researchers will almost certainly not fully explore all these alternatives.
That does not mean the first patients are guinea pigs, but they are probably in that neighborhood.
Drug Maker Responsibility
Pfizer has already inked a deal with the U.S. government to sell fifty million vaccines for $2 billion.
Additionally, when Moderna announced its vaccine was entering late-stage clinical trials, its stock price increased 9 percent. So, there is an awful lot of money at stake for these two companies, and for all others racing to develop a vaccine first.
In this contest, there is no consolation prize for second place. It’s winner take all.
The Fast Track accelerated approval process is not new, and it has come under fire before.
If a new drug or device addresses an unmet need, the Food and Drug Administration significantly shortens the approval process.
Additionally, regulators usually do not focus on the new drug’s safety. Instead, they compare it to existing products.
And, if the new drug is an improvement, usually based on evidence the company provides, the FDA normally approves it.
Fast Track approval is usually reserved for cancer, coronavirus, AIDS, and other such conditions.
However, the FDA also defines illnesses like depression, epilepsy, and diabetes as “serious conditions.” Therefore, almost any new drug could qualify for Fast Track approval.
If a flawed drug or device makes it to market, the drug manufacturer is strictly liable for any resulting injuries.
In defective drug claims, a New York personal injury attorney normally partners with top experts in the field to establish a connection between the drug and the side-effect.
The bad news is that the drug company has a stable of experts who readily testify that the drug is safe.
The good news is that the burden of proof (a preponderance of the evidence, or more likely than not) is low.
The other good news is that New York’s expert witness evaluation standard is very victim-friendly.
A coronavirus vaccine might be available soon, but will it be safe for use? To have a free legal consultation with an experienced New York personal injury attorney, contact Napoli Shkolnik PLLC.
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