[Murf993]

Not posting this to create a political debate but for information as the entire Covid pandemic has impacted everyone significantly. I post this for information as things unfold.

https://www.theglobeandmail.com/worl...fizer-vaccine/

Britain warns people with serious allergies to avoid Pfizer vaccine after two adverse reactions
ALISTAIR SMOUT
LONDON
REUTERS
PUBLISHED DECEMBER 9, 2020
UPDATED 8 MINUTES AGO

FRANK AUGSTEIN/THE ASSOCIATED PRESS
Britain’s medicine regulator has advised that people with a history of significant allergies do not get Pfizer-BioNTech’s COVID-19 vaccine after two people reported severe adverse reactions on the first day of rollout.

Starting with the elderly and front line workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history.

National Health Service medical director Stephen Powis said the advice had been changed after two NHS workers reported anaphylactoid reactions associated with receiving the vaccine.

“As is common with new vaccines the MHRA (regulator) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination, after two people with a history of significant allergic reactions responded adversely yesterday,” Powis said.

“Both are recovering well.”

The MHRA said it would seek further information, and Pfizer and BioNTech said they were supporting the MHRA’s investigation.

Last week Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.

“Last evening, we were looking at two case reports of allergic reactions. We know from the very extensive clinical trials that this wasn’t a feature,” MHRA Chief Executive June Raine told lawmakers.

ALLERGIC REACTION
Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.

The new MHRA guidance, sent out to health professionals, said a much broader segment should not take the vaccine.

“Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenalin autoinjector) should not receive the Pfizer BioNtech vaccine,” it said.

It also said resuscitation facilities should be available for all vaccinations.

In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.

The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, Professor of Experimental Medicine at Imperial College London, said was a very small number.

“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.

[Murf993]

https://www.jpost.com/breaking-news/...vaccine-651488

First Pfizer coronavirus vaccines expected to land on Wednesday

FDA announces deaths of two Pfizer vaccine trial participants • Vaccines expected to arrive in Israel Wednesday

...

Ahead of the FDA’s Thursday meeting on the Pfizer vaccine, the administration announced Tuesday that two trial participants had died after receiving it. One of the deceased individuals was immunocompromised, meaning the person’s immune defenses were low.

The information was obtained from documents released by the FDA on Tuesday.

The documents were released ahead of a meeting on Thursday of external experts who will debate whether emergency authorization for the vaccine should be granted.

The FDA also said on Tuesday that the data they receive are in line with emergency use authorization, raising hopes for authorization on Thursday.

At the same time, the FDA said that currently there is not enough research to guarantee the vaccine’s safety for immunocompromized groups, pregnant women and children.

...

[Gossypiboma]

Originally Posted by Murf993

https://www.theglobeandmail.com/worl...fizer-vaccine/

So Pfizer explicitly stated do not give the vaccine to patients with known severe allergic reactions to medications or food. The UK gave the vaccine to at least two people that fall into that category which resulted in an allergic reaction.

No surprise.

[fiveohwblow]

Originally Posted by Murf993

https://www.jpost.com/breaking-news/...vaccine-651488

If I am reading this correctly, the vaccine presents the same level of challenge/danger to folks who are already at substantial risk. I believe this still poses more questions than answers for those deemed "less" at risk. hmmmmm

[fiveohwblow]

https://www.statnews.com/2020/11/12/...s-complicated/

“If you received the placebo, you may be offered the study vaccine at no cost if and when the study vaccine has been shown to be safe and that it works, but it is possible that this may not occur until 2 years after vaccination,” the J&J document reads. “This will be determined after consultation with the national health authorities in your country.”

The study completion date for AstraZeneca is years out with the primary completion date of March 2021.

https://clinicaltrials.gov/ct2/show/NCT04516746

[UncleWede]

Wait, I thought safety tests had already been conducted????

I am EXTREMELY allergic to needles. Makes being type 1 diabetic a challenge.

[wdb]

Originally Posted by Gossypiboma

So Pfizer explicitly stated do not give the vaccine to patients with known severe allergic reactions to medications or food. The UK gave the vaccine to at least two people that fall into that category which resulted in an allergic reaction.

No surprise.

Could have happened with the administering agency's knowledge. They depend on the recpient being honest and forthcoming with their medical situation and history.

[Gossypiboma]

Originally Posted by fiveohwblow

https://www.statnews.com/2020/11/12/...s-complicated/



The study completion date for AstraZeneca is years out with the primary completion date of March 2021.

https://clinicaltrials.gov/ct2/show/NCT04516746

Thats simply how large clinical trials work. Initially there is a scheduled end date for the trial, but if the therapy being investigated proves to be a success before the end date there is no reason to continue the trial. That would be unethical to know that the vaccine works but continue to give patients a placebo for an additional year.

[Mason Hatcher]

Originally Posted by fiveohwblow

If I am reading this correctly, the vaccine presents the same level of challenge/danger to folks who are already at substantial risk. I believe this still poses more questions than answers for those deemed "less" at risk. hmmmmm

Already at substantial risk for what?

[KennyFSU]

So I took the Covid-19 vaccine.
I wasn’t allowed to say anything until today, but it's now okay for me to share that I have volunteered for the Covid-19 vaccine from Pfizer. The vaccine is the one that has been developed in Russia. It is in 6 different stages and I received my first dose this morning at 06:20 am, and I wanted to let you all know that it is safe and I’m ok, with иo side effects whatsoeveя, and that I feelshκι я чувю себя немного стрно и я думю, что вытл осные уши. чувству себя немго страо. Comrade.

[Tambohamilton]

Originally Posted by Gossypiboma

So Pfizer explicitly stated do not give the vaccine to patients with known severe allergic reactions to medications or food. The UK gave the vaccine to at least two people that fall into that category which resulted in an allergic reaction.

No surprise.

No. Pfizer excluded those with potential allergy risks from their late trials, in order to get approval faster. This was in line with the MHRA's emergency guidelines.

[TboneS54]

A vaccine for a "cold" with a 99.9% survival rate.

SMH

Billions more of our money gone again...

[Tambohamilton]

Tell that to the families and friends of the 0.1%...

[Murf993]

Originally Posted by Tambohamilton

Tell that to the families and friends of the 0.1%...

I think the issue here for many folks is the terrible response by just about every government on the planet. How many have died because of the lockdowns. People aren't getting access to proper medical treatment while many hospitals sit empty waiting for "the crush" of COVID patients, suicides, lost businesses, jobs and homes. The crippling effect this will have on the economy for decades and likely generations. So, to be clear. I'm not an anti-vaxer but I have lost all faith in government over their handling of this "pandemic" and I'm clearly not the only one. So when you see that there are already some issues with folks who have received the vaccine and then there is the "emergency" roll out and likely less rigorous study.....I have question.

[fiveohwblow]

Originally Posted by Tambohamilton

Tell that to the families and friends of the 0.1%...

Quite a bit of consternation for what could literally be considered the best of margins in a stats world. I value every life, but won't throw 99 away to save 1. You sir, are clearly the opposite.

So, I'll tell "that" to the 1. You face the 99 you care not about.

[wdb]

Sigh. I guess BMW owners are incapable of conducting objective discussion.