A respiratory syncytial virus (RSV) vaccine to protect infants from severe illness is available in the private sector although not yet in public clinics, but after a recommendation by the advisory group on immunisations to make it available to all pregnant women, the proposal is being considered by the government, writes Catherine Tomlinson for Spotlight.
The highly contagious RSV is spread through airborne respiratory droplets and contact with contaminated surfaces, but is often difficult to distinguish from the common cold.
However, in some cases, it can become serious enough to need medical care or even a hospital stay, especially for babies under six-months-old. Severe illness typically affects the lower respiratory tract and can lead to bronchiolitis or pneumonia, which can cause difficulty breathing.
Babies who are hospitalised may need oxygen to help them breathe, fluids through a drip to keep them hydrated, and in serious cases, a machine to help them breathe.
A major cause of illness and death in children under five, especially in the first six months of life in low- and middle-income countries, in 2019, RSV was responsible for more than 100 000 deaths in children in this age category. This made up 2% of all deaths in the age group, and 3.6% of deaths in babies aged 28 days to six months.
Jab to prevent RSV in infants
The new vaccine provides infants with significant protection against severe RSV disease, and is given to pregnant women some time during their third trimester of pregnancy, when protective antibodies elicited by the vaccine are transferred from the mother to the foetus across the placenta.
Currently, only Pfizer markets the maternal RSV vaccine, under the brand name Abrysvo. It is also known by the generic name RSVpreF.
The South African Health Products Regulatory Authority (SAHPRA) approved Abrysvo in December 2024, and it became available in the private sector this year.
The effectiveness of the vaccine in preventing severe RSV disease was first announced in November 2022. This followed early positive results from the Maternal Immunisation Study for Safety and Efficacy (MATISSE) conducted in 18 countries, including South Africa.
It showed that infants born to mothers who received the maternal RSV vaccine had an 82.4% lower risk of developing severe RSV-associated lower respiratory tract illness within the first 90 days of life, compared with infants whose mothers received a placebo.
At 180 days after birth, the vaccine was 70% effective in reducing the risk of severe RSV illness.
Recommendations from health agencies
By September 2023, the US Centres for Disease Control and Prevention recommended giving the RSV vaccine to pregnant women to help protect their babies from severe illness.
One year later, the WHO recommended that all countries introduce the maternal RSV vaccine. It also recommended an alternative for babies whose mothers weren’t vaccinated: a single dose of the monoclonal antibody nirsevimab, ideally given at birth or before discharge from the birthing facility.
While acknowledging cost limitations, the WHO noted that if not given at birth, the antibody can be given at the baby’s first health visit.
In countries offering it only during RSV season, older infants can receive the dose just before their first season begins.
Nirsevimab is not yet registered in South Africa and cost is expected to be a barrier to its rollout in the country.
South Africa has not yet adopted formal guidelines for the broad use of the maternal RSV vaccine, but the National Advisory Group on Immunisations recently recommended that the NDoH introduce the RSVpreF vaccine into the public immunisation programme as a single-dose vaccination for all pregnant women.
This recommendation was outlined in a letter to Health Minister Aaron Motsoaledi on 23 April.
“The department is currently assessing the cost and other implications of RSV vaccine introduction,” Health Department spokesperson Foster Mohale told Spotlight.
Price remains a hurdle
Pfizer is selling Abrysvo in this country as a single-dose vaccine, priced at around R3 746 excluding VAT and dispensing fees. This price for the private sector is significantly higher than the government’s threshold for broad rollout, according to a cost-effectiveness analysis of RSV immunisation.
The analysis found that at a price of R90 per dose, the vaccine would offer savings to South Africa’s health sector. But if the price exceeds about R700 per dose, then widespread procurement may no longer be feasible.
The pricing of Abrysvo in South Africa’s private sector is “disappointingly high”, Professor of Vaccinology at the University of the Witwatersrand Shabir Madhi, told Spotlight, adding that he thinks “something has gone awry in … pricing of the vaccine here”.
He said that the Pan American Health Organisation (PAHO), which works to improve the health and quality of life, secured a price of $49 (around R800) per dose for use in Latin American countries.
“It tells us that certainly the cost of producing a vaccine is nowhere close to $200 if the same vaccine is being provided at $49 to PAHO,” he added.
Pfizer did not answer questions about whether a lower price would be offered to the public sector, but a company spokesperson said: “We are committed to working with the government and healthcare stakeholders to ensure our medicines and vaccines are available to all those who need them in South Africa.”
“There has been engagement with Pfizer, and they have indicated that the (public sector) price … is likely to align with current PAHO pricing,” said Mohale.
Apart from pricing, he said introducing the maternal RSV vaccine involves several other health system considerations, and that a comprehensive implementation guideline will be needed “to address areas such as monitoring and evaluation, supply chain capacity, healthcare worker training, and demand creation to ensure effective and sustainable rollout”.
Fortunately, South Africa, unlike some other countries, already has established vaccine programmes for pregnant women, said Madhi.
“Traditionally, we’ve been vaccinating pregnant women with the tetanus vaccine for decades now, and as of last year, we actually introduced the acellular pertussis, tetanus, diphtheria combination vaccine for pregnant women.”
See more from MedicalBrief archives:
Conflict over Pfizer RSV vaccine trial informed consent
Pfizer to apply for approval of first maternal RSV vaccine
Respiratory virus killing 100,000 children a year – systemic analysis