Pfizer’s COVID-19 Vaccine

Pfizer and BioNTech have a COVID-19 mRNA (messenger RNA) Vaccine candidate in a phase 3 trial.

Pfizer will have up to 30,000 participants in phase 3 clinical trial that started in July 2020. As of Aug 20, 2020 they had enrolled more than 11,000 participants.

BNT162b2 remains under clinical study and is not currently approved for distribution anywhere in the world. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021. Those interested in learning more about the study can visit ClinicalTrials.gov using the number NCT04368728.

Systemic events after administration of BNT162b2 were milder than those with BNT162b1. Overall, after Dose 1, systemic events reported by participants 65 to 85 years old who received BNT162b2 were similar to those reported by those who received placebo. After Dose 2 of 30μg BNT162b2, only 17% of participants 18 to 55 years old and 8% of participants 65 to 85 years old reported fever (≥38.0 to 38.9 °C), compared to 75% of 18 to 55-year-old participants and 33% of 65 to 85-year-old participants administered a second dose of 30μg of BNT162b1. Severe systemic events (fatigue, headache, chills, muscle pain, and joint pain) were reported in small numbers of younger BNT162b2 recipients and were transient and manageable. No severe systemic events were reported by older BNT162b2 recipients. There were no reports of Grade 4 systemic events by any BNT162 recipient.

The two-dose 30 μg level of the BNT162b2 vaccine was selected as the candidate vaccine. Seven days after vaccination, the SARS-CoV-2-neutralizing GMTs (immune response) 3.8 times higher among adults 18-55 than convalescent serum (getting antibodies from someone who fought off the disease) from a panel of 38 convalescing COVID-19 patients. For older adults, neutralizing GMTs were 1.6 times higher than the panel.

Moderna also has an mRNA vaccine candidate in phase 3 clinical trials. Moderna and Pfizer are both very close in the timing of their clinical testing.

Phase 3 Clinical testing in the US also has begun for UK based AstraZeneca’s COVID-19 Vaccine candidate AZD1222.

SOURCES – Pfizer, MedpageToday
Written By Brian Wang, Nextbigfuture.com

17 thoughts on “Pfizer’s COVID-19 Vaccine”

  1. What is "Infection Fertility Rate"? Fatality rate is a useful datum.
    My wife reported a programme where they showed that immunisation in Africa caused infertility- I haven't seen the original show, but do recall resistance to accepting polio vaccine because the CIA had added a sterilisation drug to the shot.
    I recall with great affection the pink Polio vaccine on a sugar cube in Grade 6 after the previous dull needle injection in younger years. Look at the Egyptian Hep C experience after an inadequately managed injection programme.

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  2. And no I don't think it is just an innocent categorizational quirk. The fact that they named their vaccine Sputnik 2, I think shows that they are skewing things for propaganda. Most likely, Putin is trying to strengthen his support.

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  3. The standard is to compare previous death rates (when there was no virus) and death rates in an area with the virus. This sidesteps all the differences in categorizing deaths. It is possible that there are more suicides and domestic violence deaths as well…but that is also due to the pandemic and our efforts to stop it. On the other hand those efforts reduce deaths by reducing crowding in hospitals and possibly reducing the number of people who will ultimately get the infection. And also because there are fewer motor vehicle accident deaths, less deaths due to air quality, and likely in less obvious ways we may never fully account for.
    Some of these things can be addressed to generate an even better figure later.
    "The data released on Wednesday showed St. Petersburg– with a population of 5 million– recorded 6,427 total deaths for May, 1,552 more than last year. That was also more deaths than have been recorded in May in the city than in any year over the past decade." https://abcnews.go.com/International/data-suggests-russias-coronavirus-deaths-higher-official-count/story?id=71066613 

    And the "comorbidities" are not rare conditions. 
    Americans with high blood pressure? 103,000,000. 102,000,000 have high cholesterol (hyperlipanemia). 
    100,000,000 or almost everyone who is obese has fatty liver disease. 
    37,000,000 million have kidney disease…and most don't know it either. 
    Diabetes? 34,200,000.
    And 18,200,000 have coronary artery disease.

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  4. The whole World is struggling with the obesity epidemic, which is almost certainly caused by Adeoviruses 5, 36, and 37. When tested, they made animals fat. We can't test humans as that would be an ethics violation. 
    Diabetes is probably commonly caused by a reaction to Staph infection toxins: https://advancedtissue.com/2015/07/the-link-between-staph-infection-and-diabetes/
    Obesity likely helps staph, because of the skin folds. And there are likely genetic factors associated with the immune response to the Staph toxins. "“What we are finding is that as people gain weight, they are
    increasingly likely to be colonized by staph bacteria – to have large numbers of these bacteria living on the surface of their skin,” Schlievert said. “People who are colonized by staph bacteria are being chronically exposed to the superantigens the bacteria are producing.”

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  5. Apparently, I am not the only one who sees their numbers as fishy: https://abcnews.go.com/International/data-suggests-russias-coronavirus-deaths-higher-official-count/story?id=71066613
    36.5% of American adults are obese. 36.0% of Russian adults are obese. You really think that 1/2% less obesity is going to make this much difference? https://www.karger.com/Article/Fulltext/493885
    The #1 comorbidity with Coronavirus is high blood pressure. 69.2% of Russians above 50 have high blood pressure. That is worse than the US, as this was with the old threshold of 140 mm Hg. They now the medical world considers 130 the new threshold for high blood pressure. They call 130-139 "stage 1 hypertension", and the other "stage 2".

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  6. Are they volunteering to get exposed to the virus? I would think that the humane and safe way to conduct second and third phase is to give the vaccine or a placebo to as many people as possible in risky populations, such as people who are living with someone who has just go infected, with a warning to follow safety measures as everyone else in similar circumstances, as they may be getting a placebo and the vaccine effectiveness is not proven.

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  7. Considering that 94% of US COVID deaths were in individuals with co-morbidities https://www.jems.com/2020/08/31/cdc-report-underlying-conditions-94-percent-covid-19-deaths/ it is quite possible that the Russian government uses different criteria when determining how to count COVID-19 deaths. Note, I am NOT saying they are hiding deaths, just that there is no worldwide criteria to determine that a person died from COVID-19 vs a co-morbidity vs effects of a co-morbidity triggered by a COVID-19 infection. I no longer have the link but there were stories earlier in the year about CDC guidelines allowing localities to list COVID-19 as the cause of death without any testing.

    COVID-19 mortality statistics will become a classic example of Garbage In Garage Out analysis in future texts. The infrastructure to capture meaningful data wasn't there and the parameters around classification were – and are still – too loose.

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  8. That still happens. Oral polio vaccine still contains a mixture of live-attenuated virus and is used in the world were wild polio is still relevant. There are cases of vaccine-derived polio from this weakened virus. This attenuated virus can mutate and start behaving more like the wild-virus and can then spread and cause paralysis. Poliovirus 2 and 3 are erradicated globaly and only polio virus 1 is still circulating and only in Afghanistan and Pakistan. Most circulating vaccine derived polio virus is polio virus 2 that has been erradicated; therefor there has been discussion of a new oral polio vaccine which does not contain polio virus 2 and 3. In Africa only CVDPV is still a problem and mainly 2. After global erradication all OPV vaccination will stop so no new CVDPV outbreaks occur.

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  9. I have some serious doubts about the Russian vaccine as well but accusing them of skewing death ratio numbers based on average lifespan because someone feel it's just impossible for them to have less deaths than US is just too 'Murica. There are multiple things at play here starting from prior vaccinations (some studies shown people that had MMR vaccine administered in the past are doing better with COVID and eastern block countries vaccinated every kid for decades, no excuse) to overall health throughout your lifespan which does not necessarily have to be worse if you consider health issues that US is struggling with like diabetes or obesity & related conditions.

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  10. The beauty of a 30,000 participant test is that even if there are effects that normally show up 6 months or a year out, there are so many people that some will have that side effect much earlier. If that is serious enough, it just will not pass, or if the patients that have the affect have something in common, like taking some arthritis pill or something, then you add that warning.
    This is not being done like "Sputnik 2". I think the Russians were desperate. I think the situation is much worse in Russia than they are saying. I think they tweaked the system so that only otherwise healthy people that died of Coronavirus are being counted. If so, the death toll could be 5 or more times higher. I don't know the relative difference in heath between Americans and Russians but they are probably significantly less healthy as they die more than 6 years earlier. 72.4 years for Russians, 78.9 years for Americans. Even our African Americans on average make it to 75.0 years, and they have not fared well with Coronavirus. The Russians claim to have had 1 million cases and only 17,528 deaths. If they were equally as healthy, they should have had 30,500 deaths. With much worse health…who knows? They could even have had more deaths than we have had.

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  11. This isn't quite the same as the yearly new flu vaccine.

    That's a standard process to get a new variant on an existing technology that's been done dozens of times previously.
    This is new vaccine tech that had to be developed (which is why we don't have is already rolled out.)

    It's not THAT new, which is why it only took months, not years. There were a whole lot of various viral, even corona viral, vaccine projects in the works that were accelerated, not started from scratch.

    And I agree that a proper stage 1,2,3 trial process should give a safe result. Safer than risking permanent lung/heart/liver damage from the actual disease.

    Still, I'd like a few million people to get it before I do. I think they probably would anyway, there'll be priority for health workers and the elderly.

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  12. To what rushed rubber stamping are you referring? This is stage 3 of the normal 4 stage process for testing a vaccine. It's the industry standard method. This is the stage where they determine whether the vaccine is actually effective.

    Out of curiosity – how do you think the drug companies develop flu vaccines every year? Moreover, the last time a vaccine truly caused serious harm to the public was in 1955 where a polio vaccine actually contained a live virus. That was 65 years ago. Could something similar happen again? Sure. How likely is it? I'll put my money on Pfizer.

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  13. No warm and fuzzy feeling from a rushed rubber stamping of this vaccine without the traditional long term data and studies. None at all.

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