Saturday, May 15, 2021

Possible effects of the COVID-19 vaccine on pregnancy and fertility. Part I.

 Copyright 2021 Robert Clark


I.)Maternal Fevers and birth defects.

 It is dismaying that the CDC has not been made clear the extent of the fevers that arise after the COVID vaccine shot. The CDC has put on its web site that fever can result after the shot but it has not emphasized the high prevalence: 15% to 30%, or perhaps as high as 50% for women is high prevalence.

 I think the CDC just putting that fevers can arise on its web site has not made this extent commonly known. Even if doctors or average citizens have heard the vaccine particularly the 2nd shot can cause a fever they would not be aware of its prevalence, or that the flu-like symptoms that arise can be so severe as to wipe you out, to the extent you can't go to work the next day.

 Most people would think it's just like the flu-vaccine. No, the flu-vaccine does not require hospitals to stagger their vaccination times for their staff to insure not too many people get knocked out on the same day.

 My guess is few doctors are aware the prevalence of fevers is as high as it is after the 2nd shot of the COVID vaccine. I certainly don't believe most OB-GYN's are aware of it. But that's where the problem comes in: maternal fevers in pregnancy are strongly associated with an increased chance of birth defects.

 I'm suggesting because of the potential danger of birth defects that can arise from these fevers when they occur in the pregnant mother, every time any health official comes on TV, every time any health agency puts out any update of any nature on COVID-19, every time any newspaper, TV news show, news web site, social media company says anything at all about COVID-19 or its vaccine, it should be accompanied by an advisory that pregnant mothers experiencing a fever after taking the vaccine should take it very seriously because of the potential of causing birth defects and so it should be reported both to their OB-GYN and to the CDC.

 In short, maternal fevers in the 1st trimester are linked to an increased chance of a very serious form of birth defect known as neural tube defect. These include spina bifida, anencephaly, and encephalocele.

 The naturally occurring fevers in the 1st trimester are at about 6‒8%. But judging by the number of fevers seen in the COVID vaccine trials, there would be an additional ~15% vaccine caused fevers. So if you add the 15% COVID vaccine fevers to the number of natural fevers, the maternal fevers could be bumped up to the 21­­­‒23% range. And actually three separate sources put the number of fevers in pregnant woman after the 2nd shot of the vaccine as ~30%, which would mean the number of maternal fevers in the first trimester would shoot up to the 36­­­‒38% range, an increase by a factor of 6. I simply can not believe that knowing the strong association of maternal fevers to birth defects that most OB-GYN's would be at ease with maternal fevers shooting up this high.

 This article gives the number of fevers, albeit in their small sample size as 32%:

ORIGINAL RESEARCH: OBSTETRICS|ARTICLES IN PRESS
COVID-19 vaccine response in pregnant and lactating women: a cohort study
Kathryn J. Gray, MD PhD, Evan A. Bordt, PhD, Caroline Atyeo, BS, Michal A. Elovitz, MD, Galit Alter, PhD, Andrea G. Edlow, MD, MSc
Open Access Published:March 25, 2021 DOI:https://doi.org/10.1016/j.ajog.2021.03.023
COVID-19 vaccine response in pregnant and lactating women: a cohort study - American Journal of Obstetrics & Gynecology (ajog.org)

  

 This report also puts the number of fevers in pregnant women as ~30%:

COVID-19 vaccine safety update
Advisory Committee on Immunization Practices (ACIP)
March 1, 2021
Tom Shimabukuro, MD, MPH, MBA
CDC COVID-19 Vaccine Task Force
Vaccine Safety Team



 And this recently published article also puts the number of fevers in pregnant women after the vaccine as ~35% after dose 2:

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
List of authors.
Tom T. Shimabukuro, M.D., et al.
April 21, 2021
DOI: 10.1056/NEJMoa2104983

 So according to this article after you add on the 6 ‒ 8% naturally occurring fevers, the number or maternal fevers could balloon to the range of 41 ‒ 43% in the first trimester. According to this data, it's particularly bad for the Moderna vaccine at 46% fevers in pregnant women after the 2nd dose. This would mean adding the naturally occurring fevers, the number of maternal fevers for those getting the Moderna shot would balloon to 52 ‒ 54% range.

 The CDC makes it seem like the COVID shot is just like the flu-shot. No, after the flu-shot perhaps 1­­­‒2% of people will get fever. But with the COVID vaccine shot a radically larger proportion of people will get flu-like symptoms such as high fever after the 2nd shot that are so severe it will keep them off work for a day or so. In fact this is so common that some hospitals have to stagger the days their staff get the vaccine to insure not too many people call in sick the same day after their shot:

Second COVID Shot Packs the Big Punch
— First dose also worse for those with previous COVID, but "small price to pay" for protection
by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today February 11, 2021
https://www.medpagetoday.com/special-reports/exclusives/91157
(May need free registration.)

 But as the article notes this can even happen after the 1st shot if the person had COVID-19 before. Most distressingly, it might even be the case that if the person had an asymptomatic case, so they didn’t know they had it, they could still get these severe reactions after just the 1st shot.

 And in this video Dr. Kavita Patel being interviewed says the side effects for 1/3rd of the people after 2nd dose feels like they have the flu. She herself had to take off. While many people wouldn’t take off for say a cold, the flu is more debilitating and most people do take off work then:

 This discusses the Pfizer and Moderna COVID vaccines. But the Astrazeneca vaccine also results in a high number of flu-like symptoms:

“But it turns out the side effects were underestimated, and we found ourselves with almost a third of health workers in some departments presenting severe symptoms and having to go on sick leave.”
https://www.thelocal.fr/20210225/french-hospitals-pause-astrazeneca-vaccine-campaign-as-temporary-side-effects-leave-many-staff-needing-sick-leave/

 It should be noted though that for the Astrazeneca vaccine the greatest side effects occur after the first shot, not the second.

 But in addition to the CDC emphasizing the  high prevalence of the "flu" after the shot, it also needs to be emphasized the length of time for these severe flu-like symptoms of a day or so is just the average length of time. For some people, perhaps 1­­­‒2%, they will be wiped out by this “flu” with high fever for over a week, obviously, quite concerning for the elderly and pregnant mothers.

 The CDC has put it on their web site there is a chance of the fevers after the COVID-19 shot. Even still, most doctors are not aware of the extent of these fevers and certainly most average citizens don’t know it.

  But I’ll explain why it is extremely important that this be commonly known.

 To obstetricians a well-known contributing factor to a very serious birth-defect known as neural tube defect is fever during first trimester in the mother. In fact the chance of this occurring can be increased multiple times when the mother has a 1st trimester fever. These birth defects include spina bífida, anencephaly, and encephalocele. Spina bifida most people have heard of where the baby is born with the spinal cord partially protruding through the back. Anencephaly is not as well known by the public, but it's where the baby is born with only a partially formed brain. And encephalocele is where part of the brain extrudes through the back of the head, [1].

 But fevers can also cause other birth defects in the 1st trimester such as heart defects, cleft palate, and autism. And the increased chance of these with maternal fever extends also into the 2nd trimester, [2].

 With the controversy over a claimed connection between vaccines in children and autism, it should be required to inform women that the chance is increased for autism in the child if the mother contracts a fever due to the COVID vaccine, under the principle of informed consent.

 Quite concerning also is the chance of the baby suffering one of these birth defects grows larger in an additive fashion with multiple fevers, up to a factor of 2 times larger with 3 fevers, [3].

 And for the serious neural tube birth defects, the degree of the increased chance is no small number. We are used to hearing of some drug causing an increased chance of some adverse effect by, say, 20% or 30%, but with maternal fevers the chance of the baby having a neural tube birth defect increases by 300% higher, when the mothers are not on the protective folic acid.

 Given this you would think obstetricians would give a caution to be wary of the fevers for pregnant mothers after getting the vaccine shot.

 So why haven’t they? My opinion is it’s because the CDC has not emphasized the prevalence of fevers after the COVID-vaccine shot. They have given the impression the side-effects are just like the flu vaccine.

 The CDC has been aware of the increased chance of birth defects with maternal fevers for several years now:

Maternal Fever During Early Pregnancy May Be Linked to Birth Defects.
https://www.cdc.gov/ncbddd/birthdefects/features/kf-birthdefects-maternal-fever-during-pregnancy.html

 A food additive called folic acid can lower, though not eliminate, the size of the increased chance. The CDC puts out an advisory that all women of child bearing years whether or not they are pregnant or plan to become pregnant take the additive and has seen that it is also included as an additive in some foods.

 The reason why it is important that all women of child-bearing years take the protective folic acid is that frequently women can be pregnant and not know it, early on. Then the warning of the danger of the increased fevers due to the vaccine in the first trimester should be extended to all women in child-bearing years even those not knowingly pregnant.

 But a problem is most women still don’t take or get enough of the folic acid.

 Then most women will still have the increased chance of the birth defects with fevers, such as those that occur to a high percentage of times with the COVID-19 vaccine.

 Moreover, this increased chance of these devastating birth defects will be worse for black women. The reason is even fewer black women get the protective folic acid, only about 20%. Then when the increase in these birth defects is seen to be especially high in black women the CDC can claim all they want they didn't know, but the response in the black community will be that they were targeted.

 The NEJM article has been cited to support the safety of the vaccine for pregnant women. But it is important note most of the completed pregnancies were for women getting the vaccine in the third trimester. But the danger of maternal fevers to birth defects is for the first and second trimesters. So the NEJM article can not address this key question.

 Tests for neural tube defects by either genetic markers, amniocenteses, or ultrasound can be done at about the 15th to 20th week of pregnancy. Women who were vaccinated in their first trimester in December or early January would now be in the time period for these types of tests to be done. It is imperative that such tests be done on all such pregnant women to insure this very serious type of birth defect does not occur at increased incidence after COVID vaccination.

II.)Possible Effect of COVID Vaccine on Infertility.

 As part of the justification being given for the safety of the vaccine in pregnancy, the animal studies Pfizer and Moderna did on pregnant rats have often been cited. The vaccine manufacturers have claimed that there were no statistically significant increases in infertility or birth defects in their rat studies. However, it is important to note there were increases in both infertility and birth defects in the rats for both the Pfizer and Moderna studies. 

 The claims of Pfizer and Moderna that these increases were not statistically significant, and therefore not "real", points out a major problem with medical studies that statisticians have complained about repeatedly in recent years. A difference in the data not being at the level of "statistical significance" does NOT mean it is nothing more than a random blip in the data, so not real. It just as well could be a real effect but the number of cases in the study is not sufficient for it to rise to statistical significance. 

 The issue is discussed in this article in the journal Nature:

COMMENT  20 MARCH 2019
Scientists rise up against statistical significance.
Valentin Amrhein, Sander Greenland, Blake McShane and more than 800 signatories call for an end to hyped claims and the dismissal of possibly crucial effects.
Valentin Amrhein, Sander Greenland & Blake McShane.

"When was the last time you heard a seminar speaker claim there was ‘no difference’ between two groups because the difference was ‘statistically non-significant’?

If your experience matches ours, there’s a good chance that this happened at the last talk you attended. We hope that at least someone in the audience was perplexed if, as frequently happens, a plot or table showed that there actually was a difference.

How do statistics so often lead scientists to deny differences that those not educated in statistics can plainly see? {emphasis added} For several generations, researchers have been warned that a statistically non-significant result does not ‘prove’ the null hypothesis (the hypothesis that there is no difference between groups or no effect of a treatment on some measured outcome)1. Nor do statistically significant results ‘prove’ some other hypothesis. Such misconceptions have famously warped the literature with overstated claims and, less famously, led to claims of conflicts between studies where none exists.

We have some proposals to keep scientists from falling prey to these misconceptions.

Pervasive problem

Let’s be clear about what must stop: we should never conclude there is ‘no difference’ or ‘no association’ just because a P value is larger than a threshold such as 0.05 or, equivalently, because a confidence interval includes zero. Neither should we conclude that two studies conflict because one had a statistically significant result and the other did not. These errors waste research efforts and misinform policy decisions."

https://www.nature.com/articles/d41586-019-00857-9

 In other words, for an observed large difference in the data, the difference should not be simply dismissed and regarded as not real just because it is not at the statistically significant level. The correct conclusion should be to do larger studies to determine if it is a real effect or not.

 A discussion of the Moderna rat study on the vaccines effect on fertility  appears on p. 50 to 51 of this report:

Assessment report
COVID-19 Vaccine Moderna.

https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf

 Moderna noted in the rat study that fertility dropped from 93.2% for the controls to 84.1% for the vaccinated rats. That means infertility doubled for the vaccinated rats, from 6.8% for the controls to 15.9% for the vaccinated.

 Moderna asserts this is within the normal range but no statistical significance values are provided so we can judge that.

 Other odd statements in this passage: Moderna’s researchers noted that the vaccinated pregnant rats wound up with limited use of their hind legs, but Moderna did not consider that to be an adverse event. That the vaccinated pregnant rats loss the use of their hind legs obviously should be concerning. Moreover, the fact it was the hind legs effected suggests also it’s related to the pregnancy.

 Then beyond that, Moderna noted that babies from the vaccinated rats had an INCREASE in skeletal birth defects. The Moderna researchers assert this is not an adverse event because it’s a common birth defect in rats. But how much was it increased? By 10%? Was it doubled, was it tripled? We’re not given that information. And again, even if the difference is not statistically significant, it is possible that these increased numbers of birth defects are real effects and that can only be determined by looking at larger studies.

 The Pfizer study on vaccinated pregnant rats is discussed here:

Assessment
Comirnaty

  The Pfizer researchers claim there were no observed difference in "fertility index" but the observed doubling in pre-implantation loss does amount to an increase in the pregnancy loss in the rats, i.e., an increase in infertility.

 The researchers assert it is within the normal range, i.e., not statistically significant, but again whether this is a real effect or not can only be determined by doing the study with a larger sample size.

 The phrasing in this passage also leads me to believe there was an increase in birth defects which the Pfizer researchers also say is not statistically significance. But again the validity of this claim can only be ascertained on a larger sample size.

 Note, even though both Moderna and Pfizer researchers assert no statistically significant difference in infertility, the size of the increase in both studies being doubled argues very strongly this is not coincidental, i.e., that it is a real effect.

 Because of the importance of this issue, these studies on vaccinated rats need to be published so they can be subjected to independent review, that is, by those not paid by the vaccine manufacturers, even if just a preprint on Medrxiv.com. 

 Other independent researchers need to confirm their validity. One key thing to check is to see if in future reproductive cycles, if the infertile rats had continue difficulty completing a pregnancy. If so, that would be alarming, since that would suggest the difference could be permanent. 

 The UK public health agency and WHO do not advise pregnant women in general to get the vaccine unless they are at high risk of getting COVID because of the lack of information either for or against its safety for pregnant women.

 But in the U.S., the CDC advises pregnant women consult with their doctor before getting the vaccine. Then both must be fully informed, including being made aware of the results of these studies.

 Even if it shown though the rat differences in infertility are real, that still would not mean that has to be the case in humans.

 For humans, fertility is usually determined over a year. However, the importance of answering this question about an effect on fertility is so great I suggest doing studies on the shorter time scale of 5 months since the vaccines have been released. Has there been a change in the number of pregnancies among those couples wanting to get pregnant when one or both members of the couple have been vaccinated?

 III. Could the vaccine induce auto-immune response within the placenta?

 Some scientists have argued that there is sufficient similarity of the spike protein to the syncytin proteins in the placenta that there could be cross-reactivity against the natural syncytins by the immune system in combating the COVID spike protein.

 This won't happen with B-cells which are very discriminating in the proteins they attack. However, T-cells are not nearly as discriminating. Still, E. Nirenberg argues against this possibility on the grounds the amino acid sequence where the synctins coincide with the COVID spike protein is too short:

Dec 3 
Written By Edward Nirenberg
Are COVID-19 Vaccines Going To Cause Infertility?

 However, to Nirenbergs credit he does mention in an addendum there is a known scenario where a similarly short amino acids sequence caused cross-reaction of rheumatic fever T-cells against normal heart muscle proteins.

 In an upcoming Part II, I'll discuss the evidence for and against the possibility the COVID vaccine could cause cross-reactivity with the synctin proteins of the placenta.


  Robert Clark


REFERENCES.

1.)Birth Defects Res. 2018 Mar 1; 110(4): 342–351.
Published online 2017 Nov 2. doi: 10.1002/bdr2.1147
Maternal report of fever from cold or flu during early pregnancy and the risk for noncardiac birth defects, National Birth Defects Prevention Study, 1997–2011
Dorothy Kim Waller,1 Syed Shahrukh Hashmi,2 Adrienne T. Hoyt,3 Hao T. Duong,4 Sarah C. Tinker,5 Michael Shayne Gallaway,6 Richard S. Olney,7 Richard H. Finnell,8 Jacqueline Tauber Hecht,2 Mark A. Canfield,3 and the National Birth Defects Prevention Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831519/

2.)Mol Psychiatry. 2018; 23(3): 759–766.
Published online 2017 Jun 13. doi: 10.1038/mp.2017.119
Prenatal fever and autism risk
M Hornig,1,2,* M A Bresnahan,2,3 X Che,1 A F Schultz,1 J E Ukaigwe,1 M L Eddy,1 D Hirtz,4 N Gunnes,5 K K Lie,5 P Magnus,5 S Mjaaland,5 T Reichborn-Kjennerud,5,6 S Schjølberg,5 A-S Øyen,5,7 B Levin,8 E S Susser,2,3 C Stoltenberg,5,9 and W I Lipkin1,2,10
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5822459/

3.)Autism Res. 2017 Nov; 10(11): 1878–1890.
Published online 2017 Aug 11. doi: 10.1002/aur.1841
Prenatal exposure to fever is associated with Autism Spectrum Disorder in the Boston Birth Cohort
Martha Brucato,1,2,3 Christine Ladd-Acosta,1,3,* Mengying Li,4 Deanna Caruso,4 Xiumei Hong,4 Jamie Kaczaniuk,3 Elizabeth A. Stuart,5 M. Daniele Fallin,3,5,6 and Xiaobin Wang4,6
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5685874/

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Monday, April 5, 2021

Asian countries routinely give anti-COVID antivirals EARLY. They have 1/100th the fatalities of the West. That’s not a coincidence.

 Copyright 2021 Robert Clark



In these articles once again nowhere did they even ask the question what treatments are they using in these countries with the radically reduced fatality rates. These are doctors investigating this remember, doctors whose job is to treat people, and they never ask the question how do you treat your sick.


 The national treatment protocols for COVID of giving antivirals EARLY for some of the Asian countries go all the way back to last year to March. It’s stunning when you think about it but if the question had been asked of them of what treatment strategies do you use, the researchers would have gotten the answer over and over again, “We use antivirals EARLY”, “We use antivirals EARLY”, “We use antivirals EARLY”, “We use antivirals EARLY”. It would then have been apparent that EARLY treatment with antivirals is important for bringing the virus under control.


 This study also concludes countries using anti-malarials are much better at keeping the epidemic under control:


National Consumption of Antimalarial Drugs and COVID-19 Deaths Dynamics : an Ecological Study.
“COVID-19 (Coronavirus Disease-2019) is an international public health problem with a high rate of severe clinical cases. Several treatments are currently being tested worldwide. This paper focuses on anti-malarial drugs such as chloroquine or hydroxychloroquine, which have been currently reviewed by a systematic study as a good potential candidate and that has been reported as the most used treatment by a recent survey of physicians. We compare the dynamics of COVID-19 death rates in countries using anti-malaria drugs as a treatment from the start of the epidemic versus countries that do not, the day of the 3rd death and the following 10 days. We show that the first group have a much slower dynamic in death rates that the second group.”
https://www.medrxiv.org/content/10.1101/2020.04.18.20063875v2


 Some national treatment protocols in Asian countries advising EARLY treatment with antivirals:


In China:


Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th edition)

Page Views 浏览量: 145539 Updated 发布时间:2020-03-16 12:00:32


http://kjfy.meetingchina.org/msite/news/show/cn/3337.html


And:


Health 17:30, 26-May-2020

COVID-19 treatment: Antivirals, anti-inflammatory drugs, blood thinner and mechanical ventilation

Updated 22:28, 26-May-2020

Antiviral treatment 
Ranko Škrbić, dean of the Department of Pharmacology at University of Banja Luka, asked about the most effective antiviral therapy that has been used in the Chinese hospital against the coronavirus. 
Hou Xinguo, Deputy Director of Endocrinology Department at Qilu Hospital, said that several antiviral drugs including alpha-interferon, ribavirin and abidol have been recommended in the COVID-19 diagnosis and treatment guideline issued by China's health authorities. But based on their clinical experience, the antivirals could be useful on patients only at the early stage of infection, as they did not have significant effects on severely ill patients. 
He added that according to the guideline, no more than two antiviral drugs should be used in combination. 

https://news.cgtn.com/news/2020-05-26/COVID-19-Frontline-Chinese-doctors-share-treatment-experience-QNHrqxKtNe/index.html


And:


Published online 2020 Oct 8. doi: 10.1080/20016689.2020.1818446

PMCID: PMC7580738

PMID: 33133431

Chinese guidelines related to novel coronavirus pneumonia

Tingting Qiu, Shuyao Liang, Monique Dabbous, Yitong Wang, Ru Han, and Mondher Toumi

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580738/


In South Korea:


Gov't recommends use of antiviral drugs for COVID-19 treatment

Published on Feb 13, 2020

'고령•중증에 에이즈치료제 권장'…코로나19 치료원칙 나왔다

South Korea has unveiled a set of treatment guidelines for COVID-19.
It consists of administering an anti-HIV medication twice a day.
This is the nation's first treatment protocol for those who show severe symptoms.
Kim Jae-hee has our top story.
Infectious disease experts in South Korea have agreed to the use of antiviral drugs in the treatment of severe coronavirus cases, senior patients, and those with underlying diseases.
On the other hand, it was concluded that young patients, or those with mild symptoms, seemed to have improved after 10 days and without any antiviral treatment.
"Young and healthy people have mostly shown improvement without any special treatment. But older patients or those with underlying diseases are in need of the medication from an early stage."
Expert says differences in treatment depending on a patient's age is actually quite normal.
"Most viral infections tend to heal even without any treatment... thanks to our body's immune system. But old age in itself can raise risks,... and many senior patients have underlying diseases, so it's recommended that they undergo antiviral treatment."
The government's guidelines recommend Kaletra, an anti-retroviral medication used to treat AIDS for a duration of 7 to 10 days.
Chloroquine or Hydroxychloroquine, a medication used to prevent and treat Malaria can be used as an alternative.
But experts says, while the government's announcement may sound promising, it might not make much of a difference to current treatment metThere won't be a significant difference in the treatment methods. It's an antiviral drug that we are already using, and its effectiveness has not been fully proven. It's still just a recommendation."
But the expert is optimistic, saying that the recurrence rate of the novel coronavirus is low.
"It seems unlikely that a recovered patient will catch the virus again. In fact, there are very few reports of patients being re-infected when they've recovered from other coronavirus diseases such as SARS and MERS."
He added that all seven of the patients who have made full recoveries in South Korea had no serious underlying diseases, and are unlikely to be re-infected.

Kim Jae-hee, Arirang News.

#Wuhan #coronavirus #drugs 

Gov't recommends use of antiviral drugs for COVID-19 treatment




In Taiwan:


Interim Guidelines for Clinical Management of SARS-CoV-2 Infection 

(5th edition) 

Translation Editor-in-Chief Prof. Wang-Huei Sheng, M.D. PhD et al.

Affiliation Department of Medicine, National Taiwan University 

Ministry of Health and Welfare 

Taiwan Centers for Disease Control 

March 26th, 2020 


https://www.cdc.gov.tw/En/File/Get/_Dv_q75ZjLcNeRvlnrPgUg


In Hong Kong:


News > Medscape Medical News

Triple Antiviral Combo May Speed COVID-19 Recovery

Neil Osterweil

May 11, 2020

https://www.medscape.com/viewarticle/930336

(May need free registration.)


And:


South China Morning Post

Hong Kong public hospitals to revise Covid-19 treatment guidelines, highlight effective drugs behind low mortality rates.

Victor Ting

27 August 2020·3-min read

Hong Kong’s public hospitals will revise clinical treatment guidelines for Covid-19 patients to better highlight the effectiveness of an antiviral drug that has helped achieve one of the lowest coronavirus death rates in the world.
Dr Owen Tsang Tak-yin, medical director of the Hospital Authority’s infectious disease centre at Princess Margaret Hospital, made the revelation at a media briefing on Thursday as the city’s third wave of infections showed signs of easing, with health officials reporting 21 new cases, taking the local tally to 4,755, with 81 related deaths.
“The third wave has been very rapid and fierce,” Tsang said. “But despite that, we have one of the lowest mortality rates worldwide, at about 1.6 per cent.”
One factor that helped suppress the death rate was effective treatment, which centred on a cocktail therapy involving antiviral drug Interferon; Kaletra, a drug originally used for HIV/Aids, and Ribavirin, which was also used for hepatitis C, according to Tsang.
The treatment guidelines, which were last updated in June, would be revised “very soon”, Tsang said, and would highlight Interferon as the major medication for Covid-19, combined with Ribavirin. But Kaletra may lead to some side effects and has proved to be unsuitable for some patients, causing liver problems in such cases.
Another antiviral drug, Remdesivir, was found to be most effective among patients in severe condition requiring oxygen support, but less effective in those who are critically ill and requiring intubation, while Hydroxychloroquine and Chloroquine have been ruled out as overseas research have shown their ineffectiveness.

https://sg.news.yahoo.com/hong-kong-public-hospitals-revise-142129309.html


 It’s notable that Hong Kong decided against HCQ following Western studies. But those studies did not test it for EARLY treatment which is essential for antivirals. But no matter. COVID-19 is a virus easy to treat. Multiple antivirals are effective treating if given EARLY.


In Thailand:


Am J Trop Med Hyg. 2020 Jul; 103(1): 48–54.

Published online 2020 May 18. doi: 10.4269/ajtmh.20-0442

PMCID: PMC7356442

PMID: 32431287

Critical Care Management of Patients with COVID-19: Early Experience in Thailand

Ranistha Ratanarat,1,* Chaisith Sivakorn,2 Tanuwong Viarasilpa,1 and Marcus J. Schultz3,4,5

Antiviral treatment before ICU admission.
Thailand has set national guidelines for antiviral treatment. Patients with mild symptoms receive chloroquine or hydroxychloroquine plus a boosted protease inhibitor, lopinavir or darunavir plus ritonavir. Favipiravir is not recommended in mild cases because of its limited availability.8
Favipiravir is an antiviral RNA polymerase inhibitor for which most preclinical data are derived from its influenza and Ebola activity.16 It is given to all patients with proven COVID-19 who have symptoms or signs consistent with pneumonia, or when there is hypoxemia (SpO2 < 95% on room air).8

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356442/


In Singapore:


Interim Treatment Guidelines for COVID-19 (Version 1.0, dated 2 April 2020) 

ABSTRACT Background In December 2019, pneumonia cases caused by a novel coronavirus occurred in Wuhan, Hubei Province. As of 11th February 2020, the World Health Organisation has officially named the disease “COVID-19”. In addition, virologists in the coronavirus study group have officially announced the name of the virus to be “SARS-CoV-2”. This guideline provides evidence-based recommendations on the therapeutic management of patients with COVID-19 in Singapore. 

https://www.ncid.sg/Health-Professionals/Diseases-and-Conditions/Documents/Treatment%20Guidelines%20for%20COVID-19%20%282%20Apr%202020%29%20-final.pdf



  Robert Clark

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Tuesday, March 16, 2021

Vaccine companies keep hidden COVID-19 safety data for elderly patients. UPDATED: 4/11/2021

                                                 Copyright 2021 Robert Clark


UPDATE: 4/11/2021

 Normally, I put updates at the bottom of the original blog post but this is so important I'm putting it at the beginning.

 Public health agencies have focused on giving the COVID vaccine to elderly recipients, such as nursing home residents. It's surprising then that the safety info has not been released to the public specifically for elderly recipients. 

The Pfizer research report included the safety data for those over 55 and the Moderna report for those over 65. On that basis it was claimed the safety data has been provided for the elderly, say, those over 75 such as residents in nursing homes. But the safety issues for vaccines specifically for the elderly can be significantly different compared to those even in the range of 65 to 74:

Coronavirus Vaccine and Seniors: Could There Be a Problem?

The fact that elderly people do not respond well to immunizations has largely been ignored in most discussions of COVID-19 vaccines, despite this being the group in greatest need. Most of the scientific community’s experience with vaccine development for any disease has been focused on vaccinating the relatively young.


by Byram W. Bridle Shayan Sharif
July 24, 2020 Topic: Public Health Region: World Blog Brand: The Reboot Tags: Coronavirus COVID-19 Vaccines Senior Citizens Elderly
https://nationalinterest.org/blog/reboot/coronavirus-vaccine-and-seniors-could-there-be-problem-165360

 So the fatalities for those contracting flu among the elderly, ~75 yrs. and above, is 8 times higher than even those in the 65 to 74 yrs age range.

 Then a key issue is that the COVID vaccines cause flu-like reactions in a large percentage of people. From the vaccine trials we would estimate the number of all people who would get fevers after the second shot, the more injurious one, to be ~15%. But disturbingly data taking from actual vaccine recipients with the v-safe collection method put the number having fever after the second dose as ~30%:

COVID-19 vaccine safety update
Advisory Committee on Immunization Practices (ACIP)
March 1, 2021
Tom Shimabukuro, MD, MPH, MBA
CDC COVID-19 Vaccine Task Force
Vaccine Safety Team

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-02/28-03-01/05-covid-Shimabukuro.pdf

 Judging by the vaccine trials these fevers only last a day or so. However for about 1-2% of cases the fever can last over a week. That would be quite concerning for an elderly patient.

 And still note this data is still not telling us about the important case of elderly patients. Then I was still looking for some reports discussing the safety question of the vaccines for the elderly.

 Two recent articles looked at the COVID vaccine for elderly recipients:

Age-dependent immune response to the Biontech/Pfizer BNT162b2 COVID-19 vaccination.

and:

Vaccine effectiveness after 1st and 2nd dose of the BNT162b2 mRNA Covid-19 Vaccine in long-term care facility residents and healthcare workers – a Danish cohort study

 They both concluded the effectiveness in the elderly after the 2nd shot is only ~60%. This is surprising since both the Pfizer and Moderna trial reports both implied that the effectiveness in the elderly approached the 90% range seen in younger recipients. But it is in keeping with the prior results that vaccines are not as protective for the elderly. 

 BUT these two recent report still did not consider the safety issues.

 Quite astonishingly there have been no reports that looked at the safety data for the COVID vaccine specifically for elderly recipients.
 
 A report that might allow us to make a comparison of the COVID vaccine recipients for serious medical conditions has recently come out:

 Characterizing the incidence of adverse events of special interest for COVID-19 vaccines across eight countries: a multinational network cohort study.

 The title is rather misleading in that it does not give the number of adverse events for COVID vaccine recipients. It estimates instead the prevalence of conditions such as strokes, blood clots, and heart attacks in the general population. This is especially important to know given the recent reports of strokes in vaccine recipients in order to see how they deviate from the rates in the general populations. 

 Now we can compare to the data collected by the v-safe collection method described in the CDC report "COVID-19 vaccine safety update, Advisory Committee on Immunization Practices (ACIP)" cited above.

 The report makes a comparison for the COVID vaccines both to unvaccinated and vaccinated cases:



 The researchers found no significant difference here.

  However, the researchers in making a comparison to other vaccinated cases claimed also "no significant difference" while actually a sizable difference is apparent in the data for some adverse events:

  This illustrates a phenomenon criticized by statisticians that is common in some medical studies, where differences apparent in the data are disregarded as "not real" because the significance level does not reach the rather arbitrarily defined "0.5" level.
 
COMMENT  20 MARCH 2019
Scientists rise up against statistical significance.
Valentin Amrhein, Sander Greenland, Blake McShane and more than 800 signatories call for an end to hyped claims and the dismissal of possibly crucial effects.
Valentin Amrhein , Sander Greenland & Blake McShane

 
 This is actually a quite serious problem in medical studies: it results in life-saving drugs and life-threatening side effects being dismissed because of it.

 In scenarios like this, rather than dismissing the validity of the results, what it is actually signaling is that larger studies need to be done to strengthen the significance level. 

 In this particular case with the number of cases in the v-safe database of 800,000 it should be doable to get a quite high level of statistical significance to determine the validity of these numbers

   Robert Clark

 (Below the original blog post discussing the fact the vaccine companies and public health agencies have not released the safety data specifically for elderly patients.)

     __________________________________________________________

  I copied below some communications I had with the European Medicines Agency (EMA) through their online contact form about the safety of the COVID-19 vaccines specifically for elderly patients.

 After writing these, the question occurred to me, “Why am I having to go through this rigmarole to get the data that should be freely available about elderly recipients of the vaccine?”

 And I finally came to a stunning realization, "I'm being stonewalled."

 A large segment of the public is already skeptical about vaccines. This concern is worse now for new vaccines, and it’s even worse for a different kind of vaccine, and still worse again when the usual roll-out period of 5 to 10 years was shortened down to a single year. Then the vaccine manufacturers should be “purer than Caesar's wife”, in regards to the openness of their vaccine data.

 Yet the vaccine manufactures have not revealed the safety data specifically for elderly patients. And the impression I got from the EMA and also from the CDC is they are no more interested than the vaccine manufacturers in providing this information. 

 The conclusion that the vaccine companies are intentionally hiding the safety data for elderly recipients from the public was confirmed by this recent report:

Early effectiveness of COVID-19 vaccination with BNT162b2 mRNA vaccine and ChAdOx1 adenovirus vector vaccine on symptomatic disease, hospitalisations and mortality in older adults in England.
Jamie Lopez Bernal, et al.

 Every other report on the COVID-19 vaccines when they were discussing younger recipients, reported both the efficacy and safety of the vaccine.

 But in this report discussing elderly recipients, only the efficacy is reported, not the safety.

 Let this sink in for a minute:

 If you were to ask the CDC or the EMA or any other public health agency what is the safety profile for the COVID-19 vaccine specifically for elderly patients, their response would be, "We don't know."

 You don't have to believe me on this. I ask any doctor in any country anywhere in the world that specializes in treating elderly patients or oversees care in nursing homes to ask for this data.

 Here’s the CDC contact page:

 Here’s the EMA contact page:


 The contact person for the NEJM report by Pfizer on their vaccine trial is given here:


 It is possible that if your specialty is gerontology that they'll provide you this information since clearly in your case it would be extremely important to know that, but my guess is you'll be stonewalled too.



    Robert Clark


============================================
Re: [EXTERNAL:]AskEMA - Response to ASK-78662 - Safety of the Pfizer vaccine.

 I read the report you suggested [https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf] and found it was less informative than the NEJM article I was referencing in regards to adverse events. For instance it doesn't say that high fevers at > 38.9⁰C (102⁰F) temperatures occur at 0.8% of cases for the vaccine compared to 0.1% for the placebo.

 I have since read other reports that now make it imperative that Pfizer release a detailed safety report on 2nd dose AE's, classified by serious, severe, life-threatening, and fatal, as well as providing an analogously detailed safety report for elderly patients.

 Here's one of the reports I'm referring to:

Second COVID Shot Packs the Big Punch.
— First dose also worse for those with previous COVID, but "small price to pay" for protection.
by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today February 11, 2021
https://www.medpagetoday.com/special-reports/exclusives/91157

 It details that healthcare workers commonly have to take off work because of side effects of the second dose. These are people of relatively good health, yet a large number are wiped-out after the 2nd dose, to the extent they have to take off a day or so to recover.

 Note that though Pfizer has acknowledged that a large percentage of recipients will experience some side effects, what's key here is these side effects in many will occur concurrently. So the common side effects of headache, fever, chills, fatigue will occur at the same time, effectively incapacitating them for a day or more.

 I had been concerned about the high fevers for the elderly but now knowing these adverse events can occur in combination it becomes even more worrisome considering the large percentage at which they occur. Younger, healthier people could weather this combination of symptoms, but elderly, frail patients may not be.

 Also, worrisome is that these symptoms, debilitating in combination, can also occur after just the 1st dose for patients who already had COVID-19. So this serious combination of symptoms could be life-threatening even after just the 1st dose for elderly patients if they had COVID-19 already.

 I don't know if this is the case in Europe but I know in the U.S. it's being recommended by health agencies that people who have had already COVID-19 should also get the vaccine. Again, for the elderly this could result in a life-threatening combination of symptoms after just the first dose, and for the young and healthy could be debilitating for a day or more.

 This also raises the possibility that those who had COVID-19 but were asymptomatic or with mild symptoms, not being aware they had it, could also suffer this serious combination of symptoms after just the first dose.

 This possibility of a life-threatening reaction for the elderly with prior COVID-19 after just the first dose may have been realized in the examples described in this report:

Deaths of Elderly Who Recovered From COVID-19, but Died After Vaccine, Raise Questions
Sharyl Attkisson
February 10, 2021 Updated: February 16, 2021 
https://www.theepochtimes.com/deaths-of-elderly-who-recovered-from-covid-19-but-died-after-vaccine-raise-questions_3692259.html 
{may require registration}

 We now know also the occurrence of the deaths in Norway nursing homes after  taking the vaccine was not an outlier but rather is now something occurring worldwide:

02/16/21
46 Nursing Home Residents in Spain Die Within 1 Month of Getting Pfizer COVID Vaccine
Health officials have reportedly halted administration of the second shot of Pfizer’s vaccine at the Spanish nursing home.
“The UK Medical Freedom Alliance — a group of doctors, scientists, lawyers and other professionals who advocate for informed consent in the UK — published an urgent open letter to Nadhim Zahawi, Minister for COVID-19 vaccine deployment; Matt Hancock, the Secretary of State for Health and Social Care; and two vaccine oversight agencies calling for an immediate audit of the deaths following vaccination in the UK.
The group refers to graphs showing a surge in care home deaths and cites data from the Office for National Statistics that residents’ deaths tripled in the two weeks between January 8- 22 at a time when there was a massive increase in the rate of vaccinations in care homes.

Similar graphs for Israel, Ireland, Bahrain and Jordan show a similar correlation.”
https://childrenshealthdefense.org/defender/nursing-home-residents-spain-die-pfizer-covid-vaccine/

  Given these examples, which apparently are common to both approved COVID-19 vaccines, both vaccine manufacturers should put out advisories making doctors aware of the possible dangers when used in these situations. 

    Robert Clark

___________________________

Robert Clark

Dept. of Mathematics

Widener University

One University Place

Chester, PA 19013 USA

___________________________

From: AskEMA No-Reply <AskEMA....@ema.europa.eu>
Sent: Friday, February 12, 2021 9:09 AM
To: Robert G Clark <rgc...@widener.edu>
Subject: [EXTERNAL:]AskEMA - Response to ASK-78662 - Safety of the Pfizer vaccine.
 
Dear Mr Clark

Thank you for your follow-up response regarding the safety of Comirnaty.

I am afraid there is not much I can add to our previous response. As noted there, we cannot comment on the information published in medical journals, which is a matter for them. Similarly, we cannot comment on what public information may or may not be available in other jurisdictions.

The side effects included in the licensed product information for the EU (https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf) are based on the safety database in all patients given the licensed regimen in prelicensing studies and our information is increasingly being supplemented with real-world evidence from the millions of persons who have now received the vaccine. EMA will take any necessary regulatory action should a signal of new side effects or a change in frequency of known side effects in particular groups be confirmed.


Kind regards

**** ****, Stakeholders and Communication Division

European Medicines Agency
Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
Send us a question. Go to [http:://www.ema.europa.eu/contact]www.ema.europa.eu/contact Telephone: +31 (0)88 781 6000

____________________________________________________________

We received your question(s) on: 10/02/2021
Subject of your enquiry: Safety of the Pfizer vaccine.
Your question(s):
Thank you for your quick response. I will read the safety reviews you made. 

By the way, I can't remember if I mentioned this to you but among the fevers mentioned as occurring in the published report were also high fevers.

This is another key point that needs to be focused on. The Figure 2 of the report shows by bar graphs the number of fevers developed by vaccine recipients. In discussing that, they give this confusingly written passage:

Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the vaccine and placebo groups reported temperatures above 40.0°C. Younger vaccine recipients were more likely to use antipyretic or pain medication (28% after dose 1; 45% after dose 2) than older vaccine recipients (20% after dose 1; 38% after dose 2), and placebo recipients were less likely (10 to 14%) than vaccine recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.

The first sentence and the second sentence give different percentages for the number of patients who got what is called in both sentences just “fever”. It must be that what they call in the first sentence “fever” are just those with temperature ≥ 38°C. But in the second sentence they should have referred to the cases they are considering then as high fevers, because these are with temperatures ≥ 38.9°C, which is ≥ 102°F. Temperatures this high can be life-threatening for elderly patients as we know from the number of elderly patients who die in hospital after contracting pneumonia.

The passage I quoted says those with the high fevers was 0.8% for the vaccine group and 0.1% for the placebo group after the 2nd dose.

The data given doesn’t allow us to say how many of the elderly developed the high fevers, but if it were 0.8% of elderly patients getting a high fever after the 2nd dose that would be concerning. That would be 160 patients of the 20,000 in nursing homes in Norway who got the Pfizer vaccine.

For this reason, Pfizer should still be required to release the data to the public on the safety profile on the 2nd dose including the classification of the adverse events by serious, severe, life-threatening, and fatal.

And in addition a similar safety profile should be provided specifically for the elderly patients. 

Robert Clark

==========================================================

AskEMA No-Reply 
Tue 2/9/2021 2:14 AM
To: Robert G Clark

Dear Mr Clark

Thank you for your message to the European Medicines Agency (EMA) regarding the safety of the Pfizer/BioNTech COVID-19 vaccine, marketed in the EU as [Comirnaty|https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty]. You raise some concerns about the data provided in a published paper in the New England Journal of Medicine and ask whether EMA has information on the safety of the medicine after a second dose.

I must point out that it is important not to confuse the information presented in papers printed in medical journals, which will have been edited by the journal and adapted for publication, with the much fuller information provided to regulators for assessment. EMA is in receipt of a full data package for the medicine, which has been provided bit by bit over the course of a rolling review. This naturally includes assessment of safety in recipients who have had both indicated doses.

You can find a report of EMA’s scientific evaluation of the vaccine, including its assessment of safety, at: [https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf].

Because the medicine was granted a conditional marketing authorisation, one of a number of options available under EU pharmaceutical law, further information is expected to be provided over time. This includes input from the EU’s extensive pharmacovigilance monitoring system, which has been enhanced in the context of the mass vaccination campaigns expected for COVID-19 vaccines.

Regular safety summaries are being published to keep the public updated on new information regarding the safety of these medicines as we receive it, and the first such summary is available at: [https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-january-2021_en.pdf]. This addresses the issues reported in frail elderly individuals in Norway.

EMA also intends to publish the more detailed information it has from the clinical studies on its clinical data site ([https://clinicaldata.ema.europa.eu/web/cdp/home]) once this has been redacted of personal/confidential information.

We cannot comment on the specifics of the published paper in NEJM, but you might consider contacting the corresponding author should you wish to enquire further about the information provided therein.

I hope you find this information helpful. We would be grateful if you could take part in a short survey on our service, which you can access through the following link:

[https://ec.europa.eu/eusurvey/runner/AskEMA].

Kind regards

**** ****, Stakeholders and Communication Division
European Medicines Agency
Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
Send us a question. Go to [http:://www.ema.europa.eu/contact]www.ema.europa.eu/contact Telephone: +31 (0)88 781 6000

____________________________________________________________

We received your question(s) on: 03/02/2021

Subject of your enquiry: Safety of the Pfizer vaccine.

Your question(s):
Hello. I was quite concerned to read of the deaths in Norway after patients were given the Pfizer vaccine. It should be noted in this regard that Pfizer has not provided a complete safety profile for the 2nd dose of their vaccine during testing, only for the 1st dose. See the supplementary file to their published report here:

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Fernando P. Polack, M.D., et al.
December 31, 2020
N Engl J Med 2020; 383:2603-2615
DOI: 10.1056/NEJMoa2034577
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577#article_supplementary_material

The table showing the safety profile after the 1st dose is Table S3 on page 9.

However, there does not appear in this supplementary file a similar safety profile after the 2nd dose.

The number of deaths of 23 after only 20,000 vaccinations in elderly patients in Norway is quite high. Given these deaths, Pfizer should be required to also reveal the safety profile after the 2nd dose.

Note though that Pfizer did provide a listing of adverse events for the 2nd dose in the paper itself in Figure 2:

https://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/2020/nejm_2020.383.issue-27/nejmoa2034577/20210201/images/img_medium/nejmoa2034577_f2.jpeg

The omission I’m referring to is that in the supplementary file in Table S3 on page 9 the listing of adverse events is classified by serious, severe, life-threatening, or fatal, but this was only for the 1st dose. There was no corresponding table for the 2nd dose provided in the supplementary file.

 In the bar graphs in Figure 2 linked above they show the number of fevers was much higher than for placebos after the 2nd dose. These fevers could have serious consequences for the elderly patients.

Then Pfizer should be required to provide the safety profile for the 2nd dose where the adverse events are classified by serious, severe, life-threatening or fatal, as was done for 1st dose in Table S3, page 9 of the supplementary file.

Going beyond that, they should also be required to provide the adverse events and safety profile specifically for elderly patients for both the 1st and 2nd doses.

Quite frankly, I’m surprised a vaccine manufacturer can get approval to the general public for a new vaccine without presenting the full safety information on both the 1st and the 2nd doses of their vaccine. 

Am I correct in assuming if someone in the public asked the European Medicines Agency what’s the safety profile on the Pfizer vaccine after the 2nd dose their response would be, “We don’t know”? 

   Robert Clark

___________________________

Dept. of Mathematics
Widener University
One University Place
Chester, PA 19013 USA
___________________________
____________________________________________________________
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