The world is anxiously waiting for the Covid-19 vaccine to be made available. Many may resort to obtaining them as quickly as possible out of fear.
So it is imperative that the public learn about the complex supply chain that governs the production and distribution of these vaccines.
Weaknesses in the supply chain can affect a vaccine's safety, quality and efficacy. Hence, it is important to pay attention to various components of the supply chain.
Good Manufacturing Practice (GMP) is essential because the way they are manufactured will have a significant impact on the final product. This is especially important in a medical product because its quality (or lack of it) will have a direct impact on morbidity and mortality.
Large-scale vaccine production must ensure the safety, quality, and efficacy of each unit/vial, influenced not only by the manufacturing process, but also by the physical facilities, quality of the raw materials, personnel, documentation and quality systems, as well as packaging.
Two local manufacturers (Pharmaniaga and Duopharma) indicated they have the necessary facilities to fill and finish vaccines. Malaysia is part of the internationally recognised Pharmaceutical Inspection Cooperation Scheme. Thus, our manufacturers and fill and finish facilities approved by the National Pharmaceutical Regulatory Agency will be in line with international standards.
The importance of GMP was highlighted recently when a mistake was made in the filling of the vaccine dose in a facility where the AstraOxford vaccine was manufactured for clinical trials. The dose was lower than what was stated on the label.
By the time the mistake was discovered, the vaccine had already been administered to subjects in the clinical trial.
However, it was found that a low dose for the first injection followed by a "normal" dose for the second produced an efficacy rate of 90 per cent, while two equal doses (as planned) produced an efficacy rate of 70 per cent. Despite the possible positive outcome, the filling of the lower dose is a serious breach of GMP.
Good Distribution Practice refers to the practices in the product distribution from the time it leaves the manufacturing site to the point of administration to the patient/healthy individual — by road, rail, water and air. Pfizer and Moderna vaccines require storage at below freezing temperature, -70°C and -20°C, respectively.
Thus, they are packed with dry ice in sealed thermal shipper boxes and shipped in refrigerated containers. Any excursions will have detrimental effects on the vaccine. The thermal shipper boxes of the Pfizer vaccine have GPS-enabled thermal sensors, which will track the location and temperature of the vaccines that are shipped across the globe.
Logistic companies, like FedEx and DHL, importers and distributors must have suitable storage facilities and refrigerated transport facilities. Companies here who have indicated interest to import vaccines for supply, primarily for the private sector will need to have the required facilities for proper storage for distribution.
Buying medicine or medical products over the Internet must be done with caution. It is illegal to sell prescription medicine (including vaccines) over the Internet, but the sale of health supplements and products not containing controlled substances is permitted.
The safety, efficacy and quality, and authenticity of products sold over the Internet cannot be guaranteed. Soon after the Pfizer vaccine was approved by the Medicines and Healthcare Products Regulatory Agency and the United States Food and Drugs Administration, there were reports of products claiming to be vaccines being sold on the Internet. Do not buy them!
Unfortunately, a good supply chain does not by itself ensure access to the vaccine to all who require it. The government has announced that vaccines will be provided free for citizens. In anticipation of regulatory approval from the Drug Control Authority, the government has placed advanced orders for the Pfizer and Astra vaccines, the Covax initiative, and from China and Russia.
Advance orders will cater for up to 82.8 per cent of our population. It is believed when 80 per cent of a population is vaccinated, the population will achieve herd immunity. However, in view of the latest highly transmittable mutation of the virus, countries like Singapore think that 90 per cent the population will need to be vaccinated for effective herd immunity.
We can only hope that all nations and pharma companies look at this collectively as a global problem and work in concert to ensure everyone has access to an effective vaccine.
The writer is the Executive Dean and Professor at the Faculty of Health and Medical Sciences, Taylor's University and Director of the Taylor's University APEC-LSIF Centre of Excellence for Global Supply Chain Integrity
The views expressed in this article are the author's own and do not necessarily reflect those of the New Straits Times