KUALA LUMPUR, Feb 10 — A paediatrician urged the government not to simply list the pneumococcal vaccine with the lowest tender price without considering other factors like degree of protection.
Dr Musa Mohd Nordin said he was consulted back in 2014 during the Ministry of Health’s (MOH) sole health technology assessment to compare American pharmaceutical company Pfizer’s pneumococcal conjugate vaccine (PCV) 13 and British drug maker GSK’s PCV10.
MOH has yet to announce which pneumococcal vaccine it will list in Malaysia’s national immunisation programme (NIP) this year for children born from January 1, 2020, after receiving an RM60 million allocation in the federal budget.
“The evidence unequivocally points to PCV13 as being the better choice,” Dr Musa told CodeBlue. “I hope the science will override the political and economic conditions — evidence-based medicine (EBM).”
The PCV10 vaccine protects against 10 serotypes, or strains, of Streptococcus pneumoniae bacteria (called pneumococcus) that causes pneumococcal disease. The more expensive PCV13 vaccine covers the same pneumococcal strains as PCV10, plus an additional three serotypes — 19A, 6A, and 3.
Dr Musa cited a Universiti Sains Malaysia study by Shafie AA et al published last month that found PCV13, compared with PCV10, was predicted to avert an additional 190,628 cases of pneumococcal disease and 1,126 deaths. The procurement of PCV13 was estimated to cost an incremental sum of close to US$90 million, offset by cost savings of about US$250 million from pneumococcal disease-related medical care and lost productivity.
“PCV13 demonstrated a higher cost-saving potential over PCV10,” the research noted.
“The introduction of PCV13 in a NIP was estimated to reduce a significant burden of disease and to be a cost-saving for the Malaysian health system.”
Besides Pfizer’s PCV13 and GSK’s PCV10, a new pneumococcal vaccine by an Indian manufacturer has come up. The Serum Institute of India announced last December that its pneumococcal vaccine Pneumosil has achieved prequalification by the World Health Organization (WHO) — which allows the vaccine that covers 10 serotypes, including 19A and 6A — to be procured by United Nations agencies and Gavi, the Vaccine Alliance, at an affordable price for low- and middle-income countries.
Serotypes 6A and 19A, which shows antibiotic resistance, were among the most common pneumococcal serotypes in Malaysia among children aged below five from 2014 to 2017.
Dr Musa pointed out that Pfizer’s PCV13 provided the highest coverage of pneumococcal serotypes in children under five years old in Malaysia at 87.3 per cent, followed by Pneumosil PCV10 at 83.3 per cent, and GSK’s PCV10 at 64.1 per cent.
Despite the WHO’s prequalification though, Pneumosil has yet to be approved by the regulatory body in India, its country of origin, nor by any other country. The pneumococcal vaccine also does not currently have clinical or quality reviews from any country. Pneumosil PCV10 doesn’t have a supply track record either.
Registration of pharmaceutical products in Malaysia requires approval from reference countries like the United Kingdom and United States, among others. Reference country approval for vaccines is optional if the vaccine has WHO prequalification, but it must have been approved in the country of origin. It takes about 12 to 18 months to register original pharmaceutical products in Malaysia.
Citing lessons from Sanofi’s Dengvaxia dengue virus vaccine that was linked with the deaths of several children in the Philippines, University of Adelaide science writer Lakshmy Ramakrishnan wrote last September that the premature and hasty introduction of a new vaccine, and exposing a population to a vaccine with considerable risks, should not have occurred at all.
“This negatively impacts society, allowing fear and anxiety to manifest, even towards established, safe and efficacious vaccines. This is not a tale to be repeated. Precaution and safety must prevail,” she said.
Physician and bioethicist Keymanthri Moodley from South Africa’s Stellenbosch University told NPR last May that the Philippines fiasco should teach governments and manufacturers to slow down in approving and selling new vaccines.
“When a vaccine goes wrong, it creates fear and anxiety in terms of the public, especially the parents,” Moodley was quoted saying. “That fear can impact negatively on the established immune programmes that are actually safe and work very well.”
Dr Musa acknowledged that the WHO has found Pneumosil PCV10 to comply with international standards of vaccine quality, safety, and efficacy, but questioned the Serum Institute’s manufacturing capacity.
“PCV is a terribly difficult vaccine to manufacture to meet all stringent criteria of GMP (good manufacturing practice). It takes at least one year to manufacture a dose of PCV13!” said the consultant paediatrician with Damansara Specialist Hospital.
Former Health deputy director-general (research and technical support) Dr Christopher Lee, who is an infectious disease expert, also said: “PCV13 would be preferred as it has broader coverage.”
He added that PCV13 was preferable to Pneumosil PCV10, but pointed out that price was a factor as he did not believe the government’s RM60 million allocation could cover the whole cohort of targeted children at the current prices offered.
“Efficacy is a given of course, but [we’re] trying to maximise the coverage with the money that we have,” Dr Lee told CodeBlue when asked which factors Malaysia should consider in listing a pneumococcal vaccine. “Clearly, it’s a balance we need to find.”
If Pfizer is unable to cut the price of PCV13, Dr Musa suggested that MOH boost value by requesting, for example, surveillance studies before and after the use of PCV13 in the NIP as part of the pneumococcal vaccine package.
The paediatrician also suggested that the US pharmaceutical company include in the package a single catch-up dose for children above two years, and fund community awareness programmes to boost PCV intake.
“Besides, Pfizer has been diligently doing PCV awareness since 2005,” he said. “And I suspect Pfizer will oblige because they see Malaysia as a leader in pioneering new vaccines in our NIP.”
The World Health Organization (WHO) estimates that pneumococcal disease kills about one million children globally every year. According to the US’ Centers for Disease Control and Prevention, pneumococcus is the most common cause of pneumonia, bloodstream infections, meningitis, and middle ear infections in young children.