Following the news that the Phase III study of the COVID-19 vaccine developed by Pfizer and BioNTech has been concluded and is showing 95 per cent efficacy in prevention of the disease; Vinie Varkey, Senior Pharma Analyst at GlobalData, offers her view.
She says, “With the mRNA vaccine candidate BNT162b2 having key safety data for the two-month follow-up period in support of an emergency use authorisation (EUA), two key stakeholders in the pharma sector are likely to face an exceptional responsibility and have their mettle tested to ensure that the vaccine swiftly reaches the market. In an anticipated first, it is very likely that both drug approval regulators around the world, as well as logistics providers, will have the eyes of the public centred on them while they undertake crucial steps towards ensuring commercial availability of the vaccine. In modern history, no vaccine has ever been considered as essential to restoring normality to our way of life as these first mRNA vaccines.”
“In many ways, COVID-19 has been associated with a lot of firsts. The effects of COVID-19 have transcended boundaries and the virus has spared no aspect of life from its impact. Nonetheless, the pharma sector has been resilient in its mission to bring an effective vaccine to the market – demonstrated by the remarkable efficacy data from Phase III trials evaluating BNT162b2, which can only be considered revolutionary. Furthermore, the fact that the efficacy results of Phase III trial were announced a mere seven months after the companies started their first Phase I study is phenomenal – especially for a novel virus,” she explains.
“With strong results from the Phase III trial, the onus is likely to be on regulators and supply chain stakeholders for the rapid roll-out of the vaccine. This is the first vaccine based on mRNA technology to have demonstrated efficacy in prevention of an infectious disease in human trials, and these results have shown that this platform is a powerful tool for tackling emerging infectious disease threats. With the global interest being that a vaccine is made commercially available as soon as possible, regulators will be pressured to rapidly evaluate the safety and efficacy of this vaccine, while also factoring in that this is based on a novel technology platform,” adds Varkey.
“While mRNA vaccines in development for COVID-19 so far have shown promising results – including the vaccine candidate from Moderna – these vaccines have also presented a new challenge, one that is associated with logistics. While Pfizer’s vaccine requires deep-freeze storage and have a short shelf-life at refrigerator temperatures, Moderna’s vaccine is understood to be more stable at standard refrigerator temperature. Nonetheless, pharma companies are engaging with cold-storage specialists to ensure a smooth supply of the vaccine when it does become commercially available. Agreements between pharma companies and logistics providers can be expected to increase to help navigate around this challenge. Once these logistics have been arranged and manufacturing has been scaled up, control of this outbreak will be on the horizon, offering relief to the myriad sectors that continue to be plagued by this continuously problematic disease,” she concludes.