Covid 19: Two million deaths, so what went wrong?BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n393 (Published 11 February 2021) Cite this as: BMJ 2021;372:n393
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The statement "The phenomenal success of the vaccination programme is the most concrete, not only for people receiving it but for those delivering it" needs to be explained in the context of efficacy and safety. Surely a vaccine is only successful if it both prevents transmission (not proven as yet with COVID vaccines) and is safe (all vaccines are currently under EUA status and and have a black triangle warning).
Clinical trials have only just ended and therefore it is too soon to know how long any of the vaccines will last. As regards the claimed efficacy by the manufacturers, I think Peter Doshi explained the flaws in the trial designs perfectly in his recent article for BMJ - his concerns re relative V absolute risk reporting, ill-defined endpoints, lack of transmissibility data and duration of the trial, all merit the highest scrutiny.
As regards safety, for the same reasons efficacy cannot be measured, nor too can safety. Instead, authorities like FDA, CDC and MHRA will have to rely on public reporting such a VAERS and Vigibase to monitor for trends in adverse events.
Currently on VAERS, as of Feb 4th, there are 12,697 reported reactions, many of which are very serious, including 653 ending in death.
21% of those deaths were related to cardiac disorders and another 27% died in their sleep or without warning. Temporality to the vaccine is also a startling figure. Half of all deaths were reported within hours of receiving the vaccine.
This is highly significant given the importance of using temporality in assessing the cause of death according to the Bradford Hill criteria. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4589117/
Some might say we can't rely on VAERS as it's a passive system and reports are not verified. That may be true but it is still the only reporting system we have accessible to the public. Moreover medical staff have been told to report all COVID 19 vaccine adverse events to VAERS, from injection site reactions to death. In fact it is a mandatory requirement mentioned on the first page of the FDA fact sheet for vaccination providers.
It would appear to those familiar with VAERS that this is in fact working and that many more vaccinators are actually reporting adverse events since there have been so many. It is often the case that new vaccines elicit more reports than older ones, that it acknowledged. However, the difference between the reports from the COVID 19 vaccines and all other vaccines is beyond anything seen before. A comparison to the flu vaccine is warranted since, unlike other vaccines, uptake of the flu vaccine has increased in 2020, peaking at 193 million doses.
If you compare flu vaccine reported deaths in 2020/21 (193m doses) to the two months of data from COVID 19 vaccines (35m doses as of Feb 4th), then the tally is as follows:
Dec 2020 - Feb 4th 2021 COVID 19 vaccine deaths: 653
Sept 2020 - Jan 31st 2021 Flu vaccine deaths: 20 (Twenty)
Using basic math, that means that the rate of deaths reported following the COVID 19 vaccine is 180 times that of flu vaccine deaths.
The CDC has actually admitted that the number of deaths reported is 1.170 as of February 7th. However It has also claimed (incredibly) that they have investigated all deaths using death certificates, autopsy reports, medical records etc and found that there was "no link" with the vaccine.
This is preposterous since even someone like myself without a medical background can tell that many of the medical personnel writing the reports into VAERS considered the vaccine to be the likely cause of death. One poor soul was vaccinated while unconscious and passed away 90 minutes later.
The CDC is monitoring all reactions and as a concerned citizen I would ask BMJ to do the same and seek accountability from the CDC and the FDA and to explain these data. The public must have full disclosure and full transparency or we will see a repeat of the 1976 swine flu debacle. Although it's likely that pharma's influence on the world stage would forbid any such similar exposure. However since we can see reactions with our own eyes (the second dose reactions are exponentially worse), then it won't take long for the public to lose confidence due to negative personal experience alone. The CDC and the FDA have a problem they need to address. Each week it is glaringly more obvious.
Competing interests: No competing interests
Fiona Godlee says “The phenomenal success of the vaccination programme” is one of the sources of hope in the otherwise grim history of the Covid-19 pandemic. (BMJ 2021;372:n393, Feb 11) Gavin Yamey says “The rapid development of safe, high efficacy covid-19 vaccines in under a year is one of the greatest scientific achievements in recent history.” (BMJ 2021;372:n373, Feb 10)….I suggest that we need to be careful about overenthusiasm.
Not many years ago US news releases from the CDC were announcing that influenza vaccines were “70%...80%...90% effective.” (Fiore et al, MMWR Recomm Rep 2010;59:1) Times changed, and in 2018 we were told that vaccine effectiveness (VE) was only 10% to 60%. (https://www.cdc.gov/ Feb 15, 2018) We have since learned that VE rapidly declines during the flu season. During two recent seasons, for example, VE against A/H3N2-associated hospitalizations among the elderly declined progressively from 51% two weeks after vaccination to –16% at 6 months; that is, a 16% increased risk of serious illness by 6 months. (https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab045/610... ) This report gave no data for the first two weeks following vaccination, but at least one study has shown that flu shots substantially increased the risk of influenza-associated hospitalizations during the first week. (Emborg et al, BMJ 2011;344:d7901)….In retrospect, universal influenza vaccination may have done more harm than good. The vaccines provide modest short-term protection against seasonal influenza, but the observational studies showing 10% to 60% VE completely ignore vaccine adverse effects, including an increased risk of illness from non-influenza respiratory viruses, such as RSV, rhinoviruses, coronaviruses, etc. (https://www.bmj.com/content/370/bmj.m3720/rr )
Maybe Covid-19 vaccines will be different, but the foregoing history should be kept in mind when we are told that a Covid-19 vaccine is 94% effective overall and 86% effective in the elderly. (Baden et al, NEJM 2021;384:403, Feb 4) This is especially important during the current frenzy driving universal vaccination. Dr. Joseph Ladapo calls universal Covid-19 vaccination a “chimera.” (Wall Street Journal, 2/5/21) He is a hospitalist and an associate professor of medicine in California, and his essay is worth quoting at length:
“Each stage of the American Covid-19 pandemic has been marked by a singular public-health message that crowded out all other perspectives. From early calls to ‘crush the curve’, with shutdowns and pleas to stay at home, then to claims that face masks would end the pandemic, these messaging strategies have sowed unrealistic expectations and delayed public acceptance of reality. The most recent message is ‘universal vaccination’, an aspiration whose unattainability may further delay the country’s return to social and economic normalcy.”
He goes on to discuss the media campaign to stoke fear, the lack of transparency of public-health officials, the uncertainties about vaccine safety and effectiveness and officialdom’s dismissal of legitimate concerns as ‘misinformation’, and the limitations in our ability to stop the spread of Covid-19 and its variants. He supports vaccination, but concludes that vaccine policy should focus on the elderly and truly vulnerable individuals, and on people who feel they can’t live or work safely without vaccination. He condemns proposals to mandate Covid-19 vaccine for schoolchildren. Dr. Ladapo now looks forward to a decline in Covid-19 mortality and more rational thinking about the pandemic. (WSJ, 2/5/21)
The pandemic in the US does appear to be on the decline. Reported Covid-19 deaths peaked in week 16 of 2020, then declined and rose to another peak in weeks 51-52 before starting the current decline. Compared with the 2017-19 average, there was an excess of 468,085 deaths from all causes in 2020, an increase of 16.6%. There were 359,781 Covid-19 deaths reported, accounting for 76.9% of all-cause deaths in 2020 (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/0205208/n... Feb 5, 2021)
As of February 5, 2021 there had been 26.8 million US cases of Covid-19 recorded, never mind precisely how the diagnoses were made. (cidrap.umn.edu) This is about 8% of the entire US population. Seroprevalence surveys suggest that this figure vastly understates the number of Americans actually infected by Covid-19. From January 21 to November 15, 2020 the CDC recorded 10,846,373 cases; seroprevalence surveys estimate the number actually infected was 46,910,006, more than fourfold higher. (JAMANetworkOpen.2021;4(1)e2033706.doi:10.1001/jamanetworkopen.2020.33706) It appears, then, that something upwards of 8% to 35% of Americans have been infected so far. During influenza epidemics attack rates in unvaccinated populations are estimated to be 10% to 20%, but rates as high as 40% to 50% have been reported. (Mandell et al, Infectious Diseases, 2010, page 2268)
The current US decline in Covid-19 may indicate that natural infections have produced a level of population immunity sufficient to end the pandemic, or are approaching that level. There are still uncertainties, not the least of which are the breadth and duration of immunity provided by Covid-19 vaccines. In general, vaccine immunity to infections is not nearly as good as natural immunity, and is less likely to sustain population immunity. In the long run the safest and most efficient approach may be focused protection of people who are truly vulnerable, while allowing broad and lasting natural immunity to develop in the ~80% of the population who are not particularly vulnerable. I admit that this may be hard to do in the face of highly emotive news stories about Covid-19 deaths in young people, ICUs filled to capacity, highly contagious variants, etcetera….but we shouldn’t forget the history of seasonal flu shots. (https://www.bmj.com/content/371/bmj.m4037/rr-3 )
The pandemic has brought at least one surprising piece of good news: there were fewer US infant deaths in 2020. Data are still provisional, but based on current figures the projected total will be around 19,200 (https://data.cdc.gov/widgets/vsak-wrfu ), compared with 20,300, the figure expected from the trend in infant deaths between 2015 and 2019. (Ely et al, Infant Mortality in the United States, 2018; NVSS Volume 69, Number 7, July 16, 2020. NCHS/NVSS Data Brief 395; Mortality in the United States, 2019) The difference is highly significant, P<0.00001. What accounts for the drop? Specific data about the causes of 2020 infant deaths should help answer the question.
ALLAN S. CUNNINGHAM 14 February 2021
Competing interests: No competing interests
Whenever I observe a poor outcome of something in which I have not been involved, I will often ask myself 'what would I have done differently if I had been in charge?'. How would I have dealt with the complexities and the unknowns, applied prior knowledge (however sparse), justified decisions based on fine-line assessments, balanced competing interests and consequences and react decisively to an ever-changing situation? I have found that it is easy to be judgemental in the cold light of day but when I do that thing we are all supposed to do, ie reflect, I often find myself thinking 'I'm glad I didn't have to deal with that' and 'there but for the grace of god.....'
As such it must be great being a BMJ editor. That you can criticize mishandling of the pandemic without offering even the first suggestion of what you might have done instead (and when you do give a view it remains untested) is the height of editorial privilege. Do you have a proper understanding of the true international Covid statistics (have all countries adopted the UK's way of defining a Covid death?) Do you really believe that every Covid death in countries with a track record of press restrictions has actually been reported, not to mention the unknown numbers in countries whose record-keeping facilities are limited and their rurality extensive. Perhaps you should just be thankful that you aren't actually the one who has to make the difficult decisions that no-one has ever been trained for.
Competing interests: No competing interests
This is a response and a request to Prof Aleem , a rapid responder.
I doubt very much that the measures implemented by the government are responsible for the low mortality. Vaccination must take a few weeks before the resistance to the virus is built up.
One might think that India is a land of sunshine and therefore there is plenty of vitamin D However, there are parts of India where the sun does not shine brightly.
There are fishermen who earn their living by catching sea fish. They are of course the recipients of plenty of sunshine, both direct and reflected. They also eat fish. Have they been spared Covid?
Competing interests: No competing interests
India 's Successful Fight Against COVID-19
As of 11.02.2021 India has a total number of 10,880,413 cases and a total number of COVID-19 related deaths of 1,55,484 with the very low death rate of 1.42%.
India’s fight against Covid-19 is bringing daily successes on other fronts as well. Seventeen States/Union territories have not reported any deaths in the last 24 hours on 11.2.21. These are Telangana, Gujarat, Assam, Haryana, Odisha, Uttarakhand, Meghalaya, Nagaland, Lakshadweep, Ladakh (UT), Sikkim, Manipur, Mizoram, A&N Islands, Tripura, Arunachal Pradesh and D&D & D&N (UT). The death rate in the state of Tamilnadu was 1.46% and in my own district of Trichy 1.42% as of 12.2.21.
Cases and death rate in India Tamilnadu and in Trichy are declining, and India's single day spike of COVID-19 of over 9k (9,353) with deaths of 85 and the total crossed the 10.8 million mark (10,880,413) on 11.2.21 during this Pandemic. The recovered cases were second to the U.S, over 10.5 million (10,587 351) on 11.2.21
In India as far as COVID-19 vaccination is concerned as of 11th February, 2021, more than 70 lakh (70,17,114) beneficiaries have received the COVID-19 vaccination under the countrywide COVID-19 vaccination program.
India becomes fastest in the world to reach 70 lakh vaccinations against COVID19 in only 26 days.
India’s active cases per million population (104) is amongst the lowest in the world.
Indian National Recovery Rate (97.26%) continues to be one of the highest globally.
Competing interests: No competing interests
Deep concern over vaccination safety
At the same time as Fiona Godlee refers to “the phenomenal success of the vaccine programme”  deaths on the Vaccine Adverse Events Reporting System (VAERS) for the two Covid vaccines currently in use in the US, manufactured by Pfizer BioNTech and Moderna, are off the scale. As of 4 February there were 653 reported deaths . This was at a time when approximately 35.2 million doses had been administered . It compares with 75 reported deaths associated with influenza vaccine for the current season  from 193.6 million doses: this is approximately 48 times the rate. Deaths are also a much higher proportion of total reports for Covid vaccines as compared with Influenza vaccines [6,7]: approximately 5% as compared with about 0.8%. Although none of these cases is confirmed VAERS is a passive reporting system which was said in 2010 to pick up less than 1% of cases .
On top of this the New York Times reports :
“ More than 34 million Americans have received Covid vaccines, but the much-touted system that the government designed to monitor any dangerous reactions won’t be capable of analyzing safety data for weeks or months, according to numerous federal health officials.”
All this is deeply concerning to say the least.
 Fiona Godlee, ‘Covid 19: Two million deaths, so what went wrong?’, BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n393 (Published 11 February 2021)
 7:12 p.m. ET, February 4, 2021, Roughly 35.2 million Covid-19 vaccine doses administered in the US, according to CDC
From CNN's Deidre McPhillips, https://edition.cnn.com/world/live-news/coronavirus-pandemic-vaccine-upd...
 Table of 2020-21 Seasonal Influenza Vaccine — Total Doses Distributed, https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm
 Found 12,697 cases where Vaccine targets COVID-19 (COVID19). , https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=O...
 Found 9,077 cases where Vaccine targets Influenza (FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 or FLUA4) and Appearance Date on/after '2020-09-01'. , https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=O...(H1N1)&VAX%5B%5D=FLU3&VAX%5B%5D=FLU4&VAX%5B%5D=FLUA3&VAX%5B%5D=FLUC3&VAX%5B%5D=FLUC4&VAX%5B%5D=FLUN(H1N1)&VAX%5B%5D=FLUN3&VAX%5B%5D=FLUN4&VAX%5B%5D=FLUR3&VAX%5B%5D=FLUR4&VAX%5B%5D=FLUX&VAX%5B%5D=FLUX(H1N1)&VAX%5B%5D=H5N1&VAX%5B%5D=FLUA4&VAXTYPES=Influenza&REPORT_YEAR_LOW=2020&REPORT_MONTH_LOW=09
 Lazarus et al, ‘Electronic Support for Public Health - Vaccine Adverse Event Reporting System, Results, p.6, https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs01704...
 Sheila Kaplan, ‘ The F.D.A. is struggling to start up its comprehensive monitoring system for vaccinations.’, 12 February 2021 https://www.nytimes.com/2021/02/12/world/the-fda-is-struggling-to-start-...
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. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid.