Philippines FDA "Reports of Suspected Adverse Reactions to Covid-19 Vaccines as of 21st August 2022 has Been Released with Critical Clarifications to Avoid Misunderstanding!

Aside from 106,681 adverse reactions (+784 since 6 Aug), and 9,599 serious reactions (+173) including 2,651 deaths (+31) important clarifications have been made.

The 21st August 2022 FDA Pharmacovigilance report was released yesterday (13 September 2022)! While most of the report, is almost identical to previous versions, and aside from the increases in reports of adverse reactions since the last report, as shown in Table 2, below, the FDA has made a few careful additions to the document to ensure that it cannot be misread!

The Summary on page 3, has been updated (cf. the 6 August report). They no longer state in this section:

“As per risk-benefit assessment, these reports do not provide a basis for revising the current recommendations regarding the use of COVID-19 vaccines”.

Instead, they state (with my highlighting)

“Based on the current available data, the benefits of the vaccines in the prevention of Covid-19 and severity of the disease outweighs any current known adverse reactions in the majority of the vaccinated individuals”.

“any current known adverse reactions”… are there other reactions not currently known or acknowledged?

“in the majority of the vaccinated individuals”… what about the minority of individuals? Is that minority sufficient to confirm harm?

Two new paragraphs are added:

We are warned, conveniently highlighted and underlined, that mere suspicion may also be reported. They state that underlying conditions may “aggravate possible adverse reactions from vaccines”…. shouldn’t it be the other way around? That the vaccine aggravated those underlying conditions, triggered their worsening, and led to severe injury, or death? Would those reactions have occurred without a triggering, causative vaccine added to the mixture? Chicken or egg?

Does this mean that people with underlying conditions shouldn’t be vaccinated for fear of aggravating possible adverse reactions to the vaccines? Should everyone be screened for underlying conditions prior to vaccination? Should only the healthy, ironically at very low risk of covid-19 infection complications, be vaccinated?

Among the priority adverse reactions that are being tracked, we have:

• 1 additional case of Thrombosis-thrombocytopenia to bring the total to 13; 1 having been dismissed as indeterminate (insufficient evidence that the vaccine caused the reaction) and 12 still under review.

• 30 additional covid-19 infections including 3 deaths, bringing the total to 4,616 infections with 250 deaths “cases not related to the use of the vaccine, but were actual Covid-19 natural infections”. Reader, please disregard that all of these infections and deaths occurred after the receipt of vaccines that were meant to prevent them!

• Still showing 17 cased of myocarditis, 3 having been judged as product-related and the rest are under review.

• Still at 1 indeterminate case of Capillary Leak Syndrome.

• 1 additional case of GBS to bring the total to 26; 7 product-related, 5 indeterminate, and the rest under review.

• 1 additional case of Bell’s palsy to bring cases up to 31; 8 product-related, 2 indeterminate, 2 coincidental, and the rest under review.

• Still 6 cases of Immune thrombocytopenia. 1 product-related, 2 coincidental, and 3 under review.

• Hospitalization rates have increased to 4.15 per 100,000 doses from the 4.12 per 100,000 doses in the 6 August report. The same wording as previously, but now bolded and underlined to be sure we don’t misinterpret that these hospitalizations were not necessarily caused by the recently received vaccines:

New discussion points have also been added to the Reports involving death, highlighted and underlined for our mandatory attention. It is also now pointed out that there were cases of Covid-19 with fatal outcome, and that Covid-19 was a leading cause of registered deaths in 2021!

[Note: Philippines Statistics Authority (PSA) reports 2.4x higher deaths from C-19 (confirmed and suspected) than Department of Health (DOH), in still preliminary data. In 2021, as of 27 August 2022 DOH reported 43,782 C-19 infection deaths, whereas PSA reported 105,723 deaths (74,008 C19 virus identified, and 31,715 C19 Virus not identified, released 29 March 22, data collated as of 31 Jan 2022)].

Page 23, provides case outcomes. 2.48% fatal outcomes. As concerning are the 8.06% of cases with unknown outcomes.

A new section on risk-benefit is added, concluding that benefits outweigh any current known adverse reactions in the majority of the vaccinated individuals.

What about the minority, FDA? Do they count? How do citizens ensure they will not be part of that growing minority?

These pharmacovigilance reports raise far more questions than they provide answers. It appears that the vast majority of the 106,000+ reports of adverse outcomes have not completed investigations, have no conclusions drawn!

Case rates of priority adverse reactions in the Philippines are suspiciously low when compared to the US VAERS system and Eudravigilance Systems reporting of similar adverse events.

None of the reported deaths have any causes identified or conclusions stated, aside from assurance that they are coincidental to comorbidities.

These reports do not engender confidence. Shouldn’t an independent investigation into the reliability and adequacy of this system be called for?