Philippines FDA Pharmacovigilance Reporting on Suspected Adverse Reaction Following Covid-19 Vaccination at 6 August 2022. Comparison with US VAERS Reporting! Mass Under Capture of Events is Evident.

105,897 reports have been made, including 9,426 serious events with 2,620 deaths. Only 19 adverse reactions have been assessed as product related, and no causal link with any deaths is acknowledged.

Deaths as reported adverse reactions to the Covid-19 vaccines have hit the news in the Philippines today after the PAO hearing on CHED’s mandated Covid-19 vaccines for college students earlier this week, which I reported on earlier this week.

The Philippines FDA has been producing weekly reports on suspected adverse reactions to Covid-19 vaccines since 4 April 2021. After 26 June 2022 the reports changed to every 2 weeks, and they will become monthly starting in October 2022.

The latest available report is dated 6th August 2022; the 20th August 2022 report has not yet been released!

US Vaccine Adverse Event Reporting System (VAERS)

Before I deep dive into the Philippines FDA’s weekly reports, I would like to give my readers a summary from the US VAERS Systems to bear in mind as a comparison for what is NOT being reported in Philippines.

Here is a comparison of vaccine and booster doses for US and Philippines. Philippines has about 63% of its population (139 doses/100 people) with completed initial protocol vs. US with about 67% (182 doses/100 people). The Philippines population is approximately 1/3 of the US. Philippines booster dose uptake are far lower than US Uptake.

As a super rough guide, I would expect that adverse reactions reported in Philippines, assuming similar event capture rate would be somewhere between 1/4 to 1/3 of that in the US. Ie. the US rates should only be 3 to 4x higher than Philippines rates.

Here is the latest US VAERS summary. Note that the VAERs system is KNOWN to under capture actual adverse events somewhere in the range of 40x for severe events, and more than 100x for milder reactions.

Philippines Reports of Suspected Adverse Reaction to Covid-19 Vaccines

The latest reports may be accessed at this Philippines FDA site. As of 6th August 2022, the Philippines FDA has received 105,897 reports of adverse reactions (13x lower than the reports captured by the US VAERS).

Presented graphically are the reported AEFI (adverse events following immunization), SAE (serious adverse events), and Deaths over time since start of monitoring.

Presented are the Total Vaccine Doses against Reported AEFI.

The Philippines FDA reports provide an update on the numbers of vaccines delivered and summarize numbers of adverse events. Deaths are not shown in this (or any) table.

The reports discuss adverse reactions under priority adverse reaction categories. I provide a summary, as follows, all with reference to the latest report dated 6th August 2022, and with a comparison against the equivalent US VAERS figures extracted from openvaers, where available.

General Adverse Events to Covid-19 Vaccination in the Philippines

These include outcomes that are either very common and/or have been as given rates / dose in the report:-

• INCREASED BLOOD PRESSURE is stated “to be one of the top adverse reactions to all vaccine platforms”.

  Interestingly this is countered by the referenced recommendations of the Philippines Heart Association and Philippine Society of Hypertension on elevated blood pressure readings during Covid-19 Vaccination, which state “Transient blood pressure elevations were reported during vaccination, but to date, none are directly attributed to any of the COVID 19 vaccines”.

  Does this mean that heart attack, stroke, or any cardiovascular events seen post vaccination are immediately considered unrelated, disregarded, and not reported?

• HYPERSENSITIVITY INCLUDING SEVERE ALLERGIC REACTIONS are reported to be occurring at a rate of 2 /million doses. This been steadily reducing over time from the initial high of 14.01/ million doses on 25 July 2021, 6.16/million doses on 19 September 2021, and 2.28/million doses on 6 March 2022. Given the current 159 million vaccine doses delivered this would represent 318 cases!

  The US VAERS reports 9,915 cases, 31x higher!

• 4,586 cases of CONFIRMED COVID-19 INFECTIONS have been reported with 247 fatal cases. The report concludes “Upon assessment, these cases were not related to the use of the vaccine, but these were actual COVID-19 natural infections.”

  Irrespective of when any Covid-19 vaccine was received, any Covid-19 case and any covid-19 death are considered by the Philippines DOH and FDA to be unrelated! Even though the vaccines are still being touted as preventative for severe outcomes AND to provide a wall of immunity!

• CASES OF HOSPITALIZATION have been increasing over the monitoring period. Cases increased from 3.53 /100,000 doses in September 2021 to 4.12/100,000 doses by 6 August 2022. This would equate to 6,566 hospitalizations to date. The report states that the most common cause for hospitalization were due to pyrexia (fever), cough, dyspnea (shortness of breath), and headache.

  The US VAERS reports 173,449 cases of hospitalization, 26x higher!

• REPORTS INVOLVING DEATH. The first reports from 4th to 18th April 2021 stated “several” deaths. After that deaths increased with every report, with weekly increases ranging from 2 to 162 cases. As of 6 August 2022, 2,620 fatal events were reported.

  The US VAERS reports 30,347 cases, 11.6x higher!

  While ages of the deceased are provided, there is no breakdown of deaths by brand of vaccine received, nor is any cause of death for these people provided. The report states:

“Underlying conditions or pre-existing medical conditions causing fatal events are usually coincidental on the use of the vaccine. It is expected that reports of fatal events will rise as the vaccination program covers more people including those with undiagnosed illness, underlying comorbidities, and pre-existing medical conditions.”

No doubt a relief for the parents of the 12 children and 41 youth who died (and those of the 331 young adults from 18 to 39), to know that their children must have had an underlying condition that they didn’t know about; that the vaccines were in no way involved in their deaths!

Priority Medical Conditions Related to Covid-19 Vaccination

• 12 cases of THROMBOSIS-THROMOCYTOPENIA SYNDROME have been reported. One case has been assessed as indeterminate (as of 20 Feb 2022, 10 total cases at that time), meaning there is insufficient evidence that the vaccine caused the reaction, while the remaining 11 are being reviewed.

  The US VAERS reports 8,891 cases, 741x higher than 12 cases!

• INFLAMMATION OF THE HEART includes 17 reports of myocarditis and two cases of pericarditis. 3 cases of the myocarditis cases were judged product related (by 24 April 2022, 13 myocarditis + 2 pericarditis at the time), while all other cases are under review. There were already 9 cases of myocarditis and 2 cases of pericarditis as of 2 Jan 2022, all of them under review.

  The US VAERS reports 51,566 cases, 2,714x higher than 19 cases!

• One case of CAPILLARY LEAK SYNDROME was first reported on 25 July 2022, and immediately reported to have been assessed as indeterminate (insufficient evidence that the vaccine caused the reaction). No US comparison is readily available.

• Guillian-Barre Syndrome has 25 reported cases; 7 were judged as product related, 5 indeterminate, and 13 are under review. No US comparison is readily available.

• Bells Palsy cases have been building since 2 January when there were already 22 cases (2 product related). As of 6th August 2022, 7 months later, there were 30 cases; 8 judged as product related, 2 indeterminate, and 18 under review.

  The US VAERS reports 15,853 cases, 528x higher than 30 cases!

• 6 cases of Immune Cytopenia have been reported: 1 product related (as per published literature), 2 judged coincidental, and 3 are under review. No US comparison is readily available.

SUMMARY OF PHILIPPINES AEFI REPORTS

There have been 105,897 reports made to the Philippines FDA as of 6th August 2022.

There have been 91 cases of priority health events documented in the reports as listed above, of which only 19 are admitted as causally linked, while the rest are stated to either not have sufficient information to allow their evaluation (indeterminate) or are still under review; many cases clearly having remained under review for many months with no conclusion reached.

How do we get to only 91 / 105,897 reports having identified diagnoses? How do we get to only 19 poor health outcomes out of 105,897 being admitted as linked, over 16 months? How do we get to no reported assessment on 2,620 deaths?

In comparison to the US VAERS system, the Philippines AEFI system is capturing magnitudes lower events; 13 - 2,714x fewer! Filipinos are surely not immune to the adverse reactions reported by other races. Surely this is evidence of massive under-reporting and under capture of events!

How can we be sure that in depth safety assessments are being conducted; that benefits always outweigh the risks? This is what the FDA state:

This is what the FDA conclude, as they have done in every single report made to date:

These reports feel like window dressing, white washing, minimal nominal compliance with a reporting requirement rather than any real assessment on the biggest experiment ever conducted on the people of the Philippines. This feels like public health failure!

Could an independent review of the safety monitoring be conducted? Don’t the Filipino people deserve better, far better!!