New vaccines pipeline on the agenda at Pfizer event
A major priority for healthcare globally over the next five years must be that we make positive use of the vaccines we already have, a leading expert told Hospital Professional News at an event at Pfizer in Dublin.
Dr Stephen Lockhart put forward the opinion as part of a stellar line-up at the event. This included some of the world’s leading vaccine experts, who offered insight into how governments use national immunisation programmes to manage disease, and the importance of vaccination in preventing antimicrobial resistance.
“Take something like the HPV vaccine uptake, it has been a disaster; not just in Ireland but almost everywhere in Europe,” said Dr Lockhart, Head EU/AP Pfizer Vaccine Clinical Research & Development.
According to Dr Lockhart, one of the problems with developing a new vaccine is that you have to first ‘recognise that there is an actual need for it’. He revealed that Pfizer is currently focused on addressing unmet medical needs with vaccination trials for the following: Clostridium difficile infections (CDIs); Staphylococcus Aureus (S. aureus); Respiratory Syncytial Virus (RSV); and Group B Streptococcus (GBS).
“I would say out of the vaccines we are researching and developing, the likes of S. aureus and Clostridium difficile will probably be initially aimed at developed western markets.
“Hospital-associated infections remain a substantial issue, so if you can take those cases out you will free up so many more hospital beds, which are obviously at a bit of a premium at the moment, particularly here in Ireland.”
UNMET MEDICAL NEED
Many infectious diseases happen in relation to the healthcare environment, especially in older people. The transmission of CDIs can be patient-to-patient, via contaminated hands of healthcare workers or by environmental contamination.
In response to the emerging problems with CDIs, the European Centre for Disease Prevention and Control (ECDC) has published background information about the changing epidemiology of CDIs, agreed on CDI case-definitions and issued recommendations for the surveillance of CDIs.
Dr Lockhart confirmed that CDIs are a significant unmet medical need in older adults and that there is currently no vaccine to prevent initial or recurrent infections. These infections occur when bacteria express toxins causing severe diarrhoea, and they account for over 120,000 cases and 3,700 deaths per year in the European Union.
“We are the only company with a clinical trial ongoing for Clostridium difficile, so we have our fingers crossed. We’ll wait and see what the results show. It is an expensive and risky business. One trial costs around $400 million, but that’s going to include 16,000 patients from around the world who are at risk of the infection, who we will follow for a couple of years. If the trial is unsuccessful then that is that money down the pan.”
According to the ECDC, on any given day, about 80,000 patients have at least one healthcare associated infection, i.e. one in 18 patients in a European hospital.
Meanwhile, surgical site infections are associated with longer postoperative hospital stays, additional surgical procedures, and may require intensive care and often results in higher mortality. In 2015, 11788 (8.3%) of patients staying in an intensive care unit (ICU) for more than two days in the EU presented with at least one ICUacquired healthcare-associated infection (HAI) under surveillance (pneumonia, bloodstream infection or urinary tract infection).
BED DAYS
Dr Lockhart emphasised that within the next five years Pfizer will have data to support whether its S. aureus vaccine works to prevent the hospital-acquired antimicrobial resistant infection, which also currently has no vaccine to prevent initial or recurrent infections. S. aureus is a major cause of surgical and wound infections, where antibiotic resistance is common (MRSA).
It is the cause of over 20% of all surgical site infections, while according to the ECDC, accounts for roughly 170,000 cases, 5400 deaths and one million bed days across Europe. “If you get a S. aureus infection when getting a hip or knee joint replacement, you can actually lose that joint, so it can be disastrous for the patient.
Also, the economic impact is huge, we are talking something like a million bed days in the EU.” Pfizer currently has a vaccine at advanced trial stage for the infection, looking at whether it can prevent S. aureus in neck surgery.
“Again, we will see how the trial goes. We are not aware of any other vaccines for this at an advanced stage, so this would be an important breakthrough,” he said.
Commenting on Pfizer’s pipeline for a possible universal flu vaccine, and its cancer vaccine development, Dr Lockhart said it is far too early to comment on what these vaccines may look like. “Influenza vaccines are very important.
They do some good at the moment but we can do better. Maybe one year we can have a vaccine that doesn’t need to change from year to year. We are thinking about how we’ll do that.
My personal view is a universal flu vaccine, which will cover all types, is too far away right now to really discuss. “Our cancer work is very early phase. We are doing it in the US, so we first have to see if we can get the right responses to that. We do have a trial that is ongoing of what we hope will be a useful prostate cancer vaccine.
” ANTIMICROBIAL RESISTANCE Also presenting at the event was Dr Nicholas Kitchin, the Senior Director of Vaccine Clinical Research at Pfizer, who spoke on the topic of antimicrobial resistance (AMR), claiming that it is one of the biggest threats to global health, food security, and development today.
Antibiotic resistance can affect anyone, of any age, in any country, he said.
It occurs naturally, but misuse of antibiotics in humans and animals is accelerating the process. A growing number of infections such as pneumonia, tuberculosis, gonorrhoea, and salmonellosis are becoming harder to treat as the antibiotics used to treat them become less effective.
Dr Kitchin believes antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality. Discussing why vaccination is important for addressing antibiotic resistance, he is adamant vaccines can help limit the spread of antibiotic resistance. “The global increase in disease caused by drug-resistant bacteria, due to overuse and misuse of antibiotics, is a major public health concern. It is more difficult and costly to treat antibiotic-resistant infections and people do not always recover.”
Dr Kitchin echoed Dr Lockhart’s earlier sentiment when he stated “making better use of existing vaccines and developing new vaccines are important ways to tackle antibiotic resistance and reduce preventable illness and deaths”.
An example he pointed to is that following the introduction of pneumococcal conjugate vaccines in the UK, Public Health England reported dramatic declines in invasive pneumococcal disease among children less than two years old.
“Expanding the use of existing vaccines will reduce the use of antibiotics and the development of resistance,” explained Dr Kitchin. “For example, if every child in the world received a vaccine to protect them from infection with Streptococcus pneumoniae bacteria (which can cause pneumonia, meningitis and middle ear infections), this would prevent an estimated 11 million days of antibiotic use each year. Vaccines against viruses, such as the flu, also have a role to play, because people often take antibiotics unnecessarily when they have symptoms such as fever that can be caused by a virus.”
He added that developing and using new vaccines to prevent bacterial diseases can further reduce the development of resistance, stating that antibiotics are currently the standard medical intervention for common diseases such as Group A Streptococcus (which causes “strep throat”), for which we do not yet have vaccines.
“We also need vaccines to stop people from catching diseases caused by bacteria that are now frequently antibiotic-resistant.
For example, there is an alarming spread of multi-drug resistant tuberculosis (MDR-TB). In 2015, an estimated 480,000 people were infected with MDR-TB.”
Similarly, said D. Kitchin, new vaccines targeting S. aureus, Klebsiella pneumonia, Clostridium difficile, and many others could protect people against diseases that are increasingly difficult to treat.
“Developing new vaccines and getting them used appropriately is lengthy and complex. The scientific community needs to prioritise which new vaccines would have the greatest impact on antibiotic resistance, and promote investment in these.”
HEALTHIER WORLD
In his presentation entitled, ‘Pfizer’s Vision For A Healthier World’, Reda Guiha, Regional President Vaccines International Developed Markets at Pfizer, echoed Dr. Kitchin’s view in relation to the threat AMR poses to modern medicine. “Vaccines can reduce AMR in people by reducing the number of bacterial infections that need antibiotics,” he said.
Guiha pointed to the fact that the health arm of the G8 has a sub-committee set up on how to tackle AMR, as they view it as a significant global health issue.
AMR is estimated to be responsible for around 25,000 deaths per year in the European Union, 700,000 at the global level and projected 10 million deaths every year in 2050, compared to, for example, eight million cancer-related deaths.
“We need to increase preventative care,” said Guiha, “evidencebased preventative services are effective in reducing disease, death and disability, and can be cost effective and cost saving. “In terms of total spending on healthcare and preventative care, preventative care is just a tiny proportion. In Europe, we spend less than 3% of the overall healthcare budget on prevention, which is less than 0.5% of overall GDP.
In fact, this means we spend a lot on treatment and far less on prevention. It is because our healthcare systems are organized in such a way to treat and not to prevent.” According to Guiha, despite improvements in individual countries and a strong global rate of new vaccine introduction, global average immunisation coverage has increased by only 1% since 2010.
Addressing the broad vaccination gap is an urgent priority to keep people living longer, healthier lives and reducing pressure on the healthcare system, he concluded.