These vaccine candidates have been in the news lately, and we’ve received a number of inquiries with respect to their ethics and potential availability. Let’s address these questions.
Corbevax
Corbevax made the news in late December of last year, following its approval for use in India. This vaccine candidate was developed by a group of researchers from Texas Children’s Hospital and Baylor College of Medicine, applying more traditional protein-based technologies and with an emphasis on simple, inexpensive manufacturing and storage. Notably, this vaccine is medicine’s equivalent of ‘open source’, enabling any manufacturer to produce the vaccine without any patent or licensing restrictions. Read the press release from Texas Children’s Hospital here.
Initial indications were that Corbevax was ethically researched, developed and tested, without connection to abortion. The research team did not directly use aborted fetal cell lines in their development and testing processes; however, a thorough review of the literature revealed the use of two biologics that are produced in aborted fetal cell lines. Human ACE-2 protein from LakePharma (reference #46672) was used in an in vitro functional assay, described in Section 2.8, Materials and Methods, in this ScienceDirect publication. This biologic is produced in HEK-293 cell lines or in CHO (Chinese hamster ovary) cell lines.
In Section 2.3, Materials and Methods, the paper also describes the evaluation of three different receptor binding domains (RBDs) and their interaction with the ACE-2 receptor. A monoclonal antibody from SinoBiological was used in this evaluation. This antibody is expressed in HEK-293 cell lines.
It is now time to apply the ‘but for’ test as it relates to the ethics of Corbevax. The first procedure mentioned was essential to the development of this vaccine. The purpose of a functional assay is to determine whether or not the stuff works, akin to ensuring that a line of computer code performs the desired operation. The second procedure is less clear in terms of necessity, in that several vaccines, including the two that are licensed and approved for use in the U.S., were developed without employing such a procedure, but the fact remains that the research team designed and executed the procedure as part of the vaccine’s development. One should note that the characteristics of materials used in these tests are well understood by the people using them and the importance of these characteristics are underscored by the supporting information made available by the suppliers, so ‘I didn’t know’ is not a reasonable excuse. ‘But for’ is answered definitively by these procedures described in the literature and a degree of ethical compromise is established. The vaccine would not be here ‘but for‘ dependency on abortion.
Novavax
Novavax finds itself in the middle of some controversy. A paper published in Science in October of 2020 clearly describes an assessment of glycosylation, comparing the spike proteins produced in Sf9 insect cell lines and those produced in aborted fetal cell lines, namely HEK-293F cells. The methods employed make reference to this National Center for Biotechnology Information publication describing the glycosylation assessment process in detail, although the specific application was not the Novavax SARS-CoV-2 vaccine. The use of aborted fetal cell lines is clear and unambiguous in this publication.
Novavax, however, has claimed that their glycosylation assessment did not make use of aborted fetal cell lines, nor in any other way in the development and/or testing of their vaccine candidate. Confusion abounds. The literature clearly describes an assessment performed by the Novavax development team and the description refers to HEK-293 cell lines. The specific methods employed are referenced in a cited publication, and the use of aborted fetal cell lines is described in detail in this paper.
It gets even better. We have encountered arguments from different sources, each claiming that the paper published in Science reflected the work product of an independent third party, the Scripps Research Institute, located in La Jolla, CA, without affiliation or involvement with Novavax. This point of contention is easily put to rest. Six of the paper’s authors are employed by Novavax and Novavax was listed among the funding organizations for the research, along with the NIAID and the Bill and Melinda Gates Foundation. So, Novavax provided funding and their cooks were in the kitchen. Done.
Here’s where we are with Novavax: What has been published seems clear, in that aborted fetal cell lines were used in assessing glycosylation of the Sf9-produced spike proteins relative to the proteins produced in HEK-293. Novavax says otherwise. It is incumbent on them to bring crystalline clarity to this, and until that is done, we will defer to what has been published in peer-reviewed journals. After all, that is what the scientists wrote down.
Covaxin
Now, for Covaxin. We have looked at Covaxin very closely and we have found no direct or indirect association with abortion. The World Health Organization granted emergency authorization to this vaccine on November 3, 2021. It is now available in 17 countries, including Mexico. Covaxin filed an Investigational New Drug Application for full approval (not EUA) in October of 2021 and that application is pending before the FDA. When can we expect approval? Perhaps we can deduce an answer from the following:
- The FDA rejected Bharat BioTech’s original application for Emergency Use Authorization in June of 2021 indicating, in part, that more robust clinical trials data would be needed. The FDA suggested an application for full approval at a later date.
- Dr. Anthony Fauci said the following during an interview on NewsNation’s ‘Morning in America’ program, when asked about Covaxin’s INDA: “We have enough vaccines, the best vaccines available, in the United States.”. . . “I’m puzzled by that question. We have more vaccines than we need right now. We just need the people to get vaccinated with the vaccines that we have. The mRNA vaccines are vaccines that are desired by everyone else in the world. So, we have what we need; we need to use it.” Dr. Fauci closed the interview with this: “We don’t need another vaccine.”
- Bharat BioTech submitted an Investigational New Drug Application (not an application for Emergency Use) for Covaxin on October 27, 2021. A clinical hold was issued by the FDA on November 26, 2021, citing deficiencies in the data submitted in support of the application.
- The FDA’s clinical hold was lifted on February 18, 2022. This means the review process can resume.
- There are two approved vaccines at this time – Pfizer’s Comirnaty and Moderna’s Spikevax. Emergency authorization is no longer a possibility from a statutory perspective.
If I had to handicap this one, I would say that Covaxin’s application will languish for quite some time. Now that new infections are down significantly and the news cycles are noticeably shifting away from COVID-19 all day/every day, I don’t like Covaxin’s chances when considering the politics of it all. We have discussed this with other organizations, and this seems to be the prevailing conclusion. See the second bullet point above. That may be more significant than the legal observation made in the final bullet point.
At this stage, NOTHING Fauci says should surprise me…his mind is twisted almost beyond belief
Regarding Covaxin being available in 17 Countries including Mexico, do you know what the other 16 Countries are? I am from Australia, thank you.
Here is an updated list from The Indian Express newspaper.
Jose thank you so much for your quick reply. I see that Australia has approved Covaxin for travellers to Australia. However it’s not available as a vaccine in Australia for Australians. I don’t know if Bharat BioTech has even made an application to Australia. I don’t understand why everybody is not talking about Covaxin???? Isn’t it “the one” we Christians/Catholics have been waiting for? I thought there would be an outcry for a vaccine with NO link to abortion.
The abortion-taint isn’t the only concern that many of us have with the vaccines. It has been made quite apparent over the past 2 years of ‘two weeks to slow the spread’ that the ‘pandemic’ was blown out of proportion and was really used by the powers that be to usher in their Godless agenda. A lot of us don’t view COVID-19 as threatening at all and thus view vaccinating against COVID as unnecessary. Additionally, although this vaccine isn’t made with the novel mRNA technology used in the other “vaccines”, it still was developed in quite a short amount of time, and therefore, may potentially have unknown side-effects.
Thank you John for your reply I agree with your viewpoint completely and I have many friends that will not be taking any vaccine however I am immuno suppressed, I take medication to suppress my immune system because it doesn’t function correctly I have Psoriatic Arthritis due to this dis functioning immune system. It is aggressive and therefore is only controlled by depressing my immune system. It is similar to Rheumatoid Arthritis. I also have Osteo Arthritis and consequently have had bilateral knee replacements and am now awaiting a back operation due to collapsed vertebrae pinching on nerves and also causing Spondylitis. So you can see why I might be excited about a Vaccine that I could have with a clear conscience. I haven’t written this to receive sympathy only to explain my thoughts however I too do still have reservations about side effects due to the rush to produce the Vaccines and I know they have not been widely tested on people like me. Anyway the bottom line is that it’s not available in my Country-Australia at the moment so that gives me more time to decide. God bless Louise
Does anyone know where to find Covaxin’s adverse events report?
There are no adverse events recorded in VAERS for Covaxin because it is not yet authorized or approved. If you search for adverse events data in other countries, you may find something useful. Also, the clinical trials data provides information on side effects during the trials.
Do you know if Covaxin has received approval in Canada yet?
Covaxin is not yet approved for use in Canada, according to Health Canada. Here’s a link to Health Canada’s web page displaying the authorized and approved products. I looked at the page displaying the authorized, approved and products under review and it appears that the makers of Covaxin have not yet filed an application for authorization.
In fact, Vaccigen Canada (a spinoff of Ocugen, Bharat Biotech’s US partner) withdrew their application to Health Canada for Covaxin BBV-152 last year, and have not reapplied.
In Canada covaxin is approved for travellers to Canada or immigrants. For residents of Canada, fugetaboutit!
By the way, Valneva has just been approved in the UK as of April 14th. Physical availability, however, for now is just limited to Scotland. For many Canadians (esp in the Atlantic probices, N-L, etc.), UK is just as close as Vancouver is, so a medium range flight over the pond. The big question is whether Canada Health will recognize those who received Valneva as “fully vaccinated.”
Dr. Trasancos,
Could you share any thoughts on Valneva? Does it have any relation to fetal cell lines? Will it obtain WHO-EUL in the near future?
Michael,
Valneva (VLA-2001) is ethically researched, tested and manufactured. It is ethically uncompromised. It has been authorized for use in the EU.
Today I received an e-mail response from the clinical team at Ocugen, the pharmaceutical co. in PA that will manufacture and distribute Covaxin if given authorization. They are currently in clinical trials. Jose, can you shed light on their response as I thought this vaccine would be the one for me? Thank you.
“We can confirm that no fetal cell lines are used in the manufacture of Covaxin. Regarding testing, please see the responses below:
The Covaxin vaccine formulation consists of an immunomodulator, IMDG, which is a TLR7/8 agonist. In order to validate IMDG manufacturing, a characterization test was performed for its TLR7/8 activity which uses HEK 293 cells. This test is not a part of the production, regular manufacturing or routine in-process or release testing of IMDG. It was used for characterization purposes only.
Per regulatory guidance, viral vaccines and the cell substrates used to manufacture them are subjected to tests for adventitious agents, including viruses, which might contaminant them. The in vitro testing for these adventitious agents are performed on all vaccines and biologics in compliance with the 2010 U.S. Food and Drug Administration (FDA) Guidance for Industry, European Pharmacopoeia 2.6.16 , and ICH Q5D. The standard cell lines used in this test are MRC-5 and HeLa cells for human viruses, and Vero cells for simian virus detection.”
The Clinical Team
E: clinical.request@ocugen.com
263 Great Valley Parkway
Malvern, PA 19355 USA
Did they happen to give you the links to show those? Thanks!
The post has links to the relevant information for Corbevax and Novavax. Here’s the link for Covaxin – Vero-6 cells were used.
I’m confused. The letter transcribed above says HEK293 cell lines (an unethical cell line) was used to characterize a component (the IMDG) of the Covaxin vaccine. How does this result in Covaxin being unconnected to unethical abortion derived cell lines?
Is IMDG something that has been around for years and so Ocugen and the other organizations involved in making Covaxin weren’t involved in that unethical characterization? If the IMDG was characterized as a part of designing/developing/testing/manufacturing Covaxin, I’d think that would make Covaxin just as abortion-tainted as Pfizer or Moderna’s shots, or the really inexpensive shot (Corbevax?) that Dr. J. Trasancos said had used some biologics manufactured with abortion derived cell lines during its development and so wasn’t so unethical after all.
Like Laura, I am also now confused. A characterization test with HEK 293 sounds like use of fetal cells. Also MRC-5 is mentioned too.
Slight edit to my recent comment: Ocugen is in the process of recruiting for the clinical trials/studies for Covaxin.
Is Covaxin linked to aborted cells lines?
No, it is not. The development of Covaxin leveraged a development and manufacturing platform that uses Vero-6 cells (non-human, primate).
The clinical team at Ocugen provided this Clinical Trials link to me in their e-mail. (See my comment above if you want to communicate with them directly. They provide an e-mail address.) It is an NIH link. https://clinicaltrials.gov/ct2/show/NCT05258669?term=NCT05258669&draw=2&rank=1
Joan, what you report, and something I have not yet validated, has nothing to do with the development of the vaccine or the adjuvant. Let’s stipulate for the moment that Ocugen’s response to your inquiry was on the level – there’s no real reason to doubt that. What the FDA did was subject a biologic (Algel IMDG) that has been in use for some time and is currently in production to a testing protocol associated with the BLA.
The testing had nothing to do with the development or manufacturing of the adjuvant and did not have any effect on its method of manufacture or formulation. This is different from the observations we’ve made with Corbevax – the biologics used in the development of Corbevax owed their very existence to the use of aborted fetal cell lines. Algel-IMDG runs through the ‘but for’ test differently. Obviously, its existence is not dependent on the use of aborted fetal cell lines since it had been in production for quite some time before the FDA requirements introduced fetal cell lines.
What follows is a quote from the WHO Background Document regarding the interim recommendations for BBV152 (Covaxin):
“Preclinical studies
Preclinical studies were conducted in 5 animal species: mice, rats, rabbits, Syrian hamster, and non-human
primates (Rhesus macaques). BBV152 vaccine formulations generated high antigen-binding and neutralizing
Background document on the Bharat Biotech BBV152 COVAXIN® vaccine against COVID-19
antibody titers, at both tested concentrations, in all mice, rats, and rabbits. No adverse events were observed after
vaccination. The inactivated vaccine formulation containing TLR 7/8 agonist adjuvant-induced Th1 biased
antibody responses with elevated IgG2a/IgG1 ratio and increased levels of SARS-CoV-2 specific IFN-γ + CD4
T lymphocyte responses (2). Further preclinical trials include 2 viral challenge studies: 1 in Syrian hamsters (8),
and the other in non-human primates (9). In both studies the vaccine formulation with Algel-IMDG showed rapid
virus clearance in lower respiratory tract with no sign of abnormal histopathological changes, while inducing
robust immune response.”
The WHO summary referenced two testing cycles prior to initiation of clinical trials. All testing platforms used rodent and non-human primate models. Here’s a link to that document.
So, is abortion associated in some way with Covaxin? Yes, after all was said and done. Is that association even remotely material? That’s a question for the individual to answer. Personally, given what I know about the chronology, I would take this vaccine with a clear conscience. It’s the practice, not the product.
Is the analysis for Algel-IMDG similar to Aspirin then (it was brought forward long before fetal cell testing but has since been tested in some circumstances with fetal cells)?
Is one of these two correct: (1) While Covaxin does not have a tie to abortion nor does its use of the adjuvant Algel-IMDG, Algel-IMDG has in some circumstances been tested with fetal cells? Or is it this: (2) Covaxin used Algel-IMDG which was tested with fetal cells?
Any idea on how and where to get Covaxin? Mexico? India?
I am an Air Force member fighting for what is correct at the expense of losing my 16-year career. Any help will be greatly appreciated.
to Michael M: I have a friend in a similar boat (19+yrs AF). This will sound crazy but Paraguay doesn’t have residency requirement but insuring that you receive Covaxin will be the tricky part…especially with the WHO disruption to production. I would insure you can find a site that has Covaxin of recent before flying to Paraguay – but it is feasible to do this. Mexico is closer but I believe you have to be a resident.
There are trials starting in the US w/ Covaxin as well (see clinicaltrial.gov ClinicalTrials.gov Identifier: NCT05258669). only active site is in FL and you could receive placebo vs. Covaxin. Also military may not accept this as satisfying requirement. I have asked my friend to inquire, you should as well.
Regards, Brian B.
Below is from the US consulate in Paraguay:
Thank you very much for your email. The CDC recommends to Do not travel internationally until you are fully vaccinated. https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel-during-covid19.html
In Paraguay, on the Paraguayan Vacunate program https://www.vacunate.gov.py/index.html , of the item “Registro de Extranjeros” every foreigner can register regarding of their immigration status to get the vaccine. The issue is that based on our experience it takes much longer for the Paraguayan government to validate the enrollees that don’t have residency in Paraguay, and until you don-t have the approval and validation from the Paraguayan Government you won’t be able to receive the vaccine until the validation is complete even if you are registered already.
You cannot choose which vaccine product you’ll receive, it depends on vaccine availability and you will have to check what vaccines are available for that specific day on the Paraguayan vaccination centers to try and get a specific vaccine product.
• Foreigners not residing in the country or within another MERCOSUR country must present international medical insurance with complete health coverage to include attention to COVID-19 cases, tests, and more.
https://py.usembassy.gov/covid-19-information-2/
Best regards,
American Citizen Services
I still don’t understand. Could you please explain this in terms that people who are not in the medical field can understand?
1.Did the manufacturer use HEK293 or any other fetal cells in testing Covaxin?
2.Did any other organization conduct testing of Covaxin using HEK293? If so, what is their relationship to the manufacturer?
Gloria, yes, they used HEK-293. The Scripps Research Institute and EMPLOYEES of Novavax conducted the test.
That is documented in the scientific literature.
Mr. Jose Trasancos. I do know about Novavax. I was strictly asking about Covaxin. I’ve been following the different Covid-19 vaccines and informing my leadership in the National Guard which ones are possibly ethical. I recommended Covaxin and I just want to make sure I’m not misleading anyone in regards to being linked to aborted cell lines in anyway. I was confused on what was posted about Covaxin.
I believe there was a mix up on my previous reply. Could you read my previous reply again? I had a couple of questions in it.
This is a complex topic both morally and scientifically. Thank you for doing the research and providing the clarification, Jose.
Just to clarify, is Covaxin is on the “Do not Take List” because of its connection to aborted human cells?”
Joan, we have not found any evidence that Covaxin’s development involved aborted fetal cells. Also, it is not yet approved for use in the U.S.