December 2022 Pharmacovigilance Report Released: 111,639 Reports of AEFI,10,482 Reports of SAE including 2,786 Deaths.
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December 2022 Pharmacovigilance Report Released: 111,639 Reports of AEFI,10,482 Reports of SAE including 2,786 Deaths.
FOI revealed Pharmacovigilance Budget of PHP40.53 Million, incompletely utilized from 2020 to 2022. This contrasts with Covid-19 and Covid-19 Vaccinations Campaign Budget of PHP625 Million for 2021.
New Pharmacovigilance Report released today. Since November 2022 +593 new reports of AEFI, +141 new reports of SAE which include 26 New Deaths.
In December 2022 there were 811,541 doses of vaccines given. 95.4% of these were Pfizer, 4.6% of these were Coronavac (Sinovac), and less than 200 remaining doses split between all other brands, with some minor negative adjustment for some prior reported doses.
Deaths are reported separately in another section of the document.
Hospitalization rates rose from 4.30/100,000 doses in November to 4.34 in December. Average age of deaths dropped from 59.22 to 59.15 years of age, indicating that the deaths include younger persons.
No new Covid-19 infections or deaths from Covid-19 were reported in December 2022.
There was little to no movement on any of the few cases of reported priority outcomes: thrombosis-thrombocytopenia syndrome, bells palsy, heart inflammation etc.
Similar to all prior reports, the report still concludes that benefits outweigh any current known adverse reactions in the majority.
The overall risk-benefit evaluation simply paraphrases the summary with no details provided.
How much budget has the FDA had assigned for Pharmacovigilance activities?
A just released response to FOI request revealed that the FDA has a Covid-19 Pharmacovigilance budget of PHP40.53 million over 3 years, with 11 personnel provided for processing and evaluation of AEFI. This budget has not been fully utilized (62 - 83%). Note though that regional field offices have their own personnel (numbers of persons not disclosed), and the DOH have their own budget (not disclosed) so actual budgets and personnel will clearly be higher than those shown.
This contrasts with the FOI disclosed DOH 2021 Covid-19 and Covid-19 Vaccines Campaigns Budget of just over PHP625 Million, more than 15 times higher that of the 3-year pharmacovigilance budget.
Does this say anything about priorities? Safety vs. pushing the products! Clearly marketing is the priority!
December 2022 Pharmacovigilance Report Released: 111,639 Reports of AEFI,10,482 Reports of SAE including 2,786 Deaths.
P625M vs P40M! It's very disheartening that marketing efforts for the covid injections are being paid for 15x more by Filipino taxes than by studying its negative effects on the Filipino population. With only 11 personnel for pharmacovigilance efforts and low fund utilization, it's very likely that they have missed a lot. The number of adverse events could be so many times more than what is reported.