Philippines April 2023 Pharmacovigilance Report is Out. 112,507 AEFI, 2,816 Deaths Reported. New Conditions of Concern Were Added: Heavy Menstrual Bleeding, Transverse Myelitis, and Encephalitis/ADE.

Vaccine Doses are not updated since March, 2023! No change to recommendations; "benefits in the prevention of COVID-19 and severity of the disease outweighs any currently known AE in the majority..."

Link is provided to the latest April 2023 AEFI report which was released this week.

This report shows has some notable changes / new inputs since the prior report:

1. The total number of vaccine doses administered is unchanged since the March 2023 report. The DOH has stopped tracking doses administered since 19 March 2023.

   

2. There are 112,507 reports of suspected AEFI received. This an increase of 57 reports since March 2023.

3. There are 10,663 reports of serious reactions received. This is an increase of 20 serious reactions since the last report.

4. The report lists 2,801 deaths in the summary Reports of fatal events. No causal like between vaccination and any death is acknowledged, though the summary states a death rate of about 0.002% of total doses administered. The total number of deaths is the same total since February 2023.

   This is incorrect! Once the death breakdown is added, it will be seen that March 2023 had 2,809 deaths, and April 2023 had 7 more deaths bringing the actual total to 2,816 deaths

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   . Of the 20 new serious reactions added in April 2023, 7 (or 35%) were deaths.

5. Three new conditions are added to the conditions that are being tracked and discussed as separate headline conditions. These are: -

   • 6 cases of Encephalitis / Acute Disseminated Encephalomyelitis. 1 of these is judged as product-related, 3 as coincidental, and 1 under evaluation.

   • 28 cases of Heavy Menstrual Bleeding, 9 of these being tagged as serious. Two cases were judged as coincidental, and the remaining are under investigation.

     Looking further in the document under suspected reactions broken down by vaccine types, there are 478 reports of reproductive symptoms listed as e.g. vaginal bleeding, vaginal spotting. Makes one curious as to why the remaining 250 reports hadn’t been considered / investigated.

   • 2 cases of Transverse Myelitis. 1 of these is judged as product-related while the other is under investigation.

6. It is notable that the other headline conditions that are being tracked, despite the 112,507 reports of AEFI, include very few cases, and most cases remain under investigation unmoving over many months.

   • 13 cases of Thrombosis and 1 case of thrombocytopenia syndrome have been listed since September 2022. All are under investigation.

   • 22 Cases of Myocarditis and 3 of Pericarditis are listed under Heart Inflammation, up by 1 case since March 2023. 5 of the Myocarditis are listed as product related), and all other cases are under review.

     Further in the document where events are classified by vaccine types, the inactivated vaccines show 1,037 suspected cardiac reactions, the viral vector show 927 suspected cardiac reactions, and the mRNA products show 858 suspected cardiac reactions. So, of these nearly 3000 reports of cardiac events, there were only 25 possible cases of peri/myocarditis? I suspect that reports of AEFI are tallied verbatim and if a referring doctor does not specifically diagnose a priority condition, then it will not be considered.

   • 1 case of Capillary Leak Syndrome has been shown since August 2022. The initial reports stated cause was indeterminate, though that has been updated to product-related in this April 2023 report.

   • 32 cases of Guillain-Barre Syndrome are listed, up by 2 cases since March 2023. 11 are listed as product-related, 5 indeterminate, 1 coincidental, and the rest are under review.

   • 9 cases of Bell’s Palsy since have been listed since October 2022.

   • 9 Cases of Immune Thrombocytopenia have been listed since October 2022. 5 cases were judged as product related, 1 indeterminate, 1 coincidental, and 2 under review.

7. There is NO change to the conclusions which, as usual, states that benefits in prevention of COVID-19 and severity of disease outweigh risks for the majority of vaccinated individuals.

   

   Both of these assumed outcomes are already demonstrably false! The vaccines never did prevent COVID-19! Accumulating evidence supports that they contribute to rather than reduce disease severity.

Is the Pharmacovigilance System Fit for Purpose? Are these monthly reports fit for purpose?

The pharmacovigilance system was meant to be an early warning system for detection of harm for the mass public vaccination efforts undertaken since March 2021.

It is well known that pharmacovigilance systems are massively under reported for degree of harm. In the US the under-reporting factor for serious adverse events was estimated at 40x, for non-serious reactions far higher.

In the Philippines lack of knowledge about the system, lack of resources to access the system, fear of repercussions for reporting, wide denial of adverse outcomes as vaccine outcomes, would make, I very strongly suspect, the under-reporting far worse than in other locations.

This system also appears to be underfunded. Prior FOI revealed that the FDA had a 3-year budget of only PHP40 Million, incompletely utilized, and a central office staffing of 11 persons. Note that the response includes advice that the DOH have a pharmacovigilance budget, though not details were provided, and I have not found any public information on DOH pharmacovigilance activities.

Is the current system fit for purpose? There has been little investigation of harm as evidenced by the small numbers and unmoving nature of the reports on the priority conditions.

The monthly reports are form reports, stating more or less the same thing every month. Down to the point of not even updating total death numbers in the past 2 reports.

The Philippines FDA has a recall procedure for defective medications and products. This requires only suspicion of harm. There is more than suspicion here, there are adverse events that have been product linked. For any other products, this would have triggered an immediate recall, a halt of products. For these products, this has just triggered silence and cover-ups.

Clearly these vaccine products do not meet pre-existing safety standards! International data (VAERS, VigiAccess, YellowCard, etc) all show massive unprecedented harm!

The current pharmacovigilance system is failing to recognize or even register the evidence of harm that it is clearly documenting.

The FDA have not raised any alarms despite 1000s of deaths and 10s of 1000s of suspected adverse reactions!

The FDA are not following their own investigation of harm and recall guidelines.

Will anyone raise an alarm? What will it take?

1. Shockingly insensitive and careless to fail to total the actual numbers of deaths!