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Anges starts Japan's 1st COVID-19 vaccine clinical trial on humans

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I am not confident on this specific candidate to be successful, DNA vaccines have not yet proven to be effective in humans even after years of being tried because the plasmid DNA does not efficiently enter the cells by itself so most is degraded without ever being converted into proteins for the immune system to recognize.

The important part is that finally Japan joined the rest of the developed world and began doing clinical trials for new therapies using nucleic acids, as long as this vaccine candidate is safe for human use that still means a huge advancement for the country. Maybe in the near future more complicated delivery systems (and not just the "naked" DNA) can be tried and Japan can become again a country that can develop cures and treatments without having to depend always on discoveries from overseas.

8 ( +10 / -2 )

It's positive news but I think they need to take drastic action to speed things up. If a vaccine only becomes widely available by the fall of next year, it might be a bit late for many people. Worldwide, numbers are roughly doubling every month, and will probably be in the hundreds of millions by next year.

-4 ( +1 / -5 )

Geronimo, how do you accurately predict the long-term effects in humans, both potentially positive and negative, in a 'sped-up' few months' trial?

7 ( +7 / -0 )

Don't understand the protocol. Were participants screened for pre-existing conditions? Ethics of doing so aside, unless the subjects are all isolated, exposed to the virus in some uniform way after receiving the vaccine, and monitored to see how many fall ill, and how ill they become, how are the researchers going to determine the level of effectiveness, or lack thereof, of the two treatments? Otherwise, they could claim that because nobody got sick, it's 100% effective. Another article that raises more questions than it answers.

Clinical trials have specific phases which cannot be skipped. The first one examines if the vaccine is safe in a small number of healthy, normal individuals, the trials do not expect any of them to get infected and will only check if any unexpected side effect appears. Depending on the trial it can also assess the production of antibodies that can neutralize the virus but that is not the same as saying that they are protected.

A brief description of the phases from the CDC:

Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.

2 ( +2 / -0 )

One has to be insane to want to be a guinea pig for especially a DNA vaccine. Who are these healthy individuals.? Are they inmates or some day labourers in nishi nari ward?

-2 ( +1 / -3 )

One has to be insane to want to be a guinea pig for especially a DNA vaccine. Who are these healthy individuals.? Are they inmates or some day labourers in nishi nari ward?

Of course not, just people not dominated by irrational fears that wish to help, the science is solid, a huge lot of data is available from animal experiments and from human trials in other countries that prove that properly designed DNA vaccines do not carry any significant risk. Statistically it can be proved that the clinical trial is not more risky than the possibility of catching COVID-19, logical rational people can understand that. Just a tiny bit of interest in helping controlling the pandemic is all that is needed for those people to volunteer.

Is for example more risky to be a nurse or a doctor, even without any pandemic active, but lots of people do it without being forced.

1 ( +1 / -0 )

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