The Phase 2 for Medigen was over 4000 volunteers
Awwhh lawwwwd help me.
Phase 2 testing only proves safety not efficacy (how well the vaccine protects against the virus).
Well, thats where we are
- 4000 is actually a small, not a big number for a vaccine given to a whole population
- As you can see in the above graphic in my previous message, phase 3 is not just phase 2 with more people, but has different objectives and therefore is also differently set up and structured
Iâm curious what they need to inspect, actually.
I assume that Moderna QCâs each batch they produce according to whatever specifications theyâve established during development, and Iâm not sure what analytical stuff could be done on the Taiwanese end that hasnât already been done. I also thought theyâd already received samples for exactly this purpose.
Theyâre not just sticking labels in Chinese on the back of each vial, are they? (Like imported food products etc.)
Donât forget using a marker to black out the âorganicâ label because itâs not organic by Taiwanâs standards.
I also believe phase I and phase II give us some idea of the safety and efficacy. If thatâs what we have to run with while phase III trial builds outâŚThatâs what we run with. Even if itâs just 60% efficacy flu shot level thatâs still pretty good and will tide us over.
Taiwan has a number of experienced vaccine manufacturers so itâs not like the expertise isnât here itâs just the timelines are so crazily short for this one.
I think, and again this is hindsight it would have been better to license AZ and manufacture here but rememberâŚTaiwanese werenât even going to accept a jab of AZ a month ago !
So we have to remember that the people here are just as much responsible as the government for this situation. The medical community were NOT taking the AZ jab.
And theyâre going to accept a jab that hasnât gone through a Phase III trial to prove that it actually works and that I would imagine might not be among the vaccines that countries accept for travel until it does so?
Needs must.
Thank you. Yeah the people not taking AZ was dumb. I mean maybe for the young there was some minute risk but the older generation should have taken it.
To be honest, I would not be surprised if the uptake is lower than people here think it will be.
Maybe initially but it should be sorted out once phase 3 finishes.
And what if it proves to not be so effective, especially against variants of concern?
Then Chen and this whole administration have dug their own graves, if they havenât already.
If that happens the only solution would be to take some other vaccines.
If the government is smart theyâll be over ordering from JandJ, Moderna, AZ all that lot for next year.
You know what they should have done last year instead of focusing on local manufacturers so much .
I think they already have TBH. Even under the most favorable scenario, thereâs going to be a lot of damage before enough people have been vaccinated with Moderna and the domestic vaccines.
Not to mention the embarrassment of the whole thing on the world stage. Weâve gone from âTaiwan can helpâ to âHELP TAIWAN!!!â in less than a month.
Between this situation, the geopolitical stuff and drought, I expect Western nations to invest heavily in their own supply chains (for semiconductors especially) even as they continue to work with TW.
TW is like the friendly guy at the company who you need right now but you know that you have to make contingencies because you canât rely on him long term.
According to the report linked below, it seems to be tied up with establishing an SOP on how to handle this product:
[Wu Shou-mei (ĺłç§ć˘ ), director-general at the Taiwan Food and Drug Administration (FDA)] said that inspection and re-sealing of vaccine packaging normally takes 40 days, but due to the pandemic, the process [for the incoming Moderna vaccines] will be shortened to 14 days. She pointed out that while AstraZeneca is an adenovirus vector vaccine, Moderna is quite different in that it is an mRNA vaccine.
Therefore, the FDA needs to have samples of the product ahead of time to set up a standard operating procedure for handling it, said Wu.
Source (helpfully linked above by @qwert_zuiop): 150,000 Moderna doses to arrive in Taiwan tomorrow | Taiwan News | 2021-05-27 19:33:00
Guy
More red tape for the sake of red tape. At least they âshortenedâ it from 40 days (wtf?) to 14.
European Commission president Ursula von der Leyen said the European Union had authorized the export to Japan of more than 100 million vaccine doses, enough to inoculate about 40% of the population.
I hope they will also consider sending some to Taiwan.