Immunologist cautions on lead vaccines

17 November 2020

Byram Bridle, a viral immunologist at the University of Guelph, cautions New Zealanders that the lead vaccines against Covid19 may not be the solution they are expecting to end its isolation under the elimination strategy.

The main points of his caution are:

  1. NZ will have to wait at least two years before the Pfizer vaccine is available, because it is in strict isolation and low on the priority list for the 500m doses available in 2021.
  2. Not enough data has been released to know whether the vaccine prevents or weakens the symptoms of Covid19, or how long the protection will last.
  3. The safety data will be incomplete if it is approved for use next year, so monitoring will need to be carried out on vaccinated people for some years.
  4. The Pfizer data has not been rigorously peer-reviewed.
  5. There is no available data on the qualitative nature of the immune response. Vaccines like this can be misinterpreted by the immune system as an extracellular pathogen, which can cause them to respond poorly to natural infections with future coronaviruses.

“Pfizer’s vaccine is a RNA-vectored vaccine. This technology is relatively new and has not been approved for clinical use before. The company has been able to move surprisingly fast. If the recent data is indicative of what data from the rest of the trial will look like, there is a good chance the vaccine could receive emergency approval by early in 2021.

However, there are many nuances…”

Insufficient public data

“The study is only partially complete. There exists the possibility that the final data set will fail to secure regulatory approval (but it looks like they may be on track).

Data that accompanied the Pfizer press release was extremely superficial and, therefore, difficult to interpret. Data being collected for the Pfizer study cannot accurately be commented on until it undergoes rigorous peer review for publication in a good quality scientific journal.”

Effectiveness of protection

“90% effectiveness sounds surprisingly high. But we have no idea what the demographics look like. Although they opened the trial to high-risk people, we have no idea who contracted COVID-19. As an extreme example, if all the vaccinated volunteers that got COVID-19 were elderly and that number was not significantly different from the elderly among the non-vaccinated volunteers that got COVID-19, that would tell us that the vaccine does not work in those who need it most.

Most of the cases of COVID-19 in the study were presumably mild to moderate since no hospitalizations or deaths were reported, so we don’t know how protective the vaccine will be for those who are susceptible to severe cases.

There is no data regarding immunological memory, which is the entire point of a vaccine. If the memory response is weak or wanes too quickly, people will not be protected over the long term. This would be a fatal flaw because the global roll-out of a vaccine will take a very long time.

Pfizer hasn’t stated what the qualitative nature of the vaccine-induced immune response is. Sub-unit vaccines like theirs have been known to be misinterpreted by the immune system as being an extracellular pathogen. If that is the case, people who receive this vaccine might have a bias imprinted on their immune system that could cause them to respond to natural infections with future coronaviruses in a sub-par fashion.”

Two dose vaccine.

  • “It can be hard to get people back for a second dose. It is probably achievable in urban centres but could be hard to get the same people back 21 days later in remote and/or difficult-to-access places, especially in developing countries.
  • A vaccine that needs two doses is arguably a ‘weak’ vaccine. For this vaccine, it will take 28 days to build up sufficient protection. So there will be a one-month window during which people will remain susceptible. A better quality, single-dose vaccine could probably reduce this to 10-14 days.
  • Fewer than 500 million people could be vaccinated within a year of the vaccine being approved. The company is going to try to stockpile 50 million vaccines this year in anticipation of the vaccine being approved, and they optimistically predict that they can make 1.3 billion doses by the end of 2021. This sounds like a lot, but a two-dose regimen cuts the number of people that can be immunized in half. The person to get the 500 millionth dose will have to wait a year compared to the person who gets the first one. Some will wonder why some people get two doses while they get none. The vaccine won’t be protective unless two doses are given.”

Roll out internationally

“What about the rest of the population? As many of us have been predicting, it could take years to roll out these vaccines. Approval of a vaccine doesn’t help anyone; what matters is when it has been administered and sufficient time has passed for the immune system to respond. Of course, where in this very long timeline for the roll-out will countries that have used strict isolation to control their cases be (arguably, low on the priority list). Pfizer’s press release is essentially saying that everyone beyond the first half-million people will have to wait over 1 year. Presumably, it also means that people beyond the first billion or so may have to wait over 2 years.”

Long term safety

“Long-term safety in people is inferred based on animal models (such as rodents) that have shorter lifespans. Usually, clinical trials are done sequentially and span quite a few years. So acute and some long-term (i.e. 4 or more years) safety data would be in-hand. With the different trial stages overlapping and being run faster than normal, we will likely have less than a year’s-worth of safety data. Ultimately, the only way to be completely sure about long-term (i.e. beyond the duration of the clinical trial phase) safety in people is to monitor vaccinated people for a long period of time after the roll-out. Things like long-term kidney damage, etc. can often (but not always) be predicted/ruled out by things like blood chemistry within the acute stages.”

/ends

Covid19 elimination strategy almost abandoned

13 November 2020

Media Release

Covid Plan B has welcomed the Government’s decision not to over-react to cases of people testing positive to Covid-19 by starting another lockdown.

Simon Thornley, spokesperson for the group, says the Government appears to finally be adapting its strategy to new information about ineffectiveness of lockdowns and the low death and ill health effects of the virus.

“We support the Government’s inclination not to go back to lockdowns. Positive tests in Auckland, Christchurch and Wellington show the elimination strategy is fragile, futile and unnecessary.

“We urge the Government to be clear about why it is less fearful of Covid and more concerned by lockdowns. The public will understand and accept an admission that elimination attempts are over,” Thornley says.

Covid Plan B experts were this week published in the British Medical Journal showing the threat of Covid-19 is not what it was initially thought to be, in large part because of inaccurate recording of deaths.

Countries such as Singapore that use a strict definition of covid-19 death have very low fatality rates from the virus. Studies show that in past pandemics, coding of death certificates exaggerate fatality rates.

Estimates of covid-19 fatality are now extremely low; at 0.05% for people under seventy years old.

Statistical evidence now shows lockdowns do not reduce mortality from the virus, while causing much health and economic harm.

“Envoys from the World Health Organisation caution against the use of lockdowns since they “… have one consequence that you must never belittle and that is making poor people an awful lot poorer.

“This has happened in Auckland, where thousands turned to food banks to make ends meet. Over 50,000 people have started on the jobseeker benefit since March this year. The disproportionate economic costs of lockdown, relative to any benefits are also now apparent.

Heavily restricted borders will continue to devastate New Zealand’s tourist economy, and are leading to labour shortages, further reducing productivity. In contrast, many academics, doctors and the public are now urging their governments to focus on protection of the vulnerable, while allowing those at low risk from the virus to return to normal life.

/ends

Contact: Simon Thornley, 021 299 1752

 NZ Doctors sign statement against ‘Covid fear’

26 October 2020

A group of New Zealand health practitioners have joined a growing international movement that says Covid19 is not a sufficient threat to warrant the elimination strategy and lockdowns. 

The founding signatories felt obliged by their professional ethics to express support by signing a statement of principles that assert the low risk posed by Covid19, the availability of treatment, the dangers of Government over-reaction, and primacy of the doctor-patient relationship.

Covid Plan B spokesperson Simon Thornley praised the medical practitioners for expressing their views.

“Around the world medical specialists are speaking out. They have seen the data and seen that the initial fear is now clearly unfounded. They are seeing the damage to people’s heath caused by institutional fear and compliance, and by elimination strategies and lockdowns. Unlike too many others, they are prepared to say so.

“Their statement will signal to like-minded New Zealanders in the healthcare sector that they can and should resist, and they should reassure patients and the public.”

The group says its statement was intended to break the silence. It says New Zealand registered health practitioners who want to join the movement should sign the international Great Barrington Declaration and email Covid Plan B (info@covidplanb.co.nz).

The Great Barrington Declaration is now supported by over 11,000 medical specialists and over 30,000 medical practitioners.

Contact: Simon Thornley, 021 299 1752

GPs support Covid Plan B

26 October 2020

Registered Health Practitioners for Covid Plan B

 Statement of principles

Health is based on freedom and trust. Free human beings can decide themselves about their health.

Free societies decide in democratic discussions how to deal with their health. The NZ Bill of Rights guarantees free choice of treatment.

Fear of the pandemic makes us unfree. It makes us see vaccination and lockdowns as the only way to get back to normality.

International health data and our own experience shows that the fear engendered in the public and our patients is not proportional to the threat to their health posed by covid-19.

Therefore New Zealand’s public health and economic response to covid-19 needs reviewing. It is very likely to be more harmful than the threat posed by the virus in the medium to long term.

Doctors can help. We can develop trust through mutual respect, transparency and democratic debate. We can take action with our patients, so they are healthier and better able to fight infection, and by providing treatments if they fall ill to Covid-19.

There is nothing we have yet seen in the features of this virus that warrants it being regarded as especially dangerous above the many other viruses that are with us every day. The most practical response is the standard precautions of improving personal hygiene, physical health and improving lifestyles.

We want the public to know that the infection fatality rate of Covid-19 is currently about 0.3% once antibody levels are accounted for. The infection fatality rate of influenza, which is strongest each winter, is about 0.1%. It is also clear that the ages of people who die with Covid-19 is about the same as that from natural mortality. This information is enough to inspire us to take better care of our health, but not to drastically change our society and economy.

It is impossible to obtain information about the severity of Covid-19 infections in New Zealand, so we have had to rely on overseas research. About a third of Covid-19 positive patients have no symptoms, with about 90% of infections treated in the community, and only about 1.5% needing intensive care. In the US, almost all hospital treated cases have had other serious medical conditions and are almost all people who die with the virus are over 50 years old. Unusual or long lasting symptoms currently appear similar to a range of responses seen in other respiratory illnesses.

Doctors now have many promising treatments against Covid-19, including easily available supplements like vitamin D. Internationally, the death rate is falling, in part, because we are getting better at treating the disease.

Immune function can benefit from minimising sugar and refined starch intake, eating several servings of fruit and vegetables daily, being physically active, socially connected and having sensible sun exposure to ensure adequate levels of vitamin D, avoiding tobacco and excess alcohol.

We have identified comorbidities that make people susceptible to Covid-19, such as diabetes, hypertension and raised cholesterol. We need to treat a condition in these patients called Metabolic Syndrome, which creates immune system dysfunction.

Decision makers, when assessing health strategies, compare the economic costs of a policy to its benefits. Recent assessments by economists indicate that the costs of lockdowns in New Zealand outweigh benefits by a ratio of between 90 and 200 to one. This indicates that Covid-19 has been disproportionately treated compared to critical health issues that our patients face day-to-day.

Policies that the Government should prioritise or review are:

  • Adequate resourcing of high-quality infection control and quality care in rest homes and hospitals to prevent the spread of covid-19 to vulnerable people.
  • Abandon the use of lockdowns to contain the virus. Strong evidence now indicates that these measures are disastrous economically and do little to contain viral spread.
  • Review the requirement for managed quarantine and compulsory detention for both community and hospital cases in the light of the updated lower fatality risk of the virus. This measure leads to social isolation and undue mental distress.
  • Further limits on border travel should be urgently reviewed in the light of a cost-benefit analysis.
  • Avoid any measures that lead to social isolation in the response to contain the virus.
  • Review the requirement for compulsory diagnostic tests in the light of the lower fatality rate of the virus. We believe that patients should continue to have the right to refuse medical tests, as they do for other procedures, and that the public health risk from this virus does not warrant these rights being superseded.
  • Abandon the requirement to wear masks on public transport. We believe that the best epidemiological evidence available does not support mask wearing to reduce the risk of respiratory virus transmission.
  • We believe that the doctor-patient relationship should be safe-guarded, along with the ability for doctors to see patients in-person rather than online. Online patient consultations detract from the quality of the doctor-patient relationship and raise the risk of mis-diagnosis.

As facts about the virus become self-evident, the public is wondering whether the current measures cause more harm than good. They will wonder why authorities have been unwilling to listen to, or even allow, discussion of the facts and alternative policies. We are deeply concerned that the consequence will be a loss of faith in health services, science and bureaucracy.

Foundation Signatories:

Dr Cindy de Villiers – General Practitioner, M.B.,Ch.B

Dr Matthias Seidel – Obstetrician and Gynaecologist

Dr Anne O’Reilly – General Practitioner. MB BCh FRNZCGP

Dr Rob Maunsell – General Practitioner

Dr René de Monchy – Consultant Psychiatrist

Dr Robin Kelly – General Practitioner MRCS, LRCP, FRNZCGP

Dr Tessa Jones – Integrative medical practitioner MBChB, Dip Obs, FRNZCGP, FACNEM, FABAARM

Dr Alison Goodwin – General Practitioner, MBChB, FRNZCGP

Dr Ronald Goedeke – Director of Appearance Medicine, BSc Hons MBChB

Dr Deon Claassens – General Practitioner, MBChB, Dip. SportsMed, FRNZCGP

Shane Chafin – Pharmacist,AGPP,BCACP

Dr Ulrich Doering – General Practitioner, MBChB, Dipl O&G, FRNZCGP

Dr Samantha Bailey – Research Physician MBChB (Otago)

Call for data on Covid-19 health impacts

22 October 2020

New Zealand has not released any analysis about the negative health impacts of the Covid-19 elimination and lockdown policy.

This is highlighted by studies released in the UK this week which indicates that their lockdowns are responsible for thousands of deaths and new illnesses, principally as a result of delayed cancer diagnoses (see note below).

The only known study of lockdown health impacts in New Zealand was of a Dunedin primary health clinic, where referrals and tests had dropped 100% and 99% respectively. Anecdotal evidence provided to the Covid Plan B group is that referrals and tests may be down across the country by two thirds. Auckland District Health Board is also investigating after four women died during and after pregnancy this year, with three dying since alert level 3 was instituted in late March. Expected numbers of deaths are between 0 and one from previous years.

Evidence provided from affected individuals indicate illnesses and health prognosis have worsened due to delayed tests and treatment. Whether these cases represent a wider problem is not known.

Dr Simon Thornley, spokesman for Covid Plan B, said the Government’s elimination and lockdown policy was based on hope, because little analysis of the downsides of the policy has been carried out.

“If you base your rationale on discredited models and you don’t count impacts, this is not a policy based on evidence.

“This is a policy based on an assumption that the low Covid-19 impact is the result of the lockdown policy. There is no proof of that, and international studies indicate it is unlikely.

“This is also a policy continued on the assumption that there are no negative effects. But firsthand testimony in New Zealand and overseas statistics suggest this is not true. Economic analysis from the government and independent sources indicate that lockdowns are a disproportionate response to Covid-19. The effect on unemployment is now clear, with a 38% rise in adults on the jobseeker benefit since late March. Now, the impact of delayed diagnosis and under treatment of other conditions must be considered.

“We are not even trying to count what the other effects have been on health. We do not know how many people have died, had conditions or prognosis worsen because of the ways lockdown and fear have affected healthcare.

“We call on the Ministry of Health to undertake the same studies we’ve seen in the UK, and to weigh those costs against what they imagine, or count, are the benefits of the elimination strategy,” Simon Thornley says.

– ends

Will NZ follow WHO lead to ‘living with virus’?

12 October 2020

Media Release

The Covid Plan B group is reassured by the shift of international policy and science consensus toward what had been a dissenting position six months ago; learning to live with the virus.

Over the weekend, the WHO’s David Nabarro said that lockdowns caused more harm than good, a position advocated by Covid Plan B back in April 2020.

But early in the Covid-19 crisis, the World Health Organisation supported lockdowns to contain ‘intense transmission’ of the virus, listing six conditions that must be met to lift such measures.

In a remarkable turnaround, Dr David Nabarro has stated that “Lockdowns just have one consequence that you must never ever belittle, and that is making poor people an awful lot poorer”.

He also commended the Great Barrington Declaration, an internationally supported statement against lockdowns, which instead calls for a change in government policy toward focused protection of the elderly and those who are vulnerable to the virus from pre-existing medical conditions, while letting the rest of the population return to normal life.

Dr Simon Thornley, spokesman for Covid Plan B, welcomed Nabarro’s statement as “a major change from the World Health Organisation”.

“We have drawn attention to the severe and disproportionate financial costs of lockdown policies in New Zealand.

“The virus is not as deadly as first claimed, so we must adjust our policies accordingly.

“The latest estimates for the infection fatality ratio, a measure of the severity of the virus, are between 0.15 to 0.2 0%, which is concordant with the range of figures for past influenza epidemics.

“Crippling our economies and sacrificing our children’s education can no longer be justified, since the harm from these policies outweighs any benefits.

“Our health system has largely avoided severe outbreaks in hospitals and nursing homes, and this is where the focus of our response to the virus should be.”

Contact: Simon Thornley, 021 299 1752

Covid19 serious questions being asked internationally

8 October 2020

Media Release

Six months after the panicked reaction to Covid-19, dissenting scientists and the public are gaining ground internationally, coalescing this week in a show of force behind the Great Barrington Declaration, a statement for protecting the vulnerable but otherwise returning to normal.

The Covid Plan B group, which originally opposed lockdowns and the elimination goal, is a co-signatory of the Declaration. The GB Declaration is headed by Jay Bhattacharya and Sunetra Gupta, who headlined Plan B’s international symposium on Covid-19 in August. The Declaration has been signed by over 1000 biological scientists and over 1500 medical practitioners.

Dissent is now being voiced within virtually every Western nation; specially organised groups of academics and professionals have taken their critique directly to the public (eg. lockdownsceptics.org, and the German Corona Investigative Committee); and as public protest on the streets and via passive or active civil disobedience.

Simon Thornley, group spokesperson, says dissent is rising because after six months of social and economic restrictions and six months of data about the virus, the truth is now readily apparent.

“This virus does not warrant this panic and these restrictions.

“The CDC (US Centre for Disease Control and Prevention) currently says its best estimate is an average Infection Fatality Ratio of 0.65%, but for people 50 to 69 years old it’s 0.5% and for adults under 50 it’s 0.02 percent – less than the average IFR for seasonal flu.

“Yet in New Zealand, some epidemiologists still claim the IFR is closer to 1%. This figure led to predictions of 60,000 deaths in Sweden, which was wrong by a factor of ten. Yet these claims aren’t questioned and are still promoted. This bizarre situation reveals a dangerous intransigence of politicians, scientists, and commentators.”

Thornley says the first announcement of New Zealand’s next Government should be an undertaking not to go back to Level Three or Four lockdowns.

“The best approach are safe havens for those with vulnerable health conditions; ensuring good infection control in rest homes and hospitals, robust personal hygiene, and tracing, tracking and isolation of cases, including with serology tests.

Thornley said if elimination was removed as the goal, and lockdowns rejected, the group was prepared to support ‘flattening the curve’, and to enjoin the growing number of dissenters in New Zealand to adopt reasonable precautionary measures.

“The next Government just needs the courage to say ‘we all did our best, but we can’t afford to do it again’.”

/ends

Contact: Simon Thornley, 021 299 1752

COVID19 vaccine is a slim-chance strategy

27 August 2020

Media Release

New Zealand experts and officials are betting the nation’s health and wealth on the slim chance of eliminating a virus and getting a vaccine before the natural end to the pandemic. 

The Covid Plan B group says today’s announcement that the Government is putting aside more money to pay for making and distributing a vaccine, highlights the narrow margin for success of the Government’s policy.

Simon Thornley, group spokesperson, says while it makes absolute sense to try for a vaccine, the framing of announcements is giving people “false hope”.

“There’s only a very slim chance that a full safety-checked vaccine will be ready before the pandemic subsides, and even then, it most likely won’t be useful for the group most at risk – the elderly.

“A vaccine would be great to have, but these announcements have the effect of enticing people to back the strategy of elimination, and its lockdowns, while holding out for a vaccine.

“This strategy requires there are no community acquired cases of Covid-19 in NZ and no deaths forever, (ie. elimination), and dissemination of a vaccine against Covid-19 that achieves herd immunity.

Other international experts concur. Dr Mark Woolhouse (Professor of infectious disease epidemiology, UK) said in a recent interview, “I would not dignify waiting for a vaccine with the term ‘strategy’. That’s hope, not a strategy.”

“For elimination to be successful, we have to do that with no decline in quality of life or mortality for other illnesses, no reduction in social wellbeing, mobility or happiness measure, no increase in people living in poverty, no decline in economic measures or at least a decline less than observed in the rest of the world.” Simon Thornley says.

/ends

Vaccine backgrounder:

Politicians, media and commentators with time to learn more about vaccines research and practicalities of safety, manufacturing and dissemination, are recommended to check out the presentation of Byram Bridle, a Canadian researcher working on a coronavirus ‘plug and play’ vaccine, at a symposium about New Zealand’s plan. https://www.covidplanb.co.nz/videos/

Contact: Simon Thornley, 021 299 1752

Extended lockdown is elimination’s ‘own-goal’

25 August 2020

Media Release

The extension of Auckland’s lockdown shows the cost of the Government’s continued pursuit of elimination of Covid19 and intention to wait for a vaccine.

The Covid Plan B group says New Zealand is now one of the few countries pursuing elimination and “hiding” behind its border and lockdowns in hope of a vaccine.

Spokesperson Simon Thornley says “the Government, and the experts it is listening to, are hell-bent on elimination. The extension can’t be justified for any other reason.”

“They are betting the house on eliminating Covid-19 long term and finding a vaccine in that time. It’s like developing policy based on winning Lotto.”

“It is a brave call to defy the conclusion the rest of the world has come to; that we must learn to live with this virus. But they must take responsibility for the success or failure of their approach.”

In a webinar on Monday evening, Plan B clarified measurable goals whereby the success or failure of the government policy may be judged, since the government and its health advisors are now talking simultaneously of elimination, but say the country must also be prepared for further frequent community outbreaks of Covid-19. Here we clarify that these outcomes are mutually exclusive.

  • Success will see no community transmission of Covid-19 in NZ forever, (ie. elimination), and dissemination of an effective vaccine against Covid19 by the end of 2021 that achieves herd immunity. Such a policy must also result in: no decline in quality of life or mortality for other illnesses, no reduction in social wellbeing, mobility or happiness measure, no increase in people in poverty, no decline in economic measures or at least a decline less than comparable countries that opt for suppression of the virus. All cases that occur during this period must have a recent history of international travel.
  • Failure will be continued community transmission of Covid-19 into the future (ie. the virus is not eliminated), with no effective vaccine delivered by the end of 2021, with: an increase in mortality from other illnesses (except influenza), worse measurements of wellbeing, more poverty, and declines in standards of living, debt, GDP that are at least as bad as international levels.

“We also point out that there are several infectious diseases in New Zealand with effective vaccines or treatments that are yet to be eliminated from this country. These include: pertussis, syphilis, scabies, viral hepatitis, HIV, chlamydia, gonorrhoea, meningococcal disease, pneumococcal disease and tuberculosis. The only successful globally eradicated viral infection is smallpox and this took thirty years to achieve.”

/ends

Contact: Simon Thornley, 021 299 1752

Covid19 death risk less than asteroid hitting earth

23 August 2020

Media Release

The risk of dying after being infected with Covid19 is 0.3%, less than the 0.41% chance estimated by NASA of asteroid 2018VP1 colliding with the earth

New data released in the UK (Howden, Oak, Heneghan) over the weekend shows the infection fatality rate (IFR) of Covid19 is 0.3%.

The UK scientists behind the new COVID19 IFR estimate that the falling fatality rate is due to better understanding of how to treat Covid patients, more testing diluting the number of severe and fatal cases, younger people are catching the virus, and the virus circulating at a much lower level.

One of the authors of the paper, Professor Carl Heneghan, has called on the UK Government to stop lockdowns immediately and reassure the public that the disease is turning out to not be the threat that was first claimed.

/ends

Contact: Simon Thornley, 021 299 1752