Vaccines

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#1
In order for it to be worth it to to take a vaccine the following has to be satisfied

side effects < (probability of the vaccine protecting you) * (probability of infection) * (severity of the disease)

The real issue with many vaccines is not side effects but the low expected benefit from taking the vaccine, often its not a particularly common virus or you will be protected by herd immunity (other people being vaccinated) and thus you can get away with not taking the vaccine yourself.
 

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#2
The pfizer covid-19 vaccine
The vaccine was given an emergency use authorization by an FDA panel

17 Yes, 4 No, 1 abstention.

https://www.statnews.com/2020/12/10...ting-on-the-pfizer-biontech-covid-19-vaccine/

The fact that only 17 of 22 voted to approve it is a minor red flag.

https://www.statnews.com/2020/12/14...ely-get-the-pfizer-biontech-covid-19-vaccine/

Hours before the FDA granted emergency use authorization of a Pfizer vaccine, New York state's independent review panel approved the use of the vaccine days before the first shipment is set to arrive, Gov. Andrew Cuomo said Friday.

nbcnewyork.com/news/coronavirus/ny-officials-expected-to-unveil-detailed-pfizer-vaccine-distribution-plans-ahead-of-emergency-approval/2775041/

Several people including dr fauci and former presidents (Obama, Goerge W Bush, Bill Clinton) have promised to take the vaccine on camera, these individuals are however all old and thus the expected benefit from the vaccine will be a lot greater than young people, it is also possible (in theory) that they are simply mistaken regarding the vaccine. They may also feel pressured to publictly take the vaccine in order to assure the public that its safe.
 

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#3
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

Due to the short duration of the study they were not able to show that the vaccinated group had better outcomes than the placebo group, all hard data we have so far is better for the placebo group but it is assumed that over time the vaccinated group will do better, this however has not yet been properly demonstrated.

Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by vaccine recipients than by placebo recipients. Sixty-four vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the vaccine or placebo. No Covid-19–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of vaccine.



nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_file/nejmoa2034577_appendix.pdf
 

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#4
Covid-19 risk vs vaccine risks
Its hard to get good data regarding the rate of mortality and various complications if for an infection.

1631123937263.png


https://www.nature.com/articles/s41586-020-2918-0

Older data from confirmed cases only:

https://theconversation.com/why-are-older-people-more-at-risk-of-coronavirus-133770

his however is only the death-rate and it does ignore the other complications covid-19 can give you.

If you are a healthy 28 year old then your risk of dying from covid might be 0.01% (probability of infection and death), given the 95% efficacy then for it to be worth taking (if you only care about survival) the risk of dying from the vaccine cannot be higher than 1 in 10000, based on the limited information we have so far this does seem to be the case.

Unfortunatily the sample size and study duration is small for the pfizer study so its not sensitive enough to detect rare additional deaths or side effects.

If you are above 60 then you should probably take the vaccine as soon as possible given how dangerous it would be for you to get infected with covid-19 and how difficult it is to fully protect yourself from it, a mask only offer partial protection when other people are not wearing one.

If you are below 60 you should still probably get the vaccine if you belong to some risk group.
 
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#6
20 of 21 voted in favor of the moderna vaccine
One abstained, nobody voted against the vaccine.

While this is a far better vote result than for the pfizer vaccine it is still a vaccine that hasn't been properly tested yet, no proper FDA approval has been given yet.

Several people who voted yes now were people who voted no for the pfizer vaccine.

One individual want to see it targeted for high-risk group since he wasn't sure the benefit outweigh the risk for all people over 18.
 

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#9
Healthcare workers refuse to get vaccinated
While you shouldn't trust these people too much when it comes to making good decisions it is still a big red flag.
Ohio Gov. Mike DeWine said only 40% of the state’s nursing home workers have gotten shots. North Carolina’s top public health official estimated more than half were refusing the vaccine there.

SavaSeniorCare has offered cash to the 169 long-term care homes in its 20-state network to pay for gift cards, socially distanced parties or other incentives. But so far, data from about a third of its homes shows that 55% of workers have refused the vaccine.
https://apnews.com/article/coronavirus-vaccine-health-workers-676e03a99badfd5ce3a6cfafe383f6af
 

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#10
23 dead in norway (phizer vaccine)
(Bloomberg) -- Norway said Covid-19 vaccines may be too risky for the very old and terminally ill, the most cautious statement yet from a European health authority as countries assess the real-world side effects of the first shots to gain approval.(Bloomberg)

Norwegian officials said 23 people had died in the country a short time after receiving their first dose of the vaccine. Of those deaths, 13 have been autopsied, with the results suggesting that common side effects may have contributed to severe reactions in frail, elderly people, according to the Norwegian Medicines Agency.

“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences,” the Norwegian Institute of Public Health said. “For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”

The recommendation does not mean younger, healthier people should avoid being vaccinated. But it’s an early indication of what to watch as countries begin to issue safety monitoring reports on the vaccines. Emer Cooke, the new head of the European Medicines Agency, has said tracking the safety of Covid vaccines, especially those relying on novel technologies such as messenger RNA, would be one of

Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths in Norway, Pfizer said in an e-mailed statement. The agency found that “the number of incidents so far is not alarming, and in line with expectations,” Pfizer said.

Allergic reactions have been uncommon so far. In the U.S., authorities reported 21 cases of severe allergic reactions from Dec. 14-23 after administration of about 1.9 million initial doses of the vaccine developed by Pfizer Inc. and BioNTech SE. That’s an incidence of 11.1 cases per million doses, according to the Centers for Disease Control and Prevention.

Though both Covid-19 vaccines approved so far in Europe were tested in tens of thousands of people -- including volunteers in their late 80s and 90s -- the average trial participant was in his or her early 50s. The first people to be immunized in many places have been older than that as countries rush to inoculate nursing-home residents at high risk from the virus.

More Than 35 Million Shots Given: Covid-19 Vaccine Tracker

Norway has given at least one dose to about 33,000 people, focusing on those considered to be most at risk if they contract the virus, including the elderly. The Pfizer-BioNTech vaccine approved late last year has been used most broadly, with a similar shot from Moderna Inc. approved earlier this month also now being administered.

Of 29 cases of potential side effects investigated by Norwegian authorities, almost three-quarters were in people age 80 or older, the regulator said in a Jan. 14 report.

In France, one frail patient died in a care home two hours after being vaccinated, but authorities said given the patient’s previous medical history there is no indication the death was linked to the vaccine. The French pharmaceutical safety agency on Thursday reported four cases of severe allergic reactions and two incidents of irregular heartbeat after vaccination.

The first Europe-wide safety report on the Pfizer-BioNTech vaccine will probably be published at the end of January, the regulator’s key medicines committee said Friday. Vaccine makers are required to submit data monthly.

In the U.K., which has carried out more immunizations per capita than anywhere else in Europe, authorities will assess safety data and plan to publish details of suspected reactions “on a regular basis,” the Medicines and Healthcare Products Regulatory Agency said, without giving a date.
 

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#11
Vaccine side effects (Sweden)
Unfortunatily most of the reports have not actually been processed so we still do not actually have any good data, it's unclear how reports are prioritized when analysed.

lakemedelsverket.se/sv/coronavirus/coronavaccin/inrapporterade-misstankta-biverkningar---coronavacciner#hmainbody1

Code:
Vaccine        Pfizer   moderna  AstraZenica
vaccinations   9895923  1543651  1335126
reported SEs   36049    13088    23929
Processed SEs  5622     840      2337
Serious SEs    3255     567      1801
deaths         222      22       39
pfizer deaths:
1631141567256.png


Moderna deaths:
1631144130787.png


AstraZenica Deaths:
1631144186901.png


older data
Code:
Vaccine        Pfizer   moderna  AstraZenica
vaccinations   7303582  947177   1309135
reported SEs   26243    7701     23194
Processed SEs  3865     516      1820
Serious SEs    2333     376      1610
deaths         212      21       31
lakemedelsverket.se/sv/coronavirus/coronavaccin/inrapporterade-misstankta-biverkningar---coronavacciner#hmainbody3

Code:
Vaccine        Pfizer   moderna  AstraZenica
vaccinations   1856000  221000   692000
reported SEs   9117     2103     19961
Processed SEs  2496     252      436
Serious SEs    1064     133      810
deaths         168      13       16
SE = Side Effect.

Code:
Vaccine        Pfizer  moderna AtraZenica
vaccinations   513000  50000   153000
Reports        4661    618     7490
Processed      1562    112     142
deaths         73      3       1
AstraZenica
lakemedelsverket.se/493e82/globalassets/dokument/behandling-och-forskrivning/coronavirus/misstankta-biverkningar/covid-19-vaccine-astrazeneca-handlagda-rapporter-om-misstankta-biverkningar-2021-03-10.pdf

moderna
lakemedelsverket.se/493e82/globalassets/dokument/behandling-och-forskrivning/coronavirus/misstankta-biverkningar/covid-19-vaccine-moderna-handlagda-rapporter-om-misstankta-biverkningar-2021-03-10.pdf

Pfizer
lakemedelsverket.se/493e82/globalassets/dokument/behandling-och-forskrivning/coronavirus/misstankta-biverkningar/comirnaty-handlagda-rapporter-om-misstankta-biverkningar-2021-03-10.pdf
 

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#12
Risk-benefit analysis using the Swedish data
Since no proper analysis regarding vaccine mortality has been done i am just going to assign all deaths to the vaccine (worst possible scenario) since not going so could incentivize not doing a proper analysis.

10 to 29: 2 vaccine deaths
18 to 29: 35% fully vaccinated https://experience.arcgis.com/experience/6df5491d566a44368fc721726c274301
18 to 29: 790855, of which 276799 fully vaccinated

Risk of dying from vaccine = 0.00072%
risk of dying from covid infection = 0.01%
Required absolute reduction of severe covid = 7.2%

If we assume the vaccine offers 70% protection against covid deaths you benefit from taking the vaccine if your risk for covid is more than 10.3%

Conclusion

A proper mortality study is needed to show the vaccine to reduce the risk of dying in the case of healthy people between 10 and 29. It's also generally unclear if the young and healthy actually benefit from any of these vaccines directly (excluding any societal impact).
 

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#13
Authority figures clearly cannot be trusted
Why are they stopping the AstraZenica vaccine while claiming there is no elevated risk for DVT? that make absolutely zero sense


Considering how badly authorities have managed this pandemic in most western countries this is not actually surprising.

Case1
what they are saying is true (the DVT risk is lower in the vaccinated group) then they are needlessly stopping a vaccine that are not actually dangerous meaning authority figures cannot be trusted.

Even if it is the case that the DVT-risk is even lower among people who got other vaccines (possibly due to better protection against covid-19) it still doesn't make sense to just halt vaccinations during a severe shortage of vaccines.

https://www.medpagetoday.com/infectiousdisease/covid19/91641

Case2
the vaccine is actually dangerous and they have good reasons to halt it but they are not telling us that, in that case authority figures cannot be trusted.
 

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#14
AstraZenica Vaccine trials
The following study did show it to be effective against covid-19 (very clearly) but what about actual outcomes that matter? (amount of severe reactions including death)?

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext

The first supplemental document didn't provide any useful information

thelancet.com/cms/10.1016/S0140-6736(20)32661-1/attachment/75bff1ea-804f-4c66-adc1-2f7d0f9b4550/mmc1.pdf

To get the actual outcomes i had to look at the second appendix

thelancet.com/cms/10.1016/S0140-6736(20)32661-1/attachment/75bff1ea-804f-4c66-adc1-2f7d0f9b4550/mmc1.pdf

1615890396826.png

1615890468519.png

It looks like the vaccinations is being halted for no good reason in many countries.

The only issue here is that there might be severe side effects excluded from analysis that did not favor the vaccine. blood clotting risk however isn't one of these since it was included in the analysis and it did favor the vaccine, unfortunatily the sample size wasn't that great.
 

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#16
Study: AstraZenica Vaccine ineffective against sourth african sars-cov-2
The study did some reduction in mild to moderate covid-19
Between June 24 and November 9, 2020, we enrolled 2026 HIV-negative adults (median age, 30 years); 1010 and 1011 participants received at least one dose of placebo or vaccine, respectively. Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients. In the primary end-point analysis, mild-to-moderate Covid-19 developed in 23 of 717 placebo recipients (3.2%) and in 19 of 750 vaccine recipients (2.5%), for an efficacy of 21.9% (95% confidence interval [CI], −49.9 to 59.8). Among the 42 participants with Covid-19, 39 cases (92.9%) were caused by the B.1.351 variant; vaccine efficacy against this variant, analyzed as a secondary end point, was 10.4% (95% CI, −76.8 to 54.8). The incidence of serious adverse events was balanced between the vaccine and placebo groups.
https://www.nejm.org/doi/full/10.1056/NEJMoa2102214?query=featured_home

This is the real issue with the AstraZenica vaccine and this poor protection will increase the risk of blood clotting and other adverse events over getting a vaccine that actually gives you proper protection.

It seems like the pfizer and moderna vaccine is also less effective in this case

https://www.cell.com/cell-host-microbe/fulltext/S1931-3128(21)00136-0

https://www.webmd.com/vaccines/covi...an-variant-challenges-pfizer-moderna-vaccines
 

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#21
The pfizer vaccine does not seem to negatively effect male fertility
The expert consensus has always been that there shouldn't be any issue when it comes to fertility but now we have a formal study indicating that this consensus was indeed correct.

https://www.medrxiv.org/content/10.1101/2021.04.30.21255690v1.full.pdf

Overall in the study the fertility was better after the vaccine (1 dose) but that difference was not statistically significant

1620311354116.png
 
#22
The issue with the AstraZenica vaccine trial
They actually gave an active placebo "MenACWY" and we have to make sure that didn't contribute to the placebo group doing better.

Giving an active placebo can make a study better but it can also make it worse. The advantage is that the participants will have a harder time figuring out if they got an active incredient, the disadvantage is that the active placebo will have some effect which may skew the results (such as people getting bad side effects).
 

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#23
Robert Malone on the nRNA vaccines
He pointed out the lack of proper risk-benefit analysis and breach of medical ethics.

foxnews.com/media/tucker-carlson-mrna-vaccine-inventor


He does believe many people (young and healthy) do not actually get an expected benefit from the vaccine but of course until we better data we simply do not know.

Here is a critical factcheck of him https://www.logically.ai/articles/who-is-dr.-robert-malone his statement about blood-clots was technically correct but misleading

https://www.logically.ai/factchecks/library/00800e21

yes it is also the case with the pfizer vaccine, not just astrazenica https://osf.io/a9jdq/

https://www.logically.ai/articles/who-is-dr.-robert-malone
 

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#24
Does the AstraZenica Vaccine help against the delta variant
This is data from the UK, they actually provide decent data unlike most governments.

assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1001354/Variants_of_Concern_VOC_Technical_Briefing_17.pdf

It is worth noting that for unvaccinated people the delta variant seems to be relatively safe.

1627037773975.png


Now let's take a look at data regarding the delta variant:

1627039883984.png

1627042633928.png

¥ Cases without specimen dates and unlinked sequences (sequenced samples that could not be matched to individuals) are excluded from this table.
* Cases are assessed for any Emergency Care attendance within 28 days of their positive specimen date. Cases still undergoing within 28-day period may have an emergency care attendance reported at a later date.
§ At least 1 attendance or admission within 28 days of positive specimen date
‡ Cases where specimen date is the same as dateof Emergency Care visit are excluded to help remove cases picked up via routine testing in healthcare settings whose primary cause of attendance is not COVID-19. This underestimates the number of individuals in hospital with COVID-19 but only includes those who tested positive prior to the day of their Emergency Care visit. Some of the cases detected on the day of admission may have attendedfor a diagnosis unrelated to COVID-19.
^ Total deaths in any setting (regardless of hospitalisation status) within 28 days of positive specimen date.
 

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#25
Moderna vaccine study
Here is a trial regarding the mRNA-1273 (moderna) vaccine.

https://www.nejm.org/doi/full/10.1056/nejmoa2035389

Table S8. Unsolicited Adverse Events 28 Days after Any Injection, Overall Safety Set:
1627473471884.png


nejm.org/doi/suppl/10.1056/NEJMoa2035389/suppl_file/nejmoa2035389_appendix.pdf

Table S10. Unsolicited Severe AEs Reported by ≥5 Participants in Any Treatment Group
up to 28 Days After Any Injection, Overall Safety Set:
1627496640791.png


Table S11. Serious AEs Reported by Preferred Term in Any Treatment Group, Overall
Safety Set:
1627476354287.png


Table S12. Unsolicited Adverse Events of Hypersensitivity, Overall Safety Set :
1627496947183.png


Table S13. Covid-19 Symptoms and Severity, Per-protocol Set:
1627496803849.png
 

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#26
Novavax vaccine trial
The study found no difference when it comes to serious adverse events but the vaccine did worse when it comes to less serious adverse events

https://www.nejm.org/doi/full/10.1056/NEJMoa2107659

All 15,139 participants who had received at least one dose of vaccine or placebo through the data cutoff date of the final efficacy analysis were assessed for unsolicited adverse events. The frequency of unsolicited adverse events was higher among vaccine recipients than among placebo recipients (25.3% vs. 20.5%), with similar frequencies of severe adverse events (1.0% vs. 0.8%), serious adverse events (0.5% vs. 0.5%), medically attended adverse events (3.8% vs. 3.9%), adverse events leading to discontinuation of dosing (0.3% vs. 0.3%) or participation in the trial (0.2% vs. 0.2%), potential immune-mediated medical conditions (<0.1% vs. <0.1%), and adverse events of special interest relevant to Covid-19 (0.1% vs. 0.3%).
 

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#27
Study: The AstraZenica vaccine is 59% effective against the delta variant
The UK initially only offered the AstraZenica vaccine but lately they did start offering the Pfizer vaccine

ctvnews.ca/health/coronavirus/u-k-to-offer-under-40s-alternative-to-astrazeneca-shot-1.5418120

I was unable to find data regarding how many had taken vaccine of each type here but they did found the vaccine used to be 59% effective

spiral.imperial.ac.uk/bitstream/10044/1/90800/2/react1_r13_final_preprint_final.pdf
 

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#29
FDA report: the pfizer vaccine is beneficial for young people
They did not however provide proper data backing this up (such as total all-cause mortality for vaccinated vs equivalent unvaccinated control group) but they did at least try to do a risk-benefit analysis and it did show the vaccine to be beneficial. The issue with the FDA risk-benefit analysis for young people is that they focused only on Myocarditis/Pericarditis and Anaphylaxis which while these individually might be the biggest concern they did not properly show that the rest of the side effects added together is less than the risk of the vaccine for young people.

https://www.fda.gov/media/151733/download

Since the issuance of the EUA (December 11, 2020), post-authorization safety data has been reported from individuals 16 years of age and older following any dose of COMIRNATY. Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Below are presented adverse reactions categorized as important identified risks in the pharmacovigilance plan that have occurred during the conduct of the clinical trial and have been reported following the issuance of the EUA.

Myocarditis/Pericarditis
During the time from Dose 1 to unblinding in Study C4591001, one report of pericarditis was identified in the COMIRNATY group, occurring in a male participant ≥55 years of age, with no medical history, 28 days after Dose 2; the event was assessed by the investigator as not related to the study intervention and was ongoing at the time of the data cutoff. One report of myocarditis was identified in a male participant <55 years of age in the placebo group, occurring 5 days after his second placebo dose.

Post-EUA safety surveillance reports received by FDA and CDC identified serious risks for myocarditis and pericarditis following administration of COMIRNATY. Reporting rates for medical chart-confirmed myocarditis/pericarditis in VAERS have been higher among males under 40 years of age than among females and older males and have been highest in males 12-17 years of age (65 cases per million doses administered as per CDC communication on August 20, 2021), particularly following the second dose, and onset of symptoms within 7 days following vaccination. Although some cases of vaccineassociated myocarditis/pericarditis required intensive care support, available data from short-term follow up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae and outcomes in affected individuals. A mechanism of action by which the vaccine could cause myocarditis and pericarditis has not been established.

These safety findings of increased risk for myocarditis/pericarditis led to warning in section 5.2 Warning and Precautions of the PI.

Myocarditis and pericarditis are considered important identified risks in the pharmacovigilance plan included in the BLA. Of note, the Applicant will be required to conduct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as well as an unexpected serious risk for subclinical myocarditis (see Section 11c Recommendation for Postmarketing Activities, for study details).

Moreover, since vaccine-associated myocarditis/pericarditis is the most clinically significant identified risk, FDA undertook a quantitative benefit-risk assessment to model the excess risk of myocarditis/pericarditis vs. the expected benefits of preventing COVID19 and associated hospitalizations, ICU admissions, and deaths. For estimation of risk, the model took a conservative approach by relying on non-chart-confirmed cases from a US healthcare claims database (OPTUM) that could provide a control group and greater confidence in denominators for vaccine exposures. Thus, the estimates of excess risk in this model are higher than the rates estimated from reports to VAERS (an uncontrolled passive surveillance system), with an estimated excess risk approaching 200 cases per million vaccinated males 16-17 years of age (the age/sex-stratified group with the highest risk). For estimation of benefit, the model output was highly dependent on the assumed COVID-19 incidence, as well as assumptions about vaccine efficacy and duration of protection. The assessment therefore considered a range of scenarios including but not limited to a “most likely” scenario associated with recent Delta variant surge and diminished vaccine effectiveness (70% overall, 80% against COVID-19 hospitalization) compared to that observed in the clinical trial. The “worst-case” scenario with low COVID-19 incidence reflecting the July 2021 nadir and the same somewhat diminished vaccine effectiveness as in the “most likely” scenario.

For males and females 18 years of age and older and for females 16-17 years of age, even before accounting for morbidity prevented from non-hospitalized COVID-19, the model predicts that the benefits of prevented COVID-19 hospitalizations, ICU admissions and deaths would clearly outweigh the predicted excess risk of vaccine-associated myocarditis/pericarditis under all conditions examined. For males 16-17 years of age, the model predicts that the benefits of prevented COVID-19 hospitalizations, ICU admissions and deaths would clearly outweigh the predicted excess risk of vaccine-associated myocarditis/pericarditis under the “most likely” scenario, but that predicted excess cases of vaccine-associated myocarditis/pericarditis would exceed COVID-19 hospitalizations and deaths under the “worst case” scenario. However, this predicted numerical imbalance does not account for the greater severity and length of hospitalization, on average, for COVID-19 compared with vaccine-associated myocarditis/pericarditis. Additionally, the “worst case” scenario model predicts prevention of >13,000 cases of non-hospitalized COVID-19 per million vaccinated males 16-17 years of age, which would include prevention of clinically significant morbidity and/or long-term sequelae associated with some of these cases. Finally, the model does not account for indirect societal/public health benefits of vaccination. Considering these additional factors, FDA concluded that even under the “worst case” scenario the benefits of vaccination sufficiently outweigh risks to support approval of the vaccine in males 16-17 years of age.

Mitigation of the observed risks and associated uncertainties will be accomplished through labeling (including warning statements) and through continued safety surveillance and postmarketing studies to further assess and understand these risks, including an immunogenicity and safety study of lower dose levels of COMIRNATY in individuals 12 through <30 years of age. The Applicant will be required to conduct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and an unexpected serious risk for subclinical myocarditis (see section 11c for study details).

Anaphylaxis
The risk of anaphylaxis was recognized early in the post-authorization time period and it is included as an important identified risk in the PVP. The estimated crude reporting rate for anaphylaxis is 6.0 cases per million doses. Therefore, the incidence of anaphylaxis after receipt of COMIRNATY is comparable with those reported after receipt of other vaccines.

There were no reports of anaphylaxis associated with COMIRNATY in clinical study participants through the cutoff date of March 13, 2021.

A contraindication for individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY is included in section 4 of the PI. Additionally, a warning statement is included in section 5.1 of the PI instructing that “appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of COMIRNATY”
 

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#30
British Medical Journal: the FDA approval (pfizer vaccine) was rushed
A lot of people were stating that they didn't want to take the vaccine before full FDA approval which resulted in FDA doing a full approval based on low quality analysis based on largely outdated data. This full FDA approval (political) will make it easier to push through vaccine mandates/passports.

blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/

Does the FDA think these data justify the first full approval of a covid-19 vaccine?
The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi

On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”

The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug Administration. It deserves careful scrutiny.

The elephant named “waning immunity”
Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater efficacy against severe disease (“100% effective,” Moderna said).

Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.

The concern, of course, was decreased efficacy over time. “Waning immunity” is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the time “flu season” arrives some months later. If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike covid vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.

And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.

Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting 20 September 2021, the US plans to follow suit for all “fully vaccinated” adults eight months past their second dose.

Delta may not be responsible
Enter Pfizer’s preprint. As an RCT reporting “up to six months of follow-up,” it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.

“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to 90% (from two months to <4 months), then to 84% (95% CI 75 to 90) “from four months to the data cut-off,” which, by my calculation (see footnote at the end of the piece), was about one month later.

But although this additional information was available to Pfizer in April, it was not published until the end of July.

And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.

Waning efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else—the bottom line is that vaccines need to be effective.

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.

The “six month” preprint based on the 7% of trial participants who remained blinded at six months
The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce further findings. And the preprint does not report any demographic comparisons to justify future analyses.

Severe disease
With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?
Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.

But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)

It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

Peter Doshi, senior editor, The BMJ.

Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

Provenance: commissioned; externally peer-reviewed.

Footnote: Calculations in this article are as follows. “About 1 month” past month 4 is based on the final row of Fig 2 in the preprint: 1030/12670*12 = 0.98 months (vaccine group) and 895/11802*12 = 0.91 months (placebo group). “53%” is based on Fig 2: (12670+11802)/(23040+23037). “4.4 months” is based on the average of 8412/22505*12 = 4.5 (vaccine) and 8124/22434*12 = 4.3 (placebo) in Fig 2.

August 23, 2021
 

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#31
Contaminant in Moderna Vaccines in Japan Suspected to be Metallic Particles
The contaminants have been found at eight vaccination sites since Aug 16, 2021. The Japanese government has told 863 vaccination sites nationwide to halt the use of vaccines from the affected lots. While contaminants were only found from vials from lot 3004667, Japan also suspended vials from 3004734 and 3004956 because they were made from the same production line as the contaminated vials.

biopharminternational.com/view/contaminant-in-moderna-vaccines-in-japan-suspected-to-be-metallic-particles
 

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#33
We do not need any covid vaccines
Media (especially left-wing) like to push the notion that vaccines are critical for getting the pandemic under control but that has never actually been true. There are other far more effective methods we can utilize.

Covid 'vaccines' are not actually that effective at protecting others, the figures for this are conflicting but there does seem to be waning immunity

https://www.nejm.org/doi/full/10.1056/NEJMoa2108891?query=featured_home

https://www.medrxiv.org/content/10.1101/2021.05.22.21257658v1

We are also seeing that in more and more places most people infected are fully vaccinated

cnbc.com/2021/07/30/cdc-study-shows-74percent-of-people-infected-in-massachusetts-covid-outbreak-were-fully-vaccinated.html

So what's be better alternative?
Countries like China, Taiwain, New Zealand, etc have demonstrated that it's possible to get the virus under control without relying on vaccines.

FFP3 masks will filtrate 99% of the particles and have at most 2% outward leakage, if everyone used these in addition to other measures the pandemic would be over within months with or without vaccines.

Only FFP3 masks (roughly equivalent to international standards such as N99, EN149 and P3) effectively protect the wearer from droplet aerosols, protein molecules, viruses, bacteria, fungi and spores
dw.com/en/coronavirus-face-mask-face-shield-ffp2-n95-kn95-whats-the-difference/a-52291265

WHen NHS switched to FFP3 infections at hospitals were cut by near 100%

https://www.bmj.com/content/373/bmj.n1663

So what about the cloth masks US officials like Andrew Cuomo recommended? well of course these do not work at all, what did you expect?

dailymail.co.uk/health/article-8507199/An-N99-effective-reducing-risk-contracting-coronavirus-study-finds.html

https://www.journalofhospitalinfection.com/article/S0195-6701(20)30276-0/pdf
 

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#34
Unvaccinated teens/children are healthier
While the study didn't look into confounding factors it does call into the question the notion that vaccines are beneficial for children. In general it seems like vaccines are pushed for the benefit of society (avoiding disruption caused by a pandemic) rather than because it's actually something individuals benefit from.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3057555/

It could be the case that a vaccine has negative health effects that are greater than the benefit from the vaccine but that these negative effects are not really picked up due to the fact that no proper study is done.
 

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#35
Two senior FDA vaccine regulators are stepping down
This illustrates how political FDA has become, we really shouldn't trust government bodies with medical decision, especially not for incompetent democratic governments.

cnbc.com/2021/08/31/two-senior-fda-vaccine-regulators-are-stepping-down.html

FDA has to please corrupt politicians which in turn has to please ignorant voters and their donors, this is why you have to do your own research, read studies yourself, the full text, all of it.

https://sci-hub.se https://sci-hub.st
 
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