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Rotarix rotavirus vaccine contaminated, officials say

Federal health authorities recommended Monday that doctors suspend using Rotarix, one of two vaccines licensed in the United States against rotavirus, saying the vaccine is contaminated with material from a pig virus.

Deep sequencing reveals viral vaccine contaminants

A little historical perspective about why we decided to analyze these vaccines even though there was absolutely no indications whatsoever that they are at all unsafe. Our intent was to use the latest technologies to show that live attenuated vaccine only contained the expected viral genomes and no other.

The Delwart laboratory obtained samples of eight infectious attenuated viral vaccines from the manufacturers: oral poliovirus vaccine (OPV, Bharat Biotech), rubella (Meruvax-II, Merck), measles (Attenuvax, Merck), yellow fever (YF-Vax, Sanofi Pasteur), human herpes 3 (Varivax, Merck), rotavirus (Rotarix, GlaxoSmithKline; and Rotateq, Merck) and multivalent measles-mumps-rubella (MMR-II, Merck). The vaccines were treated with DNAse and RNAse to remove nucleic acids that are not protected by viral capsids. Nucleic acid was then extracted from the vaccine, amplified by polymerase chain reaction, and subjected to DNA sequencing. A total of 501,753 sequence ‘reads’ were done.


The sequence analysis revealed the expected vaccine strains in each preparation, and in three (out of 8) cases, other unexpected viral sequences. The retrovirus avian leukosis virus was found in the measles vaccine, but at a very low level (700 nucleotides from 4 sequence reads). A virus similar to simian retrovirus was identified in Rotateq (276 nucleotides from 1 sequence read). Significant levels of porcine cirovirus 1 were found in Rotarix. The entire viral genome sequence was deduced from 6344 sequence reads, comprising over 40% of the reads done for that vaccine.