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It’s essential that all known risks, relating both to the pathogen but also to the particular vaccine in question, are put in the public domain, along with what’s known about the protection the vaccine offers. That’s not just headlines like 90 to 95% efficacy. That means putting the raw data into the public domain so it can be analyzed by independent scientists. To date, none of the full datasets have been released.
>>> Covid-19 vaccines: where are the data? in The BMJ, 27 November 2020
Not only that, none of the three frontline vaccines from AstraZeneca, Pfizer or Moderna have published their Phase 3 trial results. The only things we’ve got to go on so far are press releases that are deeply deficient in data on both risks and benefits. What has been blasted around the airwaves of course are these dizzying efficacy rates of between 62 and 95% that past history from vaccine trials and post-marketing surveillance suggests are unlikely to be achieved in the real world.
So what do these 62 to 95% headlines really mean? First, they relate to efficacy, not effectiveness. Efficacy measures the performance of treatment under ideal and controlled circumstances, while effectiveness is the performance under real-world conditions. Because the vaccines are being evaluated under trial conditions, you don’t have the vagaries of the real-world to contend with. And what are the performance parameters? Is it protecting people against transmitting the infection, or is it about protecting the vaccinated person from severe disease if you are infected during a specific time window?
>>> Call by Dr. Peter Doshi to “be cautious and first see the full data” in The BMJ, 26 November 2020
As it turns out, it’s only the latter. That means vaccinations are not being evaluated for their ability to stop the transmission of infections – something you’d think would be a target if you wanted to wipe out an epidemic or pandemic. But it’s actually something that takes much longer than the very short time frame these vaccines are being created within. The same applies to safety issues – some of the trials will continue to look at safety issues for 12 months or more, but the vaccines will be rolled out at least for emergency use sometimes with just a couple of months of safety data.
And as we’ve said before, history tells us it can be years before safety concerns are exposed, as we discovered with the swine flu vaccine Pandemrix and narcolepsy in children.
The current crop of novel covid vaccines is only being tested for their ability to stop people getting seriously ill, a risk that becomes less and less in a waning epidemic, and a risk that primarily only affects older people or those with underlying conditions.
On top of that, we don’t know a lot about the populations who appear to be protected from severe disease, and how many of these include groups who are the most vulnerable. Also, note that two doses are needed in all 3 vaccines to yield the highest immune response – and higher dosages generally also yield more adverse reactions.
In effect, it means that the current Phase 3 trials are really testing the vaccines as a preventative treatment, not for their ability to make you immune to the virus and incapable of transmitting it to others. This is an important distinction. In other words, what the vaccines are really trying to do it make more people respond just like an unvaccinated healthy person who has a good functioning immune system, with some possible historic cross-immunity to other coronaviruses or previous exposure to SARS-CoV-2, and adequate amounts of vitamin C, D, zinc and other cofactors in their system.
On the risks side, AstraZeneca, Pfizer, and Moderna have all claimed a lack of safety concerns.
But in Phase 1 and 2 trials of the AstraZeneca vaccine, moderate to severe adverse events were experienced by 80% of those receiving the covid jab. With the Pfizer vaccine, nearly 4% of people suffered from severe – or Grade 3 – adverse events. These grade 3 adverse events aren’t a walk in the park – they’re just one category down from grade 4 adverse events that are described as “potentially life-threatening events” that require hospitalization and critical care.
People with Grade 5 events don’t get to tell their story, but the more separated in time death is from vaccination, as hundreds of families have found in the various national vaccine courts, the harder it gets to prove a causal relationship.
Anyway, Grade 3 adverse events are certainly severe enough to give a susceptible person sufficient immunologic or neurologic shock to trigger long-term health challenges that might affect their nervous system or autoimmunity. And while Pfizer might have dismissed these as insignificant at just 3.8%, if that percentage was applied to say 70% of the US and UK populations, that would amount to a staggering 10.6 million people who would experience severe adverse events. The trouble here is that the potential for long-term consequences of an adverse event isn’t something you can just monitor in a couple of months – typically it takes years of post-marketing surveillance. And here I want to emphasize the point: Until that kind of time scale has passed, we think it would be premature, irresponsible, and unscientific to call these vaccines safe.