Estimation of Possible AEFI Underreporting Factor in the Philippines [REVISED]

Under reporting of deaths following covid-19 vaccination in the Philippines may be by a factor of at least 126. This could explain much of the observed excess deaths since the March 2021 rollout.

The Philippines has used 7 vaccines with the following breakdown: Pfizer - 37% (3.3 reported serious AE/100,000 doses), non-MRNA Coronavac - 30% (6.8 reported serious AE/100,000 doses), AstraZeneca - 14% (7.6 reported serious AE/100,000 doses), Moderna - 12% (3.4 reported serious AE/100,000 doses), and Jansen - 5% (13.2 reported serious AE/100,000 doses), Sputnik and Sinopharm together - 1% (5.4 reported serious AE/100,000 doses). From the reports Jansen had the most AEs, followed by Astrazeneca and then Coronavac. The mRNA vaccines had relatively fewer reports at 3.3 and 3.4 / 100,000 doses for Pfizer and Moderna.

There are three Covid-19 Vaccines Licensed in the US; Pfizer, Moderna, and Jansen. I have not yet found a breakdown of the relative distribution of vaccine type for the population.

Australia has used Pfizer, Astrazeneca, Moderna, and recently Novavax. I have also not found a breakdown of relative distribution of vaccine types.

Internationally, it is known that serious AEFI and deaths are underreported to the US VAERS system by a magnitude of at least 41, possibly 42.3 and likely even more than 100x for milder reactions.

There is no estimation available for the under reporting factor in the Philippines. I believe it will be far higher than in other locations. Factors affecting AEFI reporting include:-

• Lack of knowledge that the reporting system exists;

• Lack of access to computer and/or internet facilities;

• Lack of skills to make an on-line report;

• Refusal of medical professionals to acknowledge injuries and deaths as being related to covid-19 vaccination, and thus active dissuasion and/or refusal to make reports;

• Fear of possible consequences / singling out of victims and their families if a report is made;

• Apathy. It doesn’t matter if I report, nothing beneficial will happen as a result!

It is very important to estimate the magnitude of under reporting, even if imprecisely, to understand the consequences of the population wide covid-19 vaccination campaign. This may help in understanding the causes of observed excess deaths.

To assess a possible Philippines under-reporting factor, I looked at number of doses delivered in Philippines vs. US, and compared the Philippines Reporting System to the VAERS reporting system (total reports and deaths).

The Philippines FDA reporting system for reporting a suspected adverse reaction following covid-19 vaccination is relatively easy to use. One simply clicks the online link and answers questions with regards to the vaccination event and the following adverse reaction. Later the pharmacovigilance team will send an email asking for scanned copies of the vaccine card, death report, and any hospital records. A case number will be assigned.

In 2022 the Philippines has an estimated population of 112.508 Million. As of 29 May 2022 her people have been given 150,398,670 doses of covid-19 vaccines and have reported 101,156 adverse reactions which included 8,243 serious reactions, of which 2,380 were deaths.

The US is estimated to have a population of 334.805 million. As of 27 May 2022, the US VAERS system has captured 1,287,593 C-19 Vaccine Adverse Events (60% of all AE since VAERS started in 1986), and 28,532 reports of deaths (75% of all reported deaths since VAERS started). 587,866,188 doses of covid-19 vaccine have been administered.

Australia is estimated to have a population of 26.068 million. Their TGA system, as of 9th of June 2022, has captured 129,995 Adverse Reaction Reports which included 885 deaths with the delivery of 59,531,403 doses of covid-19 vaccines.

While the dates are not exactly matching, they are close enough for comparison purposes. Here is what the gross numbers look like:-

Of the 3 countries Philippines has given its citizens the fewest doses per person at 1.34, while Australia has delivered the most at 2.28 doses for every person.

Australia and the US report similar rates of AE at 2.2 reports per 1000 people, while the Philippines has only received 0.7 reports per 1000 doses (3.25x fewer reports).

The US reports much higher death rates at 4.9 per 100,000 vaccine doses than Australia and Philippines which both have received reports of approximately 3.1 x fewer deaths at only 1.5 and 1.6 deaths per 100,000 doses.

Interestingly, Australia has approximately the same rate of overall AE reporting as the US but far lower reported death rates. Excess deaths in Australia are currently well above historical levels so it will be telling to observe the relationship over time between excess deaths and vaccine doses.

Philippines all cause mortality data is not up to date later than about November 2021, thus the plunging excess death rates shown at the end of the year and into 2022 in the figure below must be disregarded for now.

To give an estimate of under reporting in the Philippines. I compared the reported death rate / dose in US VAERS vs. the reported death rate / dose in the Philippines. The Philippines has 3.1 times fewer reports. If multiply this by 41, which is the known minimum underreporting factor for VAERS. Potentially 41 x 3.1 = 126x under reporting factor. If I multiply it by 42.3, another underreporting estimate, I come up with 130x underreporting factor. While not yet validated this does give some possible indication of the magnitude of the possible underreporting here.

US and Australia have relatively advanced health care systems compared to the Philippines which offers mostly rudimentary care outside of the major urban centers. Many people in the Philippines also avoid accessing health care due to cost; a hospital bill can take a family from surviving comfortably to abject poverty. Thus serious AEs in the Philippines may not be (able to be) effectively treated and the outcomes may be expected to worse than in countries with better access to emergency / critical care. I cannot even begin to estimate the magnitude of this effect.

As of 28 November 2021, the Philippines FDA had received reports of 1,538 deaths. If this is multiplied by the 126 factor, a total possible deaths following immunization is 193,564. If we look at 2021 excess deaths as of 31 November 2021, it is 232,660 (shown graphically in the figure below); very similar.

I suggest that adoption of a minimum under reporting factor for the Philippines of 126 could be used to assess possible actual deaths following vaccination and to predict probable minimum excess mortality.

The 2,380 deaths reported to Philippines FDA as of 29 May 2022, if multiplied by 126 could suggest 299,533 vaccine (excess) deaths. If this holds true, when population all cause mortality data will continue to rise. Further, as there is a lag between receipt of a vaccine, the occurrence of an AEFI and it being reported, the underreporting factor may still be higher than this preliminary estimate.

Now we wait for PSA to release their population data so that this theory may be validated!

May God Save the Philippines!