The Moderna vaccine is a messenger RNA (mRNA) vaccine. Messenger RNA, or mRNA, is found naturally in cells. It transfers the instructions from the DNA code, the sequence of nucleic acids, to make the proteins. The mRNA vaccine instructs a patient’s cells to produce proteins, in this case the spike protein found on the outer surface of the COVID-19 virus. This is the part of the virus that interacts with our immune cells. By stimulating the production of the spike protein, an antigen (antibody generator), the body builds up antibodies to it. Then if the body is infected with the whole COVID-19 virus, it is prepared to fight it. Moderna codes the vaccine as mRNA-1273.

How does an mRNA vaccine work? See Moderna’s website.

Fetal cell line: The HEK293 cell line (info here) originated from a healthy aborted child in the 1970s, age unknown.

Did Moderna use the HEK293 fetal cell line in research? Yes, they did in the research and development of the vaccine.

• In March 2020, researchers explained in Science journal that they expressed the 2019-nCoV spike in the prefusion conformation using HEK293 cells. That means they made the spike protein so they could study it, and they used HEK293 cells as the medium to express it in.
• In this preliminary report from July 2020, researchers explain in the supplementary appendix that ACE-2-overexpressing 293T cells were used in a neutralization assay to detect the presence of antibodies, a test to make sure the vaccine works as it should.
• This August 2020 preclinical trial report in Nature journal also explains that researchers transfected HEK293 cells to test expression. That means they added the vaccine in each step of development to the cells to see if they produced the protein as expected. This is the in vitro (in the lab) mRNA expression test.
• This U.S. patent for the in vivo (in the body) production of proteins explains a similar test, including testing the mRNA encapsulated in the lipid for delivery into the body. Again, they needed to see if the vaccine was stable and worked as expected.

Does Moderna use HEK293 fetal cell line in ongoing quality control testing during manufacturing? No, they answered that they do not.

Also see:

• Measuring Moderna’s COVID-19 Vaccine: Now’s the Time to Press Hard for Ethical Options (National Catholic Register)
• Moderna Does Not Use HEK-293 Fetal Cell Line in Ongoing Quality Control or Lot Testing | Children of God for Life (cogforlife.org)

The Pfizer vaccine, developed in conjuction with BioNTech, is a messenger RNA (mRNA) vaccine. Messenger RNA, or mRNA, is found naturally in cells. It transfers the instructions from the DNA code, the sequence of nucleic acids, to make the proteins. The mRNA vaccine instructs a patient’s cells to produce proteins, in this case the spike protein found on the outer surface of the COVID-19 virus. This is the part of the virus that interacts with our immune cells. By stimulating the production of the spike protein, an antigen (antibody generator), the body builds up antibodies to it. Then if the body is infected with the whole COVID-19 virus, it is prepared to fight it. Pfizer/BioNTech codes the vaccine as BNT162b2.

How does an mRNA vaccine work? See Pfizer’s website for more information.

Fetal cell line: The HEK293 cell line (info here) originated from a healthy aborted child in the 1970s, age unknown.

Did Pfizer/BioNTech use the HEK293 fetal cell line in research? Yes, they did in the research and development of the vaccine, similar to the way Moderna (above) did. They used the HEK293 cell line for testing the vaccine.

• In September 2020, researchers explained that they used HEK293 in a neutralization assay to detect the presence of antibodies, a test to make sure the vaccine works as it should, and they transfected HEK293 cells to test expression. That means they added the vaccine in each step of development to the cells to see if they produced the protein as expected. This is the in vitro (in the lab) mRNA expression test.
• This U.S. patent describes how they made RNA molecules encoding fusion proteins (like the spike protein) and tested them in development. They used a variety of cell lines, HEK293 among them, but do not specify which cell line they used for the COVID-19 vaccine. Again, they needed to see if the vaccine was stable and worked as expected.

Does Pfizer/BioNTech use HEK293 fetal cell line in ongoing quality control testing during manufacturing? We do not know.

Also see:

• COVID-19 Vaccine and HEK293: Testing and Production are Ethically Equal

The AstraZeneca vaccine, developed in conjuction with Oxford University, is an adenovirus-vector-based vaccine, which encodes the spike protein of SARS-CoV-2. Adenoviral vectors are genetically engineered forms of the virus. AstraZeneca codes the vaccine as ChAdOx1 nCoV-19.

Fetal cell line: The HEK293 cell line (info here) originated from a healthy aborted child in the 1970s, age unknown.

Did AstraZeneca use the HEK293 fetal cell line in research? Yes, they did in the research and development of the vaccine, as explained in this scientific report from July 2020 in Nature journal. To propogate the virus in the HEK293 cells means to grow it in them. They will need to do this in ongoing manufacturing.

Does AstraZeneca use the HEK293 fetal cell line in manufacturing? Yes, see above, the viral vaccine is propogated (grown) in the cell line.

The Johnson & Johnson vaccine, developed in conjunction with Janssen Research & Development, Inc., is an adenovirus-vector-based vaccine. Adenoviral vectors are genetically engineered forms of the virus. Johnson & Johnson explains the science behind their vaccine here. Johnson & Johnson codes the vaccine as Ad26.COV2.S.

Fetal cell line: AdVac® technology uses PER.C6® cell line (info here) originating from a healthy 18-week-old aborted child.

Did Johnson & Johnson use the PER.C6 fetal cell line in research and production? Yes, they did in the research and development of the vaccine, as explained in this scientific report from July 2020 in Nature journal and in this scientific report from September 2020 also in Nature journal. To propogate the virus in the PER.C6 cells means to grow it in them. They will need to do this in ongoing manufacturing.

Novavax has submitted a request to the FDA for Emergency Use Authorization of its COVID-19 vaccine, NVAX-CoV2372. Unfortunately, a fetal cell line was used in testing. Here’s a snapshot of this vaccine candidate’s research and development history:

• Novavax used its SF9 insect cell line process throughout the vaccine’s development.
• Multimerization was observed when evaluating the vaccine against different forms of the spike protein.
• Researchers designed a test in HEK-293T cells to better understand what they observed. The research team was composed of scientists at Scripps Research Institute in La Jolla, CA as well as employees at Novavax, Inc.
• Novavax participated in the testing that used an aborted fetal cell line, and the company funded the testing research along with the NIH and the Bill and Melinda Gates Foundation. See Author Contributions and Funding sections under Acknowledgements in this Science journal paper, “Structural analysis of full-length SARS-CoV-2 spike protein from an advanced vaccine candidate.”

For most of its development, the Novavax product was the ethical frontrunner. The test with HEK-293T cells with Scripps occurred towards the end of the development, immediately prior to initiating clinical trials. See our original post and comments on Novavax here.

More information from a full post on Corbevax, Covaxin, and 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.

Corbevax made the news in late December of 2021, 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.

See our full post on Corbevax, Covaxin, and Novavax.

Covaxin is ethically produced but not likely to make it to the U.S. market.

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 we had to handicap this one, we 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, we 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.

See our full post on Corbevax, Covaxin, and Novavax.