Covid-19: Less haste, more safety
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3258 (Published 20 August 2020) Cite this as: BMJ 2020;370:m3258Read our latest coverage of the coronavirus outbreak
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Dear Editor
This was a wise article [1] and it only becomes more germane with the roll out now forecast in a very few weeks [2]. What are we to do?
[1] Fiona Godlee, ‘ Covid-19: Less haste, more safety‘, BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3258 (Published 20 August 2020)
[2] John Stone, ‘ Gung-ho, or time for serious reflection?’, 26 October 2020, https://www.bmj.com/content/371/bmj.m4037/rr-8
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor
Dear Editor
Is it correct to use the term Covid-19 vaccines?
Shouldn't these vaccines instead be described as SARS-CoV-2 vaccines?
It grates with me to use the term Covid-19 vaccine, it doesn't seem right.
Terminology was similarly incorrectly used with the initially titled 'cervical cancer vaccines', which are now more correctly described as HPV vaccines.
Surely the vaccines should be described as SARS-CoV-2 and not Covid-19?
This is an important distinction and it should be correct - can we have clarification on this?
Competing interests: No competing interests
Dear Editor
Early Vaccine For COVID-19?
During the 36th week of the COVID-19 Pandemic, more than 26.8 million confirmed COVID-19 cases have been registered globally with over 8.8 lakh deaths.
Vaccines are the only way to prevent the spread of COVID-19 along with social distancing, wearing of masks, and hand hygiene.
Vaccines for COVID-19 should undergo sufficient scrutiny, and safety and efficiency should be proved before they are approved for public use.
Premature and early release of vaccines, with inadequate trials and without any randomised controlled studies, for political gain, may add more fuel to the ongoing COVID-19 Pandemic crisis.
The ongoing COVID-19 pandemic has created unprecedented public/private partnerships to develop vaccines for COVID-19.
Operation Warp Speed (OWS) is a collaboration of several US federal government departments, including Health and Human Services and its subagencies, Agriculture, Energy and Veterans Affairs and the private sector. Within OWS, the US National Institutes of Health (NIH) has partnered with more than 18 biopharmaceutical companies to accelerate development of drug and vaccine candidates for COVID-19.
The COVAX initiative, part of the World Health Organization’s (WHO) Access to COVID-19 Tools (ACT) Accelerator, is being spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI); Gavi, the Vaccine Alliance; and WHO. The goal is to work with vaccine manufacturers to offer low-cost COVID-19 vaccines to countries. Currently, CEPI’s candidates from companies Inovio, Moderna, CureVac, Institut Pasteur/Merck/Themis, AstraZeneca/University of Oxford, Novavax, University of Hong Kong, Clover Biopharmaceuticals, and University of Queensland/CSL are part of the COVAX initiative. There are further candidates being evaluated in the COVAX Facility from the United States and internationally.
The US government has asked states to be ready to distribute coronavirus vaccines by early November; data on some key coronavirus vaccine candidates is expected to be out in the next month.
It is unlikely that a Covid-19 vaccine will be ready by the end of October, but that it is not impossible.
Around 60% of all vaccines in the world are being produced in India.
Competing interests: No competing interests
Dear Editor
Eight days ago I wrote here [1]:
“To limp along like this in the hope that we will all be rescued by a vaccine (supposing we any longer need rescuing) is not realistic, and not the basis on which policy should be directed - quite apart from the harm that it is doing to every other aspect of civil life and of health policy itself.”
I now note the publication of an article by Carl Heneghan and Tom Jefferson in The Spectator questioning whether the present rise in cases is an artefact of PCR testing, as hospitalisations and deaths continue to decline [2]. Bearing this in mind perhaps it is time the British Medical Journal itself began to move the narrative on.
[1] John Stone, ‘ Less haste, more safety, certainly, but we could do with an end to the vaccine rescue narrative as well’, 25 August 2020, https://www.bmj.com/content/370/bmj.m3258/rr-0
[2] Carl Heneghan & Tom Jefferson, ‘ Coronavirus cases are mounting but deaths remain stable. Why?’, The Spectator, 1 September 2020, https://www.spectator.co.uk/article/coronavirus-cases-are-mounting-but-d...
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor
Dear Editor
Fiona Godlee says "Few can doubt that we need a vaccine for covid-19 as soon as possible..."[1]
But why? Why do we need a vaccine for covid-19? Is it feasible to seek a vaccine for every ailment?
Consider the death statistics attributed to covid-19 in England and Wales over the past eight months - according to the ONS, a total of 52,026[2] in a population of 59.5 million people.[3]
Subtracting the deaths of people aged 85 years and over, i.e. 21,984, leaves 30,040 deaths.
Further subtract the deaths of people aged 75 to 84 years, i.e 16,820, leaves 13,220 deaths.
And further subtracting the deaths of people aged 65 to 74 years, i.e. 7,683, leaves 5,537 deaths in people aged under 65 years, over the past eight months.
There were six deaths in children 14 years and under; 562 deaths in the age group 15 to 44 years; and 4971 deaths in the age group 45 to 64 years. (Possible comorbidities unknown.)
Looking at those figures in the context of 59.5 million people, and seeing that most deaths are in people aged over 75 years, likely with comorbidities, and with negligible deaths in children and young people, how can mass vaccination be justified?
This is especially serious to consider when so much remains unknown about immunity, and about the experimental vaccine products which are currently being rushed through trials.
It's more especially serious to consider given that it's been suggested a vaccine against SARS-CoV-2/covid19 may not work well in older people, and that children will be vaccinated to supposedly protect the elderly.[4]
How can it be justifiable to risk the apparently natural defences of most of the population, particularly children and young people, with what is likely to be annual coronavirus vaccination, i.e. coronavirus vaccination throughout life? This is replacing natural immunity with purported vaccine immunity, with unknown long-term consequences. Is it ethical to risk the natural defences of the young? Should not more consideration be given to other preventative measures and treatments?
It really is astonishing that ethical consideration hasn't been given to this matter, instead rushing off to develop vaccine products for the entire global population at Bill Gates’ behest[5], without properly thinking this through.
People need to think about this...now...
References:
1. Fiona Godlee. Covid-19: Less haste, more safety. 20 August 2020: https://www.bmj.com/content/370/bmj.m3258
2. 52,026 - broken down as: Under 1 year: 2(m) 0(f); 1 to 14 years: 2(m) 2(f); 15 to 44 years: 342(m) 220(f); 45 to 64 years: 3,262(m) 1,709(f); 65 to 74 years: 4,964(m) 2,719(f); 75 to 84 years: 9,973(m) 6,847(f); 85 years and over: 10,079(m) 11,905(f)
Deaths registered by age group. Deaths registered weekly in England and Wales, provisional: week ending 14 August 2020.
https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarri...
3. Population estimates for the UK, England and Wales, Scotland and Northern Ireland: mid-2019:
https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigrati...
4. Is it ethical to vaccinate children to protect the elderly? Elizabeth Hart rapid response on The BMJ, 5 August 2020: https://www.bmj.com/content/364/bmj.l108/rr-4
5. According to Bill Gates: "Humankind has never had a more urgent task than creating broad immunity for coronavirus. Realistically, if we’re going to return to normal, we need to develop a safe, effective vaccine. We need to make billions of doses, we need to get them out to every part of the world, and we need all of this to happen as quickly as possible." What you need to know about the COVID-19 vaccine. 30 April 2020: https://www.gatesnotes.com/Health/What-you-need-to-know-about-the-COVID-... The Bill & Melinda Gates Foundation is currently the top donor of the World Health Organisation, with the BMGF founded-Gavi Alliance in fourth place, behind the United States and the UK. World Health Organization Contributors - updated until Q2-2020: https://open.who.int/2020-21/contributors/contributor
Competing interests: No competing interests
"Wars, Epidemics and economic slowdowns change the course of human evolution"
Covid 19 encompasses all three. The recent appearance of a "Vaccine nationalism" movement in the form of a rapid race to develop a potent vaccine for Covid 19 indicates the evolutionary transition of the human race. The John lyly's "All is fair in love and war" seems correct. Covid 19 is no less a war and these altruistic few are in a love to win this race and ready to rewrite regulatory frameworks, ethical principles, safety parameters and timeliness of vaccine development. There is a haste for a perceived economic upsurge by sidelining ethical principles. Some are coming with wonder drugs, some are coming with magical remedies and befooling the already fear stricken masses (populace). It seems they are in a haste for making the poor guinea pigs and pumping the economies of the wealthy few.
During this fierce race, WHO's safety, efficacy, immunogencity parameters for vaccine development are perceived to be old fads. The mass manufacturing capacity and pricing parameters can't be overlooked and are still relevant. This haste for becoming the number one shall be neutralised by the limited mass manufacturing and demand and supply proposition. In spite of all haste and even if producing thousands of vials in a day, one may wonder how many years it will take to vaccinate the last person across the geographical boundaries of this planet.
Therefore, it is wise to be" less haste and more safe" in vaccine development approaches and also to combat the Covid 19 triology of pandemic, war and economic crises.
"When uncertainty prevails, it's always better to do certain things ethically and judiciously"
Competing interests: No competing interests
Dear Editor
Thank you.
I for one will NOT accept a jab which has not been prepared, methodically, without hurrying through the normal steps. Not even if the vaccine has been engineered by Oxford . Not even if funded by Bill Gates.
Perfect storms? Please can doctors cut out hyperbole?
Competing interests: I might be caught and killed by....who knows.?
Dear Editors
Regardless of whatever outcome (success or failure) of the research into COVID-19, the world will not forget the intensity or response of the medical community and healthcare companies to the challenges of a new pandemic finally confirmed by WHO in mid March, when more than 20 000 confirmed cases and almost 1000 deaths in the European Region as a result of COVID-19 (at the same time China had 80 000+ cases and 3000+ deaths) (ref 1,2).
When Moderna’s mRNA-1273 completed its first clinical trials in April (which started in March just 66 days after SARS-CoV-2 was first sequenced) (ref 3,4), "more than 820,000 people have been confirmed to have the virus, and at least 174,000 have recovered" "more than 40,000 people have died" worldwide (Ref 5). As of now there are 31 candidate vaccines in clinical evaluation, 142 candidate vaccines in preclinical evaluation just 9 months after the virus was first discovered.
There is no doubt that any vaccine developed in such a rapid timeframe would have its efficacy determined before release for use into the market, whereas the true safety profile will not be known for some time until a large number of people have this vaccine, despite the purpose of Phase I and II clinical trials performed.
Rare adverse events are to be expected for any drug or vaccine, just as for any food we consume, organic or not; anyone who pretends this doesn't happen is a fool. On the other hand, not to have a vaccine or drug on the basis of a very small chance of an adverse outcome is akin to not getting out of bed every day for fear of having an accident in life.
Unfortunately there are many who do even have a chance to choose if they want to have a treatment for an endemic disease. Each year, some 228 million suffer from malaria worldwide with at least 400 000 deaths, more than 90% cases and deaths in WHO African region (Ref 6).
WHO listed 16 preclinical, 21 clinical and 32 inactive or discontinued candidates so far in their Rainbow Table of known Malaria Vaccine worldwide (Ref 7). Granted, the issue of malaria pathogenesis is complex but it has also been well studied for years.
Yet COVID-19, whose pathogenesis is still largely unknown and the knowledge base still evolving after 9 months of intensive research, has some of its first vaccine clinical trials starting just 3 months after its emergence when its global cases and deaths is just a fraction of malaria endemic, and to date, there are almost 3 times as much vaccine in the pipeline than all of malaria vaccine candidates on (WHO's) record.
Ironically, this vaccine inequity reminds me of a joke told by the straight-talking Paul Chowdhry on an episode of Live at the Apollo (relating to Ebola virus); curious readers should be warned that the joke may be offensive to some (privileged) of you. The world's response to COVID-19, the lack of preparation in Europe and the US despite the lead time, right through the spectre of the Chinese COVID-19 response by a lockdown of major city of 9 million and building of two 1000 bed hospitals in 1 week reflect the privileged attitude of "it's not a problem until it's my problem".
Again, whatever the outcome, I warn the world that if the interests and vast resources thrown at the search for a COVID-19 vaccine is not replicated for malaria, then it will (further) reveal the disparity and the hypocritical facade of the rich countries, and those who suffer from malaria will not forget.
And I haven't even touched on the issue of how the privileged nations are calling shotgun on the prospective COVID-19 vaccines, a new form of nationalism or imperialism by proxy, and the commercial benefits from all these stakes in the ground.
References
1. https://www.euro.who.int/en/health-topics/health-emergencies/coronavirus...
2. https://www.who.int/docs/default-source/coronaviruse/situation-reports/2...
3. https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931252-6
4. https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19
5. https://www.aljazeera.com/news/2020/03/trumps-flags-tougher-coronavirus-...
6. https://www.who.int/news-room/fact-sheets/detail/malaria
7. https://www.who.int/immunization/research/links/Rainbow_Table_Reference_...
Competing interests: No competing interests
Dear Editor
We have been in countless meetings of different organisations where there have been important discussions about making the workplace COVID-secure or COVID-safe (and in one unfortunate malapropism, COVID-friendly!). This language is problematic as it suggests that we can make places 100% safe for staff, which will never be possible. The language can also drive irrational behaviour; the term COVID-secure suggests a very high degree of certainty requiring extreme procedures.
Thus, COVID-secure transport to hospital required patients not to use taxis, public transport or even walk – they had to find someone who had self-isolated for 2 weeks to drive them.
A more useful way we should think about workplaces (and indeed other public and private spaces and activities) during the pandemic is to describe them as COVID-mitigated. This follows standard risk assessment approaches; the risk of a person entering a space or taking part in an activity should be risk assessed and categorised. Factors that need to be considered include the estimated prevalence of infection in that space, contact time and distance and other factors such as the degree of aerosolization.
Once the risk has been categorised there needs to be a judgement as to whether it is a reasonable risk. Where possible steps should be taken to reduce the risk and the risk reassessed. Then, depending on the level of the risk, appropriate mitigation should be undertaken. This could include appropriate PPE or physical barriers to reduce the risk to the individual.
The term COVID-mitigated emphasises that there is always a residual risk, and that steps should be taken to reduce that risk. Even in a situation where there is a low incidence of infection and good social distancing then it is necessary to mitigate the risk, for example, by good handwashing.
This approach also emphasises the dynamic nature of risk. As things changes (especially prevalence) then the risk changes and so may the necessary mitigations. It also discourages people and organisations taking extreme steps in an attempt to eliminate negligible risks.
It also gets people to think about their own safety in a considered way. Every activity or place where there is more than one person will carry some risk of COVID-19 infection, but that risk can be so small that most people may choose to accept it.
While the risk of infection is broadly the same for everyone in the workplace, the consequences of infection are different depending on age, ethnicity and co-morbidities. This now becomes a familiar two-axes risk assessment, and further mitigations will be needed as the potential severity of infection will be higher for people in these groups. This is important for safety and ensuring equity of opportunity and access for all.
COVID-mitigation is a less misleading way of describing how we should approach preparing to start activities and open places following the lockdown. We would suggest that a simple algorithm to help assess the risk and plan the appropriate mitigations would be helpful.
Professor Catherine Urch
Professor Andrew George
Competing interests: No competing interests
Five years imprisonment and/or a $66,600 fine for refusing coronavirus vaccination?
Dear Editor
From Australia, I'm watching the fast-tracked development of coronavirus vaccines with mounting concern.
Under the Australian Biosecurity Act 2015, refusers of coronavirus vaccination[1] in Australia could be at risk of five years imprisonment and/or a $66,600 fine.[2] [3]
This emergency power has been active since March 2020, and has been extended to December 2020 [4], with the potential for unlimited extensions.[5]
It's possible this emergency power could be extended until a coronavirus vaccine is available, and that people in Australia could be under duress to have coronavirus vaccination, i.e. at risk of imprisonment and/or a huge fine, for a virus which is not a threat to most people under 70.[6]
We need to talk about this...
References:
1. Biosecurity Act 2015. Australian Government Department of Health - Listed Human Diseases (page last updated 21 September 2020): https://www1.health.gov.au/internet/main/publishing.nsf/Content/ohp-bios... (Accessed 30 October 2020.)
2. Biosecurity Act 2015 -C2020C00127 https://www.legislation.gov.au/Details/C2020C00127 (Accessed 30 October 2020.)
3. Notice of Indexation of the Penalty Unit Amount, Attorney-General, dated 14 May 2020. -F2020N00061 https://www.legislation.gov.au/Details/F2020N00061 (Accessed 30 October 2020.)
4. Human Biosecurity Emergency Period Extended By Three Months. Media Release, Ministers Department of Health, 3 September 2020: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/human-bio... (Accessed 30 October 2020.)
5. COVID-19 Legislative response - Human Biosecurity Emergency Declaration Explainer. Parliament of Australia. Posted 19/03/2020 by Howard Maclean & Karen Elphick: https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parlia... (Accessed 30 October 2020.)
5. Why do we need a vaccine for Covid-19? Elizabeth Hart, BMJ rapid response, 1 September 2020: https://www.bmj.com/content/370/bmj.m3258/rr-9
Footnotes to references:
1. Human coronavirus with pandemic potential (e.g. COVID-19), is included as a 'Listed Human Disease' under the Biosecurity Act 2015.
2. See the Biosecurity Act 2015, Chapter 2 - Managing biosecurity risks: human health, Part 3 - Managing risks to human health: human biosecurity control orders, Division 2 - Imposing human biosecurity control orders on individuals, Subdivision C - When an individual is required to comply with a biosecurity measure, 74 When individual is required to comply with a biosecurity measure (1) (e) section 92 (vaccination or treatment) and (2) The individual is required to comply with the measure only if: (a) the individual consents to the measure; or (b) the Director of Human Biosecurity has given a directive for the individual to comply with the measure in accordance with paragraph 72(5)(a)...(etc...), and Note 1: A person who fails to comply with a biosecurity measure that the person is required to comply with may commit an offence (see section 107) - see Division 4 - Other provisions relating to human biosecurity control orders, Subdivision C - Miscellaneous, 107 Offence for failing to comply with a human biosecurity control order...Penalty: Imprisonment for 5 years or 300 penalty units, or both.
3 A 'penalty unit' is $222 under Commonwealth law, multiplied by 300 equals $66,600
4 (to reference 5) "...The Governor-General may extend a declaration indefinitely (with each extension being for no longer than three months) if the Health Minister remains satisfied that the conditions that required a declaration of a human biosecurity emergency continue".
Competing interests: No competing interests