A peer-reviewed paper documenting the first known case of a newborn having inherited SARS-CoV-2 antibodies from a Covid-19 vaccinated mother has been accepted in the journal BMC Paediatrics and will be online within the next few days, said coauthor Dr Paul Gilbert, paediatrician, Boca VIPaediatrics, Boca Raton, Florida. The mother received a single dose of Moderna’s mRNA-1273 three weeks before delivery.
Although the non-peer-reviewed version of the manuscript was posted on medRXiv on 5 February, the paper gathered significant media attention this week. Although Covid-19 vaccine authorisations around the world do not exclude pregnant women, official advice in this subgroup lacks clarity.
The BMC Paediatrics paper will have the same detail as the one posted on medRXiv, added coauthor Dr Chad Rudnick, also a paediatrician at Boca VIPaediatrics. The mother received her first dose at the end of December 2020, and was full term three weeks later, he noted. She received her second dose postpartum, he added. Two-dose mRNA-1273 is administered 28 days apart. mRNA-1273 garnered FDA Emergency Use Authorisation (EUA) on 18 December 2020.
According to the medRXiv manuscript, cord blood antibodies were detected for the SARS-CoV-2 spike protein at a level of 1.31 U/mL. The mother, at the gestational age of 36 weeks and three days, received mRNA-1273 as provided for Covid-19-naïve frontline healthcare workers.
Moderna has yet to announce it will stage an mRNA-1273 clinical trial recruiting pregnant women, which is in contrast to Pfizer/BioNTech’s Comirnaty (BNT162b2) and Johnson & Johnson’s JNJ-78436735, which do have such trials. The 4,000-participant Phase II/III Comirnaty trial recruited its first participant on 16 February. Meanwhile, the Phase II HORIZON 1 trial investigating JNJ-78436735 in 400 volunteers has yet to start enrolment.
Reynald Castaneda is Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.