Why did a distinguished virologist withdraw his signature from my petition to lift CU COVID vax/booster mandates and update guidance to reflect global data on their risks & benefits?
He asked me why I think boosters pose more risks than COVID-19. I replied and invited healthy disagreement. Instead he tweeted out misleading and defamatory claims about me to his 150K followers.
In June, 2021, I embarked on a mission to raise awareness about the true risks and benefits of the COVID vaccines and boosters, based on available global scientific evidence and data, and drafted and circulated an open petition letter in hopes it would shift public health policy at my institution, Columbia University (CU), which has mandated the primary series and the first booster dose for its members. You can read more about these efforts here.
Dr. Vincent Racaniello is a world-reknowned virologist at CU. In an email forum I recently set up for petition signers, it was brought to my attention that he tweeted the below to his 150K followers in early September:
Unfortunately, the tweet does not link to the contents of the email, so readers do not have a chance to discern for themselves whether it is “replete with anti-vaccine misinformation”. Moreover, no clarification or explanation is given about why he felt I “used [his] name without [his] permission.”
Because I mass circulated the petition at CU, which has been reported on by local media, it does not take much effort to piece together that I am the person he is referring to. Without additional information, readers of the tweet are left believing that I behaved unethically or in a dishonest way. This is what happened when someone in the forum brought the tweet to my attention. Therefore I must clear the record here.
Did I use Dr. Racaniello’s name without his permission in an email that was replete with “anti-vaccine misinformation”?
Below I link to the actual email he is referring to. It was an email I sent on September 5th to the CU Senior Executive Vice President, the CU COVID response director and the CU COVID task force, asking whether they had made a decision to mandate the bivalent booster or not, and if not, requesting to schedule a time to debate and discusses the pros and cons of mandating the booster. According to a local news article published August 25th, almost two weeks after I first started circulating my petition, they were still considering a bivalent booster mandate. As part of the proposed discussion, I offered to contribute a 5-10 minute presentation on the flaws in the risk-benefit models used by the FDA in recommending the 1st booster, and why CU should not rely on them when setting their own policy decisions. I gave a preview of my presentation in the Appendix of that email.
The email that Dr. Racaniello is referring to in his tweet
Regarding my use of his name, this is the relevant section of that email:
Dr. Vincent Racaniello, a virology expert at CU, communicated to me that he signed our petition because there is virtually no human clinical data indicating the upcoming fall boosters will be effective against current and future omicron sub variants. In addition, all if not >99.9% of the CU community already has enough protection against severe disease due to previous vaccine- and/or infection-derived immunity. Dr. Paul Offit, a vaccinologist who sits on the FDA advisory board, voted against recommending the 1st booster dose for all adults as well as the upcoming bivalent booster being released this fall for the above reasons and has also expressed some concern about the myocarditis risk in young males and the theoretical risk of “original antigenic sin” in all age groups. Vincent is CC’d on this email in case he has additional points to add.
1. Given the above paragraph as well as the additional reasons in our letter, will you be able to commit to not mandating another booster this academic year?
2. Will you also consider circulating a CU-wide email and publishing a CU media article that recommends against the bivalent boosters this fall, quoting Dr. Racaniello and Dr. Offit’s reasons?
As you can see, I also used Dr. Paul Offit’s name in the email when I cited his previously expressed views and statements regarding the 1st booster. Did I need his permission as well? No, of course not, because that is what scientists do, they always use other scientists’ names when they communicate their previously expressed conclusions or views. In the case of Dr. Racaniello, I was citing his reason for the signing the petition based on his personal communications with me, which is a completely legitimate way scientists cite one another.
How did I know Dr. Racaniello’s reasons for the signing the petition? He responded to my CU-wide email and let me know that he signed the petition because “there is no evidence that such a booster will be beneficial.” He went on to state “You should have known about our communication work in this area and reached out to me to co-sign your email.”
It almost appeared as thought he felt slighted that I did not reach out to him to co-sign my emails before the campaign. I responded and asked him if he would co-sign my emails going forward. He responded and said he would need to see the exact text of the email:
Before you add my name to any email I need to see the exact text of what will be sent out. For example, you cannot say that mandating the vaccine is ‘unethical’. Columbia is a private institution and that can mandate an FDA-approved vaccine. Before you make such proclamations you should check your facts.
I responded by clarifying and citing several reasons why mandating the vaccine is ‘unethical’:
While I would agree that it [may be] “legal” for Columbia to mandate an FDA-approved product, I don’t see how it can be “ethical” if the product poses more risks than benefits to the population, and those risks are not divulged to give true informed consent (i.e. the CU FAQ on vaccine safety does not mention myocarditis risk in young males with the Pfizer and Moderna vaccines, only stroke risk from the Janssen vaccine in women under 50).
About 4,500 FDA approved products are recalled each year (https://www.drugwatch.com/fda/recalls/) so just because a product is FDA-approved does not mean it is sufficiently safe. But even if the COVID vaccines were perfectly safe, mandating them essentially amounts to discrimination on the basis of innate biological characteristics, which is unethical as argued in https://jme.bmj.com/content/48/4/240
Vaccine mandates also restrict “people's access to work, education, public transport and social life based on COVID-19 vaccination status” and “impinges on human rights, promotes stigma and social polarisation, and adversely affects health and well-being.” as argued in https://pubmed.ncbi.nlm.nih.gov/35618306/
Dr. Racaniello replied “Why do you think the booster poses more risk than getting COVID-19 itself? That is not the issue; rather it is that we do not know if the booster will provide any benefit. It’s best if you go ahead with your email without my signature as we are clearly on different pages.”
Important: Given our conversation up until this point was about including his co-signature on my emails circulating the petition, I understood the “signature” he is talking about above to be his co-signature on the bottom of my emails that circulated links to the petition form and letter, not his signature on the actual petition. Is it possible that by “signature”, he meant his signature on the petition, which could explain why he later felt that I used his name without his permission in my email to CU admin?
I responded to his question about why I think the booster poses more risk than COVID-19:
In terms of safety, the FDA’s own risk-benefit analysis strongly suggests the booster poses more risk to males 16-19. Below I paste my own summary of the FDA’s memo to recommend the [1st] booster in this age group. Please let me know if you think I missed something in my analysis. The full document is worth a close read.
1. The FDA’s recommendation to administer a single homologous Pfizer booster dose to individuals 16 to 17 years of age was based on a risk-benefit assessment (conducted by Pfizer) and also discussed data from Pfizer’s placebo-controlled booster clinical trial which include 78 individuals ages 16-17 yrs old (out of 10,125 total in in the trial) [1]. Even with only ~39 participants in the booster arm, 1 case of myopericarditis was observed, while 2 cases of symptomatic COVID-19 (neither resulting in hospitalization) occurred in the placebo arm in this age group. In their risk-benefit analysis, Pfizer predicted that boosters would prevent 29-69 COVID-associated hospitalizations per 1M booster doses which would come at a cost of 11-54 and 23-69 myopericarditis cases per 1M booster doses in 16-17 and 16-19 yr age groups, respectively (see Table 1 on pg 7 of the memorandum). There are several important things to note about the risk benefit assessment. First, ‘COVID-associated hospitalizations’ is not a good comparison with myocarditis cases because ‘COVID-associated hospitalizations’ need not be due to COVID [2]. Second, Pfizer’s own analysis suggested boosters would prevent as many ‘COVID-associated hospitalizations’ as myocarditis events following boosters. Third, Pfizer’s myocarditis incidence rates used for their risk-benefit assessments are for the 2nd dose (not booster), and the risk is underreported since it is based on passive surveillance (VAERS). Most importantly, Marks goes on to note that Pfizer’s estimates of myocarditis risk post 2nd-dose in 16-17 year old males is about 6-7x lower than the risk estimated by the FDA’s own analysis of the Optum healthcare claims database (200 cases 1M). In other words, the letter presents data suggesting boosters will cause 6-7x more cases of myocarditis (many or most which result in hospitalizations) than a ‘best case scenario’ estimate of hospitalizations prevented in males 16-17 yrs old (assuming Pfizer’s assumptions about effectiveness against hospitalizations were accurate), and yet still recommended the booster for this age group.
Endnotes
1. https://www.fda.gov/media/154869/download
2. https://gis.cdc.gov/grasp/COVIDNet/Documents/320393-A_COVID-NET_cumulative-qeo2.pdf
Dr. Racaniello did not respond to this email. I followed up and sent him another reason why I think boosters pose more risks than COVID-19:
Hello Vincent,
Please also see this report which I just came across:
1. A recent review of preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus concluded that COVID-19 vaccines “may worsen COVID-19 disease via antibody-dependent enhancement (ADE)” and that the “risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.” [1]
Cardozo T, Veazey R. Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease. Int J Clin Pract. 2021 Mar;75(3):e13795.
This is more outside my field. Any comments (critical or corroborative etc) are greatly appreciated.
Again, Dr. Racaniello did not respond to this email.
If anyone reading this can see where else there might have been a breakdown in communication, or explain what, if anything, in my emails above constitute “antivaccine misinformation”, I would greatly appreciate it.
I don't see any reason for his tweet with negative connotations for you, except that he probably feels some risk to his career and/or research and is afraid to take anything even resembling a strong stand, no matter how much sense it makes. Not engaging in scientific discussion and using the familiar "anti-vaccine misinformation" label usually indicates that something other than logic and facts are the causes. It's perfectly fine for him to disagree at whatever point but the almost-smear is not necessary. At the very least, any misunderstanding can be cleared up with a conversation, and the tweet should be removed or amended. At least that's what an ethical person would do.
He's a shill for big pharma. A lot of people die from the misinformation he and others spread.