My colleague and Medika co-founder Dr Jeff Livingston published an article yesterday morning that caught my eye. It’s about the Houston-based Methodist Hospital System and you can read the full article here. Essentially, here is the gist of the piece. The hospital’s Chief Executive Officer Dr. Marc Boom informed staff that they will now be required to be vaccinated. The new mandate will require all staff to receive their first vaccine dose by the middle of April.

They are the first hospital in the US to formalize this policy in writing, an important step that will be closely watched by other institutions, as this is in direct contravention to Federal Law and CDC guidelines, that state very clearly that experimental drugs — remember that none of the vaccines have finalized trials and only enjoy Emergency Use Authorization(EUA) approval with the FDA — may not be forced upon the public.

Individual rights and freedom of choice lie at the heart of this federal legislation. There is an unknown long-term element of risk (we have no idea if there will be any long-term adverse consequences to either of the two types of vaccine) in accepting the covid vaccine and the Federal government acknowledges and accepts this. As they don’t offer any form of compensation in the event things go wrong and have in fact indemnified drug makers against any claims relating to the covid-19 vaccines, it should only be considered fair that the choice to take the vaccine, be a personal one.

EUA MEDICINES CAN NOT BE MANDATED.

But it is happening, across the US, and various mechanisms are being employed to ensure you get your covid jab. Schools and universities will be at the forefront of the coming standoff. As early as September of 2020 articles were being published by NBC News, poorly researched and based on the flawed assumption that we’d be dealing with a normal vaccine and parents would have no legal foot to stand on. The truth is a very different beast.

Companies engaged in public-facing services are insisting, albeit less formally, that staff get vaccinated. Vaccine passports are on the verge of being released on an unsuspecting public and I’ve discussed the discriminatory mechanisms of these in-depth here.

Doctors tend to use the logic applied to mandatory vaccination for influenza and apply this to the covid vaccines. This is fundamentally flawed reasoning. We are not dealing with an influenza vaccine here, that has proven itself over decades and for which well-established risk profiles exist.

What are the facts?

• The covid vaccines, short term, have proven themselves both safe and very effective. FACT. There is however concern that they may not fare so well against variants and more data are required to answer this question definitively. You can validate existing reported data on adverse reactions recorded on the VAERS system via the CDC’s Wonder interface.
• We are dealing with a novel method of administration for two of the vaccines, mRNA is new and in a normally cautious medical environment, these products would have taken another four to five years to reach the market. FACT. We’ve rushed this, out of necessity. Another mRNA vaccine targeting Zika is in clinical trials. It will be interesting to see the timeline on this vaccine for final FDA approval.
• The SARS-CoV2 virus poses minimal risk to younger, healthy individuals with no co-morbidities. In fact, many older people who are otherwise healthy, also survive the virus. It poses a marginal, quantified risk unless you are obese and/or suffer from co-morbidities, a comprehensive list of which you can find here. FACT. The virus has already claimed over half a million lives in the US alone. There is clearly a risk, but it is a qualified one that we can now begin to statistically address.
• The covid vaccines we are offered are unapproved medicines. FACT. None have as yet completed trials (Long-duration Phase 3 findings). They all enjoy Emergency Use Authorization, which is not the same as a formally approved drug that has satisfied all the testing criteria.
• There is no existing data on the long-term efficacy and possible unforeseen side effects of an mRNA vaccine. FACT. While there may in fact, and we all hope this to be the case, be no side effects, we cannot exclude the possibility of negative unforeseen outcomes. It is an unquantified risk that will only be resolved over time and new research highlights our minimal understanding of the processes we are attempting to control.

The US government recognizes these facts and has passed legislation to protect its citizens accordingly. Sensible legislation, not influenced by pandemic paranoia, but a law that places the interests of the individual at the forefront. You can access the US legislation in full here and if you’re based in the EU. here’s the EU legislation passed to protect unvaccinated individuals against discrimination.

The Federal law is emphatic. Emergency Use Authorization (EUA) medications are not compulsory and your decision not to partake in vaccination, cannot be used to discriminate against you.

Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required, Her answer was emphatic.

“ under an EUA, “vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandatory.” Cohn later affirmed that this prohibition on requiring the vaccinesapplies to organizations, including hospitals.”

What if companies, businesses, and hospitals persist?

The solution is a simple one. Accept liability for any potential future negative impacts the vaccines may have on the recipient’s health. One would assume from his policy that individuals like Dr. Marc Boom, from Houston Methodist, is completely convinced the covid vaccines are safe and will not produce any adverse reactions in the years to come?

If not, then he is knowingly subjecting an employee to a medication he is himself unsure of. Let’s clarify this even further. If the employee is in an established risk category, the argument becomes moot, as the benefit of taking the vaccine outweighs the risk. I am certain that the majority of Dr. Boom’s workforce is in fact healthy and not classified as being in a risk group for developing Covid.

Let’s see the employers put their money where their mouth is. If you are completely convinced the recipient will suffer no future ill effects from the vaccine, put it in writing. Accept liability. Except you won’t, will you? Not even the U.S. government is willing to go down this route. It is too fraught with risk and yet Dr. Brown seeks to remove the choice from his healthy employees, to roll the dice for them. What gives him the right?

Who gives any employer the right to ask this of their employees. It is offensive and completely at odds with medicines’ prime directive. To do no harm. If you are not 100% sure of the product and the disease poses negligible risk to the patient, can you in good faith proceed? What kind of medicine do you practice and what side of the fence are you on?

Time has just published an article suggesting people who won’t accept the vaccine now will be shamed into it later. Vaccine passports and schools will add to the pressure. All wrong, all hopelessly at odds with the law, and each process these institutions engage in, further distances people from the vaccines. The anti-vaccine brigade must be holding house parties celebrating your stupidity and arrogance.

The covid vaccine is a tool of health

It is not a political weapon to be wielded for commercial purposes, for political gain and to alter the global balance of power. It is a tool to combat the pandemic and to save lives. For those at risk, for the aged, for those who are obese, suffer from other risk factors, and struggle with immune disorders, this vaccine is a life-saving tool.

Despite this, it is still an unproven medicine, one not fully tested and one that cannot be enforced on any sector of the community. Getting the vaccine is a question of choice. It must remain this way. I look forward to your considered responses.

The post Enforcing Emergency Use Vaccines on an Unwilling Public. We Must Say NO appeared first on Medika Life.

On its release, the vaccines suffered poor uptake, with even medical staff in some cities in the US refusing to be vaccinated. Healthcare tried to come to the rescue, countering misinformation and launching campaigns where doctors, nurses, and prominent public figures showed themselves being vaccinated to increase public confidence. 

It worked, but only marginally, aided to no small extent by the fact that, as the weeks progressed, no one grew horns or mysteriously morphed into a mutant. The vaccine was gradually establishing itself as safe.

The vaccines also worked, in fact, all the covid vaccines did, and miraculously and fortunately, with very few side effects, given the limited development and testing of the products. All the vaccines severely reduce the incidence of serious covid. Yet, despite all the efforts to the contrary, resistance to the vaccines continues. 

The “why” isn’t really difficult to figure out and we may, in a telling few weeks of quiet announcements by the FDA, the CDC, and the European council, have finally overcome the last obstacle to widespread acceptance.

Vaccinate, or else!

You cannot effectively roll out a public health vaccination campaign at gunpoint. Pandemic or no pandemic. Enforcing the covid vaccine as mandatory was never clearly dealt with in the public mind, with no government coming out directly and saying it was to be mandatory. In the same breath, no government has openly decried enforced vaccination as an option.

The public has been left in limbo, to wonder as to the true narrative, and uncertainty, as we know, breeds mistrust. It also serves as compost for the germination of conspiracy theories. Nowhere has this been more evident than in the case of the covid vaccine.

Vaccine or Immunity passports simply fuelled the flames even further. It’s one thing to say the vaccine is not mandatory, quite another if you’re discriminating against those that have chosen not to be vaccinated. Need a job? Get vaccinated. Want to fly? Get vaccinated. Sorry sir, this restaurant only serves vaccinated people.

The vaccine debate has rapidly moved away from the field of medicine to a question of human rights, commercialism, and political control. There seemed to be no clear path to de-escalating the debate until now, and it has come from a surprising source. A legal decision handed down by the Commission of Europe has seriously altered the covid vaccine’s fortunes for the better.

Surprisingly, it received very little attention in mainstream media. We’ll examine the European announcement first and then look at current American Federal Law.

What the European Council Decided

On the 27th of January this year, the European Parliamentary Assembly issued Resolution 2361 (2021) with very little fanfare. This important document entitled Covid-19 vaccines: ethical, legal, and practical considerations states, amongst other guidelines, the following. 

7.3 with respect to ensuring high vaccine uptake:

7.3.1 ensure that citizens are informed that the vaccination is NOT mandatory and that no one is politically, socially, or otherwise pressured to get themselves vaccinated if they do not wish to do so themselves;

7.3.2 ensure that no one is discriminated against for not having been vaccinated, due to possible health risks or not wanting to be vaccinated;

7.3.3 take early effective measures to counter misinformation, disinformation and hesitancy regarding Covid-19 vaccines;

7.3.4 distribute transparent information on the safety and possible side effects of vaccines, working with and regulating social media platforms to prevent the spread of misinformation;

7.3.5 communicate transparently the contents of contracts with vaccine producers and make them publicly available for parliamentary and public scrutiny;

7.3.6 collaborate with non-governmental organisations and/or other local efforts to reach out to marginalised groups;

7.3.7 engage with local communities in developing and implementing tailored strategies to support vaccine uptake;https://medika.life/media/0d266c291981d75e381497e2e38f67d2

You can read the resolution in full by following the linked document above. This document effectively deplatforms individuals who argue against the vaccine, claiming it is being enforced. It is illegal to do so within the European Union. Interestingly, this document also serves to seriously throw into doubt the legality of Vaccine Passports, as they serve as discriminatory mechanisms.

Unbeknown to most Americans, they enjoy exactly the same protection.

Where American stands

It turns out American legislators have got your back on this one and the Federal law is emphatic. Emergency Use Authorization (EUA) medications are not compulsory and your decision not to partake in vaccination, cannot be used to discriminate against you.

Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required, Her answer was emphatic.

“ under an EUA, “vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandatory.” Cohn later affirmed that this prohibition on requiring the vaccines applies to organizations, including hospitals.”

The EUAs for both the Pfizer/BioNTech and Moderna vaccines require fact sheets be given to vaccination providers and recipients. These fact sheets make clear that getting the vaccine is optional. For example, the one for recipients states that

 “It is your choice to receive or not receive the Covid-19 Vaccine,” and if “you decide to not receive it, it will not change your standard of medical care.”

This means that an organization will likely be at odds with federal law if it requires its employees, students, or other members to get a Covid-19 vaccine that is being distributed under EUA.

State law often prohibits retaliating against an employee for refusing to participate in a violation of federal law. Organizations that require Covid-19 vaccination in violation of federal law may face lawsuits under these state laws, not only to block the policy, but also for damages and attorneys’ fees. Such potentially costly lawsuits can be avoided by refraining from adopting policies that require vaccination or penalize members for choosing not to be vaccinated.

Organizations are free to encourage vaccinations through internal communications, educational events, and other measures to urge employees to be vaccinated. They can take these measures so long as: 

• they are not viewed as coercive,
• the organization makes clear the decision regarding whether to receive the vaccine is voluntary, and 
• the measures comply with the requirements in the EUAs and the related regulations for these products.

Changing the public mindset matters

It’s time for countries and their marketing arms focusing on vaccination to get on board with the laws that regulate the vaccination of people with EUA products. Any avenues that provide relief from the sea of misinformation and attacks the vaccines are continuously subjected to, need to be fully explored to their conclusion. 

Transparency is central to regaining trust and explaining to a skeptical public that they are in fact being offered a choice would encourage people to accept the vaccine. Enforcement, coercion, or the appearance of the removal of choice imply there is another agenda. There isn’t, but until we get the marketing right, the PR disaster will simply continue, and in all probability worsen.

Now is the ideal time. Be honest, be open and be forthcoming about freedom of choice. Law enshrines this right and it may be the biggest ally vaccines possess in terms of regaining public trust. It’s time to use it.

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