Victor Luca,
Published in The Beacon 31-Dec-20.
COVID Free for Now
Dr Victor Luca
The views expressed here are solely our own and do not express the views or opinions of any organization with which we are associated.
On the cusp of the New Year we in New Zealand are in the fortunate position of being COVID free. We got into this position by being a lifeboat in the middle of the pacific with relatively few passengers and leadership that seems to care about us and in whom we have been prepared to place our trust. There is however no room for complacency or smugness because in other parts of the world this pandemic is raging like a forest fire that is refusing to be brought under control.
And the longer the disease rages around us, the more chance there is of variation or mutation in the SARS-CoV-2 virus genome. With more people to spread among the virus can, and undoubtedly, will change. Any change could be for the better or for worse.
We should not be relaxed thinking that a vaccine is just around the corner and that the virus will miraculously be vanquished. In the history of humanity we have developed relatively few effective, durable and safe vaccines and never has one been developed so quickly. During the past quarter century only seven successful vaccines have been developed, four of those by Merck. The fastest vaccine to have ever been developed is the mumps vaccine and this took four years. So what has just been achieved in the field of vaccine development is nothing short of amazing.
This light speed development of the current suite of COVID-19 vaccines has rested on rapid sequencing of the genome by Chinese scientists, early study of the SARS, MERS and other corona viruses, mostly undertaken in publically-funded laboratories and advances in biochemistry, virology and microbiology.
I am by no means suggesting that folk do not take the vaccine when it becomes available, they absolutely must! Although the vaccines developed by Pfizer-BioNTech, Moderna, Oxford-AstraZeneca and others have been proven to provoke a strong immune response and to be safe, we don’t really know how durable this immune response will be. Early studies of the Moderna vaccine for instance have shown that the immune system response between 18-55 year olds and the 56-70+ may not the same. There simply has not been time to do these long-term studies. But since the virus is raging, the longevity of the immune response has to take second place because we need to douse the flames as soon as possible.
In the meantime, I urge folk to remain prepared and stocked up with face masks that have proven to be an effective weapon against this and other viruses. Also, keep the hand sanitizer, well, on-hand.
Opinions of Non-Experts can be Dangerous
Dr Victor Luca
The views expressed here are solely our own and do not express the views or opinions of any organization with which we are associated.
I was extremely perturbed to read the communication by Mr Steve Clark in the Letters section of The Beacon of Wednesday 23-Dec-20.
Mr Clark begins his letter by pointing out to readers that he has read the Pfizer-BioNTech Covid-19 vaccine product monograph. The monograph states that studies of carcinogenicity and genotoxicity were not considered relevant and reproductive and developmental toxicology studies are ongoing.
I have to strenuously object to the message that Steve is giving in his communication. Calling attention to the absence of carcinogenicity, genotoxicity or reproductive and developmental toxicology testing as if they are a necessary part of the Emergency Use Authorization (EUA) issued by the U.S. Food & Drug Administration (FDA) is extremely disingenuous. Has Steve considered that the EUA was issued in the absence of this information because there is no a priori reason to suspect that this type of vaccine should cause any of the toxicologies mentioned because this vaccine contains no adjuvants. If there were any significant risk of these toxicologies, I am certain an expert body such as the FDA would not have issued an EUA.
The other consideration that Steve appears to have either overlooked, or has been totally unaware of, is that preclinical toxicological testing of vaccines is usually performed to assess the toxicity of adjuvants. The Pfizer-BioNTech vaccine is an mRNA vaccine and as such it contains no adjuvants and hence due to urgency these studies have been deemed unnecessary.
Following on from sounding the alarm on toxicology, and after reproducing the relevant sections of the monograph, Steve states that page 22 suggests that the vaccine alters the DNA of the recipient. In his words:
“Because the fact that this vaccine alters the recipient’s DNA and the fact that the carcinogenicity, genotoxicity and reproductive and developmental toxicology have not been monitored prior to the use of this vaccine on the New Zealand population; the above information will have to be disseminated to the population so that this vaccine’s recipients are informed when they are asked to consent to receiving the Pfizer-BioNTech Covid-19 vaccine [Covid-19 mRNA] vaccination.”
Nowhere in the monograph could I find any statement that the vaccine alters the recipient’s DNA. And even if it were true, what would it actually mean?
As if he has not been mischievous enough, it is totally disingenuous of Steve to make the bold assertion that “the vaccine alters the recipients DNA” implying it would do harm without supporting it with something. I cannot be sure from where Steve has got this idea, but it certainly was not the monograph he cites. If he had got it from a scientific paper then he should have cited it. In science you don’t just go around spouting rubbish without providing references to scientific sources.
I rather suspect (although I can’t be sure) that his idea might come from a manuscript that was recently uploaded to the bioRxiv preprint server for biology. The manuscript by Zhang et al. entitled “SARS-CoV-2 RNA reverse-transcribed and integrated into the human genome” garnered much attention in social and in traditional media. Social media is definitely not a forum for the dissemination of science. Although the authors of the manuscript come from the two very prestigious institutions, Massachusetts Institute of Technology and Harvard University, the manuscript (which is not a scientific paper) invoked the ire of many scientific peers.
It is important to reiterate that this manuscript is not a scientific publication because it has not undergone scientific scrutiny by other expert scientists in the field. This is what is called peer-review and is an indispensable part of conducting good science. Many experts consider that this manuscript is seriously flawed and should be taken down from the server. The bioRxiv site states “bioRxiv preprint (which was not certified by peer review) is the author/funder”.
Mr Clark is clearly not a scientist and therefore might be forgiven for not understanding how the scientific process works. What he should not do is jump to conclusions regarding material that is not in his area of expertise, and which he most probably does not understand. Science works by being skeptical, asking the right questions, proposing hypotheses, conducting experimentation, interpreting results, and then writing them up in the form of a scientific paper. A scientific paper must of necessity be peer-reviewed and published in a reputable scientific journal. Other scientists can then attempt to reproduce, re-interpret and criticize the results and their interpretation and then publish their own paper also containing data and evidence. Sometimes it takes many iterations of this process for the ‘truth’ start to reveal itself. If Mr Clark had ever done any science he would know that this is how the system that has propelled humanity’s technological advancement has worked.
Mr Clark should stick to commenting on what he knows about. The area of vaccine development is highly technical and should be left to experts with the specific technical background, training and experience!
Promulgating furphies can be downright irresponsible in the area of vaccine development and can cost lives.