Company Gearing Up To Produce Millions of COVID-19 Vaccine Doses Has To Ask FDA for Special Permission
As you may have heard Monday, a potential COVID-19 vaccine developed in less than two months between the National Institutes of Health and a company called Moderna was entering into first-stage trials.
Four healthy volunteers were given the vaccine in a test which will eventually include 45 people.
“Such rapid development of a potential vaccine is unprecedented, and it was possible because researchers were able to use what they already knew about related coronaviruses that had caused other diseases outbreaks, SARS and MERS,” The New York Times reported Monday.
Indeed, Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases said it was “launched in record speed.” The fact that the vaccine has entered human trials this early is a massive breakthrough, in other words.
“Moderna uses genetic material — messenger RNA — to make vaccines, and the company has nine others in various stages of development, including several for viruses that cause respiratory illnesses. But no vaccine made with this technology has yet reached the market,” The Times reported.
Furthermore, researchers want to be sure they’re ready for the next pandemic.
“The goal here is to be ready for all the virus families that can infect humans,” Dr. Barney Graham, deputy director of the NIH’s Vaccine Research Center, said.
However, the Food and Drug Administration is holding it back — not because they have some secret reason for wanting to withhold the cure, but because they want to be sure the vaccine is safe and effective.
The timeline for the vaccine to be available, if tests are successful, is between 12 to 18 months.
According to The Times, “Moderna … is already buying new equipment so that it will able to produce millions of doses. [CEO] Stéphane Bancel acknowledged that the company was taking a risk, because neither safety nor efficacy has been proved yet.”
“Humans are suffering and time is of the essence,” Bancel said. “Every day matters. We have taken these decisions to take the risk, because we believe it is the right thing to do.”
Though the participants in the first trials will be monitored for a year, safety data will be available within weeks.
“If the vaccine then appears safe, [Bancel] said, Moderna will ask the Food and Drug Administration for permission to move ahead to the next phase of testing even before the first stage is finished.”
“The second round of testing, to measure efficacy as well as to verify safety, will include many more participants,” the outlet reported.
This is a good thing. A vaccine that comes with too many risks and not enough protection should be rejected until proven safe — even with something as deadly as coronavirus.
However, there’s a school of conservative — usually libertarian — thought that if you’ve received informed consent, have a reason to receive the vaccine and yet aren’t included in the trials, shouldn’t you be able to pay for it and receive it on your own?
If that’s the case, why not allow an informed consent program — something like a right-to-try law for people at high risk?
The idea that our doctors, health care and social workers and other front-line staff can’t access the vaccine if it could be produced seems remarkably short-sighted. If someone is immunocompromised but has to return to work, are we to say the risks outweigh the benefits? Shouldn’t that be their decision?
Do they need a paternalistic government to tell them they have to wait 12 to 18 months to fully determine whether the vaccine is safe for them?
Trying unproven vaccines, if you’re not at risk or aren’t in an essential job, is very much a gas-station grab-bag; work from home and wash your hands.
For many, however, 12-to-18 months simply won’t do. Not only will it put them at risk, but it will also put others around them at risk.
We don’t know what’s possible yet. If the vaccine seems to be safe and efficacious in early trials and it can be produced in quantity, it’s an option that should be looked at.
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