Credit CDC
#15,520
One of the problems with vaccinating millions of vulnerable (i.e. mostly elderly) individuals is that some percentage of them will experience an adverse medical incident - or even die - within days or a few weeks of receiving the flu shot.
This is entirely expected, and most - if not all - of those incidents will have nothing to do with the flu shot.
That said, while the flu shot has an enviable safety record, adverse reactions have occurred; anaphylactic shock - while rare - can be life threatening, and there is a minuscule chance of other adverse reactions, such as GBS (Guillain-Barre Syndrome).
So whether obviously caused by receipt of a vaccine or not - when a cluster of deaths or illnesses are observed following vaccination - an investigation is warranted. And in South Korea, authorities are currently investigating 56 deaths that have occurred within 7 days of receiving the 2020 flu vaccine.
While that may sound bad, it must be weighed against more than 14 million flu shots administered since September. And as the chart above shows, 49 of the 56 reported deaths were in those over the age of 70.
So far, autopsies and investigations have not shown any causality between receiving the shot, and these deaths, although the investigation is ongoing.
Overnight the South Korean CDC issued a statement (see below) on their findings to date:
○ The Korea Centers for Disease Control and Prevention held a quick response meeting for the damage investigation group on October 25, and the vaccination damage investigation group judged the causality of vaccination for 20 additional death cases.
-There was no anaphylaxis that showed symptoms acutely after influenza vaccination, and all 20 cases were checked for adverse reactions in the same medical institution, the same date, and the same serial number, and as a result, mild adverse reactions that may appear after vaccination (pain at the vaccination site, etc.) ) There were no serious adverse reactions other than the case, so it was judged that the possibility of abnormal vaccine or errors in the vaccination process was low.-In addition, as a result of reviewing the results of basic and epidemiologic investigations, autopsy results, etc. for each case,
① no findings presumed to be adverse reactions of the vaccine in the death case,
② underlying diseases (cardiovascular disease, cerebrovascular disease, diabetes, 46 cases reviewed so far due to the high likelihood of death due to exacerbation of liver cirrhosis, arrhythmia, chronic lung disease, malignant tumor, etc., and other obvious causes (aortic dissection, cerebral hemorrhage, pulmonary thromboembolism, etc.) In both cases, the causality between death and vaccination was very low, so it was judged that it was not the stage to consider retesting the vaccine or discontinuing the national vaccination project.
-The number of vaccines related to death cases reported up to the previous day is 37 serial numbers of 7 manufacturers, of which 14 have more than two death reports from the same serial number. The damage investigation team will review the case of two or more serious adverse reactions (death, etc.) that cannot exclude the causality of vaccination among vaccination cases with the same serial number for re-validation or sealing (suspension). It was judged that this was not the case.-Therefore, it was judged that the causality was low for 46 of the total 59 cases reported as death cases up to the previous day, and the damage investigation team meeting was held as soon as the epidemiological investigation was completed for additional cases reported including 13 cases being investigated It was held to judge causality.
For now, South Korea continues with their flu vaccination campaign, although that could change if the evidence shows causality.
Meanwhile, in Singapore - out of an abundance of caution - their MOH has temporarily suspended the use of two imported vaccines from South Korea.
TEMPORARY CESSATION OF USE OF TWO INFLUENZA VACCINES
25TH OCT 2020
The Ministry of Health (MOH) is advising that use of two influenza vaccines – SKYCellflu Quadrivalent and VaxigripTetra – should be temporarily ceased. This is a precautionary measure following reported deaths after influenza vaccination in South Korea. No deaths associated with influenza vaccination have been reported in Singapore to date. MOH and the Health Sciences Authority (HSA) are monitoring the situation closely.
2. HSA is in touch with the South Korean authorities for further information as they investigate to determine if the deaths are related to influenza vaccinations. Based on information released by the South Korean health authorities, seven brands of influenza vaccines were administered to the individuals involved in the deaths reported in South Korea. Of the seven brands, two are available in Singapore. They are SKYCellflu Quadrivalent, manufactured by SK Bioscience and locally distributed by AJ Biologics, and VaxigripTetra, manufactured by Sanofi Pasteur and locally distributed by Sanofi Aventis.
3. As a precautionary measure while HSA is assessing the implications of the reported deaths in South Korea, MOH has informed healthcare providers and medical practitioners to temporarily stop the use of these two vaccines. Healthcare providers and medical practitioners may continue to use the two other influenza vaccines that have been brought into Singapore for the Northern Hemisphere 2020/21 influenza season. MOH and HSA will assess the situation as more information becomes available and further advise on the use of the affected vaccines.
4. Persons recommended to receive the influenza vaccination, including those recommended under the National Childhood Immunisation Schedule (NCIS) and National Adult Immunisation Schedule (NAIS), may continue to receive their influenza vaccination using other brands of influenza vaccines. Influenza vaccination provides protection against seasonal influenza viruses, and is effective in reducing the risk of complications and deaths due to influenza. This is especially so for vulnerable groups such as the elderly, the young, pregnant women and those with certain pre-existing medical conditions.
5. Influenza vaccination is generally safe and well tolerated. Like any medicines, vaccines can cause side effects. Common side effects from influenza vaccination may include soreness and redness at the injection site, fever, headaches, muscle aches, fatigue and nausea. These side effects are generally mild and resolve on their own. In rare instances, a person may experience high fever or severe allergic reactions (such as breathing difficulty, wheezing and swelling around the eyes) and immediate medical attention should be sought.
6. Vaccines approved for use in Singapore have been evaluated by HSA to ensure that they meet the required international standards of quality, safety and efficacy. To ensure that the benefits continue to outweigh the risks, HSA monitors the safety of vaccines through an adverse event monitoring system. It draws on the network of local healthcare professionals and international regulatory counterparts to pick up adverse events suspected to be associated with the vaccines.
7. MOH and HSA will continue to monitor the situation closely for any concerns related to influenza vaccination and keep members of the public updated on new developments.
MINISTRY OF HEALTH
HEALTH SCIENCES AUTHORITY
25 OCTOBER 2020
As you might expect, the anti-vaccine contingent on the internet are using these reports to their advantage - offering it as further `proof' that flu vaccines are deadly - even though no evidence of causality has been provided.
With a COVID-19 vaccine likely to be rolled out sometime next year - and likely targeting an equally vulnerable population - it doesn't take much of an imagination to predict that similar stories will emerge during the opening weeks and months of that vaccination campaign.
Every death, every adverse reaction in a vaccine recipient - whether related to the jab or not - will become national news and fodder for endless internet debate.
Last August, in Remembering An Emergency Pandemic Vaccine Program That Went Awry, I wrote (see below) about my minor involvement with the ill-fated 1976 Swine Flu vaccination campaign, and the chilling effect that several media stories of `suspicious deaths following vaccination' had on the program.
Then the first reports of suspicious deaths, and a strange form of paralysis made the paper.
Three people dropped dead in Philadelphia shortly after receiving the injection, although it was never clear that the shot was responsible. Nevertheless, the newspapers had a field day.
Gerald Ford, in an attempt to reassure the nation, rolled up his sleeve on national TV to get the shot.
But the seeds of mistrust had been sown. Fewer and fewer people showed up to get their shot.
The vaccine was blamed for a number of deaths, and cases of Guillain-Barre Syndrome (a form of paralysis). The fear of the vaccine was exacerbated by newspaper speculation.
But the truth is, we were vaccinating a lot of elderly people, and many of their deaths, while attributed to the vaccine in the press, were likely due to other causes.
Since the feared pandemic virus never showed up, and vaccine uptake had plummeted, the emergency campaign was unceremoniously canceled in early December of 1976.
Overall, the incidence of Guillain-Barre Syndrome from the flu shot was estimated somewhere around 10 out of a million vaccinations. Or about five times higher than the background level of this disease.
This was 44 years ago, when people still got their news from evening TV newscasts and newspapers. Before 24 hour cable news, and a full 20 years before the internet revolution. Today, a single story can be amplified a thousand times with a simple re-tweet.
While I have reservations over `Operation Warp Speed', and will need to see real evidence that any COVID-19 vaccine is both safe and effective, a successful COVID-19 vaccine could end this pandemic much sooner, and with fewer losses.
Whether and how that can be accomplished in this rancorous and divided internet age, however, may be the greatest vaccine challenge of all.
