Vaccine Megathread No 2 - Read OP before posting

tfeldi

I see that other countries are publishing incidence rates for vaccinated vs. unvaccinated. Example Austria: They have introduced a lockdown for the unvaccinated. The reason given is that the incidence rate for the unvaccinated is 1700 vs. less than 400 (and slightly falling) for vaccinated for the age group of 18 - 59 year olds. Irrespective of the question if a lockdown for the unvaccinated makes sense or not, I think these numbers are quite powerful. Why is this not being tracked / published here?

Red Silurian

https://www.boards.ie/discussion/comment/118169456#Comment_118169456

Austria have also introduced vaccines for 5-11 year olds... Fair play to them, somebody had to stick the middle finger to the EMA's ridiculously slow approval process

Lumen

https://www.boards.ie/discussion/comment/118169731#Comment_118169731

That's an extremely weird decision, given that they have one of the lowest adult take-ups in Europe.

floorpie

https://www.boards.ie/discussion/comment/118169731#Comment_118169731

This will almost certainly come back to haunt them and is a ridiculous decision.

Safety data for 5-11 year olds was published literally only 5 days ago and is not promising. E.g. from Pfizer: Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age | NEJM

"Adverse events from the first dose through 1 month after the second dose were reported by 43.8% of participants who received two 10-μg doses of BNT162b2"

...

"Frequencies of fatigue, headache, and chills were similar among BNT162b2 and placebo recipients after the first dose and were more frequent among BNT162b2 recipients than among placebo recipients after the second dose. In general, systemic events were reported more often after the second dose of BNT162b2 than after the first dose. Fever occurred in 8.3% of BNT162b2 recipients after the first or second dose. Use of an antipyretic among BNT162b2 recipients was more frequent after the second dose than after the first dose. One BNT162b2 recipient had a temperature of 40.0°C (104°F) 2 days after the second dose; antipyretics were used, and the fever resolved the next day."

...

"This study was also not powered to detect potential rare side effects of BNT162b2 in 5-to-11-year-olds. However, the safety of BNT162b2 observed in the study combined with widespread use of BNT162b2 in older populations should provide reassurance."

odyssey06

https://www.boards.ie/discussion/comment/118170084#Comment_118170084

"However, the safety of BNT162b2 observed in the study combined with widespread use of BNT162b2 in older populations should provide reassurance."

Nothing there suggesting unsafe for kids, just a temporary feeling of being unwell which paracetamol helps with and then resolves... your headline is fake news compared to the details.

is_that_so

https://www.boards.ie/discussion/comment/118169731#Comment_118169731

It looks like an attempt to get a higher overall vaccination rate but seems to presume that parents will consent do so. We know from our 12-15 year olds that may not happen.

floorpie

https://www.boards.ie/discussion/comment/118170121#Comment_118170121

"However, the safety of BNT162b2 observed in the study combined with widespread use of BNT162b2 in older populations should provide reassurance."

You realise I posted that quote yes? Do you understand the context of the quote, which I also posted?

The safety study they undertake is NOT sufficiently powered to detect rare side effects. Their "reassurance" is based on studies with other populations, and is NOT a finding from this safety trial. I posted this quote because it's a very bad attribute of this trial.

By the way, a 2 day fever of 40 degrees is no joke, and is classed as a serious adverse outcome in the study.

Like I said, this decision will almost certainly come back to haunt them.

odyssey06

https://www.boards.ie/discussion/comment/118170236#Comment_118170236

The quote states "The safety of BNT162b2 observed in the study"

This is the conclusion of the report you linked to:

A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age... The data reported herein support vaccination of 5-to-11-year-old children with two 10-μg doses of the BNT162b2 vaccine.

It's the report you picked, and that's what it states. Important to call that out because it contradicts the spin you wrapped around it.

floorpie

https://www.boards.ie/discussion/comment/118170294#Comment_118170294

the spin you wrapped around it.

What you're doing here is ignoring the actual content of the trial, and instead posting lines from the conclusion. That is spin.

I posted their safety findings and I've read the report and data supplements in detail. Do you believe that a serious adverse outcome in 1% of participants, in a study not designed to catch such signals, for a population who are almost entirely unaffected by covid, is safe?

Is your belief that it's safe entirely based on a line in a conclusion that says "it's found to be safe"?

It's the report you picked

This is the safety/efficacy trial publication from Pfizer, not just an arbitrary report that I chose.

odyssey06

https://www.boards.ie/discussion/comment/118170315#Comment_118170315

Where in the report does it state it was not designed to detect serious adverse outcomes.

"In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted."

Within the limits of the trial conducted the vaccine was found to be safe, or to put it another way, within the limits of the trial conducted no safety issues were detected. So no, I don't know if it's safe, but I see nothing in this to indicate it is unsafe.

The spin you are putting on the report is your own, and should be declared as such and is not supported by the report and is in fact contradicted by its conclusion.

floorpie

https://www.boards.ie/discussion/comment/118170370#Comment_118170370

Where in the report does it state it was not designed to detect serious adverse outcomes.

"This study was also not powered to detect potential rare side effects of BNT162b2 in 5-to-11-year-olds."

To my reading, the protocol (in the supplements) lists the "rare side effects" as myocarditis, pericarditis, and anaphylaxis. In the adult trial these were catagorised under serious adverse outcomes rather than "rare side effects".

The spin you are putting on the report is your own, and should be declared as such and is not supported by the report and is in fact contradicted by its conclusion.

I've pasted a paragraph from the safety section verbatim. If you believe that something is safe enough, when we're told 1% of the child population had a serious adverse outcome, entirely because a conclusion says "it's safe", then that's up to you.

odyssey06

https://www.boards.ie/discussion/comment/118170493#Comment_118170493

Where is your source for 1% of the child population having a serious adverse outcome?

And nowhere in the report does it state it was not designed to detect serious adverse outcomes. That was your claim, and it is untrue. It did look for serious adverse outcomes within the parameters of the trial and it did look for adverse events such as myocarditis. Because of its parameters it was not designed to detect rare events - whether serious or not. If myocarditis was rare its' size may mean it would not detect it, but it was looking for serious adverse events.

Severe adverse events were reported in 0.1% of BNT162b2 recipients and 0.1% of placebo recipients. Three serious adverse events in two participants were reported by the cutoff date; all three (postinjury abdominal pain and pancreatitis in a placebo recipient and arm fracture in a BNT162b2 recipient) were considered to be unrelated to the vaccine or placebo. No deaths or adverse events leading to withdrawal were reported... No vaccine-related serious adverse events were noted.

Data on unsolicited adverse events, including confirmed diagnoses of myocarditis or pericarditis, were collected from the first dose through 1 month after the second dose... Neither myocarditis nor pericarditis was observed.

floorpie

https://www.boards.ie/discussion/comment/118170600#Comment_118170600

Where is your source for 1% of the child population having a serious adverse outcome?

My fault, I was off by a power of 10, I meant 0.1%. Regardless, the risk of ICU for children in this cohort is approximately 1 in a million, and the risk of severe outcomes from this trial is 1 in 1000. That's not good.

It did look for serious adverse outcomes within the parameters of the trial and it did look for adverse events such as myocarditis. Because of its parameters it was not designed to detect rare events - whether serious or not. If myocarditis was rare its' size may mean it would not detect it, but it was looking for serious adverse events.

Of course it's looking for serious adverse outcomes, however they tell you it isn't sufficiently powered to detect rare side effects including myocarditis.

No vaccine-related serious adverse events were noted.

This sentence in the intro doesn't make sense because they do report a vaccine-related serious adverse outcome, phase 2-3 safety:

And the protocol, which classes such a fever as a serious adverse outcome:

floorpie

https://www.boards.ie/discussion/comment/118170695#Comment_118170695

Oh wait I see. A fever is classed as a severe outcome if it's >40, not >=40. That child only had a fever of 40.00, so it's not severe.

odyssey06

https://www.boards.ie/discussion/comment/118170695#Comment_118170695

0.1% was also the same outcome observed in the placebo group.

Severe adverse events were reported in 0.1% of BNT162b2 recipients and 0.1% of placebo recipients.

The fever was not a serious adverse event (as per Appendix 3 of the Protocol), and did not meet the stopping rule criteria for duration as it resolved itself within 24 hours when treated with antipyretics  (e.g. paracetamol).

So your claims about the report have shown to be untrue e.g. that the study was not design to catch serious adverse events or that 1% of children getting the vaccine in the trial experienced serious adverse outcomes. I think it's pretty clear and obvious any claims made by you about this report cannot be trusted and are likely to be untrue.

Within the parameters of the trial, it has not found any safety issues with the vaccine dose for children of this age group, completely contrary to the 'spin' you attempt to surround it with.

No vaccine-related serious adverse events were noted.

floorpie

https://www.boards.ie/discussion/comment/118170801#Comment_118170801

The fever was not a serious adverse event (as per Appendix 3 of the Protocol), and did not meet the stopping rule criteria for duration as it resolved itself within 24 hours when treated with antipyretics (e.g. paracetamol).

The stopping rule duration isn't resolution within 24 hours after treatment, it's that they have a >40.0 fever for >=1 day after vaccination, and to my reading that child had a fever that was resolved 3 days after their second dose, albeit it was 40.0. If it was 40.01 it'd be classed as serious.

So your claims about the report have shown to be untrue e.g. that the study was not design to catch serious adverse events 

It wasn't sufficiently powered to catch signals from rare side effects. What rare side effects does it mean?

ceegee

https://www.boards.ie/discussion/comment/118170936#Comment_118170936

The rare side effects it means are those that generally occur at rates lower than the size of the study.

Ie if you study 1000 children, and don't detect any occurrences of a side effect that generally occurs in 1 in a million people, you can't determine if the absence of that side effect is due to (a) it not happening to children, or (b) coincidence due to the size of the group relative to likelihood of side effect.

floorpie

https://www.boards.ie/discussion/comment/118171013#Comment_118171013

Ah I get that but I mean what ones specifically. E.g. the adult trial talks about Bell's Palsy. The sample size in this trial is tiny so it'd be useful to know what side effects or outcomes it is unable to detect in comparison to the adult trial.

Cmor123

Hi all. Would I be correct in saying that someone who has received Covaxin (a COVID-19 vaccine developed and produced in India and recently approved by the WHO) should be considered fully vaccinated in Ireland?

Reference: HSE Clinical Guidance for COVID‐19 Vaccination - Section 15.20: "those who have documentary evidence of a complete COVID-19 vaccination course with a COVID-19 vaccine authorised by the FDA, MHRA or recommended by WHO should be considered fully vaccinated"

Asking for Indian family members. Thanks in advance (apologies I am unable to share link to HSE Document, but it can be found online)

Apogee

https://twitter.com/MichealLehane/status/1460321938040143876

https://www.boards.ie/discussion/comment/118169207#Comment_118169207

ICU was what you were talking about

Charles Babbage

https://www.boards.ie/discussion/comment/118170315#Comment_118170315

Almost entirely unaffected by Covid could easily still mean several % of the population. In these times, every child will get Covid, few will have problems with it, but few have problems with the vaccine either.

@odyssey06

https://www.boards.ie/discussion/comment/118170695#Comment_118170695

You have been thoroughly outed as a joke by @odyssey06 at this stage, purposely selecting what you think might suit your agenda while ignoring what you don’t like. Purporting to read the full study yet here you a claiming “study not designed to detect serious events still did”, yet completely missed this while bigging up a child who had a fever that resolved with paracetamol in a day

Three serious adverse events in two participants were reported by the cutoff date; all three (postinjury abdominal pain and pancreatitis in a placebo recipient and arm fracture in a BNT162b2 recipient) were considered to be unrelated to the vaccine or placebo.

The reason the sample was enough was that it established the pattern of side effects observed in children was similar but less frequent to that observed in adults, except at a lower level of systemic events with the exception of swollen glands. This was a confirmatory study to see could conclusions made for adults still hold in children. And it did, because children are humans too.

As compared with adults and adolescents in the pivotal trial, 5-to-11-year-olds reported a higher incidence of injection-site redness (15 to 19%, vs. 5 to 7%) and swelling (10 to 15%, vs. 5 to 8%), but a generally lower incidence of systemic events, including fever (3 to 7%, vs. 1 to 20%) and chills (5 to 10%, vs. 6 to 42%).3,4 Lymphadenopathy was reported in 0.9% of 5-to-11-year-old BNT162b2 recipients, an incidence similar to that in 12-to-15-year-olds (0.8%) but higher than that observed in adults (0.3%)

floorpie

https://www.boards.ie/discussion/comment/118172000#Comment_118172000

Very possible. I'm not opposed to vaccinating anyone to reduce harm. My issue above is that Austria have approved it, a few days after a paper is published on a trial conducted on 1500 kids, which the manufacturer says is unable to detect rare side effects.

floorpie

https://www.boards.ie/discussion/comment/118172060#Comment_118172060

Read the conversation and paper properly. The 3 serious adverse events you mention are unrelated to the cases of fever.

The reason the sample was enough

The sample wasn't enough to detect rare side effects that were detected in the more substantial adult trials.

Tyrone212

Irish times reporting that those who got J&J will be offered a booster. If they refuse will their covid pass be revoked I wonder?

Cienciano

https://www.boards.ie/discussion/comment/118170126#Comment_118170126

Hard to see the point in it unless the child has underlying conditions. I don't think I'd bother, but my kids are 8 or 9

Markus Antonius

https://www.boards.ie/discussion/comment/118172162#Comment_118172162

Funny how most reasonable people respect those who choose not to have their children vaccinated (including myself). But if I choose not to get vaccinated, I'm "antivaxr" scum who's higher viral load is killing everyone's granny

astrofool

https://www.boards.ie/discussion/comment/118172162#Comment_118172162

We'll hit about 50% uptake I reckon, I'd be surprised if it was much lower or higher than that.

is_that_so

https://www.boards.ie/discussion/comment/118172162#Comment_118172162

I'd see this as a likely approach in many households with small kids. Any who've not bothered with 12-15 will not do smaller ones.