Thursday, August 18, 2022

Why Did it Take So Long for the US to Get the Novavax Vaccine?

Even as Covid-19 infections and deaths decrease globally, the World Health Organization warns that “the pandemic is not over.” The Biden Administration seems to feel the same. Earlier this month, the federal government extended the Covid-19 public health emergency again.

Why the concern? As WHO Director Tedros Ghebreyesus stated, “A new and even more dangerous variant can emerge any time and vast numbers of people remain unprotected.” Covid’s BA.4 and BA.5 sub-variants could be an example.

According to the Centers for Disease Control, BA. 5 currently composes 80 percent of new Covid-19 cases in the US. Although most research on these variants is preliminary, both the WHO and CDC consider BA. 5 a “variant of concern.” A fearful CNN article labeled BA. 5 the “worst variant.”

Whether these concerns are justified or not, Covid-19’s future variants pose a risk to public health as long as the disease is with us. As more variants emerge, they will likely become more infectious and able to evade past immunity developed from previous infections, vaccinations, or boosters. Although challenging, this means our best hope to minimize the harm of future outbreaks is to develop new treatments to tackle current variants.

Fortunately, a newly authorized Covid-19 vaccine provides hope.

Recently granted an emergency use authorization from the Food and Drug Administration, the Novavax Covid-19 vaccine effectively protects against severe Covid-19 infection. Unlike other available Covid-19 vaccines in the US, Novavax is protein-based (instead of mRNA developed). It can also be stored at higher temperatures, making it easier to transport to rural communities.

Most importantly, Novavax seems to provide better protection against BA. 5. As a BioRxiv article finds, two or three injections of the Novavax vaccine triggered strong immune responses to the omicron variant and all its subvariants. While receiving two or three injections of almost anything is unappealing, this is a considerable improvement from receiving nearly double the number of injections from mRNA-based boosters, which provide less protection.

While a welcomed addition to Covid-19 vaccines in the US, Novavax is hardly new. Other countries started using it in November 2021. By January 2022, Novavax was available in 170 countries. So why did it take so long for the US to authorize the Novavax vaccine?

Ironically, the answer boils down to a government partnership to quickly give us Covid-19 vaccines.

On May 15th, 2020, President Trump launched Operation Warp Speed. The project partnered private vaccine developers with federal agencies to bring a Covid-19 vaccine to the public in record time. Providing an expedited approval process, laboratories, and a “blank check” of funding seemed to work. By late October 2020, the Food and Drug Administration authorized the first Covid-19 vaccine for patient use. Two more Covid-19 vaccine authorizations followed in the next few months.

But the program’s quick approval of the first set of Covid-19 vaccines came at the expense of current developments. Because mRNA technologies provided the chance for quicker (but less likely to succeed) vaccine development, Operation Warp Speed only selected vaccines using this technology to receive the program’s benefits. Vaccines using older but more reliable technologies were not selected. Consequently, they could not utilize an expedited authorization process to reach patients. Sadly, Novavax’s vaccine is an example.

Operation Warp Speed brought the US three Covid-19 vaccines (although I have argued before it may not have been necessary). But it was still a government program designed to pick winners and losers for a vital medical good.

In the case of Novavax, our government picked wrong—and it has been a costly mistake.


Health Care Company Denied Religious Exemptions for COVID Vax, Now It's Going to Have to Pay Workers Millions

In a landmark lawsuit regarding a COVID-19 vaccine mandate, about 500 health care workers will be receiving $10 million worth of payouts after challenging a hospital’s vaccine mandate.

Hundreds of workers at NorthShore University HealthSystem in Illinois filed a lawsuit in October 2021, claiming that the health care organization was not granting religious exemptions for the mandated vaccine, the Washington Examiner reported.

In July a settlement was reached, and 473 current and former health care employees will be compensated.

Liberty Counsel was the group to represent the original 13 plaintiffs.

Horatio Mihet, the vice president of legal affairs at Liberty Counsel, made a statement that this lawsuit and subsequent settlement should “serve as a strong warning to employers across the nation that they cannot refuse to accommodate those with sincere religious objections to forced vaccination mandates.”

There are gradations of payouts and compensation for the workers and plaintiffs depending on circumstances.

Worker who lost their job because of an inability to comply with the vaccine mandate will receive $25,000.

Any of the original 13 plaintiffs are also eligible for another $20,000, according to Liberty Counsel’s founder and chairman Mat Staver.

Other health care workers who got the vaccine, despite religious objections, can be eligible for about $3,000 in compensation.

Anyone who was fired because of a refusal to be vaccinated based on religious belief will also be considered eligible for reemployment, the Examiner reported.

Along with these payouts, the settlement also allowed another $2 million for attorneys fees.

“This classwide settlement providing compensation and the opportunity to return to work is the first of its kind in the nation involving COVID shot mandates. This settlement should be a wake-up call to every employer that did not accommodate or exempt employees who opposed the COVID shots for religious reasons,” Staver said in a statement released by Liberty Counsel.

“Let this case be a warning to employers that violated Title VII. It is especially significant and gratifying that this first classwide COVID settlement protects health care workers. Health care workers are heroes who daily give their lives to protect and treat their patients. They are needed now more than ever,” he added.

The judge who ruled in the case was John Kness, appointed by former President Donald Trump.

The Examiner reported that Kness sided with Liberty Counsel’s claims that the NorthShore University HealthSystem had violated Title VII of the Civil Rights Act by denying religious exemptions to its vaccine mandate.

This is the first major case settled concerning the health care industry and COVID vaccine mandates.


Fertility matters. What’s going on with birth rates?

There is a significant drop in live birth rates occurring in some developed nations. Germany’s Federal Bureau of Statistics documented a reduction of over 12 per cent and similar falls have been reported in Switzerland, Sweden, Taiwan, the UK, Slovenia, and some US states. In other countries – the Netherlands, Belgium, and Portugal – this is not the case but given the temporal association with the Covid pandemic we should investigate the matter seriously.

Start with the basics. A reduction in population fertility may be due to fewer pregnancies, or increased pregnancy failures and both could be caused by viral infection, societal adaptation, or adverse effects of medical interventions.

Looking at viral infections, several micro-organisms can damage the unborn at different phases of intrauterine life. Rubella, for example, causes abortions, stillbirths, and malformations. So, a viral pandemic could reduce live birth rates. This is unlikely with Covid as intrauterine infection appears to be rare and a direct effect should already be evident. Still, here’s a research question:

Are Covid cases and hospital admissions associated with a reduction in live births six to eight months later?

Societal adaptation to the pandemic – more stress, less sex, less IVF, more terminations – could cause a decline in fertility. It’s happened before. After Chernobyl there were hundreds of thousands of additional terminations in Europe, but weren’t people more stressed in 2020 than in 2021? If so, it should have led to a drop in live births between late 2020 and mid 2021. So, here’s another research question:

Was there an increase in pregnancy terminations and/or fewer fertility treatment associated with a reduction in live births 6-9 months later?

The third possibility is that a fall in fertility could be an adverse effect of a medical intervention. There are precedents. Thalidomide was launched in 1956. At the time, it was known that medications might affect the unborn, but there was no mandatory testing for such effects. The principles of reproductive toxicology were only defined in 1959: depending on gestational age at exposure there might be a miscarriage or stillbirth, malformations, intrauterine growth retardation or functional disturbances only apparent in childhood or beyond.

Thalidomide resulted in about 10,000 cases of limb malformations. Once Widukind Lenz in Germany and William McBride in Sydney sounded the alarm in November 1961, the drug was no longer given to pregnant women. Thalidomide studies in animals form the basis of modern reproductive toxicology. Increasingly, agencies were tasked with regulating the clinical testing of new drugs. Since 1990 there have been international standards, but scandals still happen. Merck’s drug Vioxx caused up to 140,000 heart attacks prior to withdrawal.

Testing drugs on pregnant animals is mandatory and drug trials almost always exclude pregnant women to minimise risks. With most Covid vaccine trials, pregnant women were excluded. Pregnant women are now being encouraged to be immunised in what amounts to a real-life experiment. It led to a joke. One lab rat asks another, ‘Been immunised yet?’ ‘No,’ the rat replies, ‘They’re still testing it on humans.’ Make that pregnant humans.

Could immunisation impact live birth rates? Biodistribution studies of injected nanoparticles show that they do not remain in the deltoid muscle, accumulating in several sites, including the ovaries. This may influence ovarian function, and menstrual disturbances are a well-documented adverse effect. Sperm production may also be affected. Even if a pregnancy starts, the result may be implantation failure, a subclinical miscarriage or a clinically overt first trimester miscarriage. These normally occur in 12 to 15 per cent of confirmed pregnancies. Second-trimester miscarriages and stillbirths are much rarer. That doesn’t mean later immunisation is harmless but to date there is only anecdotal information. Toxic effects in the first trimester are most likely at four to eight weeks and could increase miscarriages and reduce live births seven to eight months later. This would be a temporary effect (as was the effect of Thalidomide). There is some evidence in publicly available data that this might be occuring following the mass vaccination of women of reproductive age in 2021-22, potentially affecting live birth rates from early 2022. So, here’s a research question:

Is there a temporal association between vaccination campaigns, first trimester miscarriages and live birth rates seven to eight months later?

There are other issues. Documented menstrual irregularities suggest a disturbance of ovarian or uterine function. A possible consequence would be an increase in premature menopause. Other consequences may take longer to manifest. Given that conditions such as myocarditis and blood clots are recognised adverse effects of some Covid vaccines, are there similar effects in the unborn? There is a precedent. It took over 30 years for the effects of stilbestrol – an estrogen treatment used in pregnancy – to become evident; it caused cancer in the offspring of patients.

Academic physicians don’t normally publish anonymously but regulators, health ministries and professional organisations refuse to ask, let alone try to answer, the questions posed here and wage smear campaigns against those who do. Papers published in reputable journals are at times indistinguishable from propaganda.

In the face of widespread systemic failure, the principles ‘My body, my choice’ and ‘First do no harm’ should put an immediate end to Covid vaccination of women of reproductive age. And then let’s hope the blind hysteria of postmodern media, politics and medicine has not caused the worst medical disaster in human history.




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