Covid Vaccine: Will you get it? - Page 12

newtoswitz · #**221** 08.12.2020, 12:33

	Quote:	bowlie
	It wouldn’t be your medical records. It will be your COVID-19 vaccination record. Certainly other vaccinations (Malaria, Yellow Fever, etc) could be added to this as many countries still require these for visitors. An ID or Passport identifies you as being you. Something separate doesn’t do that. But can anyone answer my question rather than comment on the principle. Can biometric data on ID cards or passports be edited in a secure manner?

Vaccination is a medical record.

No, the data is not defined as being writable according to the standard:

https://www.icao.int/publications/Do...10_cons_en.pdf

John William · #**222** 08.12.2020, 12:54

So Russia and the UK are the first countries to start vaccinating their people against Covid-19.

Any thoughts, frustrations or impatience on why the regulatory authorities in other countries are
taking their time doing the same with the Pfizer/BioNtech, Moderna and Astrazeneca-Oxford
vaccine approval ?

olygirl · #**223** 08.12.2020, 13:00

	Quote:	John William
	So Russia and the UK are the first countries to start vaccinating their people against Covid-19. Any thoughts, frustrations or impatience on why the regulatory authorities in other countries are taking their time doing the same with the Pfizer/BioNtech, Moderna and Astrazeneca-Oxford vaccine approval ?

I appreciate that Switzerland is doing their own research before giving approval. Perhaps it's naive, but I have faith in the Swiss authorities regarding this issue.

fatmanfilms · #**224** 08.12.2020, 13:00

	Quote:	John William
	So Russia and the UK are the first countries to start vaccinating their people against Covid-19. Any thoughts, frustrations or impatience on why the regulatory authorities in other countries are taking their time doing the same with the Pfizer/BioNtech, Moderna and Astrazeneca-Oxford vaccine approval ?

Probably because the authorities are not yet convinced they are safe. UK had madcow disease, just saying.

Susie-Q · #**225** 08.12.2020, 13:24

Well, I wouldn't ever trust Russia to stand by and do what is right for their people...or China/many other nations.

Regarding the UK, I am selfishly glad to watch from afar to see if there any significant adverse reactions. If there aren't any, I will be genuinely ticked off if Switzerland takes their time and we have to wait until the Spring/Summer.

RufusB · #**226** 08.12.2020, 13:25

	Quote:	olygirl
	I appreciate that Switzerland is doing their own research before giving approval. Perhaps it's naive, but I have faith in the Swiss authorities regarding this issue.

The MHRA know their stuff. They wouldn't have passed it if it wasn't safe.

Spaceghost · #**227** 08.12.2020, 13:39

	Quote:	Axa
	There should be a way to put the vaccine in cocaine, vaping liquids for e-cigarettes or bar cocktails......no one, no one cares about what's in there, ever

They just need to get a few dealers to cut it into coke and a good chunk of the UK population of under 30s would be vaccinated in a month.

The laughable part of being an ex-DJ is watching the amount of people I know from my DJ/clubbing days who are now staunchly against the Covid vaccine but who would bosh a pill or line of gear they obtained from literally anyone in a club.

TonyClifton · #**228** 08.12.2020, 14:31

	Quote:	EastEnders
	I think in Switzerland, abuse can't be the case, as we have a 'Impfausweis' since birth, I presume the vaccination will then be added to all the other inoculations we had. Also, people who were not vaccinated from birth, will then get a new Impfausweis, with the Covid-19 as their first and perhaps only entry. The link I ad d to this post, is just to show the photo. I still hold the old brown one and my kids have the blue one. https://www.anzeigervonsaanen.ch/comment/reply/36276

I also have one of these from Switzerland, but if I remember correctly, these are just written by hand into the booklet? I don't think this would be a very secure way of tracking the vaccine if so.

EastEnders · #**229** 08.12.2020, 14:57

	Quote:	TonyClifton
	I also have one of these from Switzerland, but if I remember correctly, these are just written by hand into the booklet? I don't think this would be a very secure way of tracking the vaccine if so.

Yes, written and stamp only that was the case in the very olden days.
Nowadays, there is also a little sticker with the number from the vial that contained the medication injected. A signature of the doctor as well as the stamp of the doctor etc.

fatmanfilms · #**230** 08.12.2020, 21:05

"Ahead of the Thursday meeting of the FDA on the Pfizer vaccine, the administration announced Tuesday that two trial participants have died after receiving the Pfizer coronavirus vaccine. One of the deceased individuals was immunocompromised.
This information was obtained from documents released on Tuesday by the FDA.
The documents were released ahead of a meeting on Thursday of outside experts who will debate whether emergency authorization for the vaccine should be granted.
The FDA also said on Tuesday that the data they're presented with is in line with emergency use authorization, raising hopes for Thursday.
At the same time, the FDA said that there currently is not enough research to guarantee the vaccine's safety for immunocompromised groups, pregnant women and children."
https://www.jpost.com/breaking-news/...vaccine-651488

RufusB · #**231** 08.12.2020, 21:09

They can never guarantee for those groups - where are they going to get the test subjects?

fatmanfilms · #**232** 08.12.2020, 21:28

	Quote:	RufusB
	They can never guarantee for those groups - where are they going to get the test subjects?

Test subjects are usually healthy without co-morbidities, I guess all the vulnerable, women who then become pregnant & children will try the vaccine soon in the UK.

MegsB · #**233** 08.12.2020, 21:37

	Quote:	fatmanfilms
	"Ahead of the Thursday meeting of the FDA on the Pfizer vaccine, the administration announced Tuesday that two trial participants have died after receiving the Pfizer coronavirus vaccine. One of the deceased individuals was immunocompromised. This information was obtained from documents released on Tuesday by the FDA. The documents were released ahead of a meeting on Thursday of outside experts who will debate whether emergency authorization for the vaccine should be granted. The FDA also said on Tuesday that the data they're presented with is in line with emergency use authorization, raising hopes for Thursday. At the same time, the FDA said that there currently is not enough research to guarantee the vaccine's safety for immunocompromised groups, pregnant women and children." https://www.jpost.com/breaking-news/...vaccine-651488

The overall tone of the article you posted (from the Jerusalem Post) was quite positive for the vaccine! I'll add more from the same article..

""The vaccine is safe for every person on an individual level and for us as a company at the national level,” wrote Gamzu on Twitter. “I am proud to receive this treatment first as part of the global technological advancement. I am convinced that leading by personal example will help gain public trust so all citizens take the vaccine for their health.”

"The association noted that in large trials of tens of thousands of people, death can occur without any connection to the trial, but that companies like Pfizer are required to report those deaths.
“According to the published data, six of the participants in the experiment died, two of whom received the vaccine and four of the control group,” said Dr. Uri Lerner, the scientific director for Midaat. “After an in-depth examination, no connection was found between the experiment and the cause of death.”

Pancakes · #**234** 08.12.2020, 22:58

This in the BBC headlines today...

Covid-19 vaccine: First person receives Pfizer jab in UK
https://www.bbc.com/news/uk-55227325

"A UK grandmother has become the first person in the world to be given the Pfizer Covid-19 jab as part of a mass vaccination programme.

Margaret Keenan, who turns 91 next week, said the injection she received at 06:31 GMT was the "best early birthday present".

It was the first of 800,000 doses of the Pfizer/BioNTech vaccine that will be dispensed in the coming weeks.

Up to four million more are expected by the end of the month."

I guess only time will tell...

BoredToDeath · #**235** 08.12.2020, 23:05

	Quote:	John William
	So Russia and the UK are the first countries to start vaccinating their people against Covid-19. Any thoughts, frustrations or impatience on why the regulatory authorities in other countries are taking their time doing the same with the Pfizer/BioNtech, Moderna and Astrazeneca-Oxford vaccine approval ?

We let UK and Russia go first to be an open label trials for the rest of the World.

ennui · #**236** 09.12.2020, 00:14

	Quote:	fatmanfilms
	Test subjects are usually healthy without co-morbidities, I guess all the vulnerable, women who then become pregnant & children will try the vaccine soon in the UK.

I thought the Phase 3 trials for moderna included some at risk participants, though perhaps just by age.

RufusB · #**237** 09.12.2020, 00:25

	Quote:	fatmanfilms
	Test subjects are usually healthy without co-morbidities, I guess all the vulnerable, women who then become pregnant & children will try the vaccine soon in the UK.

What does this even mean? Jog on. You're conflating two separate points.

Chuff · #**238** 09.12.2020, 08:09

Pfizer Phase III results have been released and analyzed... https://yourlocalepidemiologist.com/category/vaccine/

	Quote:
	Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes… Things are looking good. Well, not just good, they are looking great. This trial was as clean as it can get. There is nothing (big) we didn’t expect.

	Quote:
	• Overall, the Pfizer vaccination gives more adverse events than the flu vaccination but less than the shingles vaccine. • The most common solicited adverse reaction (i.e. what we were expecting) were mild to moderate: injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%) • The chance of getting a severe adverse event was low (0.5%). A severe event is more likely in the second dose than the first and were less frequent among older adults compared to younger participants.

	Quote:
	There are a few unknowns. From this study, we do not know… • Duration of protection • Effectiveness against transmission • Effectiveness or safety among certain high-risk populations, such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals. There were just not enough people in the study to make meaningful conclusions. This likely means that the FDA will not approve emergency use for these populations. We will know more on Thursday.

I really hope I can get it as early in 2021 as possible.

Spaceghost · #**239** 09.12.2020, 08:28

	Quote:	fatmanfilms
	At the same time, the FDA said that there currently is not enough research to guarantee the vaccine's safety for immunocompromised groups, pregnant women and children." https://www.jpost.com/breaking-news/...vaccine-651488

So pretty much the same groups who they don't recommend to get flu or most other vaccines, because they don't tend to use pregnant women as test cases ever.

This is nothing out of the ordinary at all for any new vaccine.

leonie · #**240** 09.12.2020, 08:58

FDA said that there currently is not enough research to guarantee the Pfizer vaccine's safety for immunocompromised groups, pregnant women and children — this is because most of those groups have been excluded from the trial. I found the study protocol and read the exclusion criteria, they excluded these groups by the study design.

https://pfe-pfizercom-d8-prod.s3.ama...020.pdf#page41

from exclusion criteria:
8. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
11. Women who are pregnant or breastfeeding.

Phase 2/3 age inclusion was from 12 years according to the inclusion criteria for non-EU, I guess they didn’t have enough children enrolled:
from inclusion criteria:
1. Male or female participants between the ages of 18 and 55 years, inclusive, and 65 and 85 years, inclusive (Phase 1), or ≥12 years (Phase 2/3), at randomization. Note that participants <18 years of age cannot be enrolled in the EU.

Probably more trials will be coming, for children and people with immunodeficiency.

Moderna protocol:
https://www.modernatx.com/sites/defa...col.pdf#page41