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On July 23, 2018, my local Duluth, Minnesota TV news teams reported the following short bit of information that they had received from Essentia Health’s media relations folks. Essentia admitted that their clinic’s varicella (live chickenpox virus) vaccines and ProQuad inoculations (= MMR [live measles, mumps, rubella viruses plus varicella]) had been injected into a number of pediatric patients over an unspecified period of time. Essentia had discovered that the inocula had been stored at an “improper temperature”. The parents of the patients had been urged by a separate letter to return for a repeat shot of the live virus vaccine.
I checked Essentia’s website and found no clarification of the brief bit of information that had been reported on TV, so I decided, in the interest of providing the information that patients are supposed to be given before giving their consent to being injected with a potentially hazardous group of substances, I went online to get it for them through this column. After doing my research, I obtained the following information, some of which I will comment upon below.
1) Essentia Health Duluth Says Certain Vaccines Were Improperly Stored at Duluth Clinic
The Hospital is Unaware how Many Children are Affected
From www.kqdsfox21.com - July 24, 2018
DULUTH, Minn. – Pediatric patients who received two types of vaccines at the Essentia Health-Duluth Clinic may need to return for a second round due to improperly stored doses.
According to a letter sent out to parents, the vaccines at the clinic were not stored at the manufacturer’s recommended temperature.
Essentia is recommending that patients who received a dose of Varicella or Proquad return to the clinic to receive a second dose so they can ensure the children are fully protected against illnesses.
Essentia says they are unaware how many children, if any, received a dose of the less-than-optimal vaccines.
Proquad vaccinations protect children against measles, mumps and rubella while Varicella is a vaccine that protects against chickenpox.
The hospital says they have put measures in place so this type of incident does not occur again and that no children have experience any ill effects from the earlier vaccine.
[Ed note: the ingredients in the chickenpox virus portion of each vaccine need to be stored at freezing temperatures until immediately before the inoculation or else it must be discarded as useless. Merck has provided no information as to why or if administering a thawed vaccine is either useless of dangerous. See immediately below for information on the (surprising) ingredients in the two shots (2), the (potentially serious and frequent) adverse effects of the shots (3) the (unaffordable) costs of the two shots (4)] and the recent sudden deaths of two infants in Samoa who died within minutes of being inoculated with their routine MMR shots (which are widely advertised as being “safe and generally well-tolerated” (5).
2) Data on Merck’s Varivax (varicella/chickenpox) and ProQuad (MMR + varicella) vaccine
Merck’s ProQuad vaccine contains sucrose, hydrolyzed gelatin, urea (refrigerator stable formulation only), sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate, recombinant human albumin, sodium bicarbonate, potassium phosphate, potassium chloride, components of MRC-5 cells, including DNA and Protein – see# 1 below), neomycin, bovine serum albumin (see # 2 and # 3 below), other buffer and media ingredients, sodium phosphate dibasic (frozen formulation only), potassium phosphate monobasic (frozen formulation only), potassium phosphate dibasic (frozen formulation only)
1) MRC is Medical Research Council 5, human diploid cells (containing two sets of chromosomes) that were derived from the normal lung tissues of a 14-week-old male fetus aborted for “psychiatric reasons” in 1966 in the United Kingdom,
2) Bovine serum is the centrifuged fluid component of either clotted or defibrinated whole blood. Bovine serum comes from blood taken from domestic cattle. Serum from other animals is also collected and processed but bovine serum is processed in the greatest volume.”
“Bovine serum is a by-product of the meat industry. Bovine blood may be taken at the time of slaughter, from adult cattle, calves, very young calves or (when cows that are slaughtered are subsequently found to be pregnant) from bovine fetuses. It is also obtained from what are called ‘donor’ animals, which give blood more than once.
3) Fetal bovine serum is blood taken from bovine fetuses only because some female animals that are slaughtered for meat for human consumption are found (often unexpectedly) to be pregnant.
3) Adverse effects of Merck’s Varicella live virus vaccine (Varivax) and Merck’s ProQuad (MMR + Varivax)
“In addition to fevers over 102F (15% incidence), pain and swelling at the injection site (19% incidence) and, generalized or localized chicken pox rash (3.4%), adverse events occurring at an incidence rate of over 1% are, in decreasing order of frequency: upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching. Pneumonitis has been reported rarely.”
4) Comparative costs of a single shot of ProQuad, Varivax, MMR and Gardasil-9
According to the CDC, a shot of Merck’s ProQuad costs $202.41; a shot of Merck’s Varivax costs $122.02 and a shot of Merck’s MMR costs $70.92. (And, incidentally, a single shot of the likely to be useless for cancer prevention (HPV) human papillomavirus vaccine, Merck’s Gardasil-9, which was initially marketed for the prevention of cancer of the cervix 20 – 30 years hence!) costs $204.87. These fees do not include the costs of an office call or any possible administration fee!!
5) Two babies die in Samoa hospital minutes after receiving MMR vaccinations; Investigation underway
July 12, 2018
The Samoan Government has seized the MMR (Measles, Mumps and Rubella) vaccine from around the country and launched an investigation following the deaths of two babies last Friday.
The first baby, a 1-year-old girl, died within three minutes of being injected by the vaccine by a nurse at Safotu Hospital in Savaii.
Two hours later, another family brought their baby, a 1-year-old boy, to the hospital for his vaccination.
According to TV1 Samoa, when the family heard about the first death they refused to let their son be vaccinated but allegedly the nurse did it without the parents’ consent.
He died within a minute of being injected.
The Ministry of Health CEO Dr Take Naseri has ordered the immediate withdrawal of the vaccine and all hospital staff involved have been stood down.
Prime Minister Tuilaepa Sailele Malielegaoi has sent his condolences to the families and says he has called for a full inquiry into this “devastating incident”.
“There are already processes that will determine if negligence is a factor - and if so, rest assured, those processes will be implemented to the letter to ensure that such a tragedy will not be repeated and those responsible will be made to answer,” he said.
Note: The MMR vaccine is recommended for all children in New Zealand, and the Ministry of Health says it has an “excellent safety record”.
6) Inquest in Samoa to determine cause of death of two babies
https://www.radionz.co.nz/international/pacific-news/361972/inquest-in-samoa-to-determine-cause-of-death-of-two-babies - July 13, 2018
An inquest next week in Samoa will further investigate the cause of death of two babies who died minutes after receiving the MMR vaccine at Safotu district hospital, the police say.
Police said samples from the post mortem of the two infants had been sent overseas for further medical analysis.
Meanwhile, the Samoa Medical Association has expressed grave concern about the deaths.
The association’s president, Tanyamarie Petaia, said she believed health care providers in Samoa had an astronomical task ahead in regaining people’s confidence in the safety of the health service.
The continuation of the expanded immunisation programme was of particular concern, Dr Petaia said.
The association joined all Samoan health care professionals and providers in expressing sincere apologies for inadvertently causing pain and sadness to the families of the two deceased infants, she said.
7) Samoa Halts MMR Vaccine Program Following Death of Babies
Samoan government officials have launched an investigation into the deaths of two one-year-old infants. The babies were brought to Safotu Hospital in Savai’i and given “routine” MMR vaccines. They died within minutes of receiving it.
(The) Samoan Prime Minister expressed condolences following the news. He also stated “I have called a full inquiry into the circumstances leading up to this devastating incident which I do not
8) China to investigate vaccines after safety problem
By Preetika Rana - July 23, 2018
HONG KONG--Chinese Premier Li Keqiang called for a government investigation into “the entire process chain of all vaccine production and sales,” after a drug company allegedly sold more than 250,000 doses that failed to meet safety standards.
Shares of major local vaccine makers, including a Merck & Co. partner, tumbled Monday after Mr. Li’s statement was released a day earlier. He didn’t elaborate on what more his government would do to investigate.
Mr. Li’s investigation was sparked by public outrage against Changsheng Biotechnology Co., a large vaccine maker based in Jilin, a province in Northeast China. Earlier this month, the national drug regulator said Changsheng fabricated production records of a rabies vaccine. The company said it suspended production of the vaccine, pending the results of an investigation. It said none of the batches in question were shipped.
Then a week ago, Changsheng said a separate investigation conducted by Jilin’s food and drug authority showed that 253,338 doses of another vaccine--administered to protect against diphtheria, pertussis and tetanus--failed to meet safety standards. Most of the doses, the company said, were sold to the government of Shandong province. Authorities in Jilin province fined it $380,610 and seized $126,683 worth of assets from sales of the vaccine, the company said.
Authorities in Beijing have recently tried to clean up the world’s second-largest drug market by sales, after a series of safety scandals--involving drug ingredients, milk and infant formula--led to deaths and angered the public. The latest incident touched a nerve.
Anger on Tencent Holdings Ltd.’s WeChat and Twitter-like microblogging site Weibo Corp. was largely directed at Beijing’s inability to restore public faith in domestic goods. That deals a blow to President Xi Jinping’s government, which is seeking to transform the drug industry into a producer of complex products.
There were eight times more searches and mentions of the term vaccine on Sunday compared with a day earlier, according to WeChat Index, an app for big data analysis. Searches and mentions involving the company, Changsheng, were 50 times higher over the same period.
Mr. Li sought to soothe worries about safety as anger intensified over the weekend. “We will resolutely crack down on all illegal and criminal acts that endanger the safety of people’s lives, and resolutely punish those who violate the law,” his office said Sunday. It added that Beijing was committed to ensuring “a safe, secure and trustworthy living environment” for its citizens.
Trading in Chongqing Zhifei Biological Products Co., which sells Merck’s Gardasil vaccine in China, and Shenzhen Kangtai Biological Products Co. Ltd., which produces vaccines for hepatitis B among others, were temporarily suspended after both companies’ shares fell by the maximum 10% daily limit on Monday.
Shenzhen-listed Changsheng was halted from trading after falling by more than 40% since last Monday.
China’s drug regulator is overhauling regulation and cracking down on fraudulent research in a bid to clean up the pharmaceutical industry. In 2015, it allowed companies to voluntarily withdraw new drug applications, while warnings about harsher penalties for applicants whose research failed to meet its standards. By mid-2016, more than 80% of the 1,429 pending applications had been withdrawn.