February 15, 2021
A Doctor’s View About the New mRNA Vaccines
By Thomas Siler
It’s important to know both what we know about the new vaccines and what we don’t know.
I’ve practiced for 35 years. I am always honest with my patients, even if conversations are difficult or confrontational. I will also be honest about saying “I don’t know.” This happens when a diagnosis is not readily apparent or when there are limits to the help I can give. With the passage of time, I’ve learned that what we don’t know about medicine outweighs what we do know.
I’ve always been a proponent of older, more established vaccines. However, they are imperfect and, like all medical treatments, can have side effects. Unfortunately, in the conversation about the new COVID-19 vaccines, the tenets of honesty and a willingness to admit ignorance are being compromised.
Operation Warp Speed was remarkable, but it leaves an uncomfortable question: Is it a good thing to rush a vaccine (or medicine) to the public without the usual safeguards? Operation Warp Speed might be a great business objective or military goal, but is it great for a medical treatment?
The pharmaceutical industry, government health authorities, and the media insist the new vaccines are safe and effective. While the initial results are promising, this is not the whole truth. Both honesty and acknowledging ignorance require answering a few questions.
What do we know about the new TYPE of vaccine being given?
Pfizer and Moderna were the first COVID-19 vaccines to be approved. Both use a new technology called mRNA vaccine, which has never been broadly given to a human population to prevent any disease.
Let that sink in for a moment.
All previous vaccines take a weakened virus or a piece of the virus and inject it into humans to induce an immune response sufficient to prevent a disease. Pfizer’s and Moderna’s vaccines inject mRNA, which is a protein code that instructs the body to make a part of COVID-19’s spike protein that will then induce an immune response.
Our bodies daily use our own mRNA to carry instructions from DNA to make various proteins the body uses. While this new vaccine science sounds intriguing, it has never been tried in humans in this scope. It may be a breathtaking scientific advancement heralding a new path for all vaccines. It may also be less effective or have currently unknown side effects.
Is the mRNA vaccine for COVID-19 safe?
So far, the limited study of the vaccines approved for emergency use (one major study for each vaccine approved) has shown some short-term side effects. The vaccine is a two-shot series and side effects were prominent after the second shot. Side effects were more common if the recipient was younger than 65 years old.
Pain at the injection site has usually gone away in 4-5 days. The other side effects resolve, on average, in 2-3 days.
Early reports after giving the vaccine have also included allergic reactions ranging from mild to a few cases of anaphylaxis (serious allergic reaction). Allergy may be to mRNA itself or the lipid nanoparticles/PEG vehicle it is housed in. The long-term side effects are not currently known, as the main study length and follow up have only been four months.
Is the mRNA vaccine effective?
In the main study from Pfizer’s vaccine, 8/17,000 patients got symptomatic COVID-19 in the treatment group during the short follow up. In the placebo group, 162/17,000 patients got symptomatic COVID-19 during the study time. There was also a trend towards those getting the vaccine having a less severe disease and needing less hospitalization.
The Moderna study had 30,000 patients split into treatment and placebo arms. In the vaccine group, 11/15,000 patients came down with COVID-19. In the placebo group, 185/15,000 patients came down with COVID-19.
It was hard to ascertain death avoidance in these small studies. However, the two initial studies are favorable and show a 95% efficacy. Now that more information about the studies is known, Peter Doshi, associate editor of the British Medical Journal, wrote an editorial that the true efficacy may be much lower because the study excluded people with COVID-19 symptoms but a negative test and other factors.
How long does immunity last?
This is unknown. Injected mRNA goes away in days, but it is thought that the immune response will be long lasting. Whether patients will need boosters at some point is not known.
What about mutations in the COVID-19 virus? Will the vaccine still work?
Viruses always mutate and scientists following COVID-19 estimate it mutates, on average, twice a month. Most of these mutations are minor and will likely not change the vaccine effectiveness. These mutations also usually do not make the virus more deadly.
What is antibody dependent enhancement?
COVID-19 is in the family of Coronavirus that causes the common cold. The pharmaceutical industry has been trying without success for the last two decades to make a vaccine against the common cold. A safe vaccine against the common cold would make some company a lot of money!
One problem in the animal studies on coronavirus family vaccines was “antibody dependent enhancement.” When animals were inoculated, they developed a robust immune response, which is a good result.
However, when the animals were later exposed to the coronavirus against which they were vaccinated, their immune system went into overdrive, and they developed an overwhelming, fatal immune response called a “cytokine storm.” Fatal cytokine storms also happened to some COVID-19 patients when their infection was severe.
Human responses do not always correlate to animal responses. So far, there have been no signs that humans have a cytokine storm when exposed to COVID-19 after receiving the vaccine. Obviously, this would be catastrophic for any vaccine.
Should we be concerned about other long term side effects from mRNA vaccines?
A concern that deserves mention is the possibility that a cross-reaction and immunity to other parts of the spike protein could cause auto-immune disease or other problems.
A former Pfizer VP, Dr. Michael Yeadon, who has over 30 years of experience in immunology and drug research, filed a Stay of Action petition with the European Medicine Agency (like our FDA) to halt the trials of mRNA vaccines over concerns it might affect sterility in women.
Yeadon is worried that the mRNA vaccine was coded for a region of the spike protein that was similar to Syncytin-1, which is a protein that is essential for the development of the placenta. If a woman’s body makes antibodies to this protein, she could become sterile when vaccinated for COVID-19. This is a theory, not a proven fact, and no one has studied it. Yeadon’s insistence on more studies to make sure this will not happen seems reasonable.
What to make of all these concerns?
Medicine is always about a risk/benefit analysis, subject to the first maxim of “do no harm.” Usually, new medicines or new vaccines are used only after multiple studies show over long periods of time (for vaccines, at least five years) prove they’re safe and better than the older treatments.
While the new mRNA vaccines have good initial results and may be a breakthrough, they should be viewed as experimental and would best be used in high-risk patients (older patients or those with health conditions raising COVID-19 mortality) until we know more. Patients should receive extensive informed consent to understand the risks and benefits. Patients also need to know that if they have a serious complication, Congress already protected the pharmaceutical companies from litigation around emergency vaccines.
The mantra of “safe and effective” is not only incomplete, but it also ignores other pathways out of the pandemic. For healthy people, early outpatient treatments are being developed to treat COVID-19. These would be a safer option than taking an experimental vaccine. Young people (<60 years old) who have very low mortality from COVID-19 should approach getting the new vaccine as if they were consenting to be in an experimental trial of a new vaccine.
Our history shows there are good reasons why new medicines and vaccines are not rushed into widespread use until we have multiple studies and time to assess the safety and efficacy of the new treatments. If the death rate from COVID-19 were much higher, it might make the risks acceptable to try an experimental vaccine. Given that the COVID-19 death rate is a little higher than a bad flu, my opinion is that younger and healthier people need a more rigorous risk/benefit analysis before taking the mRNA vaccines.
Portuguese mother, 41, dies two days after taking Pfizer COVID-19 vaccine
PORTO, Portugal, January 6, 2021 (LifeSiteNews) — A Portuguese health care worker and mother-of-two died two days after receiving the Pfizer COVID-19 vaccine.
Sonia Acevedo, 41, was inflicted with “sudden death” on New Year’s Day, following her vaccination which happened on December 30th. An autopsy is expected very soon, the Daily Mail reports.
Acevedo, who worked in pediatrics at the Portuguese Institute of Oncology in Porto, did not experience any immediate side-effects to the vaccine, beyond the “normal” soreness in the area where she received the shot.
Her father, Abilio Acevedo, said she was quite healthy, and “hadn’t had any health problems.”
“She had the Covid-19 vaccine but she didn’t have any symptoms,” he said. “I don't know what happened. I just want answers … I want to know what led to my daughter’s death.”
Ms. Acevedo’s employer, for whom she had worked the past ten years, confirmed she had been vaccinated on December 30 and stated they had not been notified of any “undesirable effect” to the shot in her case. They also expressed their “sincere regret to family and friends in the certainty that this loss is also felt here.”
Her employer added, “The explanation of the cause of death will follow the usual procedures in these circumstances.”
The death of Ms. Acevedo comes in the wake of many concerns regarding these vaccines, which have been rushed through the process of development, testing, approval and now distribution, with a new “messenger RNA” technology, no industry-standard animal trials, nor any sufficient studies on long-term effects.
Indeed, in early December, a former vice president and Chief Scientist at Pfizer, Dr. Michael Yeadon, petitioned for the halting of all testing of coronavirus vaccine candidates in Europe due to the significant safety concerns of a growing number of renowned scientists.
These concerns included, “allergic” and “potentially fatal reactions,” risks that these vaccines may cause infertility in women, result in an increased vulnerability to the virus, and present unacceptable dangers of long-term effects due to a lack of proper testing.
The U.S. Food and Drug Administration also drew up a document this fall listing the possible side-effects from a COVID-19 vaccine, including strokes, encephalitis, auto-immune disease, birth defects, Kawasaki disease and death.
5 questions about the coronavirus vaccine that should scare everyone
December 5, 2020 (LifeSiteNews) — The United Kingdom has announced its approval of the Pfizer coronavirus vaccine. The U.S. is expected to approve a vaccine within weeks, as well.
The U.K.’s government-produced safety instructions indicate that the vaccine should not be used by pregnant or breastfeeding mothers, that it is unknown what effect the COVID-19 mRNA vaccine will have on fertility, and “women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.”
In light of the fact that despots around the world have suggested, some using stronger language than others, that their citizenries will be forcibly vaccinated, or that there should or will be penalties for not receiving the vaccine, one wonders:
- What happens if a woman receives the vaccine and does become pregnant within two months of receiving it? Will she be pressured to abort her child? What impact would such a vaccine have on the baby?
- Will “women of childbearing age” be pressured — or even forced — to go on birth control or forgo pregnancy in order to receive the vaccine, which has been touted as the all-important key to “going back to normal”? In what world would it be considered just or fair to tell women they mustn’t become pregnant so they can receive an optional medical intervention — which has no shortage of side effects and risks — for a disease the vast majority of people survive?
- Will new mothers be pressured to forgo breastfeeding so they can be vaccinated?
- Will Catholic bishops tell women they ought to forgo pregnancy so they can be vaccinated? The Catholic bishops of California say they are committed “to promoting and encouraging COVID-19 vaccinations in the communities we serve.” If they will tell women to forgo childbearing, at least temporarily, so they can receive the shot, how will that be squared with Church teaching that children are the primary end of marriage and contraception is intrinsically evil?
- According to the U.K. government’s guidelines, which will presumably be similar to Pfizer vaccine guidances in other countries, pregnant women shouldn’t receive the shot. Will unvaccinated pregnant women be discriminated against because of this, and denied access to airlines and other spaces?
The fact that these questions even need to be asked is chilling (not as chilling as the vaccine itself, which bizarrely has to be stored at -70°C — colder than Antarctia).
The future of the human race, civil society, and very basic freedoms are at stake here. The time to ask these questions is now. It’s not too late — but it will be soon.
Covid vaccines – like apples and oranges
22 July 2020
By Robert Verkerk PhD, founder, executive & scientific director
The vaccine race is well and truly on as you’ll see from the Milken Institute’s Covid-19 Treatment and Vaccine tracker. But it could just as easily be described as a vaccine war – with the US having accused China of cyber-based espionage for stealing secrets from US vaccine companies that might give Chinese efforts an advantage. Hidden away in the 130-page supplementary appendix published in The Lancet alongside the Oxford/AstraZeneca Phase 1/2 trial, the British team have definitely got it in for the US team at Moderna/NIAID, stating: “Subunit vaccines [like Moderna’s] usually require the use of adjuvants and whilst DNA and RNA vaccines can offer manufacturing advantages, they are often poorly immunogenic requiring multiple doses, which is highly undesirable in the context of a pandemic.” [see Section 3.5 of supplementary appendix, p. 72]
Cooperation? Competition? Or war?
So much for the $18 billion global cooperation effort on vaccines, supposedly led by the World Health Organization (WHO) and Gates’ brainchild, the Coalition for Epidemic Preparedness Innovations (CEPI), that Gates threw nearly $100 million at in 2017.
The idea, agreed at an extraordinary virtual summit of the G20 on the 26th March, was that there would be no ‘profiteering’ over vaccines. The US Food and Drug Administration (FDA) has also widely claimed its commitment to full transparency, including around clinical trials and data. Recognising reports that the US President has pressurised the FDA to cut corners on vaccine development and deployment, a US House of Representatives Oversight Committee has demanded transparency to allow independent scientific review of vaccine safety and effectiveness.
As we start to digest the flurry of Phase 1 and 2 clinical trial reports coming out in some of the world’s most prestigious journals, we’ve been increasingly shocked. It’s a million miles from the kind of transparency we believe is in the public interest that we outline in our Vaccine Transparency Manifesto.
Which data are hidden?
Here are our three top concerns:
Data disclosure is definitely not transparent. Even in the case of the Oxford/AstraZeneca vaccine trial with its 130 pages of supplementary data, there are huge holes in the data – including about which subjects suffered which adverse reactions, and no breakdown of the adverse reaction data for the biggest groups tested.
The trial designs are not standardised. Take the two non-replicating viral vector vaccines, the Chinese CanSino Biologics/Beijing Institute for Technology one and the Oxford/AstraZeneca one. Both trials are published in the same journal, The Lancet, one of the world’s most prestigious medical journals. The CanSino one is double blind, the Oxford one single blind. Adverse events for the two trials cover entirely different time periods: 14 days for the CanSino vaccine, and solicited adverse event reports in the first 7 days following vaccination in the case of the Oxford vaccine and 28 days for unsolicited reactions. Apples and oranges.
Prestigious journals have dropped their standards for research reporting. Tell us how The Lancet allows the Methods in the CanSino trial to mention that the control involves only the adjuvant, yet fails to mention what it is – even broadly speaking, assuming some might argue for confidentiality to protect intellectual property. Wasn’t this all meant to be for the greater good, and open book? Why wasn’t the detailed data for the CanSino trial published in the The Lancet, when in the same journal, the Oxford trial included 130 pages of supplementary data? But in this, why is the detailed breakdown of adverse event reactions for the most important Group 2/4 plain missing? Why is it we can’t work out which subjects suffered from multiple adverse reactions?
Many vaccine candidates are already in manufacture preparing for roll-out in early 2021 if given green light by regulators.
The World Health Organization (WHO) tells us there are 24 candidate vaccines currently being evaluated clinically in humans. In case you thought the pipeline might be a little light, the WHO assures us there are a further 142 candidate vaccines in pre-clinical evaluation.
The contenders for commercial vaccines are publishing their preliminary data, and there’s huge political and public pressure for one or more of these to be rolled out by the end of this or early next. Among those at the front of the pack are the following 5:
Moderna/National Institute of Allergy mRNA-1273. We reported on this one last week. The work is being coordinated by Dr Anthony Fauci, head of the National Institute of Health’s National Institute of Allergy and Infectious Diseases. It’s a genetically engineered mRNA vaccine that’s delivered using a lipid nano particle (LNP) encapsulation system. The mRNA is encoded to instruct the muscle cells of the vaccinated person to express a stabilised form of the virus spike protein. It effectively turns your muscles into a vaccine factory and from there it triggers a humoral (antibody) and cell-mediated (T-cell) response. As we reported, even in a very small trial of just 45 people, it produced significant and severe side effects in some and moderately severe adverse reactions in 80% of those vaccinated.
Oxford-AstraZeneca vaccine. This is a non-replicating viral vector vaccine. It’s based on a synthetic, genetically engineered chimpanzee adenovirus. Once injected, the synthetic code causes the vaccinated person’s body to produce the coronavirus spike protein. That in turn triggers the immune system, both the humoral (antibody) and cell-mediated (T-cell) side. A booster dose is required to trigger sufficient immune response to be potentially useful in the real world. The team at the Jenner Institute had already been working on finding relatively innocuous viruses that could act as vectors for Ebola, so they could quickly redirect their efforts to Covid-19 in January. Some argue that the Oxford vaccine is presently leading the vaccine race.
While the trial results were promising from an immunogenicity viewpoint, the median age of the healthy participants was only 35, so we still don’t know much about how it might work on older people, including with comorbidities, who suffer the most serious cases of disease. Nor do we know much about how it affects those of non-white ethnicity, given 91% of subjects were white. The vaccine is non-adjuvanted which is a plus in terms of side effects, but the vaccine still showed more adverse reactions than the comparators, either Pfizer’s Nimenrix or GSK’s Menveo vaccines, both targeting meningitis (MenACWY). We also cannot deduce from the non-transparent data which subjects suffered different combinations of adverse events, and detailed adverse event data relates only to the initial Group 1 (n= 88) trial that also tested the effects of paracetamol. Surprisingly there were no comprehensive data on the Group 2/4 in which 489 volunteers were vaccinated with the genetically engineered chimpanzee virus vector. In short, the data are insufficient to allow independent evaluation of safety.
CanSino Biologics/Beijing Institute of Technology. Like the Oxford-AstraZeneca vaccine, this one is also based on a non-replicating viral vector vaccine. This time, the vector is a weakened, replication-defective human adenovirus (type 5) that causes the ‘common cold’ and does contain an adjuvant. Like Moderna, CanSino has never produced a vaccine before, but it’s very well funded and has the might of the Chinese government behind it. The project, as well as executives at CanSino, have strong ties with Canada. We know the vaccine is adjuvanted because the recently published Lancet paper with preliminary results of its double, not single, blind trials, tells us this much in its methods, the control being the same as the treatment (i.e. just so-called excipients) minus the genetically engineered sub-unit of the viral vector. But incredibly in our view, the Lancet paper omits to tell us what the adjuvant is. Is it an aluminium salt? Possibly, but we don’t know. The immune response looks good at face value, but it’s impossible to compare with other vaccines as no assessments are comparable. As far as adverse events are concerned, 9% suffered severe ones at the highest dose, 1% at the lower dose. Given that immunogenicity was comparable, they’re now going for the lower dose in the Phase 3 trial. Putting that in perspective, assuming a country the size of the UK, even the lower dose, if exposed to 70% of the UK population, would elicit 466,550 severe adverse events based on these preliminary results. That’s over one and a half times more than have been confirmed infected by Covid-19 in the UK to-date.
Pfizer-BioNtech’s BNT162b vaccine. Don’t discount this one – using the same lipid nano particle (LNP) platform as Moderna, with the world’s largest pharma company, Pfizer, in the mix for manufacturing and roll-out. Initial results are cited as promising in terms of immunogenicity and "lack of adverse events. The UK has ordered 30 million doses of one of two of the mRNA vaccines, whichever works best. But that’s dwarfed by a patriotic US order of 600 million doses.
Zydus Cadila - ZyCoV-D vaccine. Another candidate we should all keep our eyes on is the all-Indian vaccine project, based on a plasmid DNA vaccine. Details are sketchy, but apparently preclinicals yielded a strong immune response.
Transparency, or no trust
We’re moving rapidly towards a significant crossroads - one we can't afford to be sleeping at the wheel at when we arrive. Those who believe (and right now, it’s about belief and not scientific evidence) that vaccines are our only way out of this pandemic and into some semblance of normality, better soon realise that transparency is going to be a prerequisite. Many who have been denigrated as ‘anti-vaxxers’ or vaccine hesitants are simply those wanting more information, those who are concerned about the abominable lack of transparency around vaccine development and trials, or are parents or family members of those who have been vaccine-injured.
Hidden by a PR-machine intent on preparing people to roll up their sleeves is another critically important issue no one seems to be talking about. Where was the public debate on genetically engineered vaccines? Europeans have long been opposed to consuming genetically engineered foods – and many US states fought hard to force companies to label products containing genetically modified ingredients, albeit often unsuccessfully given the might of the pro-GMO lobby.
But at least foods are filtered through the digestive tract, including our very sophisticated intestinal mucosa and gut microbiome. Vaccines, including any adjuvants, other excipients and any free-loading contaminants bypass this sensing system. Many of the genetically engineered vaccines now heading the vaccine race do things we recently reserved for science fiction. They get our bodies to become the vaccine factories, having received information to do this from instructions issued by synthetic genetically coded material.
If you’re OK with all of this, that’s fine. But we believe you should be told and given all available information about the known risks and benefits, as well as about the composition of the medical treatment you’re being subjected to - before it’s given. That’s what medical consent is about - and it’s written into the rule book of every supposedly civilised nation, yet so often flouted in the case of vaccination.
We owe it to future generations to push the authorities to ensure we’re all provided with all the information we need to make an informed choice prior to being exposed to such an unproven medical procedure that breaks all the laws of nature that have preceded us for around four and half billion years. This issue will come to a head if the G20 countries get to produce their desired new, chip-enabled, machine-readable immunisation record that will be as important as your passport if you want to move from your country of residence.
Take action NOW!
Find out more about our Vaccine Transparency Manifesto and tell your elected representative why it’s so important for all of our futures by downloading the UK or international flyer below.
Which COVID-19 vaccines will be derived from aborted children’s cell lines?
There are now more than 120 COVID-19 vaccine candidates in development.
Navigating the ethics of using them will be a challenge.
Thu Jun 11, 2020 - 9:33 am EST
By Jonathan Abbamonte
June 11, 2020 (Population Research Institute) — The race is on to find a vaccine for COVID-19. The good news is that many of the world’s largest vaccine companies are developing promising vaccine candidates using ethically-derived cells. The bad news is that many of the leading vaccine candidates for the 2019 novel coronavirus (SARS-CoV2) are being developed using fetal cell lines that were originally derived from the tissues of aborted babies in the 1970s and 80s.
With more than 6.2 million reported cases so far and more than 375,000 deaths worldwide, the burden of disease from the 2019 novel coronavirus continues to mount. And so does the urgency to find a cure. From big pharma to small biotech companies and universities, researchers have been pushing out dozens of vaccine candidates and have fast-tracked promising vaccine candidates to clinical trials in record time. Pharmaceutical companies are sprinting to have a vaccine ready by the end of the year or by early 2021.
According to a tracker from the World Health Organization, there are now more than 120 vaccine candidates in development. Of these, 10 vaccine candidates have already advanced to clinical trials to test the vaccine candidate’s safety and efficacy. Several more candidates are expected to begin clinical trials before the end of the year.
Fetal Stem Cells Being Used
Several COVID-19 vaccine frontrunners, including those being developed by Moderna, Oxford University/AstraZeneca, CanSino Biologics/Beijing Institute of Biotechnology, and Inovio Pharmaceuticals, are using a human fetal kidney cell line called HEK-293 to develop their trial vaccines. HEK-293 was originally derived from kidney tissue taken from a baby girl who was aborted in the Netherlands in 1972 and later developed into a cell line in a lab in 1973.
Additionally, Janssen, the pharmaceutical division of consumer product giant Johnson & Johnson, is using the human fetal cell line PER.C6 to develop its vaccine. The PER.C6 fetal cell line was derived from retinal tissue taken from an 18-week-old baby boy who was aborted in the Netherlands in 1985 and later converted into a fetal cell line in 1995.
The U.S. government has made grants totaling nearly $2 billion in support of the development of COVID-19 vaccines using fetal cell lines. Most of this funding has been awarded through the Biomedical Advanced Research and Development Authority (BARDA), a division within the U.S. Department of Health and Human Services (HHS).
BARDA has awarded a $1.2 billion grant for AstraZeneca to fund research for the trial vaccine it is jointly developing with Oxford University. BARDA has also made grants for up to $483 million for Moderna’s vaccine and $456 million for Janssen Research and Development, LLC of Johnson & Johnson. Inovio has also received an unspecified grant for developing its vaccine candidate from the Defense Advanced Research Projects Agency (DARPA) at the Department of Defense.
On June 1st, BARDA issued a $628 million task order under a preexisting government contract with Emergent BioSolutions Inc. to accelerate development and manufacturing capacity for COVID-19 vaccines and drug treatments. Emergent BioSolutions is currently working with Janssen of Johnson & Johnson to manufacture their trial vaccines. BARDA’s funding for Emergent, however, was not awarded specifically for scaling up production of J&J’s vaccine candidate.
Worse still, the U.S. Centers for Disease Control and Prevention (CDC) has been producing samples of the SARS-CoV2 virus for biotech and pharmaceutical companies to use for vaccine research using fetal HEK-293T cells (a decedent cell line of HEK-293).
Moderna is also receiving substantial research assistance for its COVID-19 vaccine from the National Institute of Allergy and Infectious Diseases (NIAID) which helped develop the vaccine and conduct clinical trials. NIAID is a division of the National Institutes of Health (NIH) led by Dr. Anthony Fauci.
Ethically Produced COVID-19 Vaccines in the Pipeline
While many COVID-19 vaccines are being developed with fetal cell lines, a number of promising vaccine candidates, such as those being developed by Novavax, Sanofi Pasteur, GlaxoSmithKline (GSK), and Sinovac, are using ethically derived cell lines.
Of particular note, rival pharmaceutical giants Sanofi Pasteur and GSK have teamed up in an unprecedented partnership to jointly develop a vaccine for SARS-CoV2. Sanofi Pasteur will be bringing to the table an ethically produced antigen for the vaccine and GSK will be contributing an adjuvant — an immune response booster that improves the effectiveness of a vaccine.
U.K.-based GSK and France-based Sanofi are the world’s #1 and #3 largest vaccine producers respectively by total revenue in 2017 according to FiercePharma.
A vaccine being developed by Maryland-based Novavax is using an ethically derived invertebrate cell line Sf9 to produce protein nanoparticle antigens that make its vaccine work.
In animal studies, Novavax’s candidate demonstrated that the vaccine produces antibodies to the SARS-CoV2 spike protein and produces neutralizing antibodies capable of isolating and destroying the SARS-CoV2 virus. Novavax’s vaccine has already been approved for a fast-tracked phase I/II stage clinical trial. Results for the vaccine candidate’s safety profile and immunogenicity (the ability to induce an effective immune response in the body) are expected by July.
Sinovac, a China-based biotech company, is also working on an ethically derived vaccine candidate called PiCoVacc. PiCoVacc uses a purified inactivated SARS-CoV2 as an antigen. Sinovac’s antigen is ethically grown in Vero (monkey kidney) cells. Sinovac’s vaccine is currently undergoing expedited phase I/II clinical trials.
Pharmaceutical giant Merck also recently jumped into the COVID-19 vaccine race with an announcement on May 26th that the company will be pursuing 3 vaccine candidates. Merck was the first company to develop a proven vaccine for Ebola. Merck’s Ebola vaccine was granted regulatory approval by the FDA last December.
As of the writing of this article, it is still too early to tell whether Merck’s COVID-19 vaccines will use fetal cell lines or ethically derived cells.
But one of Merck’s vaccine candidates for COVID-19 being developed in partnership with the International AIDS Vaccine Initiative (IAVI) will be utilizing the same platform Merck used in successfully developing its Ebola vaccine (V290). The company’s Ebola vaccine is manufactured using a cell line ethically derived from the kidney cells of an African green monkey.
Another vaccine candidate being developed by Merck through Themis, a biotech company recently acquired by Merck, is seeking to use the live measles vaccine as a viral vector. Merck’s measles vaccine is produced using chicken egg [Note: Merck’s MMR vaccine (measles-mumps-rubella) is manufactured using human fetal cell line WI-38 which was derived from the lung cells of an aborted baby].
How Do Vaccines Work?
Cell lines are often used in vaccine production to grow viral proteins that make the vaccine work.
Vaccines produce immunity by training immune cells to fight off infection by exposing them to weakened or dead viruses or an isolated protein from the virus (or a synthetic look-alike). Providing immune cells the chance to fight off weakened viruses or viral fragments prepares the body to identify and neutralize the virus if encountered in the future.
Weakened viruses, inactivated viruses, and viral proteins used in a vaccine to produce immunity are called antigens. Antigens are any protein or molecule that triggers an immune response in the body, causing immune cells to produce antibodies. Antibodies are proteins the body’s immune cells produce to bind with and tag viruses and harmful bacteria with markers that help the immune system identify and destroy pathogens.
Traditionally, vaccines are manufactured by growing antigens in animal, plant, or fungi cells or tissues such as embryonated chicken eggs, yeast, or monkey kidney cells. After the antigens have been grown in these cells, the antigens are harvested, purified, and then added to a solution that is later injected or ingested as a vaccine.
Sometimes, however, vaccine manufacturers will use human fetal cells instead of animal cells to grow the antigens for their vaccines.
Several COVID-19 vaccines under development, such as those being developed by Oxford University, CanSino Biologics, and Johnson & Johnson, are utilizing a technology known as “non-replicating viral vector” vaccines.
Unlike traditional vaccines which involve injecting antigens into the body that were previously grown in chicken eggs or Petri dishes, viral vector vaccines grow the antigens in a person’s own cells.
In viral vector vaccines, a segment of DNA from the SARS-CoV2 virus is spliced into the genome of a benign carrier virus. The viral vector is also genetically modified to prevent the virus from replicating. When injected into the body, the viral vectors carry coronavirus DNA to the body’s cells that provide the cells with instructions on how to make antigens.
In order to make these vaccines, vaccine manufacturers must grow a sufficient number of these genetically modified viral vectors to induce immunity. Viral vector vaccines being developed by Oxford University, CanSino Biologics, and Johnson & Johnson are currently using fetal cell lines from aborted babies to grow their viral vectors.
A number of COVID-19 vaccine candidates under development are utilizing completely new vaccine platforms that require no cells at all. Several biotech and pharmaceutical companies are racing to develop vaccines that contain no viral proteins at all but only messenger RNA (mRNA) or DNA plasmids that provide the body’s cells with instructions on how to produce antigens.
Although no mRNA or DNA plasmid vaccine has yet received regulatory approval for normal use, the technology is promising. Experimental mRNA vaccines in recent years have shown promising results in clinical trials and in animal studies. mRNA vaccines could have distinct advantages over traditional vaccines because they can be developed much faster, cheaper, with a higher potency, and they can even be created without samples of the pathogen. The genome sequence is all that is needed to create these vaccines, slashing the amount of time it takes to produce a vaccine.
Additionally, mRNA- and DNA-based vaccines have the benefit that no fetal cells (or any cells for that matter) are needed to produce them.
Moderna is developing a mRNA COVID-19 vaccine candidate (mRNA-1273) in collaboration with NIAID. Meanwhile, Inovio Pharmaceuticals is developing a DNA plasmid vaccine for SARS-CoV2 (INO-4800).
Despite the fact that no fetal cell lines are needed to produce DNA plasmid vaccines, Inovio has chosen to test the immunogenicity and efficacy of its vaccine candidate using human fetal kidney cells (HEK-293T), sadly tainting what could otherwise have been a promising vaccine candidate.
As for Moderna’s vaccine, NIAID claims to have helped Moderna develop mRNA-1273.
In February, NIAID scientists working in collaboration with researchers at the University of Texas at Austin (UT) successfully identified and isolated the SARS-CoV2 spike (S) protein and its receptor binding domain using previous research it had on similar coronaviruses such as those which cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). However, the scientists in this study used human fetal kidney cells (HEK-293) to culture the SARS-CoV2 virus before isolating the S protein. The results from this study were later published in the peer-reviewed journal Science.
In a news release on February 19th, NIAID claimed that the study “supports NIAID’s approach to a gene-based vaccine for COVID-19.” In the same new release, NIAID also mentioned that it was working with Moderna to produce a mRNA vaccine, presumably using the findings from its study using HEK-293 cells to help identify the genetic sequence for mRNA vaccine.
Moral and Ethical Issues with Using Fetal Cell Lines to Develop Vaccines
The use of fetal cell lines for vaccine production has long stirred significant controversy among ethicists and people of faith, particularly among Catholics and Protestants that have deep religious and moral objections against the use of cell lines that were originally derived from aborted babies.
The Catholic Church has long vocally opposed the development of vaccines using unethically derived fetal cell lines. The Congregation for the Doctrine of the Faith’s 2008 Instruction Dignitas Personae states that the use of fetal cell lines for developing vaccines “gives rise to various ethical problems with regard to cooperation in evil and with regard to scandal” and that “everyone has the duty to make known their disagreement and to ask that their healthcare system make other types of vaccines available.”
Although it is not widely known or clearly disclosed by pharmaceutical companies, fetal cell lines have been used for decades in the development and manufacture of many widely used vaccinations including measles/mumps/rubella (MMR), rubella, varicella (chickenpox), polio, hepatitis A, rabies, and shingles. For some vaccines, such as MMR, chickenpox, and hepatitis A, no ethically produced alternatives exist in the U.S.
Why Are Fetal Cells Ever Used to Manufacture Vaccines?
Although alternative ethically derived cell lines exist for vaccine development, pharmaceutical companies often prefer to use fetal cell lines because the characteristics of fetal cell lines are well known and because they do not contain significant contaminating viruses or bacteria that are often found in cells derived from animals.
For example, the polio vaccine in the mid-20th century was once manufactured using primary cell cultures harvested from the kidneys of monkeys. However, it was later discovered that the vaccines were often contaminated with a common monkey virus known as Simian Virus 40 (SV40). Although SV40 is harmless to humans, the incident alarmed vaccine manufacturers. Since then, vaccine developers have relied more heavily on cell lines rather than cell cultures taken from live animals.
To provide a more contemporary example, the FDA is currently investigating whether there is any potential from harm in using primate cells for vaccines and biologics. Simian foamy viruses (SFV) are widespread among non-human primates and it is known that these viruses are sometimes able to cause infection in humans. Although no one is ever known to have become sick as a result of SFV, the FDA is investigating whether there could be long-term effects due to this.
With cell lines, it is possible for researchers to know the characteristics and inherent flaws in the cells they are working with. Cell lines have been rigorously inspected by scientists across the industry for contaminating virus DNA or genetic mutations, whereas tissues taken directly from live animals may have unknown contaminants that may potentially be harmful to humans.
But why use fetal cell lines instead of animal cell lines or embryonated chicken eggs which have an excellent track record and have been used for decades to manufacture vaccines? Many vaccines, including vaccines for the seasonal flu, are grown in embryonated chicken eggs.
However, there is a potential for supply issues when using chicken eggs to manufacture vaccines. If, for instance, there were a widespread outbreak affecting chickens that causes the supply of eggs to suddenly drop, it could impact the ability for manufacturers to make vaccines quickly. The supply issue could especially present problems in the event of a pandemic such as the current COVID-19 pandemic where the ability to produce hundreds of millions of vaccines quickly is paramount.
More significantly however, some viruses, such as chickenpox for instance, do not grow well in animal cells. In such cases, there are few other options available other than using human cell lines for vaccine production.
Researchers also often prefer to use human cells for experiments testing the effect of drugs or vaccines because they more closely resemble how a drug will work in humans.
But if human cells are better for manufacturing certain vaccines, why are fetal cell lines derived from aborted babies used instead of ethically derived adult cells?
Fetal cells are often preferred to adult cells because there are a limited number of splittings (passages) cells can undergo before they age and eventually die off. Fetal cell lines can be put through more passages than adult cells would and they are less prone to cell aging and senescence (when cells in a culture no longer divide and start dying off). Fetal cells are also less likely to be contaminated with human viruses or with genetic mutations or alterations that naturally occur as cells age.
Certain fetal cell lines such as PER.C6 are uniquely designed for manufacturing non-replicating viral vector vaccines. The viral vectors are genetically modified to prevent replication in the human body by deleting a portion of the viral vector’s genome. PER.C6 cells are designed to fill in this deleted genome gap. In this way, vaccine manufacturers can replicate viral vectors for their vaccines in the lab but such viruses are incapable of producing an ongoing infection in the body.
However, there is no need to derive cell lines from aborted babies. Human cell lines for vaccines could easily be produced in an ethical manner if they are derived from adult cells. Cell lines could be derived from tissue discarded during surgery or from organs donated after death. If fetal cells are needed, there are thousands of stillbirths and neonatal deaths in the U.S. every year. There is no reason why cell cultures cannot be derived from tissue donated from prematurely born infants that, despite the best medical technology, aren’t able to survive and die of natural causes while in a hospital setting. In these scenarios, developing a cell line would be no different from an ethical perspective than donating organs. In such context, however, it is imperative that any tissues obtained from naturally deceased neonates be strictly done in an ethical manner that respects the fundamental right to life of the child and the deceased child's bodily integrity. The procurement of tissue from the deceased could present a whole new set of ethical problems, particularly if the primary right to life of the donor is not sufficiently respected.
There is also the possibility that cell lines could be developed using cells ethically derived from human umbilical cord, cord blood, or placental tissue—tissues and organs that hospitals routinely discard as medical waste.
And ethical alternatives for human cell lines specially designed for producing viral vector vaccines may soon be available to vaccine manufacturers.
The John Paul II Medical Research Institute in collaboration with Cellular Engineering Technologies (CET) is currently in the process of developing an ethically-derived adult human cell line specially designed for growing viral vectors for vaccines that could replace ethically-fraught cell lines like HEK-293 and PER.C6.
But even so, it is not necessary for viral vector vaccines to be manufactured using fetal cell lines. Merck’s Ebola vaccine, for instance, is a viral vector vaccine that is grown in monkey kidney cells.
Immortalized adult human cell lines that were ethically derived from the cancer cells of cancer patients have also been available to researchers for decades. Immortalized human cancerous cell lines have some of the benefits of fetal cell lines in that they are high passage cells (in fact cancerous cell lines divide infinitely). However, the genetic mutations in these cell lines often change too much and there is concern that these cells could be contaminated with oncogenic viruses (i.e. viruses that induce the formation of cancerous tumors). There is fear that DNA from oncogenic viruses could find their way into vaccines if these cell lines are used for manufacturing vaccines.
However, fetal cell lines such HEK-293 and PER.C6 are also tumorigenic. There is concern that these cell lines too could be infected with oncogenic viruses or oncogenic DNA.
Although rigorous purification processes are used when manufacturing vaccines, purification is an arduous process and it is practically impossible to filter out all contaminants. The FDA is currently researching tests and methods to better determine whether certain cell lines are safe enough for vaccine production.
For the current ongoing COVID-19 pandemic, there is no reason for vaccines to be developed using unethically-derived fetal cell lines. Many of the world’s largest vaccine companies, including Sanofi, GSK, Merck, and Novavax, have demonstrated that it is possible to develop promising vaccine candidates using ethically-derived cells such as Vero, Sf9, and perhaps even embryonated chicken egg. Ethical alternatives exist.
If pharmaceutical companies are not willing to use ethical alternatives, then they must be required to.
Published with permission from Population Research Institute.
The 10-point vaccine transparency approach
29 April 2020
ANH together with the British Society for Ecological Medicine calls on UK government to heed vaccine transparency
We’re told repeatedly by our governments that we’ll only be allowed to emerge from various degrees of restriction to our freedoms once a vaccine is ready. That might take 12 to 18 months. We’re being given the impression it’s a straightforward process, that’s why it can be fast-tracked at a rate that surpasses any other vaccine ever produced. Hindsight’s a fine thing, but surely we need to learn from what went wrong last time round - when vaccines were produced for the last pandemic, the influenza A/H1N1 ‘swine flu’ virus back in 2009/10?
The solution has to be vaccine transparency. And we need to change the narrative from the World Health Organization (WHO)’s ‘vaccine hesitancy’, that the WHO rates as among the 10 greatest threats to global health, to vaccine transparency.
- Find related articles, information and videos in our Covid Zone
So today, in conjunction with our medical doctor colleagues at the British Society for Ecological Medicine, we’ve sent an open letter to Matt Hancock, the UK Secretary of State for Health and Social Care calling on a new public narrative around vaccines. This narrative is about transparency, something that’s been sorely missing through the development and roll-out of a number of recent vaccines.
Download Open Letter to Matt Hancock that includes the 10-point vaccine transparency approach (the full letter can be found in text below)
The taboo that has been created around even debating vaccination is unacceptable in a world that is rushing ahead with the development of global vaccines for Covid-19, often relying on untried or embryonic technology platforms.
Instead of pitching the blame at those citizens who choose to not give their consent for their own or their children’s vaccination, the powers-that-be must recognise their own role in contributing to this situation through the withholding of data and information, as well as inadequate safety testing.
Transparency must occur in multiple areas: clinical trial designs, the results from trials, raw data from trials to allow independent analysis, clarification around vaccine injury payments in the event of no-fault injuries, eligibility criteria for such payments, and, among other things, details of government indemnities, where applicable, for vaccine manufacturers.
The aim is to avoid the mistakes of the past in which sponsorship bias, withholding of data by health authorities, incomplete communication of information to the public and the academic community, among other shortcomings, has led to unnecessary vaccine injury and public distrust of vaccines.
Members of the public or academics who seek answers to questions around vaccine safety have been routinely vilified and labelled ‘anti-vaxxers’ and their communications are censored on social media.
If we are to establish a ‘new normal’, as our politicians seem intent to do, this approach is not tenable. Lack of transparency around the development and testing of Covid-19 vaccines will lead to further divisions in communities, at a time when division will only exacerbate the challenges facing societies since the pandemic arose. It will give governments more reason to deny citizens fundamental human rights and freedoms, as well as increase the risk of martial law being imposed.
The narrative around vaccines must fundamentally change. We must transition away from coercive public policy driven by vaccine protagonists that projects a view of the unassailable safety and effectiveness of vaccines. Doing so only misleads the public over the quality and certainty of the science on which mass vaccination programmes are justified, and denies the public the information needed for properly informed consent.
We call on our friends and colleagues in other parts of the world to also pressure their governments to heed vaccine transparency, using whatever parts of our letter to Matt Hancock that may be relevant.
Open letter to the UK Secretary of State for Health and Social Care, Matt Hancock MP
Open letter to the Rt Hon Matt Hancock MP [By email and hard copy]
The Rt Hon Matt Hancock MP
Secretary of State for Health and Social Care
House of Commons
29 April 2020
Dear Secretary of State
RE THE CRITICAL NEED FOR TRANSPARENCY AROUND COVID-19 VACCINES
As a non-profit organisation representing diverse interests in natural and sustainable health, and a medical association of doctors who practice ecological (including nutritional and environmental) medicine, we hereby request that the Department of Health, the Joint Committee on Vaccination and Immunisation (JVCI), the UK Vaccine Network, Public Health England and the Medicines and Healthcare products Regulatory Agency (MHRA) maintain a policy of full transparency around the development, testing and roll-out of vaccines targeting Covid-19.
The UK Government, other governments and health authorities, including the World Health Organization, have repeatedly made clear concerns over vaccine hesitancy and the potential impact on public health.
Two major drivers of vaccine hesitancy include:
- Low levels of trust in the medical science behind vaccination safety and effectiveness, pharmaceutical companies who produce these vaccines, and government health agencies who promote vaccination (Xu et al, Health Comm. 2020; Apr 19: 1-14). Trust is readily eroded by misleading claims issued by health authorities which consistently refer to vaccines as ‘safe’ when it is clear that adverse events occur at varying, albeit low, frequencies. To-date, in the UK, around 1000 claims have been paid out to those who have been severely disabled (from over 6,000 claims) after establishing proof of causation through the Vaccine Damage Payment Act 1979. Furthermore, public trust in a pandemic vaccine will have been adversely affected by claims that vaccines targeting the influenza A/H1N1 ‘swine flu’ pandemic of 2009 had been “thoroughly tested” when this was more recently found to be false (Doshi P. BMJ 2018; 362: k3948);
- Insufficient communication of relevant information, including trial designs and results by health authorities and vaccine manufacturers. Such inadequacies have been revealed around HPV vaccine trials (Doshi et al. BMJ Evid Based Med. 2020; pii: bmjebm-2019-111331) as part of the Restoring Invisible and Abandoned Trials initiative (RIAT) and in retrospective analysis of information and events surrounding the roll out of vaccines during the last pandemic (influenza A/H1N1, ‘swine flu’) in 2009 (Stephen W. BMJ2018; 362: k3948).
Health authorities, as vaccine protagonists, must therefore take some responsibility for their role in creating an environment that fosters distrust and hesitancy over vaccination rather than always blaming citizens or scientists for being irrational when they express concerns about vaccine testing or safety. Coercive public policy on vaccination, coupled with the categorisation of comments by citizens, doctors and others that question vaccine safety as ‘fake news’, which then often leads to censorship, are therefore counter-productive.
Informed risk/utility decisions around mass vaccination require increasing public engagement (Williamson & Glaab. BMC Med Ethics. 2018; 19(1): 84) and benefit from clear disclosure of sponsorship bias and the capacity for re-analysis of raw data by independent researchers (Jefferson T. J R Soc Med. 2020; 113(4): 148-157). Full disclosure of results from clinical trials, including provision of raw data, is vital given data on fast-tracked vaccines will inevitably be uncertain and incomplete to some degree. It is important that the extent of such shortcomings are communicated to the public.
It is therefore in the public interest to ensure that all relevant data that could feed into properly informed decisions are placed in the academic and public domains. Public confidence in vaccination can only be re-established if there is much greater transparency and sharing of data than has been the case historically (Godlee F. BMJ 2018; 363: k4152). This is more relevant than ever with the prospect of Covid-19 vaccines, given their unprecedented rate of development.
Key areas for vaccine transparency
Having consulted with medical doctors, other health professionals, research scientists, lawyers and citizens in our various networks, we consider it imperative that the following information is released for public scrutiny prior to commercial release of any Covid-19 vaccines:
- Full disclosure of all raw data from safety studies of commercial Covid-19 vaccines. Disclosure of raw data allows independent researchers to analyse data and draw conclusions independently of health authorities, regulators and vaccine manufacturers. Such transparency and data sharing are essential if the aim is to establish confidence in mass immunisation using a novel vaccine developed in a fraction of the time typical of previous vaccines;
- Transparency in relation to safety and efficacy studies. Safety studies for any vaccine that is fast-tracked (6-18 months) prior to approval will be compromised as compared with those for which more time (several years) has been allowed for safety studies and regulatory approval. If the Government is planning to encourage vaccination, it is crucial that it is clear about the limitations in safety and efficacy studies supporting public roll-out as compared with those required for normal licensing of vaccines. Without such knowledge, it is neither possible for citizens to balance risk versus utility, nor can they determine “…if the safety of the product is not such as persons generally are entitled to expect” (Consumer Protection Act 1987);
- Transparency over the type of platform used for commercial vaccines. Currently there are several different platforms being investigated for candidate vaccines for Covid-19 and it appears that the most likely (and well funded) options involve platforms that have never been previously used on a global scale (Amanat & Krammer. Immunity. 2020; 52(4): 583-589). It is imperative that there is clear communication to the public over the nature of the platform(s) being used for Covid-19 vaccines prior to their commercial release, as well as the extent of their previous use, if relevant, for pre-existing commercial vaccines;
- Conduct and transparency of studies to elucidate any risks associated with adjuvants as distinct from antigens. Given that commercial vaccines for Covid-19 are likely to be adjuvanted, it is essential that the safety of the adjuvanted vaccines are compared with non-adjuvanted vaccines and saline controls. Adjuvants may trigger specific side effects in susceptible individuals, which may include those with underlying conditions, including autoimmune diseases (e.g. Watad A, et al. Front Endocrinol (Lausanne). 2017; 7: 150);
- Transparency in relation to vaccine composition. There is a significant public lack of confidence in the purity and composition of vaccines. It is essential that the detailed composition of Covid-19 vaccines are declared, this going beyond simply specifying added ingredients. It is also imperative that any impurities are also declared given some of these have the potential to trigger adverse reactions. Given there is a strong move towards transparency in labelling in the food sector, itself supported by the Food Standards Agency and Department of Health, it is even more important that such transparency occurs with vaccines given they are administered systemically;
- Full disclosure of cases and potential cases of vaccine injury. Recent history of UK government communication around legal cases linked to vaccine injury caused by Pandemrix® and seasonal flu vaccines discovered during trials or post-marketing surveillance has been grossly inadequate. This inadequacy has only been revealed through multiple freedom of information requests under the Freedom of Information Act. Only a handful of cases have been made public, while many others have received Vaccine Damage Payments after establishing proof of vaccine causation but without any public communication of the cases or the nature of the injuries (see special report in Independent, 18 April). This non-disclosure does not afford the public a balanced view of the risks associated with a given vaccine, nor does it allow them to determine if their own health condition might make them more or less susceptible to adverse reactions;
- The Government must clarify eligibility and criteria for no-fault vaccine injury payments for Covid-19 vaccines. We have noted that the Government no longer considers citizens eligible for vaccine injury payments in the event of proven damage caused by a “pandemic influenza virus”. This exclusion was made only after the Government recognised from post-marketing surveillance that narcolepsy was a significant, albeit uncommon, autoimmune side effect of Pandemrix®. The Government must ensure that vaccine injury payments will be made to individuals injured by any approved Covid-19 vaccines, while also clarifying the level of proof required to establish causation and the statutory time limit for making such claims in relation to Covid-19 vaccines, prior to their administration to the public;
- The Government must clarify indemnity offered to vaccine manufacturers. In a reply made by the Department of Health to a freedom of information request (Your Ref: DE-1029593), it was stated that in relation to GlaxoSmithKline’s Pandemrix®, Baxter International’s Celvapan® and Sanofi Pasteur’s Liquid Smallpox Vaccine, “The Authority shall fully and completely indemnify the Contractor against all claims, proceedings, actions, legal suits, damages, legal costs and expenses and any other liabilities in respect of any death or personal injury arising from the Authority’s use of the Goods.” The indemnity, if applicable to Covid-19 vaccines, must be made public prior to the commercial release of vaccines because, ultimately, the financial burden of such indemnity lies with the taxpayer;
- The public must be informed of the extent of naturally-acquired immunity prior to public release of Covid-19 vaccines. In order to balance risk and utility, the public must be made aware of the extent of population herd immunity, which will necessitate carefully conducted, stratified, random sampling of the UK population and testing with a validated serological (antibody) test. We are aware that the Department of Health is evaluating such tests, and it is of paramount importance that comprehensive, periodic evaluation of population immunity is conducted to determine the persistence of such immunity. This would be greatly facilitated by quarterly testing of randomised, stratified samples of the national population and would not necessitate ‘universal’ testing of all individuals that has been correctly declared as not feasible. The public should also have ready access to validated antibody tests so that individuals can assess their own state of immunity prior to giving consent for vaccination;
- Parliament must be engaged to ensure due democratic process if the Government is planning to consider making Covid-19 vaccines mandatory. While the Public Health (Control of Disease) Act 1984 technically allows for the mandatory treatment of persons who are, or may be, infected, the decision to apply these emergency measures to Covid-19, when it has not been applied to any previous infectious disease, is a matter of great public importance. It is therefore critical that due democratic process is followed so that the will of the people can be factored into any such decision.
As Secretary of State for Health and Social Care, we are extremely aware of how hard you and your team have been working in an effort to protect the public interest during the current pandemic. However, it is crucially important that in the drive to provide one or more vaccines to enhance the population’s immunity to SARS-CoV-2, corners are not cut that expose the population to unnecessary risks, especially if these are undisclosed.
We look forward to receiving information about your Department’s approach to transparency of information and data surrounding Covid-19 vaccine trials, including post-marketing surveillance once initiated. We especially request your response to specific points set out in the ten discrete areas we have highlighted above.
We greatly look forward to hearing from you, or a member of your Departmental team, at your earliest convenience. Our respective emails are given below.
Robert Verkerk MSc DIC PhD FACN
Executive and scientific director
Alliance for Natural Health International
Dr Damien Downing MBBS MSB
British Society for Ecological Medicine