The CDC, by means of its publication MMWR (Morbidity & Mortality Weekly Report), just released data on the first 30 days of vaccine safety monitoring of the two presently available vaccines (Pfizer’s and Moderna’s) for COVID-19. The information came from two sources: VAERS (Vaccine Adverse Event Reporting System) and V-safe. VAERS is a national vaccine surveillance system that accepts reports of potential adverse events due to a vaccine from health care providers, vaccine manufacturers and the public. Serious events are followed up by the program and usually entail a review of medical records, reports from healthcare providers and evaluation of any other materials. V-safe is a special, voluntary reporting system that the CDC established for people who have received a COVID-19 vaccine. participants take a daily survey on their smartphone for the first week after vaccination. If they had to seek medical care, they are contacted and a VAERS report is filed. Although the reporting systems are not comprehensive, they do give a reasonable amount of information for analysis.
Why are we looking at this information? It is important to see how published studies can be misinterpreted and used to justify conclusions that are absolutely wrong.
When you look at the CDC report, it is important to realize that you are only looking at accounts of events reported to VAERS and V-safe, and many, if not most of these occurrences, have already been reported in the clinical studies where their incidence was compared to those events in a group of people who received a placebo and not the vaccine. Without knowledge of this comparison, and only the information found in VAERS and V-safe, one could erroneously conclude that the vaccines lead to significant serious adverse events. Consequently, I am sure that there will likely be a few media postings that will misinterpret the CDC’s report.
Between mid-December and mid-January, close to 14,000,000 doses of the vaccines were given. The first encouraging set of results is that the total number of reported adverse events, as a reflection of the number of doses given, was only 6,994, or a 0.05% incidence.
Of the number of adverse events reported, ~91% were not considered serious and only 9% were considered serious. The vast majority of the non-serious symptoms had also been noted in the clinical trials - such as headache, fatigue, muscle and joint aches, fever and chills which all occurred within a day of each shot and were very short-lived.
Of the 640 serious events reported, 113 were deaths and 527 were other conditions. It is to be noted that VAERS and V-safe define a “serious adverse event” as one of the following: death, life-threatening illness, hospitalization or prolongation of hospitalization, etc. If we look at both the Moderna and the Pfizer study two things are apparent: 1. Serious adverse events were practically no different in the vaccine vs. the placebo groups; 2. If we look at the clinical study results and apply the percentage of serious adverse events to the number of doses the VAERS and V-safe data encompass, the outcome is that significantly far fewer serious events have been reported during the vaccine implementation phase versus the study phase. Again, just looking at the CDC report and not at any of the clinical trials data gives a totally skewed impression of the safety of these vaccines.
The press has already reported on the number of deaths noted in the CDC report, but neglects to say that in the Pfizer clinical trials there were 2 deaths in vaccine recipients and 4 deaths in the placebo recipients’ group; in Moderna’s clinical trials there was 1 death in a vaccine recipient and 2 deaths in a the placebo recipient’s group. In both cases these were well within the expected number of deaths occuring over that time in the general population. If we look at the CDC report from a different perspective and do a proportion of the number of doses administered and deaths within the following 1 month this figure shows a death incidence of only 0.0000819%. Again, looking just at VAERS and V-safe numbers a very different, erroneous impression can occur. Normally, the number of deaths in the U.S. is ~776 per million people during each of the months of December and January. Based upon this, the number of reported deaths in vaccine recipients appears to be far below the expected number in the general population during those months. Another important point is that of these 113 observed deaths, just under two thirds occurred in people who resided in a long-term care facilities (LTCF) - one half of these occurred in residents who were in hospice care or had a “do-not-resuscitate” status. Another one quarter of those LTCF residents who died after vaccination had heart disease, dementia, pneumonia, or failure to thrive listed as causes of death.
One final point is that those fatalities that were reported in people who were not living LTCF, a little less than half of were found to be in people who had underlying cancers, heart disease, strokes, pulmonary problems, or frail health – all predisposing causes to a sudden death. So, I would have to say that the presently reported data does not support a causal relationship of vaccination with a subsequent demise, since the numbers are still far below what is expected in the non-vaccine recipient population.
The other important observation from the data is that the risk of anaphylaxis (a serious allergic reaction) is not at all out of the range that one would expect with any vaccine. It was reported as 4.5 incidents per million doses; for instance, as reported by the CDC, the anaphylaxis rate with Influenza vaccine is 1.4 per million doses administered; with the pneumonia vaccine 2.5 per million; and with the shingles vaccine 9.6 per million doses administered.
We know, from the clinical studies, that the most commonly reported side effects are injection site pain (~75+%), fatigue (16.5%), headache (22.4+%), muscle aches (~30%) and chills-(~20+%) - more commonly seen the day after vaccination, short-lived and more likely after the second dose. Fever and chills were more often reported after the second Pfizer dose than after the first, and this, too is the case with Moderna’s vaccine. The CDC report bears this out and none of the side effects are of a greater magnitude than seen in the studies.
So, what does this CDC report tell us then? Most of the reactions are non-serious and reports of serious events appear to be consistent with what was seen in the placebo group of the studies. Will this data change as we continue to monitor and observe those who have received the vaccine? It could, particularly as newer vaccines are added. However, we now have one month’s worth of data for vaccines that have been given under “everyday” conditions and not under the strict conditions of a rigorously controlled clinical study…. and they look very good. Waiting and watching for additional information is not worth the risk of contracting COVID-19. Do the math; there were only ~6,350 non-serious adverse events after ~13,800,000 vaccinations and only 640 serious adverse events after ~13,800,000 vaccinations!
Remember, “The best vaccine to get is the one you can get now, not the one you wait for later!”