Dr. Dalmacion’s Rejoinder to the UP Manila statement Re: Safety of Covid-19 Vaccines

Godofreda V. Dalmacion MD, epidemiologist, Retired Professor, Dept. of Pharmacology, College of Medicine, University of the Philippines Manila (published with her permission)

Apologies to my former colleagues at the Dept. of Pharmacology and Toxicology but in the interest of fairness and truth – I really have to react to your very bold statement that the benefit of the COVID-19 vaccines outweigh their risk. It was said so confidently that  it gives me the creeps without seeing any estimates.

The safety of the vaccines especially with the new platform remains uncertain and contentious (1).  Adverse event (AE) is a function of number and duration of exposure. Why?  Because toxicities can occur after a latent period and the effects of epigenetics play a role such as in male infertility, autoimmune disorders, cancers and other mutagenic effects. With the COVID-19 vaccines, AEs vary  based on age, e.g. clotting more in young females and myocarditis and pericarditis among young men 14-24 years old. Please refer to VAERS. 

Secondly, vaccine-related toxicities are questions of excess risks, for example the background incidence of pericarditis is almost 0 in the normal young, so even 1 case after vaccination is significant and morally unacceptable.

Third, ALL the COVID-19 vaccines are under EUA and still under Phase 3 and thus incompletely studied. The Sample size of RCTs i.e. Pfizer are underpowered to determine efficacy, more so safety. Multi-country studies such as Pfizer’s vaccine trials are  methodologically flawed because the risk for COVID-19 across different countries are different.

Fourth, Pfizer study published in NEJM has only  18556  / 21720 evaluable  cases under the vaccine arm because 100 withdrew, 304 did not receive dose 2 , 62 were lost to follow-up, 28 had AEs, 2 withdrew and 1 died etc etc– all unfavorable information.

Fifth. The attributable risk reduction from vaccination based on the Pfizer study is only  0.733%. Epidemiologists planning on a public health intervention do not use RRR (relative risk reduction) but ARR (attributable risk reduction) and NNV (number needed to vaccinate). It is self-serving and misleading to use 95% relative risk reduction to describe the efficacy of  the vaccine. RRR only compares the reduction of risk of one who got the vaccine relative to the CONTROL IN THE STUDY, NOT the population.

Lastly, DOH data itself shows  a Case Fatality Rate of 1.74 % and  cases that are  mild and asymptomatic account for 96.5% of cases . Good Lord, maski hindi ka mag-vaccine ang baba ng risk for severe disease and hospitalizations mo from the infections! Thus the threshold for AE from the vaccines should be very, very low and the clotting, neurologic, cardiovascular and hematologic  adverse effects are theoretically unacceptable. Meantime, where are the cases overwhelming the hospital capacity coming from if only 4.5% of cases based on the DOH tracker is essentially severe? Maybe the Department  of Pharmacology  can explain the metrics and release a full discussion of their benefit:risk ratio calculation.

To all PLEASE  do not reduce discussion of alternative opinions TO AN ANTI-VAXXER ISSUE because it is cowardly and unprofessional. Thanks .

1) Jiang, S. Don’t rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees. Nature. (16 March 2020)

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