Common side effects of Abrysvo
According to clinical trial data and the vaccine's labeling [1], common side effects of RSV vaccine Abrysvo, which is administered in two doses, include injection-site reactions, headache, fever, runny nose, loss of appetite, and irritability. Injection-site reactions occurred in more than half of participants during clinical trials, with approximately 30% experiencing more severe reactions.
Serious side effects: what's documented?
Rare but serious side effects have been reported, including an elevated risk of seizures in premature infants. The vaccine's manufacturer has highlighted the need for close monitoring in vulnerable populations. In the clinical trials conducted prior to its approval, some cases of seizures, bronchiolitis, and pneumonia occurred after vaccination, but a direct causal link to the vaccine remains uncertain [2].
Can Abrysvo cause long-term side effects?
The long-term side effects of Abrysvo remain unknown, as most clinical trials followed participants for only a short period after vaccination. Ongoing safety monitoring and post-marketing surveillance are essential to capture any possible long-term effects [3].
Who makes Abrysvo and who are the competitors?
Abrysvo was developed by GSK with support from European Union Horizon 2020 research funding and the Global Access Program by GSK. The market for RSV vaccines is rapidly expanding, with other companies, such as Novavax and Johnson & Johnson, also working on various RSV vaccine candidates.
Timeline and patent expiration: when will exclusivity expire?
As the first RSV vaccine approved for use in the prevention of hospitalization, Abrysvo has exclusivity until 2032 in the EU and the US, after which biosimilars, which are similar but not identical copies, may enter the market.
Sources
[1] European Medicines Agency. Abrysvo 3-μg vaccine, suspension for injection, in a pre-filled syringe. Summary of product characteristics. [Available at] https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo#product-availability-and-registrations
[2] Global Research and Development team at GSK. Abrysvo – Clinical development plan. Slide 15: Vaccine Safety
[3] GSK, Global Access Program. A Commitment to Improving the Lives of Patients Worldwide. https://www.gsk.com/en-gb/responsibility/global-access-program