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Daily Maverick
3 days ago
- Health
- Daily Maverick
New respiratory virus vaccine a game changer for babies, but cost remains a barrier
A new respiratory syncytial virus vaccine to protect infants from severe illness is available in South Africa's private sector, but not yet in public clinics. The country's advisory group on immunisations has recommended making it available to all pregnant women. This proposal is now under review by the national Department of Health. Like the common cold, respiratory syncytial virus (RSV) is highly contagious. It is spread through airborne respiratory droplets and contact with contaminated surfaces. RSV infection is often difficult to distinguish from the common cold. This is because it has similar symptoms and typically clears up without medical intervention. 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, who are the most vulnerable. Severe illness typically affects the lower respiratory tract and can lead to bronchiolitis or pneumonia, which can cause difficulty breathing. Babies who are admitted to hospital may need extra help, such as oxygen to help them breathe, fluids through a drip to keep them hydrated, and in serious cases, a machine to help them breathe. RSV is 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. A recent global study estimated that in 2019, RSV was responsible for just over 100,000 deaths in children under five. This made up 2% of all deaths in this age group, and 3.6% of deaths in babies aged 28 days to six months. Nearly half of all RSV-related deaths occurred in babies under six months, and 97% of these deaths were in low- and middle-income countries. A new vaccine to prevent RSV in infants A new vaccine provides infants with significant protection against severe RSV disease. It is given to pregnant women during their third trimester of pregnancy (from week 28 to birth). Protective antibodies elicited by the vaccine are transferred from the mother to the foetus across the placenta. Currently, only one pharmaceutical company, Pfizer, markets the maternal RSV vaccine. It is sold under the brand name Abrysvo. It is also known by the generic name RSVpreF. The South African Health Products Regulatory Authority approved Abrysvo in December 2024, and it became available in the country's private sector in 2025. 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) which was 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 than 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 United States Centers for Disease Control and Prevention recommended giving the RSV vaccine to pregnant women to help protect their babies from severe illness. One year later, in September 2024, the World Health Organization (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 could 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 the 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 national Department of Health 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 Dr Aaron Motsoaledi on 23 April 2025. 'In line with the National Advisory Group on Immunisations' terms of reference which govern the committee's work, the department is currently assessing the cost and other implications of RSV vaccine introduction with relevant senior managers and other stakeholders,' the health department's spokesperson, Foster Mohale, told Spotlight. 'Feeback will be provided to the group's chairperson once a decision regarding possible introduction has been reached,' he added. Price remains a barrier Pfizer is selling Abrysvo in South Africa as a single-dose vaccine, priced at R3,746 ($US 210), excluding VAT and dispensing fees. This price for the private sector is significantly higher than the government's threshold for broad roll-out, according to a cost-effectiveness analysis of RSV immunisation. The analysis found that at a price of US$5 (about R90) per dose, the vaccine would offer savings to South Africa's health sector. But if the price exceeds US$40 (about R700) per dose then widespread procurement may no longer be feasible. Pfizer's pricing of Abrysvo in South Africa's private sector is 'disappointingly high', Shabir Madhi, Professor of Vaccinology at the University of the Witwatersrand, told Spotlight. He added that he thought 'something has gone awry in terms of pricing of the vaccine in South Africa'. He pointed out that the Pan American Health Organization, which works to improve the health and quality of life, secured a price of US$49 (about R800) per dose for procurement of the vaccine for use in Latin American countries. 'It does tell us that certainly the cost of producing a vaccine is nowhere close to $200 if the same vaccine is being provided at $49 to the Pan American Health Organization,' said Madhi. Pfizer did not answer questions from Spotlight 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 of the maternal RSV vaccine is likely to align with current Pan American Health Organization pricing,' said Mohale. Apart from pricing, he said that introducing the maternal RSV vaccine involved several other health system considerations. '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,' said Mohale. Fortunately, South Africa, unlike some other countries, already had established vaccine programmes for pregnant women, said Madhi. '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,' he said. DM
Hans India
30-05-2025
- Health
- Hans India
WHO calls for maternal vaccine, monoclonal antibody to protect babies against RSV
New Delhi: The World Health Organization (WHO) on Friday recommended all countries to use both maternal vaccine and a monoclonal antibody to protect babies against respiratory syncytial virus (RSV) -– the leading cause of acute lower respiratory infections in children globally. While the maternal vaccine -- RSVpreF -- can be given to pregnant women in their third trimester to protect their infant, the long-acting monoclonal antibody -- nirsevimab -- can be administered to infants from birth, just before or during the RSV season, stated the recommendations, published in the Weekly Epidemiological Record (WER). 'Every year, RSV causes about 100,000 deaths and over 3.6 million hospitalisations in children under the age of 5 years worldwide. About half of these deaths occur in infants younger than 6 months of age,' the WHO said. "The vast majority (97 per cent) of RSV deaths in infants occur in low- and middle-income countries where there is limited access to supportive medical care, such as oxygen or hydration," it added. Although RSV causes mild symptoms similar to the common cold, including runny nose, cough, and fever, it can lead to serious complications. This can include pneumonia and bronchiolitis -– in infants, young children, older adults, and those with compromised immune systems or underlying health conditions. Both RSVpreF and nirsevimab were recommended by the Strategic Advisory Group of Experts on Immunisation (SAGE) for global implementation in September 2024. In addition, the maternal vaccine received WHO prequalification in March 2025, allowing it to be purchased by UN agencies. While the vaccine can be given during routine antenatal care, nirsevimab is given as a single injection of monoclonal antibodies that starts protecting babies against RSV within a week of administration. It lasts for at least 5 months and can cover the entire RSV season in countries with RSV seasonality. The global health body recommends that infants receive a single dose of nirsevimab right after birth or before being discharged from a birthing facility. If not administered at birth, the monoclonal antibody can be given during the baby's first health visit. If a country decides to administer the product only during the RSV season rather than year-round, a single dose can also be given to older infants just before entering their first RSV season, the WHO said. The greatest impact on severe RSV disease will be achieved by administering the monoclonal antibody to infants under 6 months of age. However, there is still a potential benefit among infants up to 12 months of age, it added. 'RSV is an incredibly infectious virus that infects people of all ages, but is especially harmful to infants, particularly those born premature when they are most vulnerable to severe disease,' said Dr Kate O'Brien, Director of Immunisation, Vaccines, and Biologicals at WHO. 'The WHO-recommended RSV immunisation products can transform the fight against severe RSV disease, dramatically reduce hospitalisations, and deaths, ultimately saving many infants lives globally,' O'Brien added.
