To Develop A Coronavirus Vaccine, Synthetic

Biologists Try To Outdo Nature

By Sharon Begley @sxbegle March 9, 2020

Scientists at the University of Washington's

Institute for Protein Design are using
software to model and create new vaccines,
including one to prevent infection with the
new coronavirus. Ian Haydon/Institute for
Protein Desig

Even as companies rush to develop and test

vaccines against the new coronavirus, the
Bill and Melinda Gates Foundation and the
National Institutes of Health are betting that
scientists can do even better than what‘s
now in the pipeline.

If, as seems quite possible, the Covid-19

virus becomes a permanent part of the
world‘s microbial menagerie rather than being eradicated like the earlier SARS
coronavirus, next-gen approaches will be needed to address shortcomings of even the
most cutting-edge vaccines: They take years to develop and manufacture, they become
obsolete if the virus evolves, and the immune response they produce is often weak.

With Gates and NIH funding, the emerging field of synthetic biology is answering the
SOS over Covid-19, aiming to engineer vaccines that overcome these obstacles. ―It‘s all
of us against the bug,‖ said Neil King of the University of Washington, who has been
part of the hunt for a coronavirus vaccine since 2017.

Although the Gates Foundation is spreading its bets among several cutting-edge
vaccine platforms, including those using genetic material, one based on synthetic
biology has real promise. ―We may need an approach that can get you millions and
even billions of doses,‖ said immunologist and physician Lynda Stuart, who directs the
foundation‘s vaccine research. Gates announced last month that it will funnel $60
million to Covid-19 research, including vaccines.

A vaccine created through the tinkering of synbio looks not only scalable to a level of
billions but also like it will work without the need for refrigeration. All that, Stuart said,
―will be super important to protect people from coronavirus who are otherwise left
behind, such as those in sub-Saharan Africa.‖
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time contribution to support our journalism.

King and his synbio colleagues knew there would be another coronavirus epidemic, like
the SARS and MERS outbreaks before this one, he said, ―and there will be another one
after this,‖ perhaps from yet another member of this virus family. ―We need a universal
coronavirus vaccine.‖

Achieving that is so high on scientists‘ to-do list that when President Trump visited NIH
last week, his tour included the lab that‘s collaborating with UW‘s, and researchers
showed him a mock-up of what synthetic biology can do: Design and build nanoparticles
out of proteins and attach viral molecules in a repetitive array so that, when the whole
thing is packed into a vaccine, it can make people resistant to the new coronavirus.
(The human immune system has evolved to interpret repetitive arrangements of
molecules as a sign of danger: bacterial cell walls have repetitive chemical groups on
them.)

With a few tweaks, the nanoparticle can be studded with molecules from additional
coronaviruses to, scientists hope, protect against all of them — the original SARS virus,
MERS, and, crucially, a mutated form of the Covid-19-causing virus, called SARS-CoV-
2.

President Trump is shown a vaccine

model during a tour of the National
Institutes of Health‘s Vaccine Research
Center in Bethesda, Md., on March 3.
BRENDAN SMIALOWSKI/AFP via
Getty Images

Even compared to the DNA and RNA

vaccines against Covid-19 that
Moderna Therapeutics, CureVac, and
Inovio Pharmaceuticals are speeding
toward human testing, the synbio approach has advantages. These companies‘
experimental vaccines contain synthetic (that is, lab-made) strands of RNA or DNA that
code for protein molecules on the virus‘s surface. Once the vaccine delivers the genetic
material into cells, the cells follow the genetic instructions to churn out the viral protein.
The idea is that the body would see that as foreign, generate antibodies to it, and if all
goes well thereby acquire immunity to the virus. But safety tests of mRNA vaccines
have turned up adverse events, and it‘s not clear how potent they‘ll be. Moderna plans
to begin safety testing in healthy volunteers next month.

With all due respect to nature, synthetic biologists believe they can do better. Using
computers, they are designing new, self-assembling protein nanoparticles studded with
viral proteins, called antigens: these porcupine-like particles would be the guts of a
vaccine. If tests in lab animals of the first such nanoparticle vaccine are any indication, it
should be more potent than either old-fashioned viral vaccines like those for influenza or
the viral antigens on their own (without the nanoparticle).

Related:

A detailed guide to the coronavirus drugs and vaccines in development

The first step toward the molecule that was presented to Trump is to ―play Legos with
proteins,‖ as King put it.

That starts with the nanoparticle — the body of the porcupine. Its shape and
composition must be such that the protein‘s building blocks not only spontaneously self-
assemble and stick together but also turn into something that can display the viral
antigens in a way the immune system will strongly respond to. Using a computational
protein-design algorithm, scientists might determine that, for instance, a nanoparticle 25
nanometers across and made of 60 identical pieces is ideal for presenting the antigens
sotheir most immunity-inducing side faces outward, where the immune system can most
easily ―see‖ it.

―We might try 1 million variants on the computer‖ before finding the optimal shape and
protein composition, meaning which protein sequence will spontaneously form the ideal
nanoparticle, King said.

Planetary Genetic Overwrite: The Big Picture

Behind COVID mRNA Vaccines
by Daniel Taylor | Old-Thinker News December 10th 2020,

The very genetic code of the planet‟s biosphere, including humans, is being
overwritten; The ultimate goal being the ability to manipulate, patent and program
at will the biological processes of all life.

―Within 50 years we could have more life forms invented in a lab than we have
ever identified in nature.‖ – Fidelity Investments

Thinking Big: Synthetic Biology, Fidelity from Tian Hughes on Vimeo.

Tom Knight, professor at MIT‘s Artificial Intelligence Lab, said in 2007 that ―The genetic
code is 3.6 billion years old. It’s time for a rewrite.‖

Now, Knight‘s synthetic biology company Ginkgo Bioworks is using its synthetic biology
tech to develop COVID vaccines.
Bill Gates has also poured millions into synthetic biology. As reported by Newsweek in
2007, ―UC Berkeley received $42 million from Bill Gates to create living
microfactories…‖

Geneticist Craig Venter is a pioneer in the field of synthetic biology. In 2010 the media
hailed his team‘s success in creating ―the first self-replicating species we’ve had on the
planet whose parent is a computer.‖

Google founder Larry Page met with Craig Venter in California at the Edge billionaires
meeting in 2010. Also present were representatives from the State department, Bill
Gates, Anne Wojcicki, Bill Joy and dozens of other tech company CEO‘s and scientists.

The Edge billionaire meetings have discussed the future of genetic engineering,
biocomputation and re-designing humanity in a Transhumanist era. Physicist Freeman
Dyson described the individuals leading this group as having god-like power to create
entirely new species on earth in a ―New Age of Wonder‖. He describes them as:

―…a new generation of artists, writing genomes as fluently as Blake and Byron wrote
verses, might create an abundance of new flowers and fruit and trees and birds to
enrich the ecology of our planet.‖

Patenting life

Synthetic engineering of plant and animal life has enabled corporations to patent and
profit from genetic code.

Because synthetic biology is a different technique than older genetic engineering

tech, the supreme court ruled in 2013 that synthetic DNA can be patented because it is
not a ―product of nature‖. Justice Clarence Thomas wrote,

―…the lab technician unquestionably creates something new when cDNA is made.
cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from
which it was derived. As a result, cDNA is not a ―product of nature‖ and is patent eligible
under §101, except insofar as very short series of DNA may have no intervening introns
to remove when creating cDNA‖.

“Food 2.0”

Synthetic biology ingredients have already quietly entered our food supply. Nature
reported in 2014, ―This year [Evolva] will release a product that has been created by
genetically modified yeast that converts sugars to vanillin. It will be the first major
synthetic-biology food additive to hit supermarkets.‖

Since then, other synthetic foods have been developed. Synthetic biology has created
plant based burgers, eggs, and shrimp. Forbes reports,
―With the advent of synthetic biology, the easy reading, writing and editing of DNA could
open up a whole new world of designer proteins with enhanced nutrition, flavors,
fragrances, and material properties.‖

Humans re-engineered with new vaccines

The New York Times reported on the developing vaccine technology called
―immunoprophylaxis by gene transfer‖ in 2015. As the Times reported, animal tests on
the synthetic DNA vaccine ―are essentially re-engineering the animals to resist
disease.‖

The New York Times piece went on to say, ―…the prospect of genetically
engineering people to resist infectious diseases may raise concerns among
patients―.

Now, in the aftermath of the COVID pandemic, human beings are set to be genetically
altered with mRNA vaccine technology based on synthetic biology.

As reported, the Gates funded synthetic biologists believe that they can ―do better‖ than
nature with ―self-assembling nanoparticles‖ that will be injected into your body:

―With all due respect to nature, synthetic biologists believe they can do better. Using
computers, they are designing new, self-assembling protein nanoparticles studded with
viral proteins, called antigens: these porcupine-like particles would be the guts of a
vaccine.‖

Dr. Francis Boyle joins The Alex Jones Show to expose how the untested lethal mRNA
vaccine violates a Nuremberg ruling against Nazi medical experimentation cruelty.

Top Medical Inventor: COVID mRNA “Vaccine”

Not A Vaccine
Infowars.com January 19th 2021, 6:26 pm

Learn how Big Pharma uses emergency authorizations to force

untested gene therapies onto the population under the guise of mass
vaccinations

Medical inventor and author David Martin proves that the Pfizer and Moderna
mRNA vaccines are not vaccines by medical definition and how Big Pharma is
using national and state emergency authorizations to force these untested gene
therapies onto the population.
References

• It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product or
service can prevent, treat, or cure human disease unless you possess competent and
reliable scientific evidence, including, when appropriate, well-controlled human clinical
studies, substantiating that the claims are true at the time they are made.

• Definition of Vaccine: A product that stimulates a person‘s immune system to produce

immunity to a specific disease, protecting the person from that disease. Vaccines are
usually administered through needle injections, but can also be administered by mouth
or sprayed into the nose.

• Immunity: Protection from an infectious disease. If you are immune to a disease, you
can be exposed to it without becoming infected.

• ―The primary endpoint is the prevention of symptomatic COVID-19 disease. Key

secondary endpoints include prevention of severe COVID- 19 disease and prevention of
infection by SARS-CoV-2.‖

• ―As of this writing, no correlate of protection for SARS-CoV-2 has been established.‖

• ―No existing vaccines have been shown to be effective against infection with any
betacoronavirus, the family that includes SARS-CoV-2, which causes Covid-19.‖ Polack
FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19
vaccine. N Engl J Med 2020;383:2603-2615.

In Jacobson v. Massachusetts, 197 U.S. 11 (1905), the court held that the context for
their opinion rested on the following principle:

―This court has more than once recognized it as a fundamental principle that ‗persons
and property are subjected to all kinds of restraints and burdens in order to secure the
general comfort, health, and prosperity of the state…‖

The Moderna and Pfizer ―alleged vaccine‖ trials have explicitly acknowledged that their
gene therapy technology has no impact on viral infection or transmission whatsoever
and merely conveys to the recipient the capacity to produce an S1 spike protein
endogenously by the introduction of a synthetic mRNA sequence. Therefore, the basis
for the Massachusetts statute and the Supreme Court‘s determination is moot in this
case.

From Iowa Code:

Vaccine means a specially prepared antigen which, upon administration to a person, will
result in immunity.
―Vaccine‖ means a specially prepared antigen administered to a person for the purpose
of providing immunity.

Pursuant to the authority of Iowa Code section 147.76, the Board of Pharmacy hereby
gives Notice of Intended Action to amend Chapter 8, ―Universal Practice Standards,‖
and to adopt new Chapter 39, ―Expanded Practice Standards,‖ Iowa Administrative
Code.

Section 5(a) of the FTC Act, 15 U.S.C. § 45(a), prohibits ―unfair or deceptive acts or
practices in or affecting commerce.‖ Further, misrepresentations or deceptive omissions
of material facts constitute deceptive acts or practices prohibited by this section of the
Act. Notably, Section 12(a) of the FTC Act, 15 U.S.C. § 52(a), prohibits the
dissemination of any false advertisement in or affecting commerce for the purpose of
inducing, or which is likely to induce, the purchase of food, drugs, devices, services, or
cosmetics. Supple is a ―drug‖ as ―drug‖ is defined in Section 15(c) of the FTC Act, 15
U.S.C. § 55(c).

David’s book, “Lizards Eat Butterflies”, is now available on Amazon and Barnes &
Noble:

As A Doctor, People Ask Me If It‟s Safe To Take

A New Covid Vaccine. Given That Criticism Is
Risky, Here‟s My Very Careful Answer
24 Nov, 2020

By Malcolm Kendrick, doctor and author who works as a GP in the National Health
Service in England. His blog can be read here and his book, 'Doctoring Data – How to
Sort Out Medical Advice from Medical Nonsense,' is available here.

The type of vaccine being developed against the virus has never – outside of Ebola –
been used before. The trials have been extremely rushed & involved testing only small
numbers. What could possibly go wrong?

Since the first positive results on vaccines have come out, a lot of people have asked
me if I think everyone should take them? For some reason, a number of people out
there trust my judgement on such things.

I noticed that the Daily Mail recently ran a poll, which showed that three quarters of
Britons would agree to have a jab – Although 40 Percent Wanted
Politicians To Take It First To Prove It Was Safe. Frankly, I pity any
vaccine injected into certain politicians, as I am not certain it would survive.
Anyway, are the majority of Daily Mail readers right to be so enthusiastic about
vaccination? I must admit that I write this article with some caution, because I am
acutely aware that the slightest hint of criticism of a vaccine, any vaccine, is
risky.

As I remarked to a friend recently, the moment anyone says „vaccine‟, the only
acceptable response is to leap to your feet and salute, whilst singing Ode to Joy.
Followed by fifteen minutes of enthusiastic clapping. Failure to do so, means you
are taken out and shot for thought crimes. Doubleplusgood, indeed.

The first thing I want to say here is that the type of vaccine being developed against
Covid-19 has never been used before, outside of Ebola. Some people feel that they
should not really be called vaccines, because they are completely different from
anything that has gone before.

Up to now, vaccination has meant injecting a dead virus (or bacteria), or one that has
been weakened and can only poorly replicate, or parts of the virus, or suchlike. Once
inside the body, the immune system spots this ‗alien‘ material, and creates a response
against it, which will hopefully be remembered for years and years.

The next time the dangerous virus appears, the body will use the immune memory of
something very similar, to wipe out the virus (or bacteria) at high speed, giving it no
chance to do damage. The first ever ‗vaccine‘ worked by using the cowpox virus to
immunise against smallpox.

It had been noticed that milkmaids who caught cowpox, a relatively mild disease in
humans, did not then get smallpox. It was Edward Jenner who wondered how, or why,
this happened. In 1796, he scraped material from cowpox sores, and then scratched it
into the skin of people uninfected with smallpox, to see if they would be protected.

His first volunteer was a young boy, who he ‗immunised‘ with cowpox scrapings. Jenner
then tried to infect the boy with smallpox scrapings. A form of research that would be
rather frowned upon today. Luckily, the young boy survived, and vaccination was born.
Everything since has been a variation on this theme, of using a less dangerous ‗thing‘ to
create a defence against a damaging infection. Until now.

Now, we have a thing called a messenger RNA vaccine (mRNA). RNA is, effectively, a
single strand of DNA – the double helix that sits within our cells and makes up our
genetic code. Many viruses are made up of a single strand of RNA, surrounded by a
protein sphere.
They enter the cell, take over the replication systems, make thousands of copies of
themselves, then exit the cell. Sometimes killing the cell as they do so, sometimes
exiting more gently. Covid19 (Sars-Cov2) Is An RNA Virus.

Knowing this, rather than attempting to create a weakened virus, which can take years,
or break the virus into bits, the vaccine researchers decided to use Sars-Cov2‘s RNA
against itself. To do this, they isolated the section of RNA which codes for the ‗spike‘
protein – which is the thing the virus uses as a ‗key‘ to enter cells.

They then worked out how to insert this small section of RNA, messenger RNA, into the
cell, where it takes over a part of the protein replication mechanisms that sit inside all
cells. They turn the mechanism into a 3D printer, churning out copies of the spike
protein.
These spike proteins then leave the cell – somehow or other, this bit
is unclear. The immune system comes across them, recognises them as ‗alien‘ and
attacks. In doing so, antibodies are created, and the immune memory system kicks into
action. If, later on, a Sars-Cov2 virus gets into the body, the immune system fires up
and attacks the remembered spike protein. Hopefully killing the entire virus.

This is all, certainly very clever stuff. What, as they say, could possibly go
wrong?

The first thing to say is that, with something this new, we don‘t really know. It could be
that it is absolutely 100 percent safe. We are told that none of the mRNA can get into
the nucleus of the cell, where it could become incorporated into the DNA. I hope so.
Could it trigger an immune cascade? I hope not.

I know that the researchers will be looking very, very, closely at the novel safety issues
that could emerge. If they are not, they damned well should be. However, the timelines
here are very short. It normally takes many years to create safe and effective vaccines.
Here is it happening in, effectively, weeks.

The early stage human safety studies have been crammed very tightly together. In
addition, we will also have very little information on such things as whether or not the
vaccine actually reduces serious infections or death, as noted by Professor Haseltine in
a recent article: “These [vaccine] protocols do not emphasize the most important
ramifications of COVID-19 that people are most interested in preventing: overall
Prof. Haseltine also argues
infection, hospitalization, and death.”
that the trials have all been “designed to succeed.”
The reality is that we are rushing and rushing. There are very good reasons for this
rush, but I advise caution. Should everyone take the vaccine? Probably yes for those at
highest risk of serious infection and death, where the potential benefit is high. As for
anyone healthy, under the age of sixty, I would wait. As I shall be.

All Vaccines, Including The New Covid Ones,

Carry A Tiny Risk Of Serious Side Effects. But
Does That Mean We Shouldn‟t Take Them?
Rob Lyons 30 Nov, 2020 18:30

Vaccines are a wonder of modern medicine and serious reactions are vanishingly rare,
so let's reduce ‗vaccine hesitancy‘ by guaranteeing help for the few who are affected.

“I think vaccines are really important. Obviously, this is demonstrated beyond any doubt:
vaccines are really important for public health… I think if we can get more people
vaccinated, our public health will increase and suffering will reduce.”

Peter Todd is a lawyer who has represented many people who have suffered serious
side effects from vaccinations. But he is very far from being an ‗anti-vaxxer‘. What he is
concerned about is the way we treat the tiny minority whose lives are irreparably altered
after being vaccinated.

With the UK government putting the NHS on standby to start delivering vaccinations
early in December, many are now talking about a light at the end of the tunnel of the
Covid-19 crisis. This is an unalloyed good thing and I, for one, will be delighted when I
get the chance to be vaccinated. But we shouldn‘t allow this good news – and a desire
to counter anti-vaccine voices – to mean we don‘t discuss some of the downsides of
vaccinations.

Vaccines work by provoking a response from our immune systems. Most people won‘t
suffer any more discomfort than a sore arm, but some people will feel unwell for a few
hours, maybe a couple of days. These aren‘t really side effects; they are the normal
responses to the jab, even if they can be rather unpleasant for a short while.

But very rarely, recipients will have much more serious reactions to a vaccine. Since the
odds of any particular individual suffering serious harm from the actual disease are
usually low, even in the case of Covid-19, receiving a vaccination can be viewed as an
act of social solidarity, of mutual protection. So, on the extremely rare occasions that
someone suffers harm after getting a jab, shouldn‘t we make absolutely sure they are
supported?
The trouble is that, as Todd has found over the years, this has often
not been the case.
Of particular relevance to the current situation is what happened during the
„swine flu‟ epidemic of H1N1 influenza. The first known human case was in March
2009 in Mexico, and by late April, the World Health Organization (WHO) declared its
first ‗public health emergency of international concern‘, before declaring a ‗pandemic‘ in
June.

By September of that year, the European Commission gave approval to a vaccine,

Pandemrix, produced by pharmaceutical giant GSK. Pandemrix was created so
speedily because it was based on a mock-up of a vaccine based on the H5N1 strain of
influenza from the ‗bird flu‘ outbreak three years earlier. Crucially, it seems, it included
an adjuvant, which amplified the immune response to the active ingredient. Clearly,
given the speed of approval, Pandemrix had not been through the usual extensive
testing.

However, a very serious but rare side effect became apparent. In as few as one in
50,000 recipients, Pandemrix caused NARCOLEPSY. According to a support charity
for sufferers, Narcolepsy UK: “Narcolepsy is a rare neurological condition that
affects the brain’s ability to regulate the normal sleep-wake cycle. This can lead
to symptoms such as disturbed night-time sleep, excessive daytime sleepiness
and cataplexy.” For those with CATAPLEXY, sudden muscular weakness triggered by
strong emotions, the result can be collapsing to the floor.

Narcolepsy can significantly alter someone‘s life. Many day-to-day activities, like driving,
become dangerous, and many sufferers have to give up work. Even having a bath can
be hazardous, due to the risk of falling asleep.

In 2018, Buzzfeed Interviewed several health workers who received the vaccination. A
nurse, Meleney Gallagher, received the jab at Sunderland Royal Hospital in the north-
east of England. She was diagnosed with narcolepsy in 2013, but only after years of
being unable to stay awake and having cataplexy attacks several times a day,
sometimes caused simply by laughing. She tried working in different roles, but
concluded she was not safe to practice. She was given medical retirement in 2017, but
received just 12 weeks‘ pay despite 20 years working for the NHS.

Last week, Meissa Chebbi told Yahoo News of similar experiences in Sweden. “I have
sleep attacks all the time in all kinds of situations and at inappropriate times... In my
food, at job interviews, at lectures, seminars, at university. I’ve fallen asleep at my
workplace, I fall asleep on buses and everywhere.” According to the article, Swedish
Pharmaceutical Insurance has so far approved 440 of 702 narcolepsy claims linked to
Pandemrix, paying out a total of 100 million kronor (9.8 million euros, $11.6 million) in
compensation.

As Matt O‘Neill, chair of Narcolepsy UK, tells me, one complication is that narcolepsy
symptoms can be progressive and tricky to diagnose. “Cataplexy doesn't happen all the
time. Someone has to see it, and whoever sees it has to know what they’re looking at. If
it happened to me now, when I’m 52, someone is going to think I’m having a stroke. And
they’re going to try to shock me or something, which is the last thing I want. It’s an easy
one to solve if it’s what you’re looking for. And if you don’t even know what you’re
looking for, then it’s not so easy.”

In Order To Get Pandemrix Vaccinations Up And Running, The UK Government

Gave An Indemnity To GSK For Any Subsequent Claims. Yet the government has
taken a parsimonious approach to the problem, with legal action dragging on for years.
The claims have now been ―resolved,‖ according to Peter Todd, but for legal reasons he
is unable to comment further on that.

The UK does have a Vaccine Damage Payment scheme for cases where someone is
―severely disabled as a result of a vaccination,‖ paying a fixed sum of £120,000 to those
approved. As Todd tells me, that sum “doesn’t really go very far for providing for serious
permanent disablement. And initially cases were rejected on the basis of no causation. I
really got involved when I realised that the government had decided to reverse the
rejection regarding causation. If you accept that these cases of narcolepsy were caused
by the vaccine, then you’ll have to kind of deal with this under your indemnity.”

O‘Neill believes that the picture as regards other support for those affected has been
mixed. For the most part, “you can’t fault the clinical help that they’ve been given
because our NHS is pretty good.” But financial support has often depended on the
generosity of employers. Moreover, there were problems with recording vaccinations
given to groups of health workers, so some people had difficulty proving they had been
given Pandemrix.

So, what does this all mean for the rollout of Covid-19 vaccines? Todd and O‘Neill both
argue that a good starting point would be to give open and honest information about the
side effects and risks to recipients. More broadly, he argues, we shouldn‘t leave the
burden of dealing with these very rare but life-changing side effects to those who suffer
them.

“We’re looking at a phenomenon that is only one in a million or one in 10 million. I

think for me, it’s a question of social justice, as there is a benefit to the whole of
society to get people vaccinated, for example, against things like flu, because it
feeds massively on hospital spending, other health resources. It also avoids
tragic death and personal suffering if people are vaccinated.”
Making financial support clear, suitably generous, and easier to obtain would also
reduce people‘s fears, Todd says. “I really think that the government should actually be
concerned about trying to reduce hesitancy about vaccines and get the rate of people
vaccinated up.

“I think that offering a really generous compensation scheme would be one way to
really relieve public concern." In comparison with the costs of the vaccine rollout, the
costs would be trivial, he says, noting that only about one claim per year is accepted
under the current compensation scheme.

Todd adds that claimants shouldn't have to go to the same lengths as now to prove they
have been affected: “We could say if there are any close calls, claimants will always get
the benefit of the doubt in favour of the patient rather than the government. That’s what
the Americans do in their vaccine programme.”

The risks of not being vaccinated are worth emphasising. For example, O‘Neill tells me
he believes his narcolepsy was probably triggered by swine flu itself, not a vaccine.
Even those who do not face a high risk of death from Covid-19 may suffer long-term
effects – so-called ‗Long Covid‘ – which we still need to learn more about. It is highly
likely that these relatively unusual effects will be far more prevalent than serious vaccine
side effects.

There is no doubt that vaccination is one of the greatest achievements of modern

medicine, saving countless lives and avoiding a huge amount of suffering. The Covid-19
vaccines look to have had more testing than Pandemrix received, too. Those who want
to spread fears about vaccinations are likely to do far more harm than good, and their
arguments should be countered relentlessly.

Nonetheless, it seems clear that the government should be honest that there is a
vanishingly small risk of such side effects with vaccination, and work swiftly to make
sure that those who suffer them don't also suffer from financial hardship.

Covid-19 Vaccine Protocols Reveal That Trials

Are Designed To Succeed

William A. Haseltine Contributor

MOSCOW, RUSSIA - SEPTEMBER 9, 2020:

Moderna, Pfizer, AstraZeneca, and Johnson & Johnson are

leading candidates for the completion of a Covid-19 vaccine
likely to be released in the coming months. These companies have published their
vaccine trial protocols. This unusually transparent action during a major drug trial
deserves praise, close inspection of the protocols raises surprising concerns. These
trials seem designed to prove their vaccines work, even if the measured effects are
minimal.

What would a normal vaccine trial look like?

Prevention of infection must be a critical endpoint. Any vaccine trial should include
regular antigen testing every three days to test contagiousness to pick up early signs of
infection and PCR testing once a week to confirm infection by SARS-CoV-2 test the
ability of the vaccines to stave off infection. Prevention of infection is not a criterion for
success for any of these vaccines. In fact, their endpoints all require confirmed
infections and all those they will include in the analysis for success, the only difference
being the severity of symptoms between the vaccinated and unvaccinated. Measuring
differences amongst only those infected by SARS-CoV-2 underscores the implicit
conclusion that the vaccines are not expected to prevent infection, only modify
symptoms of those infected.

We all expect an effective vaccine to prevent serious illness if infected. Three of the
vaccine protocols—Moderna, Pfizer, and AstraZeneca—do not require that their vaccine
prevent serious disease only that they prevent moderate symptoms which may be as
mild as cough, or headache.

Three Types Of Misinformation In This Election And How We Can Fight It

The greatest fear people have is dying from this disease. A vaccine must significantly or
entirely reduce deaths from Covid-19. Over two hundred thousand people have died in
the United States and nearly a million worldwide. None list mortality as a critical
endpoint.

We recognize that the influenza vaccine does not prevent infection with that virus, but
does have a measurable impact on hospitalization and death. The moderate protections
from the influenza virus can potentially be replicated and improved on with Covid-19,
but only with extensive trials that ensure the efficacy of a future vaccine.

Vaccine efficacy is typically proved by large clinical trials over several years. The
pharmaceutical companies intend to do trials ranging from thirty thousand to sixty
thousand participants. This scale of study would be sufficient for testing vaccine
efficacy. The first surprise found upon a closer reading of the protocols reveals that
each study intends to complete interim and primary analyses that at most include 164
participants.
These companies likely intend to apply for an emergency use authorization (EUA) from
the Food and Drug Administration (FDA) with just their limited preliminary results.

Interim analysis success requires a seventy percent efficacy. The vaccine or

placebo will be given to thousands of people in each trial. For Moderna, the initial
interim analysis will be based on the results of infection of only 53 people. The judgment
reached in interim analysis is dependent upon the difference in the number of people
with symptoms, which may be mild, in the vaccinated group versus the unvaccinated
group.

Moderna‘s success margin is for 13 or less of those 53 to develop symptoms compared

to 40 or more in their control group. For Johnson & Johnson, their interim analysis
includes 77 vaccine recipients, with a success margin of 18 or less developing
symptoms compared to 59 in the control group. For AstraZeneca, their interim analysis
includes 50 vaccine recipients, with a success margin of 12 or less developing
symptoms compared to 19 in the 25 person control group. Pfizer is even smaller in its
success requirements. Their initial group includes 32 vaccine recipients, with a success
margin of 7 or less developing symptoms compared to 25 in the control group.

The primary analyses are a bit more expanded, but need to be less efficacious for
success: about sixty percent. AstraZeneca, Moderna, Johnson & Johnson, and Pfizer
have primary analyses that distribute the vaccine to only 100, 151, 154, and 164
participants respectively. These companies state that they do not ―intend‖ to stop trials
after the primary analyses, but there is every chance that they intend to pursue an EUA
and focus on manufacturing the vaccine rather than further thorough testing.

The second surprise from these protocols is how mild the requirements for contracted
Covid-19 symptoms are. A careful reading reveals that the minimum qualification for a
case of Covid-19 is a positive PCR test and one or two mild symptoms. These include
headache, fever, cough, or mild nausea. This is far from adequate. These vaccine trials
are testing to prevent common cold symptoms.

These trials certainly do not give assurance that the vaccine will protect from the serious
consequences of Covid-19. Johnson & Johnson is the only trial that requires the
inclusion of severe Covid-19 cases, at least 5 for the 75 participant interim analysis.

One of the more immediate questions a trial needs to answer is whether a vaccine
prevents infection. If someone takes this vaccine, are they far less likely to become
infected with the virus? These trials all clearly focus on eliminating symptoms of Covid-
19, and not infections themselves. Asymptomatic infection is listed as a secondary
objective in these trials when they should be of critical importance.
It appears that all the pharmaceutical companies assume that the vaccine will never
prevent infection. Their criteria for approval is the difference in symptoms between an
infected control group and an infected vaccine group. They do not measure the
difference between infection and noninfection as a primary motivation.

A greater concern for the millions of older people and those with preexisting conditions
is whether these trials test the vaccine's ability to prevent severe illness and death.
Again we find that severe illness and death are only secondary objectives in these trials.
None list the prevention of death and hospitalization as a critically important barrier.

If total infections, hospitalizations, and death are going to be ignored in the preliminary
trials of the vaccines, then there must be phase four testing to monitor their safety and
efficacy. This would be long term massive scale monitoring of the vaccine. There must
be an indication that the authorized vaccines are reducing infection, hospitalization, and
death, or else they will not be able to stop this pandemic.

These protocols do not emphasize the most important ramifications of Covid-19 that
people are most interested in preventing: overall infection, hospitalization, and death. It
boggles the mind and defies common sense that the National Institute of Health, the
Center for Disease Control, the National Institute of Allergy and Infectious Disease, and
the rest would consider the approval of a vaccine that would be distributed to hundreds
of millions on such slender threads of success.

It appears that these trials are intended to pass the lowest possible barrier of success.
As this is being written, the FDA is poised to announce tougher standards for a Covid-
19 vaccine in the near future. It is my hope that these new standards for an EUA will at
a minimum include requirements for protections from infection itself, protections from
severe virus-related disease leading to hospitalization, and a significant improvement in
Covid-19 related mortality.

It is clear from these studies that the vaccines currently under trial will not be the silver
bullet needed to end the pandemic. We must do all we can public health measures to
control Covid-19 as China and other Asian countries have successfully done.

Correction (10/7/20): A former version of the article stated that 53 people received a
vaccination for interim analysis in the Moderna trial. The vaccine was in fact given to
thousands of people, with 53 being the number of people who must be infected with
Covid-19 to run the analysis.

Researchers Warn Some Covid-19 Vaccines

Could Increase Risk Of HIV Infection
Robert Hart Forbes Staff
TOPLINE
Some of the Covid-19 vaccines currently in development could increase the risk of
acquiring HIV, warned a group of researchers in the The Lancet medical journal
Monday, potentially leading to an increase in infections as vaccines are rolled out to
vulnerable populations around the world.

Some Covid-19 vaccines could increase risk of HIV infection, warn researchers who
have seen increases in similar vaccines.
KEY FACTS
1. The researchers warn of a ―cautionary tale‖ from efforts to create an HIV vaccine
over a decade ago, where a promising vaccine candidate actually increased the
risk of some men catching the virus.
2. The vaccine made use of a modified virus — called adenovirus 5 (Ad5) — as a
vector to transport some of HIV‘s genetic material into the body.
3. Exactly how the vaccine increased the risks of HIV transmission is unknown, but
a conference convened by the National Institutes of Health recommended
against further use of Ad5 as a vector in HIV vaccines (Dr. Anthony Fauci was
lead author of the paper outlining this position.)
Ad5 is used as a vector in some Covid-19 vaccines — Science identifies four such
candidates that are currently undergoing clinical trials in various countries around the
world, including the U.S., with two in large scale phase 3 trials ongoing in Russia and
Pakistan.

The researchers stressed the need to understand the role Ad5 might play in increasing
the risks of HIV in vulnerable populations before developing and deploying vaccines
using the vector, adding that informed consent documents should reflect the
―considerable literature‖ on the risk of HIV acquisition with Ad5 vectors.
KEY BACKGROUND

Lots of vaccines make use of modified viruses to transport material into the human
body. Many make use of a modified adenovirus to do this, a virus which is usually
harmless except the ability to cause the common cold. Some of the leading candidates
for a Covid-19 vaccine, including those from Johnson & Johnson and AstraZeneca, use
adenoviruses as vectors. There is no evidence that those vectors increase the risk of
HIV infection.

CRUCIAL QUOTE

The authors said they went public because Ad5 vaccines for Covid-19 might soon be
tested in populations with high HIV prevalence. Lawrence Corey, one of the authors
who now co-leads the Covid-19 prevention network in the U.S. that is testing vaccines
on behalf of the NIH, told Science that if he were in a sub-Saharan African country,
where there‘s a high prevalence of HIV, ―I don‘t see why I would pick an Ad5 vector
(vaccine) when there are many other alternative choices.‖

Could Certain COVID-19 Vaccines Leave People

More Vulnerable To The AIDS Virus?
By Jon Cohen Oct. 19, 2020

Certain COVID-19 vaccine candidates could increase susceptibility to HIV, warns a

group of researchers who in 2007 learned that an experimental HIV vaccine had raised
in some people the risk for infection with the AIDS virus. These concerns have
percolated in the background of the race for a vaccine to stem the coronavirus
pandemic, but now the researchers have gone public with a ―cautionary tale,‖ in part
because trials of those candidates may soon begin in locales that have pronounced HIV
epidemics, such as South Africa.

Some approved and experimental vaccines have as a backbone a variety of

adenoviruses, which can cause the common cold but are often harmless. The ill-fated
HIV vaccine trial used an engineered strain known as adenovirus 5 (Ad5) to shuttle into
the body the gene for the surface protein of the AIDS virus. In four candidate COVID-19
vaccines now in clinical trials in several countries, including the United States, Ad5
similarly serves as the ―vector‖ to carry in the surface protein gene of SARS-CoV-2, the
viral cause of the pandemic; two of these have advanced to large-scale, phase III
efficacy studies in Russia and Pakistan.

In today‘s issue of The Lancet, four veteran researchers raise a warning flag about
those COVID-19 vaccine candidates by recounting their experience running a placebo-
controlled AIDS vaccine trial dubbed STEP. An interim analysis of STEP found that
uncircumcised men who had been naturally infected with Ad5 before receiving the
vaccine became especially vulnerable to the AIDS virus. The vaccine, made by Merck,
had been the leading hope for what was then a 20-year search for a shot that could
thwart HIV. But after the STEP results appeared, the field went into a tailspin. ―It took a
decade to recover,‖ says one of the co-authors of the Lancet correspondence,
Lawrence Corey of the Fred Hutchinson Cancer Research Center.

Corey, who now co-leads the COVID-19 prevention network in the United States that is
testing vaccines at the behest of the National Institutes of Health, says he and his co-
authors went public because Ad5-based COVID-19 vaccines may soon be tested in
populations with high HIV prevalence and thus a greater risk of accidental infection
during a clinical trial. ―If I were in a sub-Saharan African country and making a decision
as to what I would want for my country for a general population use of a SARS-CoV-2
vaccine, I don‘t see why I would pick an Ad5 vector [vaccine] when there are many
other alternative choices,‖ Corey says.

The backfire in STEP—which evaluated the efficacy of the Merck vaccine in people at
high risk of HIV infection in the Americas and Australia—also appeared in a second
study, dubbed Phambili, of the same vaccine. It was taking place simultaneously in
South Africa and was stopped early because of the STEP data.

Precisely how Merck‘s Ad5 vaccine increased the risk of HIV transmission in STEP and
Phambili remains murky. The Lancet editorial spells out several possibilities, including
dampening of HIV immunity, enhancing replication of the AIDS virus, or setting up more
target cells for it.

In addition to the Ad5 COVID-19 vaccine candidates, several other leading vaccines,
including ones made by Johnson & Johnson and AstraZeneca/the University of Oxford,
use different adenoviruses as vectors. There‘s no evidence that any of those
adenoviruses increases the risks of an HIV infection.

I don‟t see why I would pick an Ad5 vector [vaccine] when there are many other
alternative choices.
Lawrence Corey, Fred Hutchinson Cancer Research Center

Of the Ad5-based COVID-19 vaccine candidates, from China-based CanSino Biologics,

has developed the furthest. In a Lancet report in May, researchers from the company
recognized the ―controversial‖ possibility of their vector increasing the risk of HIV
infection and said they would watch for it in the candidate‘s trials. CanSino‘s COVID-19
vaccine is being tested in efficacy trials in Russia and Pakistan that together hope to
enroll more than 40,000 people, and the company is discussing starting studies in Saudi
Arabia, Brazil, Chile, and Mexico.

China has already approved a CanSino vaccine against Ebola that uses the Ad5 vector.
Yu Xuefeng, CanSino‘s CEO, tells Science the risk of increased HIV susceptibility may
be limited to Ad5 vaccines that produce an AIDS virus protein. ―There‘s no clear answer
yet,‖ Yu says. ―We certainly haven‘t seen anything with the Ebola vaccine.‖ The
company‘s Ebola vaccine was tested in a population in Sierra Leone that, he notes, had
a relatively high HIV prevalence, making it more likely to have detected the problem if it
existed.

Russia‘s Gamaleya Research Institute has a COVID-19 vaccine candidate that uses a
combination of Ad5 and Ad26 vectors; it‘s now in an efficacy trial in that country.

Last week, ImmunityBio received approval from the U.S. Food and Drug Administration
to begin human trials of its COVID-19 vaccine, which uses Ad5 as a vector. The first
trial will take place in Newport Beach, California, but Patrick Soon-Shiong, the
company‘s CEO, says he also hopes to test it in South Africa, where he grew up and
went to medical school.

He calls the STEP study results ―very, very fuzzy‖ and stresses that ImmunityBio‘s Ad5
has four deleted genes that reduce the immune responses it triggers. ―It‘s 90% muted,‖
he says.

ImmunityBio is discussing the risks with scientists and regulators in South Africa of a
trial there to test its modified Ad5 COVID-19 vaccine. The informed consent process for
that proposed study would tell participants about potential risks given the previous
STEP and Phambili results.

Soon-Shiong emphasizes that his company‘s experimental COVID-19 vaccine, unlike

every other candidate that uses an adenovirus vector, presents two different SARS-
CoV-2 genes and might therefore offer more protection from infection or disease. Why
only test this in wealthy enclaves of Southern California, he asks? ―Why not South
Africa? Why not for the underserved people of the world?‖

Pediatrician Glenda Gray, who heads the South African Medical Research Council and
was the protocol chair of Phambili, has taken part in several discussions with the
ImmunoBio team. ―When [Soon-Shiong] contacted South Africa, we were obviously
quite concerned,‖ Gray says. ―All of us who were in Phambili and quite traumatized by
what happened asked whether there was an appetite to do something in South Africa.‖

But after several months of deliberations, the South Africans concluded that regulators
should consider a small trial of the vaccine there in people at low risk of HIV infection,
Gray says. ―We decided not to throw the baby out with the bath water just yet,‖ she
adds. ―If it does go ahead in South Africa, there has to be huge consultation with
communities, and we have to make doubly sure that the participants understand what
happened in the past.‖
Gray says South Africa appreciates ImmunoBio‘s offer to allow the country to
manufacture the product. ―We‘re in the middle of a COVID-19 epidemic in South Africa,
and we don‘t know if we‘ll ever get access to the current suite of vaccines‖ produced
elsewhere, she says.

The decision to move forward, she insists, has to be left to South African scientists,
regulators, and ethics committees. ―It‘s incredibly patronizing for people to determine
what science is good or bad for other countries,‖ she says. ―Everyone knows about
Phambili and STEP, and the scientists understand that there‘s an important need to be
cautious.‖

Gray, who has co-authored papers about HIV vaccines with Corey and the other three
authors of the Lancet correspondence, says there are no easy answers. ―What if this
vaccine is the most effective vaccine?‖ she asks. ―If this works out to be an important
vaccine, we‘ll have some experience with it.‖