Dr/Prof. Victor Luca
Published in The Beacon, Friday 26-Nov-21
On Monday 22-Nov-21 two leaflets produced by a mob called ‘Voices for Freedom’ were delivered to our letterbox. One brochure was entitled “You Can’t Take it Back …” and it hits out at the Pfizer-BioNTech COVID-19 mRNA vaccine making a series of eight, at best, dubious claims under the title “Did they tell you?”. The other leaflet was entitled “Going to Wear that Mask All SUMMER?”. This leaflet makes a number of claims intending to cast doubt on the usefulness of mask wearing.
I don’t have space here to address each and every claim made in these two leaflets of mostly errant nonsense. A few of the claims may have some validity, others are clearly disingenuous.
Here I will focus on the claim in the first leaflet that is clearly a load of bollocks. It is stated that the Pfizer-BioNTech COVID-19 vaccine is an “experimental gene therapy still in clinical trials - including for children”.
It is very rare in science that transformational discoveries come out of the blue. Almost every scientific discovery builds on what went before it. And so it was with the mRNA vaccines which started with the discoveries of a Hungarian researcher, Katalin Karikó, and Drew Weissman (University of Pennsylvania) and many others almost three decades ago. In particular Karikó and Weissman showed that mRNA could be modified in such a way that the body’s own immune system didn’t attack it. More detail on the discovery and development process can be found in the article by Elie Dolgin entitled ‘The tangled history of mRNA vaccines’ and published in the journal Nature 2021, Volume 597, pages 318-324.
Following the discovery of a method to modify mRNA, a method had to be developed to transport the mRNA into mammalian cells and trigger the production of certain proteins. This involved the use of lipid nanoparticles which also protect the modified mRNA. For the Pfizer-BioNTech COVID-19 vaccine the piece of mRNA transported into the cytoplasm of cells codes for the spike protein of the SARS-CoV-2 virus.
The Pfizer-BioNTech vaccine was given emergency use authorization (EUA) by the US Food and Drug Administration (FDA) on 11-Dec-20.
The EUA was granted following strictly the usual rigorous three-stage experimental trial process. Initially, in phase 1 trials, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies.
Phase 3 trials of the Pfizer vaccine involved the undertaking of a randomized double-blind placebo-controlled trial involving 44,000 volunteers. This type of clinical trial is the gold-standard in modern medical science research.
An EUA allows the FDA to make an unapproved medical product available for use. The FDA may grant such authorization provided the available evidence makes it “reasonable to believe that the product may be effective” and there is “no adequate, approved and available alternative.” Importantly, the authorization is limited to the duration of the health emergency.
What facilitated the rapid progress from discovery to initial laboratory development of the technology to human trials and the issuance of an EUA and eventual scale up of the manufacturing process was that rather than processes being run sequentially, they were run in parallel. For example, construction of manufacturing facilities were started well before trials were completed.
The Pfizer-BioNTech vaccine received full FDA authorization for persons 16 years of age and older on 23-Aug-21 almost one year after the EUA. The difference between a EUA and full authorization is time. Time to observe possible long-term effects. So mRNA vaccines have passed muster by any measure anyone cares to mention.
On 29-Oct-21, the U.S. FDA authorized the emergency use of the Pfizer-BioNTech vaccine for use on children 5 through 11 years of age.
According to the Bloomberg vaccine tracker, almost 8 billion doses have now been given. Sure, a very small number of people can have an adverse reaction to the vaccine just as with any medication.
People also can have severe, even fatal, allergic reactions to bee stings, antibiotics, peanuts and many other things. However, the number of people showing adverse reactions to the mRNA vaccine is miniscule compared to the number of people that would die from COVID-19. Robust data are available on this issue.
So when the imbeciles from Voices for Freedom that are responsible for these scare mongering leaflets say that mRNA vaccines are still in clinical trials, that is plainly a load of bollocks!
The next time these folk really get sick and think about visiting a doctor so as to avail themselves of the fruits of modern medical research, they should perhaps rather go and visit their local witch doctor for a cure. Good luck with that!
Rather than promulgating BS these folk should consider doing some real research as opposed to what is depicted in the image to the left. Real research requires extensive tertiary training to learn to think analytically and to acquire sufficient knowledge so as to be able to understand technically complex peer-reviewed science literature which is needed to synthesize what is really going on. They would then require the judgment and experience to sort the wheat from the chaff. There have been more than 200,000 peer-reviewed scientific publications on COVID-19, so good luck with the real research.
When it comes to expert opinion, it is always possible to find the odd expert who will come to a different conclusion to the vast majority of other experts. For instance, there is a greater than 99% consensus among climate scientists that humans are making a major contribution to warming the planet. That leaves 1% of experts that may have a different view and are prepared to stake their otherwise impeccable reputation and go against the overwhelming consensus view. That is OK, it is how science works. For those that are non-experts they would probably do well to bet on the overwhelming majority rather than the miniscule minority.
In the meantime, sourcing your science information from facebook, twitter, instagram and other social media sites is plain nonsense, dishonest and potentially very dangerous. To go around putting leaflets containing misinformation in people’s letter boxes with the aim of turning people off the consensus view of modern medicine is an afront to reason.
As for the second brochure, I wont even dignify it with an analysis because these voices for freedom wack jobs are completely oblivious to how masks actually work.