In the update, Prolacta reiterated how the vat pasteurization method is effective at inactivating SARS-CoV-2, the virus that causes Covid-19, should it be present in breastmilk. Used by neonatal intensive care 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 pasteurization, quality/safety processes, and the data showing the ability of pasteurization to inactivate the virus."
While three studies have suggested transfer of the virus into breastmilk is a possibility, 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 pasteurization inactivates SARS-CoV-2, the company said.
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 pasteurization is highly effective in inactivating these viruses. Two studies were done in diverse carrier media for plasma-derived products, and another study was conducted using animal milk in which the virus was found during epidemic infection.
Currently, evidence indicates pasteurization inactivates SARS-CoV-2 should it be present in breastmilk. All of Prolacta's products are pasteurized using time and temperature profiles defined by the Food and Drug Administration (FDA) in its Pasteurized Milk Ordinance (PMO) to ensure the destruction of pathogens.
Prolacta's pasteurization process has been independently validated using the same study design principles as the pathogen inactivation studies used in the biologics industry. This validation demonstrates Prolacta's pasteurization provides appropriate bacterial killing and viral inactivation, including inactivating enveloped viruses. SARS-CoV-2 is an enveloped virus.
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 totaling nearly 21,100 square feet.