It has been known for a long time that polio vaccines contained a monkey virus called the coryza virus, which was later renamed respiratory syncytial virus (“RSV”).
In humans, RSV causes mild, cold-like symptoms but may be severe in a small number of people, especially in infants and older adults.
Since August last year, regulators in Western countries have approved Pfizer’s RSV vaccine for use in pregnant mothers that increases the risk of pre-term birth, which carries risks of short and long-term health complications for the baby.
On 21 August 2023, the US Food and Drug Administration (“FDA”) approved Pfizer’s Abrysvo vaccine. It is the first vaccine approved for use in pregnant mothers to prevent lower respiratory tract disease caused by respiratory syncytial virus (“RSV”).
“Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as infants through maternal immunisation,” Pfizer announced in September.
Two days after the FDA, on 23 August 2023, Abrysvo received an EU-wide marketing authorisation for use in in adults 60 years of age and older and mothers during pregnancy.
In November, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) approved Abrysvo for both pregnant women and older adults. The approval came after the Joint Committee on Vaccination and Immunisation (“JCVI”) recommended in June that the UK introduce routine RSV vaccination for both babies and those over 75.
On 4 January 2024, Health Canada approved Abrysvo for use in adults 60 years of age and older and pregnant mothers.
On 17 January, Medical Xpress reported that The Therapeutic Goods Administration (“TGA”) had approved GlaxoSmithKline’s (“GSK’s”) Arexvy RSV vaccine for adults over 60.
“The recent Australian TGA approval of Arexvy is likely to be the first of several, with other vaccines from Pfizer and Moderna currently in development … The GSK and Pfizer RSV vaccines are similar. They both contain a small component of the virus, called the pre-fusion protein … Abrysvo, the Pfizer RSV vaccine, has been trialled in pregnant women … It has been approved in pregnant women in the United States, but is not yet approved in Australia,” Medial Xpress wrote.
Further reading: What is the difference between Arexvy and Abrysvo?
The Highwire’s Del Bigtree examined the newly approved RSV vaccine’s side effects on pregnant women. Using data straight from Abrysvo’s package insert, he highlights the increased risk of pre-term birth and buffer ingredients such as polysorbate 80 and residual DNA from host cell proteins from Chinese hamster cell lines.
