select search filters
briefings
roundups & rapid reactions
before the headlines
Fiona fox's blog
A press release from Pfizer gives top line data from the phase 3 maternal immunisation trial of its bivalent Respiratory Syncytial Virus (RSV) vaccine candidate.
Prof Alastair Sutcliffe, Professor of General Paediatrics, UCL, said:
Is this a peer-reviewed journal paper or more preliminary data?
“I read with enthusiasm the first paper in a series of studies regarding this novel vaccine. That was in the NEJM.
“As a practising Paediatrician and clinician scientist I am impressed by this study. The decision to stop the trial for reasons of efficacy is exciting news and critically was made by an independent DMC (data monitoring committee) and thus is likely to be valid.
“DMC have a right (seldom exercised) to request to see unblinded data and in this case the effect size (i.e. the benefit to the Mums and critically their babies) is sufficient not to complete the full trail. Indeed to do so would be unethical.
Is it possible to tell whether the press release accurately reflect the science?
“The press release is accurate, Pfizer and GSK are the world leaders in vaccine technologies and both their programmes are excellent.
“Historically the efforts to crack the conundrum which is RSV (respiratory syncytial virus) resulted in a vaccine that caused deaths and was withdrawn, but this has been needed forever and a day.
“One colleague once said that paediatricians would be ‘put out of business’ if an RSV vaccine was developed. Exposure to RSV in the winter months is expensive to the NHS in bed occupancy days, morbidity and has down stream effects on the exposed infants such as a higher risk of wheeze.
Does this work fit with the existing evidence?
“Yes very much so.
Have the authors accounted for confounders?
“That is what happens in all RCTs – confounders are averaged out by random chance.
Are there important limitations to be aware of?
“None.
What are the implications in the real world? Is there any overspeculation?
“No, this study is joyful news and is to be welcomed.”
Prof Beate Kampmann, Professor of Paediatric Infection & Immunity, and Director of the The Vaccine Centre, London School of Hygiene and Tropical Medicine, said:
“RSV is a major reason why babies end up in hospital, and it can be a lethal virus anywhere in the world. To have an effective vaccine that can be given to the expecting mothers before the babies are born is a great way of preventing this complication. The results of this large scale clinical efficacy trial conducted across in many countries, including in low-and middle income settings are absolutely excellent, and speaking as a paediatrician, this is just what we are waiting for to implement soonest now, once all has undergone regulatory review and can then be adopted for clinical practice in many countries. There is also already commitment from GAVI, the global vaccine initiative, to help with funding of a safe and efficacious RSV vaccine in resource-poor settings.”
Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said:
“Vaccines are our best defence against viral infections. RSV causes an infection that can result in pneumonia and is particularly problematic in very young children.
“Previous attempts to use vaccines to protect them, especially during the first-year life, has proven difficult, so the news from Pfizer that their early clinical trial data suggests good protection against lung infection following vaccination of pregnant mothers (who will pass on the immunity to their new born children) is great news.”
Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases, University of Southampton, said:
“It is an absolute game-changer and of high global importance. This data shows that a vaccine against RSV given to pregnant women could substantially reduce the burden of severe RSV disease in young infants. What is remarkable about this data is that high efficacy is still since up to six-months of age. If this vaccine is approved by regulatory agencies, this vaccine would have a substantial impact on admissions to hospital for RSV disease. It is highly important for the UK, but crucial for low- and middle- income countries.
“The data has not yet been peer-reviewed or published, so we need to assess the data in more detail, but this is extremely exciting and we wait with bated breath to see if this vaccine receives a license from regulatory agencies. We have been awaiting an effective solution to combat RSV for many years.”
Declared interests
Prof Alastair Sutcliffe: “I have no conflict of interest.”
Prof Beate Kampmann is a principal investigator in the trial that has supported this data at a trial site in West Africa.
Dr Chrissie Jones carried out a clinical trial on behalf of her institution testing another RSV vaccine in pregnancy, sponsored by Novavax. She received no personal funding for this. She attended an advisory board on RSV vaccines sponsored by Sanofi, for which she received remuneration.
Prof Jonathan Ball: “None.”