COVID vaccine manufacturers won't share information about their vaccines

Thus, stifling research endeavors and closer examinations into what exactly these vaccines contain. Also, Leqembi seeks approval while one adviser is removed due to conflicts of interest.

Edit 6/11/2023: A link to the Science article was not included originally. A link has been included both inside the text as well as in the image below.

Last week Science published a rather interesting article, in which writer Jon Cohen laments the fact that the surplus of COVID vaccines are being wasted.

On the surface, this may sound like something that would just make someone groan. However, Cohen’s argument here is a rather interesting one. It’s not for the fact that millions of doses of COVID vaccines are being thrown out that could otherwise be given to people that is the main problem, but that many of these vials could be given to researchers to further research endeavors:

The U.S. government has tens of millions of unused doses of messenger RNA (mRNA) COVID-19 vaccines, regularly trashing shots as they pass their expiration dates. It’s a dismal reflection on recent vaccine uptake, but it’s also a serious roadblock for scientists testing and developing vaccines that could protect against future variants of SARS-CoV-2—and the next pandemic. Developers need existing vaccines as a benchmark to compare with new candidates. But government contracts with the vaccinemakers, and the companies’ own policies, prohibit the use of the vaccines for research purposes.

Cohen’s perspective here is likely one that many would disagree with, as his argument here is that vials of these COVID vaccines should be provided to researchers in order to further research into this technology and allow for updated vaccines in the near future.

I would caution this approach given the surplus of unknowns with the vaccines up to this date, with many of these adverse reactions still being left unanswered and uninvestigated.

So on one hand, the argument that these vaccines should be provided to researchers in order to create more, allegedly up-to-date vaccines isn’t one that many would be too happy about. On the other hand, it does allow for something that many people would hope for, in that it would allow researchers to determine what exactly is in these vaccines. That is to say, if vials of the vaccines were made widely available then researchers would be able analyze these vials more deeply and determine if there really is anything of concern outside of the LNPs and the genetic material.

Note that several reports have been made online about possible DNA and plasmid contaminations in some of these vials, as reported by Nepelactone Newsletter.

This would be rather shocking, although this has led people to speculate under the limited data available. In this case, it appears researchers conducting these endeavors are doing so with a huge degree of discretion, and without corroborating evidence given the inability for researchers to source out these vaccines without repercussions.

Thus, the inability for researchers to obtain these vaccines also harms the ability for people to determine whether contamination of these vaccines are widespread, or if there are any additional concerns that should be looked into and would require explaining on the part of the vaccine manufacturers.

As of now J&J is no longer producing their adenoviral vector-based vaccines, with their EUA being revoked last week and the last batch of vaccines being tossed in early May.

This would mean that there are no vials left for investigation, and that the only data that can be used to discern these adverse reactions must rely on the data already made available, which is not much to begin with as it doesn’t appear that these vials of vaccines have received the same level of scrutiny as the mRNA vaccines have. Thus, any ability to figure what may be going on with J&J’s vaccines likely went along with all the vials trashed in early May.

The same may occur with Pfizer/BioNTech and Moderna as they begin to trash their older, expired monovalent vaccines leaving many people with the inability to further investigate these vaccines.

So it appears that these vials are likely to be thrown out when their time comes. As reported by Cohen, Pfizer seems adamant that they are not selling their vaccines for private research, again adding to the fact that further investigations are going to be stifled:

The companies could make their vaccines available. But Pfizer and Moderna would not discuss the issue with Science, although Pfizer did confirm that its vaccine is not for sale in any private market. “We are not currently providing it directly to other research organizations, with the exception of certain government-funded research organizations, outside of our own targeted clinical development program,” the company stated.

Philip Krause, who for 11 years was deputy director of the FDA division that oversees vaccines, says he can understand why a company with vaccines on the market might look askance at sharing them with a potential competitor. “But obviously, it’s something that works substantially against public health,” says Krause, who left FDA in 2021 and now is a vaccine consultant. “If they’re throwing doses away, or if those doses can’t really be given to anyone anymore, that’s all the worse.”

Unfortunately, as things begin to move on away from the pandemic it’s just as likely that many of these vaccine-related concerns may fade along with them, with the same inevitable fate of ending up in a trash heap along with any possible chance of further investigation.

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FDA adviser for Leqembi’s approval removed due to COI

In other news, the FDA’s committee titled the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) is set to discuss the full approval of Biogen/Eisai’s Alzheimer’s immunotherapy Leqembi today.

I have written extensively over my concerns with respect to Leqembi and Adulhelm, as both of these therapies seem to have been rushed towards approval without clear evidence that they work. More importantly, a Congressional committee released information suggesting that Adulhelm did not undergo typical FDA regulatory approval, with many concerns raised towards the cost of the drug as well as Biogen’s alleged attempts of targeting communities in order to peddle their therapy. There’s also the fact that the accelerated approval of Adulhelm was seen as so controversial that 3 advisers on the approval committee resigned.

In any given case, the information surrounding Adulhelm should have left a stained mark on Biogen/Eisai, and yet their second attempt at an immunotherapy Leqembi received accelerated approval, with many appearing to have forgotten all of the issues that had plagued Adulhelm and Biogen/Eisai just a few months prior.

This is made even more pronounced due to the fact that FDA regulators may have met with Biogen employees at undocumented times, with this approach appearing to suggest that members of the FDA may have allegedly provided some information on how to skirt some of the typical regulatory pathways (emphasis on allegedly here).

And shockingly, this issue appears to be appearing again with Leqembi’s approval, as it has been reported that one adviser intended to sit on the approval committee today was removed due to their alleged ties to Biogen, as reported in BioSpace on Tuesday:

From BioSpace

In this case, neurologist David Weisman was removed on Monday from the approval committee due to conflicts of interest, including being a site principal investigator for a clinical trial being sponsored by Biogen. There’s also the fact that Weisman served as a site principal investigator for the Phase-II clinical trial of Leqembi. In both instances, it appears that Weisman was receiving was receiving a salary for his work.

The conflicts of interest also don’t appear to end there, as Manalac notes in BioSpace that Weisman appears as a signatory in a letter addressed to PCNSDAC from the Alzheimer’s Association urging for the approval of Leqembi by members of the committee (his name appearing on Page 25 with his conflicts of interest noted on Page 39).

Thus, it’s rather strange to see an otherwise staunch proponent of this immunotherapy sitting on the same committee intent on approving the drug, as if his vote for approval would be anything but a yes.

Unfortunately, all of this points to the ever obvious fact that many of the people set up to approve of these drugs are the very same people that have vested interest in seeing these drugs come to market. It’s quite apparent that many people within these regulatory agencies have closer ties to industry that they let on.

We’ll see if Leqembi receives full approval later today, although as I’ve remarked before the evidence still appears to be lacking, including evidence of long-term consequences of these therapeutics.

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