Maintaining Safety with SARS-CoV-2 Vaccines
Giovanni Rolla, Luisa Brussino, Iuliana Badiu
Abstract
To the Editor: In the review article by Castells and Phillips on vaccines for the prevention of infection with SARS-CoV-2 (published on Dec. 30 at NEJM.org), 1 the authors describe cases of anaphylaxis associated with the Pfizer-BioNTech messenger RNA (mRNA) vaccine.The estimated incidence of anaphylaxis is 1 in 100,000 injections, as compared with an expected incidence of 1 in 1 million injections. 2 The incidence of anaphylaxis after vaccination with the quadrivalent human papillomavirus (HPV) vaccine (Gardasil) has been estimated at 1 in 190,000 injections 3 ; this incidence is similar to that reported for the Pfizer-BioNTech vaccine.Polysorbate 80 is an excipient in Gardasil, and we identified polysorbate 80 as the culprit in a case of anaphylaxis that occurred in a young girl after the third intramuscular administration of that vaccine. 4 Castells and Phillips note that the implications for the future use of SARS-CoV-2 vaccines, which are commonly formulated with polysorbate 80 (with a structure similar to that of polyethylene glycol [PEG]), are unknown.Allergists should be aware that cross-reactive immediate hypersensitivity to macrogols (PEGs) and polysorbates can occur.We have reported 5 a case of multiple drug reaction due to hypersensitivity to PEGs of a wide variety of molecular weights, from PEG 80 to macrogol 6000.