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Philippines FDA Issues CPR for Pfizer Comirnaty. This product is now "approved" for use in the Philippines and may be imported and sold.
This approval comes despite the FDA's data showing 23,417 reports of suspected adverse events following vaccination, 2,913 of these serious (possibly including 770 deaths), up to the end of May 2023.
The FDA has issued CPR for Comirnaty. It now will treated as a regular product for commercial procurement and sale in the Philippines Market.
This explains why Herbosa is already willing to finally lift the state of public health emergency, as he stated during an ambush interview on Monday 26 June 2023. The ability to continue use of Comirnaty products is now in place.
The State of Health Emergency was declared under Proclamation 922 issued on 9th March 2020. The Proclamation stays in effect until lifted or withdrawn by the president. It has not yet been lifted despite the WHO declaring the end of the public health emergency of international concern last May 2023.
Somewhat cynically, I wonder if the FDA recall procedures for products which have adverse health outcomes will also be followed for the Comirnaty product.
To date, no alarm signal has been recognized through the Philippines Covid-19 Vaccines pharmacovigilance system as of May 2023 despite there having been overall reports of 112,644 suspected Adverse Reactions, 10,709 of them serious and including 2,826 deaths.
The now approved Comirnaty product has had 23,417 reports of suspected adverse reaction, 2,913 (12.4%) of these serious. If proportion of reported deaths is in line with the overall deaths as 26.4% of serious reactions, this could represent 770 reported deaths. The actual numbers of death reports attributed to each product are not revealed in the monthly reports and have not been revealed despite FOI request.
Was the FDA’s own pharmacovigilance system and these reports considered or fully investigated as part of the approval process?
How many reports of harm, how many reports of deaths will it take? Will the persons approving this product be held responsible if it is found that their approval did not take into account all of the public domain data relevant to that decision?
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