DUARTE, Calif., 9 January, 2021 – Prolacta Bioscience, the world’s leading hospital provider of 100% human milk-based nutritional products, today provided updated data reinforcing the continued safety, quality, and supply of its human milk-based nutritional products during the COVID-19 pandemic. In the update, Prolacta reiterated how the vat pasteurisation method is highly effective at inactivating SARS-CoV-2, the virus that causes COVID-19, should it be present in breastmilk. Used by Special Care Baby Units (NICUs) throughout the world, Prolacta’s products as part of an exclusive human milk diet (EHMD) address nutritional risks for low birth weight premature infants.

'We continue to closely review all of the emerging scientific data around the coronavirus and are committed to providing up-to-date guidance regarding the use of our human milk-based nutritional products', said Scott Elster, president and CEO of Prolacta. 'We are confident in our pasteurisation, quality and safety processes, and the data showing the ability of pasteurisation to inactivate the virus'.^1,2,3,4

Breastmilk and COVID-19 Infection

• While three studies have suggested that transfer of the virus into breastmilk is a possibility,^1,5,6 there have been no confirmed cases of an infant contracting SARS-CoV-2 via breastmilk.
• Even if it is possible for SARS-CoV-2 to pass into breastmilk, several studies have now demonstrated that Holder pasteurisation inactivates SARS-CoV-2.^1,2,3,4
• Studies of other epidemic coronaviruses, such as the virus responsible for the 2003 SARS epidemic and the virus responsible for the 2012 MERS outbreak, demonstrate that pasteurisation is highly effective in inactivating these viruses. Two studies were done in diverse carrier media for plasma-derived products,^7,8 and another study was conducted using animal milk⁹ in which the virus was found during epidemic infection.

Prolacta’s Effective Pasteurisation Protocol

As of now, evidence indicates that pasteurisation inactivates SARS-CoV-2 should it be present in breastmilk. All of Prolacta’s products are pasteurised using time and temperature profiles defined by the US Food and Drug Administration (FDA) in its Pasteurised Milk Ordinance (PMO) to ensure the destruction of pathogens. Prolacta’s pasteurisation process has been independently validated using the same study design principles as the pathogen inactivation studies used in the biologics industry. This validation demonstrates that Prolacta’s pasteurisation provides appropriate bacterial killing and viral inactivation, including inactivating enveloped viruses. SARS-CoV-2 is an enveloped virus.

Setting the Highest Standard for Human Milk Safety

Prolacta operates the first and only pharmaceutical-grade manufacturing facilities for the testing and processing of human milk. Its two facilities have standard ISO-7 and ISO-8 clean rooms totalling nearly 21,100 square feet.

▪ Prolacta modelled its stringent quality and safety protocols on those used in the plasma and blood industries.

▪ Prolacta has developed, validated, and implemented more than 20 donor milk screening tests to ensure the quality and safety of its human milk-based nutritional products.

About Prolacta Bioscience

Prolacta Bioscience^® Inc. is a privately held life sciences company dedicated to Advancing the Science of Human Milk^®. Prolacta is the world’s leading hospital provider of 100% human milk-based nutritional products. These life-saving products as part of an Exclusive Human Milk Diet (EHMD) have reduced complications and improved the health of more than 63,000 extremely premature infants globally.¹⁰ In addition, the company is exploring the therapeutic potential of human milk across a wide spectrum of human diseases, including applications for infants requiring surgery for congenital cardiac and gastrointestinal disorders. Operating the world’s first pharmaceutical-grade human milk processing facilities, Prolacta leads the industry with the highest quality and safety standards for the screening and testing of donor milk. Prolacta is a global company with headquarters in Duarte, California, and can be found online at www.prolacta.com, on Twitter @prolacta, on Instagram @prolacta_bioscience, on Facebook at www.facebook.com/prolacta and LinkedIn at www.linkedin.com/company/prolacta-bioscience/.

Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310-721-9444

References:

1. Chambers C, Krogstad P, Bertrand K, et al. Evaluation for SARS-CoV-2 in breast milk from 18 infected women. JAMA. 2020;324(13):1347-1348. doi:10.1001/jama.2020.15580
2. Conzelmann C, Groß R, Meister TL, et al. Holder pasteurization inactivates SARS-CoV-2 in human breast milk. bioRxiv; 2020. DOI: 10.1101/2020.06.17.155689.
3. Unger S, Christie-Holmes N, Guvenc F, et al. Holder pasteurization of donated human milk is effective in inactivating SARS-CoV-2. CMAJ. 2020;192(31):E871-E874. doi:10.1503/cmaj.201309
4. Walker GJ, Clifford V, Bansal N, et al. SARS-CoV-2 in human milk is inactivated by Holder pasteurisation but not cold storage. [published online ahead of print]. J Paediatr Child Health. 2020; 10.1111/jpc.15065. doi:10.1111/jpc.15065
5. Groß R, Conzelmann C, Müller JA, et al. Detection of SARS-CoV-2 in human breastmilk. [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;395(10239):1757-1758. doi:10.1016/S0140-6736(20)31181-8
6. Wu Y, Liu C, Dong L, et al. Coronavirus disease 2019 among pregnant Chinese women: case series data on the safety of vaginal birth and breastfeeding. BJOG. 2020;127(9):1109-1115. doi:10.1111/1471-0528.16276
7. Gröner A, Broumis C, Fang R, et al. Effective inactivation of a wide range of viruses by pasteurization. Transfusion. 2018;58(1):41-51. doi:10.1111.trf.14390
8. Yunoki M, Urayama T, Yamamoto I, Abe S, Ikuta K. Heat sensitivity of a SARS-associated coronavirus introduced into plasma products. Vox Sang. 2004;87(4):302-303. doi:10.1111/j.1423-0410.2004.00577.x
9. van Doremalen N, Bushmaker T, Karesh WB, Munster VJ. Stability of Middle East respiratory syndrome coronavirus in milk. Emerg Infect Dis. 2014;20(7):1263-1264. doi:10.3201/eid2007.140500
10. Estimated number of premature infants fed Prolacta’s products from January 2007 to August 2020; data on file.