Breaking: Pfizer says COVID-19 vaccine effectiveness erodes over time (within 6 months)

22 Questions for Implications of this failure

If your tracking, I posed a bunch of data on the “effectiveness” of the Pfizer vaccine a couple weeks ago. Today it seems almost prophetic, the manufacturer “Pfizer”, themselves are standing up to say our vaccine is waning.

Breaking News:

Pfizer says COVID-19 vaccine efficacy erodes over time (or wanes) …
https://www.bostonglobe.com/2021/09/15/nation/pfizer-says-covid-19-vaccine-efficacy-erodes-over-time/

“Pfizer said that data from the US and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time, and that a booster dose was safe and effective at warding off the virus and new variants. The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots. “Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier,” Pfizer said in its presentation, which was posted on the FDA website. The drug giant is partnering with Germany’s BioNTech SE to make the shots. The decrease in effectiveness is “primarily due to waning of vaccine immune responses over time,” rather than the delta variant, Pfizer researchers said in the presentation.

As of Sept 14th, 2021, CDC estimates over 97 million people in America are “fully” vaccinated with Pfizer.

https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total

My 22 Questions

  1. Does this mean that the 56% of vaccinated Americans (or 97 million people) that took Pfizer are now down-leveled and no longer considered “fully” vaccinated?

  2. Will herd immunity ever be achieved with some vaccines that wane over a 4 to 6 months period?

  3. Do we know the current “effectiveness” of Pfizer (assuming I am at 2-dose)?

  4. Israel data implies people fully vaccinated in January were only 16% effective in July. Does that mean if I had a Pfizer vaccine in April, I am now less than 16% efficacy here in Sept (without booster)?

  5. Why is the vaccine manufacturer (Pfizer) the one relaying this information on effectiveness, contracting the recently released FDA report?

  6. Is this information Pfizer is providing coming from Israel/UK data only?

  7. Where is the data, why is the public not generally aware of this information?

  8. Do we have any CDC/FDA data to support these claims by the manufacture (Pfizer)?

  9. Are the other vaccines waning and can we get the latest information on how much they are waning?

  10. How can a vaccine that cannot even make it 6 months get FDA approval? I believe a vaccine needs 50% efficacy, to get EUA, so its suprising something with less than 16% effectiveness could get FDA approval?

  11. How is it possible the FDA/CDC would approve a vaccine that is only perhaps 16% effective in late August (early Sept)?

  12. Is there any data or clinical research to support the efficacy and how long the Pfizer booster will last?

  13. Is there any extended time period data, or research that might support how effective these vaccines are over a 2, 3, 5 year span?

  14. Will a person with 2-dose Pfizer, need to go back every 6 months and get another booster?

  15. Is it possible the “rushed” science to produce a vaccine “quickly”, made an ineffective vaccine, that actually might make things worse?

  16. Does this meet the definition of a “leaky” vaccine? https://www.healthline.com/health-news/leaky-vaccines-can-produce-stronger-versions-of-viruses-072715

  17. If indeed this is a leaky vaccine, does this mean, it might propagate the worst “variants” to the front of the line so-to-speak?

  18. Is there data or any information to support whether this could lead to Antibody Dependency Enhancement?

  19. If these vaccines are not “truly” long term effective, how can one form a policy of a “mandates” based on something that is not effective? It seems that could create legal complications ??

  20. How do you plan to enforce a vaccine mandate, when 56% of the vaccinated population (over 97 million Americans) appears to be down leveled and no longer has “effective” vaccine protection?

  21. Do the 97 million people that are vaccinated with 2 doses of Pfizer need to provide weekly negative COVID-19 Tests?

  22. How does this mRNA vaccine “effectiveness” compare with natural immunity “effectiveness”?

  23. Why is the FDA against adding boosters? Didn’t one or two people resign over this recently?

FDA Report: Considerations in boosting COVID-19 vaccine immune responses

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02046-8/fulltext

  • “Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.

  • “Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines). If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.

  • “Of interest, reported effectiveness against severe disease in Israel was lower among people vaccinated either in January or April than in those vaccinated in February or March,11 exemplifying the difficulty of interpreting such data. A recent report on the experience in Israel during the first 3 weeks of August, 2021, just after booster doses were approved and began to be deployed widely, has suggested efficacy of a third dose (relative to two doses). Mean follow-up was, however, only about 7 person-days (less than expected based on the apparent study design); perhaps more importantly, a very short-term protective effect would not necessarily imply worthwhile long-term benefit. In the USA, large numbers of adults are fully vaccinated, large numbers are unvaccinated, and systematic comparisons between them are ongoing. Recent reports of large US studies (one from the US CDC's COVID-NET13 and two from major health maintenance organisations) demonstrate the continued high efficacy of full vaccination against severe disease or hospitalisation.”

  • “The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination. Public health authorities should also carefully consider the consequences for primary vaccination campaigns of endorsing boosters only for selected vaccines. Booster programmes that affect some but not all vaccinees may be difficult to implement—so it will be important to base recommendations on complete data about all vaccines available in a country, to consider the logistics of vaccination, and to develop clear public health messaging before boosting is widely recommended.”

  • “The vaccines that are currently available are safe, effective, and save lives. The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine. Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated. If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants. Indeed, WHO has called for a moratorium on boosting until the benefits of primary vaccination have been made available to more people around the world. This is a compelling issue, particularly as the currently available evidence does not show the need for widespread use of booster vaccination in populations that have received an effective primary vaccination regimen.”

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