Doc Robinson
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This article published in The Lancet similarly addresses the problem of “immune evasion.” It calls for an end to “fear-based approaches based on seemingly haphazard stop-start generalised confinement as the main response to the pandemic; approaches which expect citizens to wait patiently until intensive care units are re-enforced, full vaccination is achieved, and herd immunity is reached.”
Dealing with immune evasion will require a re-evaluation of public health strategies…
If substantial immune evasion occurs, current vaccines are likely to still offer some benefit to individuals. At the population level, however, they could induce viral selection and escape, making the prospect of achieving herd immunity increasingly remote.
This virological game changer has numerous consequences, not only for vaccines and treatment, but also for prevention and control strategies. The fervently awaited end of this global health crisis might be continually postponed, as new variants emerge and immune evasion reduces vaccination effectiveness in the short and medium term.
Hence, it is time to abandon fear-based approaches based on seemingly haphazard stop-start generalised confinement as the main response to the pandemic; approaches which expect citizens to wait patiently until intensive care units are re-enforced, full vaccination is achieved, and herd immunity is reached.
Populations have so far been relatively complacent, but their doubts and distrust are visible in protest movements in several countries. The impact of general confinement on entire economies has been devastating, with worse still to come in levels of unemployment and national debt. Social and health (including mental health) consequences are also colossal, in particular for the younger generations, despite them being at low risk in terms of morbidity and mortality from SARS-CoV-2 infection.
https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(21)00036-0/fulltext
A related article:
Tuberculosis vaccine may help protect against COVID-19Scientists developed the BCG (bacillus Calmette-Guérin) vaccine more than 100 years ago to protect against the bacterial infection tuberculosis (TB). According to the World Health Organization (WHO), by 2004, around 100 million children a year were receiving the vaccine…
Scientists believe the vaccine primes the “innate” immune system, the body’s first line of defense against viruses and other invading organisms. Unlike adaptive immunity, innate immunity rarely targets specific pathogens that the body has encountered in the past…
In August 2020, Medical News Today reported another observational study, which suggested countries with mandatory BCG vaccination had a degree of “herd immunity” against the disease.
There are 22 clinical trials currently investigating BCG’s potential to prevent or treat COVID-19, which should provide more definitive evidence.
https://www.medicalnewstoday.com/articles/tuberculosis-vaccine-may-help-protect-against-covid-19
A summary of the problem, using quotes from above:
“We are currently turning vaccinees into asymptomatic carriers shedding infectious variants.”
“Basically, we’ll very soon be confronted with a super-infectious virus that completely resists our most precious defense mechanism: The human immune system.”A summary of the proposed solution, using quotes from above:
“Natural Killer] NK cell-based vaccines will primarily enable our natural immunity to be better prepared (memory!) and to induce herd immunity (which is exactly the opposite of what current Covid-19 vaccines do as those increasingly turn vaccine recipients into asymptomatic carriers who are shedding virus).”Which vaccines result in more NK cells? The BCG vaccine sounds promising against Covid-19 (and it’s been safely used for more than a century.) The OPV and MMR vaccines may also be promising.
From the Journal of Clinical Investigation:
Through the epigenetic and metabolic reprograming of innate immune cells, particularly monocytes, macrophages, and NK cells, BCG vaccination induces a long-lasting memory and the capacity to respond more strongly upon restimulation (17). This nonspecific boosting of the innate immune response following BCG vaccination has also been reported for other live, attenuated vaccines, including the OPV (19) and MMR (20) vaccines. Indeed, studies have shown that both OPV and MMR vaccines are associated with a decreased number of hospital admissions for infections, including fewer respiratory tract infections (37–39). Therefore, in addition to BCG vaccination, OPV or MMR vaccination may also be considered to mitigate the SARS-CoV-2 pandemic until safe and effective COVID-19–specific vaccines become available.
…Taken together, these results indicate that a history of BCG vaccination confers a nonspecific protective effect against SARS-CoV-2 infection and is associated with fewer self-reports of COVID-19 symptoms.
Re: Vitamin D article in the Guardian
The first study cited by the Guardian doesn’t apply to people with a Vitamin D deficiency, as noted above.
The other study cited by the Guardian is on shaky ground, as it used aggregate data for Covid mortalities and recoveries (obtained online from Worldometer) and estimations of overall prevalence of Vitamin D deficiencies in various countries (from mention they found in unrelated studies on PubMed.) It sounds like a high school level project. In my opinion, it doesn’t really address whether the Vitamin D deficient people in those countries would get improved Covid outcomes after taking Vitamin D supplements. The study admits that their findings are “not in line with outcomes of similar research works published recently.”
https://www.medrxiv.org/content/10.1101/2021.03.04.21252885v1.full.pdf
island raider: “Vaccine adverse event reporting from the US CDC website…”
A more comprehensive view of the data can be found at this site, using the VAERS data once it’s made public. These are the results as of 2/26/2021:
From the 2/26/2021 release of VAERS data:
Found 25,212 cases where Vaccine is COVID19Death 1,265 5.02% [of reports)
Permanent Disability 479 1.9%
Office Visit 3,888 15.42%
Emergency Room 22 0.09%
Emergency Doctor/Room 4,908 19.47%
Hospitalized 2,742 10.88%
Hospitalized, Prolonged 1 0%
Recovered 9,236 36.63%
Birth Defect 36 0.14%
Life Threatening 886 3.51%
Not Serious 8,946 35.48%(Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 25212 (the number of cases found), and the Total Percentage is greater than 100.)
https://www.medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=CAT&EVENTS=ON&VAX=COVID19
My above comment wouldn’t post until I divided it into 3 sections.
Here’s the link to the study I quoted:
https://www.medrxiv.org/content/10.1101/2020.09.08.20190975v5.full.pdfThis bears repeating: That study, which questioned the Covid-related benefits of Vitamin D, did not apply to people having a vitamin D deficiency.
If the Guardian were honest, it would instead report something like “Vitamin D supplements may offer no Covid benefits for those who already have adequate levels of Vitamin D, data suggests”
Followed by reporting on the significant percentage of the population that is indeed deficient in vitamin D.
Yet, the study which the Guardian uses to support its claim says this:
“our results do not apply to individuals with vitamin D deficiency.”(continued)
That article in the Guardian (linked by chettt) says that “evidence for a direct link between vitamin D deficiency and Covid outcomes is lacking.”
(continued)
• Overweight, Obese Americans Make Up 8 in 10 Covid Hospitalizations (F.)
As I pointed out in a comment above, “Overweight, Obese Americans” make up more than 7 in 10 Americans. The percentage hospitalized for Covid isn’t much different than the percentage in the general population.
However, I looked at the hospitalization data in that CDC report and found:
Americans Over 64 Make Up Nearly 8 in 10 Covid Deaths.A relevant comparison: 16.5% vs 76.5%
Americans age 65 and older are only 16.5% of the population.
Yet, that CDC report shows that 76.5% of the Covid deaths occuring in hospitals were age 65 and older.US population demographics:
https://www.census.gov/quickfacts/fact/table/US/PST045219• Overweight, Obese Americans Make Up 8 in 10 Covid Hospitalizations
This sounds fairly incriminating, at first glance. The “8 in 10,” more accurately stated, is 79.1%.
“Among 148,494 adults who received a COVID-19 diagnosis during an emergency department (ED) or inpatient visit at 238 U.S. hospitals during March–December 2020, 28.3% had overweight and 50.8% had obesity.”
But, hold on. What’s the percentage of the American adult population (in general) that is overweight or obese? 73.6% (in 2017-18, and might be higher for 2020?).
So, 79% of those hospitalized for Covid are obese or overweight, while 74% of the general population is obese or overweight.
79% vs 74% is not as remarkable as the headline might suggest.
Well then, what if we only look at the data for the obese. “One half (50.8%) of adult COVID-19 patients in this analysis had obesity, compared with 43.1% in the total PHD-SR sample and 42.4% nationally.”
If obesity was totally unrelated to the likelihood of being hospitalized with Covid, then we would expect around 42.4% of the hospitalized patients to be obese. The data shows that 50.8% are obese. This is frankly not as big a difference as I expected, based on earlier news coverage.
The CDC admits that this change in policy is being made to get more people to accept the vaccine. They also admit the decison is a judgement call (not simply and strictly following “the science”), where benefits may (or may not) outweigh the risks.
“Additionally, taking steps towards relaxing certain measures for vaccinated persons may help improve COVID-19 vaccine acceptance and uptake.”
Increasing the pressure to get vaccinated:
As of today, the CDC now says “Fully vaccinated people can visit with other fully vaccinated people indoors without wearing masks or physical distancing.” (This applies to non-healthcare settings.)
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html
My previous comment shows a graphic from that CDC report, with their summary that dumbs down the data and puts a different spin on it:
“In counties where states required masks,
case and death rates slowed.”“In counties where states allowed on-site restaurant dining,
case and death rates sped up.’• CDC: Face Masks Have Negligible Impact On Coronavirus Numbers (OAN)
The CDC’s takeaway from that study was different.
What are the implications for public health practice?
Mask mandates and restricting any on-premises dining at restaurants can help limit community transmission of COVID-19 and reduce case and death growth rates. These findings can inform public policies to reduce community spread of COVID-19.• Stay-at-Home Policy Is A Case Of Exception Fallacy (Nature)
The study “found no evidence that the number of deaths/million is reduced by staying at home,” and suggested that “regional differences in treatment methods” (instead of lockdowns) may better explain the differences in death rates.
Treatment methods such as prescribing ivermectin? (instead of proscribing ivermectin?)
In conclusion, using this methodology and current data, in ~ 98% of the comparisons using 87 different regions of the world we found no evidence that the number of deaths/million is reduced by staying at home. Regional differences in treatment methods and the natural course of the virus may also be major factors in this pandemic, and further studies are necessary to better understand it.
That link from island raider (above) has a good critique of the ivermectin study published by the JAMA (March 4).
Early treatment study, López-Medina et al., JAMA
Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical TrialRCT low risk patients, 200 ivermectin and 198 control, showing lower mortality, lower disease progression, lower treatment escalation, and faster resolution of symptoms with treatment, without reaching statistical significance.
With the low risk patient population, there is little room for improvement with an effective treatment… Less than 3% of all patients ever deteriorated.
The primary outcome was changed mid-trial, it was originally clinical deterioration, which is more meaningful, and shows greater benefit. The new outcome of resolution of symptoms includes “not hospitalized and no limitation of activities” as a negative outcome and is not very meaningful in terms of assessing how much treatment reduces serious outcomes. Using this measure could completely invalidate results – for example a treatment that eliminates all COVID-19 symptoms but has a temporary minor adverse event could be seen as worse.
Authors state that “preliminary reports of other randomized trials of ivermectin as treatment for COVID-19 with positive results have not yet been published in peer-reviewed journals”, however there was actually 8 peer-reviewed RCTs with positive effects published prior to this paper (and 19 total peer-reviewed studies with positive effects).
Authors advised taking ivermectin on an empty stomach, reducing lung tissue concentration by ~2.5x.
76 patients were excluded due to control patients receiving ivermectin. However, there was a similar percentage of adverse events like diarrhea, nausea, and abdominal pain in both treatment and control groups. These are potential non-serious side effects of treatment and suggest that it is possible that many more control patients received some kind of treatment.
The study protocol specifically allows “the use of other treatments outside of clinical trials”. The paper provides no information on what other treatments were used, but other treatments were commonly used at the time, for example [2]. Additionally, the control group did about 5x better than anticipated for deterioration, also suggesting that the control patients used some kind of treatment. Patients which enroll in such a study may be more likely to learn about and use other treatments, especially since they do not know if they are receiving the study medication.
Most data was collected via surveys, without physical examination.
Grants and/or personal fees, including in some cases during the conduct of the study, were provided by Sanofi Pasteur, GlaxoSmithKline, Janssen, Merck, and Gilead.
87% medication adherence.
• Ivermectin Does Not Alleviate Mild Covid-19 Symptoms – Study (NYT)
Details of that study show that the ivermectin wasn’t taken by the patients until almost a week after the onset of symptoms. (The time from symptom onset to randomization was 4-6 days, median 5 days, plus perhaps another day before the ivermectin was dispensed.) Is this early enough to test the study’s hypothesis that “ivermectin would accelerate recovery in patients with COVID-19 when administered during the first days of infection.”
The JAMA article has this published response with some excellent questions from Eric Osgood, MD:
1. “Having received ivermectin within the previous 5 days,” was an exclusion criterion. The drug is used prophylactically monthly or every 2 weeks. Do we know if participants used it during a window outside the 5 days but recently enough where residual levels could have effects? If it does have benefit, couldn’t this explain why deterioration was so much rarer than anticipated based on the literature?
2. What measures were taken to ensure the placebo arm did not receive active drug prior to 9/29/20? Shouldn’t all placebo subjects have had serum ivermectin levels drawn?
3. Is “total symptom resolution” a validated metric?
4. Why do authors propose initial clinical deterioration rate of 18% was not even close to being met, and only 3.5% in the placebo arm worsened by 2 points? Could an explanation be what I proposed in question 1? With a placebo arm doing this well, would a statistically significant benefit of experimental arm even be mathematically possible?
5. Bioavailability of ivermectin is much greater if taken with a lipid-rich meal. Why were participants instructed to take it on an empty stomach?
6. Why was there no virological assessment?
Updated stats on excess deaths in Europe were published yesterday.
The most recent weekly excess deaths (from all causes) are not only below the corresponding data from 2019, they are below the baseline (less than zero) for every age grouping.
https://www.euromomo.eu/graphs-and-maps#excess-mortality
(choose Weekly instead of Cumulated)• Majority of Brits Say They Will “Miss” Some or Many Aspects of Lockdown
One aspect of the British lockdown:
Alcohol deaths rise sharply in England and Wales (BMJ, 05 March 2021)January-March, a 9.7% increase compared with 2019.
April-June, a 17.7% increase compared with 2019.
July-September, a 22.6% increase compared with 2019.The alcohol-specific death rate reached its highest peak since the data time series began in 2001
Alcohol-specific deaths only include those health conditions where each death is a direct consequence of alcohol misuse (that is, wholly attributable causes such as alcoholic liver disease).
• New York Rolls Out ‘Covid Passport’ At Event Venues
Besides the obvious flaw that the Covid vaccines aren’t known to stop transmission, it seems that the “passes” could be easily gamed at event venues and other places where everyone’s individual IDs aren’t scrutinized the way they are at airports.
Sure, the QR code on the phone screen (or paper printout) may say you’re clear, but is that really your QR code (or could it be someone else’s)? Or are they scanning your face at the same time, to match your face with the name?
It goes without saying that such methods of surveillance and control are ripe for abuse. At the very least, they can be used to selectively harass and detain certain individuals. “Your papers, please…”
Noirette: “Finland Had a Patent-Free COVID-19 Vaccine Nine Months Ago — But Still Went With Big Pharma.” (Why?)
Thanks for that link, the article is illuminating. For example…
In fact, the development of all first-generation COVID-19 shots has been straightforward.“The background research was finished in an afternoon, which then set the direction for all of them,” Saksela says. “Based on what we already know about SARS-1 and MERS, it was all quite obvious — not some triumph of science.” Instead of introducing an inactivated or weakened germ into the human body, the new coronavirus shots train our immune system to respond to a “spike protein” — in itself, harmless — which forms the characteristic protrusions on the virus’s surface.
The widely shared understanding of this mechanism predates the pharmaceutical companies’ contributions. This raises questions about the impact of patent-driven research on the end product. To what extent is the work guided by medical efficacy, and how much is based on the need to retain proprietary ownership?
“Different biotech firms would slap the spike protein onto some type of delivery mechanism, whether it was RNA technology or something else,” Saksela explains. “And typically, the choice is based on what applications they have a patent on, whether it’s the best option or not.”
Data On Long Covid In UK Children Is Cause For Concern, Scientists Say (G.)
“Recently published data from the Office for National Statistics (ONS) has caused worry. The data suggest that 13% of under 11s and about 15% of 12- to 16-year-olds reported at least one symptom five weeks after a confirmed Covid-19 infection.”A recent letter in the British Medical Journal BMJ gives more context about these “long covid” symptoms, and points out the lack of a “comparator group” in that data. Some of the reported symptoms are in line with, or lower than, the prevalence in the general population.
The Office for National Statistics (ONS) prevalence of 12.9% (primary school age) and 15% (secondary school age) of long covid are widely quoted. So how much should parents and their children worry, and does this worry warrant vaccination?
The ONS figures need context. Our understanding is that they represent the proportion of children who—within five weeks of a positive covid-19 test—have one of the following symptoms: fatigue, cough, headache, loss of taste or smell, myalgia, sore throat, fever, shortness of breath, nausea or vomiting, diarrhoea, or abdominal pain. For some of these symptoms the ONS reported prevalence is as follows: fatigue 3.5%; cough 4%; headache 5.3%; loss of taste or smell 2%; myalgia 1.7%. These seem in line with or lower than the population prevalence—for example, cough reported in an unselected cohort of 7670 children aged 1-18, or headache and fatigue in children from a representative Finnish cohort. Given current high levels of family and community stress we would expect the prevalence of some of these symptoms to be higher.
The prevalence estimates being discussed need a comparator group, and to be interpreted with much more caution, especially given the lack of a dedicated case definition for children. Specifically, we need to know how many survey participants (by age) without covid-19 had similar symptoms.
Re: the Australian narrative provided by ezlxa1949
The FDA report I linked above is much more honest (about the vaccine) than that panel of cheerleaders assembled by the Australian Broadcasting Corporation.
For example, the FDA report goes over the known and potential risks of the vaccine, and tries to assess whether the known and potential benefits outweigh these risks.
“…based on the totality of scientific evidence available, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older, and [do] the known and potential benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its known and potential risks for use in individuals 16 years of age and older.”
The FDA’s advisory committee had to vote on these two questions. The winner of the vote was “Yes” but it wasn’t a slam dunk. Not everyone on the committee voted “Yes”.
The latest weekly data for Influenza in the US is showing the lowest possible minimal activity level in every state:
https://gis.cdc.gov/grasp/fluview/main.htmlThis seems unusual, since influenza activity often spikes around February (weeks 5-8):
For Europe, the aggregated data at this site shows the weekly excess deaths (from all causes) to be approaching zero, and excess deaths are are significantly below the 2019 deaths for all age categories (for Week 7, the most recent data).
https://www.euromomo.eu/graphs-and-maps#excess-mortality
click on Weekly instead of AccumulatedThe current “emergency” has not caused any more deaths than normal in the US during February, according to the CDC (even after they adjusted for the expected late reports). Excess deaths from all causes are down to ZERO (or less than zero) for February through the 13th (the most recent data):
https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm
The FDA document I quoted above:
FDA Briefing Document
Pfizer-BioNTech COVID-19 Vaccine
https://www.fda.gov/media/144245/downloadBy the way, I am not a medical doctor and have no medical training.
A comment I tried to post yesterday, in response to the story about Israel’s “Green Pass”:
This vaccine “pass” “is valid for six months after a second dose.”
Four shots per year per person? What a windfall for Big Pharma and its shareholders.
Never mind all the still-questionable benefits and unknown risks of the Covid vaccines, according to the FDA:8.2. Unknown Benefits/Data Gaps
Duration of protection
Effectiveness in certain populations at high-risk of severe COVID-19
Effectiveness in individuals previously infected with SARS-CoV-2
Effectiveness in pediatric populations
Future vaccine effectiveness as influenced by characteristics of the pandemic, changes in the virus, and/or potential effects of co-infections
Vaccine effectiveness against asymptomatic infection
Vaccine effectiveness against long-term effects of COVID-19 disease
Vaccine effectiveness against mortality
Vaccine effectiveness against transmission of SARS-CoV-28.4. Unknown Risks/Data Gaps
Adverse reactions that are very uncommon or that require longer follow-up to be detected
Vaccine-enhanced disease…However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure.
Expect more pressure in the coming months?
‘There’s a degree of mistrust’: a third of US military personnel refuse Covid vaccine“Reluctance to be vaccinated for Covid-19 is now rife in the US military, with about a third of troops on active duty or in the national guard refusing to be administered the vaccine… At the large Fort Bragg military base in North Carolina, acceptance rates for the vaccines are below 50%…”
“Soldiers have previously been given approved vaccines on a mandatory basis but because the vaccines for the coronavirus have only been given an emergency use authorization by the Food and Drug Administration, members of the military are able to opt out…”
“According to a CBS poll released on Friday, a quarter of Americans said they will not take the vaccine, with a further quarter only saying they would “maybe” get the jab.”
https://www.theguardian.com/us-news/2021/feb/27/covid-coronavirus-us-military-vaccine
HerrWerner: “She links to several sources and particularly calls out an mRNA rabies vaccine trial to support her case. No adverse events are noted in the study. This trial involved 101 participants and ended in 2017.”
If that’s what she wrote, then she’s not a trustworthy source of information (for whatever reasons). No adverse events?
Actually, 78% reported systemic adverse events in that trial.
And 10% reported “Grade 3 events — which means the reaction is severe enough to cause hospitalization, and/or is disabling (but not immediately life threatening.)Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial
The Lancet, September 2017
https://www.sciencedirect.com/science/article/abs/pii/S0140673617316653…we enrolled and vaccinated 101 participants... 50 (78%) of 64 intradermally vaccinated participants and 29 (78%) of 37 intramuscularly vaccinated participants reported solicited systemic adverse events, including ten grade 3 events… intradermal or intramuscular needle-syringe injection was ineffective, with only one participant (who received 320 μg intradermally) showing a detectable immune response.
Yesterday, Pfizer and Moderna got their Covid vaccine EUA reissued by the FDA, and the duration of the EUA can last until the emergency declaration is “terminated.”
IV. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
https://www.fda.gov/media/144412/download
https://www.fda.gov/media/144636/downloadIn the US, the emergency declaration can be renewed. An EUA is in effect for one year, or shorter if the emergency declaration is no longer in effect. The EUA can be revoked if the criteria are no longer met (such as, the requirement that “there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.”)
Criteria for EUA Authorization—The FDA will issue an EUA if the FDA commissioner finds all of the following:The CBRN agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition.
Based on the scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the disease or condition specified in the declaration of emergency or caused by another medical product to diagnose, treat, or prevent a disease or condition caused by the specified agent.
The known and potential benefits outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition that is the subject of the declaration.
There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.The EUA is in effect for one year from the date of issuance or for as long as the HHS secretary’s §564 emergency declaration is in effect, whichever is shorter. The emergency declaration can be renewed. The EUA can be amended and may be revoked earlier if the criteria for issuance are no longer met or revocation is appropriate to protect public health or safety.
Q: …If states/countries now want to open up again, it would appear that they -legally- have to lift their State of Emergency. But then they can no longer allow people to be vaccinated with the vaccines, can they?
In the US, a Determination of Public Health Emergency is used to justify the Emergency Use Authorization of some vaccines, but travel restrictions are not necessarily required during the Public Health Emergency.
https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency
https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use-authorization-declarationIf there is no Public Health Emergency, then there can be no Emergency Use Authorization, and the Covid vaccines could not be widely distributed until getting FDA approval after years of testing.
Even if there is a Public Health Emergency, the Covid vaccines could not obtain Emergency Use Authorization if an effective treatment is acknowledged to be available.
With a Public Health Emergency in place, the PREP act (Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19) provides liability immunity to both public and private distribution channels for the vaccines, including those who prescribe, dispense, and administer the vaccines.
“Liability immunity” means that the “covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure [such as a vaccine].”
In addition, “to the extent that any State law that would otherwise prohibit the employees, contractors, or volunteers who are a “qualified person” from prescribing, dispensing, or administering COVID-19 vaccines or other Covered Countermeasures, such law is preempted.”
“Brosh said that this does not mean the vaccine changes people’s genetic code. Rather, he said it is more like a USB device (the mRNA) that is inserted into a computer (your body). It does not impact the hard drive of the computer but runs a certain program.”
So a USB thumb drive that’s put into your computer cannot have unintended and unforeseen consequences, like infecting and corrupting your hard drive?
Dystopian novel idea:
Vaccine “passports” that indicate that the holder has not received the faulty vaccines having whatever long-term effects that were discovered too late. This passport would be required before someone is allowed to procreate.The excess deaths (from all causes) in the US has dropped below zero in the latest prediction from the CDC (for the week ending February 6.)
https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm
Across the country, 161,000 nursing home and other long-term care residents have died from Covid-19, an astonishing 36 percent of the total coronavirus deaths in the U.S.
And over 80% of the total deaths from Covid-19 are in the 65-and-over age group (latest CDC data as of 2/17/2021)
A recent study is critical of the CDC, and hints at how the CDC neglected to base some key Covid policy decisions on good data (the science was missing.) “CDC scientists and staff have authored a large number of studies on COVID-19; however, the majority are descriptive and provide low-quality evidence for policy and management decisions.“
“The Missing Science: Epidemiological data gaps for COVID-19 policy in the United States”
https://www.medrxiv.org/content/10.1101/2021.02.11.21251602v1.full“Current guidance for COVID-19 community mitigations relies primarily on indirect evidence. For example, pre-symptomatic transmission, proximity, and an inability to mask are the facts used to justify restrictions on indoor dining in restaurants; [91] Such restrictions may well be protective; however, rigorous studies quantifying transmission risks for restaurant settings have not been undertaken.”
“While several case series and outbreak investigations have highlighted potential hazards in “essential” and frontline work settings such as food production, no identified analytic studies quantified determinants of risks of transmission in workplace settings.”
“CDC’s estimates of the infection-fatality ratios (IFR) based on studies in six European countries may not be generalizable to the US. County to country differences in the prevalence of vulnerability factors, medical care, and ascertainment of infection affect this parameter.”
“To monitor disease burden, the CDC has routinely reported several measures of infection and disease incidence at the national and state level; however, these measures have limited geographical resolution. Each state has utilized its own distinct sets of state and regional indicators, [96] along with state-specific benchmarks, to guide control activities.”
“A robust, national approach to monitoring COVID-19 in every region using multiple measures of disease incidence should be feasible.”
“Disaggregating measures of infection and disease burden by community setting (e.g. residential setting, workplaces, neighborhoods) could further aide in targeting public health responses and focusing resources for testing, contact tracing and outbreak investigations.”
“The US currently lacks regional estimates of the cumulative infection prevalence. Regional differences in prevalence could explain part of the variation in the pace of infectious spread.”
ConclusionsTwelve months after the identification of the SARS-CoV-2 virus, the understanding of COVID-19 transmission, infection severity and disease burden has advanced, yet estimates of several essential epidemiological parameters remain absent or uncertain. Missing are comparative measures of transmission risk and disease burden for community exposure settings, including work in “essential occupations.” Estimates for infection fatality and infection hospitalization ratios representative of US settings do not exist. Indicators of disease burden, though available, have insufficient resolution to inform targeted policy and programmatic responses.
These epidemiological data gaps may be limiting the most efficient and equitable response to the COVID-19 epidemic and underscore the importance of standardizing data collection priorities and protocols early during a rapidly emerging infectious disease epidemic. CDC scientists and staff have authored a large number of studies on COVID-19; however, the majority are descriptive and provide low-quality evidence for policy and management decisions. The content of their investigations raises questions about whether and how an explicit national research agenda guided CDC epidemiological endeavors.
CDC scientists have the access to data, the expertise, and the resources to provide the data necessary for an optimal epidemic response. Moving forward, the CDC should now plan for how it might develop and implement a timely, strategic, and prioritized national epidemiological data collection and research agenda for the next emerging infectious disease epidemic.
