For the last year, the main two COVID vaccines in the USA have been Pfizer and Moderna. Now, Bharat Biotech and Ocugen have applied for approval of their Covaxin vaccine by the FDA. Covaxin got emergency use authorization from the WHO in early November 2021. Pfizer and Moderna have a remote connection to abortion via testing on fetal cell lines, but Covaxin has no connection in production, development, or testing. On top of this, Covaxin may be one of the most effective existing vaccines against the Omicron variant. Furthermore, for those who are cautious about new tech like mRNA vaccines, Covaxin is an inactivated virus vaccine.
Let’s review the basics on Covaxin, look at FDA approval, propose a response to the current situation of the vaccine, and look at the response by those who have objected to vaccines tested on fetal cell lines.
Covaxin was developed by Bharat Biotech in India with Ocugen as its US and Canadian distributor. It is an inactivated virus vaccine, similar to flu shots and several other vaccines. We’ve been using inactivated virus vaccines for over 100 years. The Lozier Institute notes that fetal cell lines were not used in any of its tests. On November 3, 2021, the WHO gave Covaxin emergency use authorization. In this, the WHO (World Health Organization) generally recommend it for most adults except those with a history of anaphylaxis or who currently had a temperature. They also note it is reasonably effective: “Vaccine efficacy against COVID-19 of any severity, 14 or more days post dose 2, was 78%… Vaccine efficacy against all variant-related COVID-19 disease was 71% with an efficacy of 90% against Kappa, and 65% against Delta.” It is not quite as effective against the original strain of COVID, but this 65% against Delta seems similar to other vaccines. A real-world study gave Covaxin a slightly lower level of effectiveness at 50%, but testing health care works in the midst of a surge of the Delta variant may easily underestimate exposures, which would underestimate effectiveness.
While other vaccine manufacturers are working on new vaccines for the omicron variant of COVID similar to their original COVID vaccines, Bharat has said they suspect their original Covaxin will be effective and have started trials to investigate Covaxin vs omicron after initial observations seemed positive.
The FDA Rejects Covaxin Without Fully Explaining Why
In November, Ocugen applied to the FDA for approval. This would be similar to that granted by the WHO. They were denied without clear reasons being stated publicly. The Nasdaq site noted:
On November 26, news that “the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States,” was not positive for Ocugen.
The Philadelphia Business Journal has more details, but its explanation still seems murky:
The FDA, according to the company, said it plans to identify the specific deficiencies that are the basis for the agency’s clinical hold and provide information to Ocugen on how to address those deficiencies. The company said it “expects to receive formal written communication with the additional information from the FDA and plans to work with the FDA in an effort to resolve its questions as promptly as possible.” No timeline for those actions was provided by the FDA or the company.
I think it’s legitimate to ask what the delay is for given that the WHO, with similar experts and standards, has approved it for a similar purpose. If this is a vaccine that would help all those rejecting a vaccine due to fetal cell lines to be vaccinated and it seems pretty effective and safe with broad international testing, why not allow it?
John Stossel did a video this week on a stalled approval for a COVID therapeutic already approved elsewhere. Stossel noted this was due to too much FDA red tape and think similar things apply here.
- Bharat/Ocugen has also applied for it’s use on minors in the USA which is also on hold.
- Bharat/Ocugen also applied to Canada for approval back in July.
A Call to Action
The USCCB has called vaccination “an act of charity.” Vaccination against covid has been repeatedly shown to reduce your risk of covid infection and death. I have argued long and hard that we can ethically take the existing vaccines, but not everyone has been convinced by these arguments. Some Catholics still have concerns about how currently available vaccines are connected to fetal cell lines. If this vaccine is approved, these people could be vaccinated without such conscience concerns. Thus, I think we should all write the FDA to ask them to approve this vaccine ASAP. Please email the FDA at firstname.lastname@example.org. This is the office that regulates vaccines. (You can also call this office at 800-835-4709.)
Here’s my letter I sent just before posting this, which can be used as a form letter:
Dear Dr. Peter Marks, Director, Center for Biologics Evaluation and Research:
It has come to my attention that you recently put the Bharat Biotech Covaxin vaccine on indefinite clinical hold. This vaccine has already been approved on an emergency use authorization by the WHO and by multiple other countries. Its safety and effectiveness have been thoroughly investigated.
I would appreciate moving this vaccine forward to emergency use authorization in the USA for two reasons. First, Covaxin seems like it may be the most effective of current vaccines against Omicron. This would be helpful for those in very high-risk circumstances like paramedics or certain hospital staff.
Second, I know many Catholics and other pro-life people who take issue with a vaccine that has any connection to abortion, even the remote connection due to fetal cell line testing. They are currently refusing all three vaccines widely available in the USA. Covaxin, however, has no such connection so they would not object. Thus, approving this vaccine would help them get vaccinated with a clean conscience.
[Some of you may want to significantly modify the preceding paragraph if you are in this group, changing it from third person to first. It could be: Second, I and many other Catholics and pro-life people take issue with a vaccine that has any connection to abortion, even if just fetal cell line testing. We object to all three vaccines widely available in the USA on this basis. Covaxin, however, has no such connection so we would not object. Thus, approving this vaccine would help us get vaccinated with a clean conscience.]
I hope that the approval of the Covaxin vaccine can be expedited so we can reach a higher level of vaccination and immunity to Covid, including the omicron variant.
If one is still unvaccinated, one can also write to major pharmacies or state health boards to say you will get vaccinated as soon as this vaccine is available. Writing multiple pharmacies in your area might even create a race to see which can get Covaxin to your area first once approved.
The Response from Catholics Objecting to Vaccines
With Covaxin being in stages of WHO and FDA approval in recent months, I would expect all those rallying against vaccines connected to fetal cell lines to be rallying for this vaccine. I would expect a call to action to write the FDA and ask for Covaxin to be approved so these people can vaccinate with a clean conscience. Something akin to the above section. As well, if your issue is the use of fetal cell lines, you might want to call up your pharmacy to ask when Covaxin will be available to schedule an appointment as soon as it is available.
I looked at sites that had published pieces supporting the idea Catholics might want to skip current COVID vaccines over the connection to fetal cell lines. I was surprised by how little was written [as of December 15, 2021]:
- The last reference I can find on COG for Life is in the comments of an August piece where Jose Trasancos is saying he doesn’t expect them to apply to the FDA until March of 2022 or later, despite the fact that they had already completed a phase III trial for Covaxin in July.
- The last reference on LifeSiteNews was in October about the WHO being slow to approve Covaxin. A good follow-up to this report might be WHO approval and applying for FDA approval. This could give hope to people whose issue is the use of fetal cell lines, and to encourage them to act.
- Crisis had an article right after the WHO authorization. But instead of encouraging people to write the FDA and ask that they approve this vaccine, the author seemed to exhibit a kind of resigned pessimism about the issue.
- The only reference to Covaxin on Catholic World Report and the National Catholic Register was from the same August wire story about the Archdiocese of Mexico City encouraging vaccination, which mentioned Covaxin among the vaccines under emergency use authorization in Mexico.
- Catholic Family News, OnePeterFive, Creative Minority Report, The Confraternity of Our Lady of Fatima (the site where you can get an exemption authorized by Bishop Athanatius Schneider), and the National Catholic Bioethics Center have never mentioned Covaxin. The only mention on Church Militant was by a commentor, not an author.
I hope this piece will alert these sites and encourage them to write about this opportunity for a vaccine without any connection to fetal cell lines like current vaccines.
I have run into a few people who told me they were applying for a religious or conscience exemption to vaccination based on the fetal cell line issue, who then also said they weren’t vaccinating for other reasons even if the fetal cell line issue was not an issue or resolved with a new vaccine. (These other reasons seem along the lines of standard anti-vax reasons that have been around for years or decades before COVID.) They clearly understood the reason they gave was not the real reason and intended to deceive whoever reviewed their application for an exemption. This is dishonest.
If our goal is a vaccine without even the slightest connection to fetal cell lines, we should not just be objecting those with any connection, but also supporting those with no such connection. I support having options without a slight imperfection even if those with that slight imperfection are morally acceptable to use. Doing only objecting, especially if one does not receive a vaccine soon after a vaccine such as Covaxin is available, might leave some wondering about how honest you were about why you were objecting. This in turn can make religious and conscience exemptions for other things harder to obtain in the future. We protect future religious and conscience exemptions by being honest about current ones.
The current COVID vaccines in the US are perfectly ethical to use: both the magisterium and the overwhelming majority of solid moral theologians or bioethicists have indicated this. However, some people have concerns about them related to the use of fetal cell lines. I’ve tried to convince them for a year, but they have not been convinced. Now, we have the possibility of a vaccine that meets the standard they set out: Covaxin. Let’s all support getting Covaxin approved so those who have objected to other vaccines can get vaccinated. Please write or call the FDA and others to move this approval and distribution forward.