When will Philippines FDA Recognize the Alarm Signal?

FDA has received reports of suspected 94,775 adverse reactions including 2,018 Deaths up to 20th March 2022. They claim there is no alarm signal and that benefits of the vaccines still outweigh risks.

The 20th March 2022 “Reports of Suspected Adverse Reaction to Covid-19 Vaccines” is discussed¹. This makes for interesting reading with 23 pages discussing vaccine doses delivered to various populations, and describing the adverse reactions reported including in pediatric and pregnant / breastfeeding populations.

Page 2, states that adverse reactions are monitored for “signal” to ensure that benefits outweigh risks, and that if a signal were identified it would be investigated, regulatory actions taken, and timely communications made, I assume to all vested parties, including recipients.

Here is a summary of the suspected adverse reactions as reported in Table 1. Quite a considerable number, and actual reactions may be far higher, if under-reporting factors were considered! The EUA vaccines are the common factor in all of these deaths and reactions. I wonder how many Adverse Reactions the FDA would require in order to consider an actionable “signal”?

Here is a summary of the reported deaths. FDA claim that most of these are coincidental and from comorbidities; is that also how they explain the 23 deaths of children between 5 and 17 years of age? We must not discount, however, that the person reporting the death to the FDA surely believed that it was related to the vaccine recently received!

Here is the summary. Although they acknowledge serious adverse reactions, based on this report, the FDA currently see no need to revise their current recommendations for receipt of this product by nearly the entire population of the Philippines including children, pregnant and breastfeeding women, adults, and persons with comorbidities. (Note that the only current non-eligible population are infants and children younger than 5 years old).

What will it take? I would have thought that nearly 100,000 AEs including 2,018 deaths (surely grossly under-reported) should constitute a SIGNAL.

Further, the clear possibility of serious adverse reactions and deaths should also be part of the Informed Consent process for all recipients.

DOH and FDA need to be called to account over this! Their own data appears to be incriminating! Medical professionals need to be fully informed and updated of this information as well!

Please access and read the weekly reports which are public domain. Please share this article widely!

1. Reports-of-suspected-adverse-reaction-to-COVID-19-vaccines-as-of-20-March-2022.pdf (fda.gov.ph)