Neither Pfizer nor Moderna make that information publicly available. Inquiries were so far unsuccessful. Some authority sources claim that the finished product would not contain anything animal derived. Some authority sources continue to claim that the products do contain animal sourced cholesterol. Neither side provides definitive evidence for their versions.
But within the area where the European Medicines Agency (EMA) regulations apply, the products would strictly have to contain cholesterol sourced from sheep's wool fat according to the definition set forth in monograph 2397 of the European Pharmacopeia (Ph.Eur.).
Exceptions to that rule — that is about to change to also include synthetic sources starting in 2022 — are possible but have to be granted. That information on whether an exception was granted or not is also not publicly available.
Publicly available info suggests that from the second half of 2021 at least a large part of cholesterol produced for the products will come from synthetic sources.
Initially both companies were told by the EMA to adhere to monograph 2397 standards and use cholesterol from wool fat.
That leaves a lot of direct and circumstantial evidence to point towards the current possibilities:
Both companies currently adhere to monograph 2397, and indeed use animal sourced cholesterol in the finished product.
The companies may have gotten explicit approval to use non-compendial cholesterol, but this exception to the rules is not made public so far.
The companies did not get the explicit approval to deviate from the current Ph.Eur. standards, but use plant-based or synthetic cholesterol anyway. This seems not impossible but rather unlikely, as that would mean that the products would currently be not marketable at all.
The above applies to the area of mainly Europe under jurisdiction of the EMA. Inferences about other regions were the products are marketed as well are not possible and await further clarification, as again: neither Pfizer nor Moderna disclosed this information.
The European Medicine Agency (EMA) published two assessment reports, one for Moderna and Pfizer.
For Moderna, it indeed states it indeed contained a non-animal derived cholesterol at the time of the assessment and that it would be therefore in violation of the European standards as codified in the European Pharmacopeia (Ph.Eur.):
Concerning the use of non-Ph. Eur. grade cholesterol also cited by the company applicant a request to only used Ph. Eur. cholesterol has been requested (REC)). […] (EMA/15689/2021 Page 22/169)
c) Cholesterol is stated to be non-compendial and compendial “Synthetic Cholesterol (Phytochol)”, whereas compendial is not further defined. In the Ph. Eur two monographs are provided for cholesterol, monograph 0993 and monograph 2397.
For parenteral use cholesterol has to be in compliance to monograph 2397. [emphasis added, LLC]
The applicant is advised to solely use cholesterol of this quality and to update the provided specification and related documentation accordingly, to use non-compendial cholesterol has to be sufficiently justified.
P.4 Control of Excipients a) The applicant should provide evidence that the impurities and/or degradation products resulting from PEG2000-DMG, cholesterol and DSPC have been sufficiently investigated and do not result in the formation of lipid-RNA species by 31-01-2021.
P.5 Control of finished product The applicant provide evidence to confirm that the impurities and/or degradation products resulting from PEG2000-DMG, cholesterol and DSPC have been sufficiently investigated and do not result in the formation of lipid-RNA species by 31-01-2021.
— 11 March 2021 / EMA/15689/2021 Corr.1*1 / Committee for Medicinal Products for Human Use (CHMP) COVID-19 Vaccine Moderna
Common name: COVID-19 mRNA Vaccine (nucleoside-modified) Procedure No. EMEA/H/C/005791/0000 Assessment report EMA/15689/2021 Page 162/169 (PDF)
A similar concern was issued for Pfizer as of 30. November 2020 for their application of approval:
Control of excipients (P.4)
10. It should be confirmed that cholesterol will be controlled in line with Ph. Eur. monograph Cholesterol for parenteral use (2397) for future batches and not Ph. Eur. monograph Cholesterol (0993).
Amsterdam, 30 November 2020
Committee for Medicinal Products for Human Use (CHMP) (link)
The substance "Phytocol® Puriss" was developed by Wilshire Technologies in the USA and is marketed through Evonik. Concluding from ads it seems to be available at least since 2016. Price seems to be 50 g for $8,410.00.
The manufacturer Evonik is now also partnered with BionTech the developer of the Pfizer product:
Commercial lipid quantities are to be produced at Evonik's Hanau and Dossenheim sites in Germany as early as the second half of 2021 as part of a strategic partnership with BioNTech.
Evonik already supplies one of the most important lipids for mRNA vaccines in pharmaceutical quality to multiple customers: A non-animal derived cholesterol under the brand name PhytoChol®.
— By Dan Hutchins : "Evonik partners with BioNTech to manufacture lipids for COVID-19 vaccine", News-Medical.Net, Mar 2 2021. [Emphasis added, LLC]
Similar data is derived from newspaper reports about previous suppliers of lipids like cholesterol for Pfizer: Merck and Acuitas (Feb 2021).
Interestingly, Merck seems to supply both: animal cholesterol (variant 1: C₂₇H₄₆O 5g/EUR 68,40; variant 2, explicitly from wool fat: C₂₇H₄₆O 1kg/EUR 1.730,00) and synthetic cholesterol SyntheChol®, C₂₇H₄₆O, price on request.
While the company indeed claims for all variants that they would meet Eur.Ph. standards for quality, they do not disclose how the synthetic variant would be able to comply to the most applicable regulation monograph 2397. The simple listing of "Ph.Eur." is therefore only in compliance with monograph 0993, and thus not for injectable use per se.
Merck did state very recently, that they are new to this, since February 2021, and now getting ready:
To meet the high demand for lipids, a key component of mRNA-based vaccines and therapeutics, Merck, a leading science and technology company, has launched a new, high-purity synthetic cholesterol product, nine months ahead of schedule.
—Merck: "Merck Accelerates Scale Up of Lipids to Meet Covid-19 Demand", Press Release, Darmstadt, Germany, 26 May 2021
The other partner Acuitas seems to be focussed on the Lipid-Nano-Particles other than cholesterol.
Initially, the Pfizer product was assessed by the EMA on conditional marketing approval as:
All excipients except the functional lipids ALC-0315 and ALC-0159 and the structural lipid DSPC comply with Ph. Eur. The functional lipid excipients ALC-0315 and ALC-0159, are classified as novel excipients. Both structural lipids DSPC and cholesterol are used in several already approved finished products.
— 19 February 2021
Committee for Medicinal Products for Human Use (CHMP)
Common name: COVID-19 mRNA vaccine (nucleoside-modified) Procedure No. EMEA/H/C/005735/0000 EMA/707383/2020 Page 23/140 (PDF) [emphasis added, LLC]
While seemingly in conflict with the communication commentary upon application as of November 30 2020, (which lists 'what EMA thinks important), the EMA approval document confirms compliance with the compendium Ph.Eur., indicating the EMA thinks it complies with monongraph 2397, making the cholesterol animal sourced — per definitionem.
That means that the Moderna product might be vegan in the sense of at least 'does not contain animal derived cholesterol' in the finished product. Although this then is in violation of the current version of European Pharmacopoeia (Ph. Eur.) 10th Edition.
How this apparent 'deficiency' that the EMA asked Moderna specifically to rectify — but both manufacturers seem to ignore by the second half of 2021 — might be compatible with for example the German law AMG $55,8: remains to be seen (and is probably out of scope here):
In the manufacture of medicinal products, only substances […] may be used […] which comply with the recognised pharmaceutical rules.
With "comply with the recognised pharmaceutical rules" meaning in accordance to the 'Good Manufacturing Practice' (GMP) as formulated in the German Pharmocopeia DAB (Deutsches Arzneibuch) and the European one, Eur.Ph.
Pfizer/BionTech brought a product to market that did and apparently does contain animal derived cholesterol, as assessed by the EMA. Meaning that it is/was in compliance with Ph. Eur. and uses animal derived cholesterol — but Pfizer plans to change that in the second half of 2021, switching to the plant-derived versions of the substance that is used by Moderna as well. If it contains animal derived cholesterol it is surely 'not vegan' at the moment.
Parenteral cholesterol as used by other vaccines would be Mosquirix or Shingrix. For Mosquirix the EMA found the following:
The applicant adequately justified the use of cholesterol that is compliant to Ph. Eur monograph Cholesterol <993>, instead of the monograph Cholesterol for Parenteral Use <2397> and will develop an endotoxin test for cholesterol raw material testing.
— 23 July 2015
Committee for Medicinal Products for Human Use (CHMP)
International non-proprietary name: Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)
Procedure No. EMEA/H/W/002300/0000 page 26/175 (PDF)
Which means that the EMA found the reasons presented to them for not using sheep's wool as a source and thus violating 2397 satisfactory. As long as the alternative source in compliance with 0993 would be monitored closely for "endotoxins". Note the date of cost-effective alternative source availability for non-animal cholesterol and the need for monitoring endotoxins closely. This is apparently still exclusively animal sourced but just not from wool fat.
Such explicit assessment and a given OK are still absent from any publicly available material I could find. Pfizer and Moderna were asked to provide either compliant products or justify not doing so. It seems they have not done so, as at least EMA has not published documentation for the manufacturers doing that to EMA's satisfaction.
Unless further information comes forward on this, we have to regard the claims made by the UK NHS and the Vegetarian society, both relying on information from Pfizer as dubious: according to EMA assessment, Pfizer's product was conditionally approved for the EU market with, and currently does contain, animal derived cholesterol.
The exact ingredients used are not fully publicly disclosed by the manufacturer.
As of November 2020 (PDF) — and in parallel to the requests to the manufacturers to adhere to monograph 2397 — there was discussion within the EMA to amend Ph.Eur..
The newest supplement 10.6, agreed upon in November 2020, published in May 2021, and to be implemented in 2022
Monograph 2397 will allow the use of either wool fat or synthetic cholesterol:
Status In use
Monograph Number 02397
English Name Cholesterol for parenteral use
Published in English Supplement 10.6
As detailed in the history of revisions here:
Definition: revised to allow the use of synthetic cholesterol; Test section indicates which tests apply depending on the source of the cholesterol used (derived from wool fat or synthetic).
Identification: section updated.
Related substances: test introduced for synthetic cholesterol.
Bacterial endotoxins: test deleted as covered by the general monograph Parenteral preparations (0520).
Which means that with the start of 2022, both manufacturers do no longer need to use strictly wool fat derived cholesterol, or present an accepted reason for using non-compendial cholesterol, as then synthetic cholesterol will be compendial as well.
An explanation for the demonstrated need to watch out for the given risk of transmissible spongiform encephalitis (TSE) in the University
of Magdeburg press release when employing animal derived cholesterol and the historic genesis of monograph 2397 requiring wool fat as the only compendial source not in need for exceptions when intended for parenteral use: these were meant as an explicit security measure to avoid any risk of TSE, as detailed also in chapter "5.2.8. Minimising the risk of transmitting TSE via medicinal products" especially section "6-7. Wool Derivatives" in Ph.Eur. 10.0. (p670 printed version).
The quality, source and status of both products now remains to to be ascertained by official sources.
A Freedom of Information request for transparency on this matter to the EMA from January 2020 is blocked and delayed to this day. (Publicly visible in English and German language at
— FragDenStaat: Antrag nach EU-Verordnungen 1049/2001 sowie 1367/2006: "Impfstoffe [#210033]" Datum: 28. Januar 2021 / Deadline: 18. Februar 2021, last exchange listed as of June 15, 2021.)