Emerging Manufacturers engagements in the COVID -19 vaccine research, development and supply


 Abstract
 
 The World Health Organization declared the COVID-19 disease as a pandemic requiring a rapid response. Through online search, direct communication with network members and an internal survey, engagements of developing countries’ vaccine manufacturers’ network members in the research and development of COVID-19 vaccines and their capacities in the manufacturing, fill-finish and distribution of vaccines were assessed.
 Currently, 19 network members engaged in research and development of COVID-19 vaccines, using six principal technology platforms. In addition, an internal survey showed that the number of vaccines supplied collectively by 37 members, in 2018-19, was about 3.5 billion doses annually. Almost a third of network members having vaccines prequalified by the World Health Organization comply with international regulations and mechanisms to distribute vaccines across borders. The use of existing manufacturing, fill-finish and distribution capabilities can support an efficient roll-out of vaccines against COVID-19, while maintaining supply security of existing vaccines for on-going immunization programmes.
 



I. Introduction and background
A new strain of coronavirus not previously identified in humans, the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), emerged in December 2019 [1]. COVID-19 is the name given to the disease associated with the SARS-CoV-2 virus. Given escalating outbreaks in over 100 countries, the World Health Organization declared on 11 March 2020 that the COVID-19 disease can be characterized as a pandemic [2]. Early June, 2020, the total number of cases identified passed 6.5 million with over 380 thousand deaths globally [3].
Coronaviruses are enveloped positive stranded RNA viruses in the order of Nidovirales [4]. Epithelial cells in the respiratory and gastrointestinal tract are the primary target cells of these viruses. COVID-19 is highly contagious which would indicate the need for widespread vaccination, once vaccines are available. The genetic sequence of the novel coronavirus was shared for developing specific diagnostic and other health products including vaccines [5].
The Developing Countries Vaccine Manufacturers Network (DCVMN) is a public-health driven alliance representing vaccine manufacturers from emerging countries engaged in research, development, manufacturing and supply of vaccines for local and international use, aiming to protect all people against known and emerging infectious diseases [6]. DCVMN members have proven manufacturing, formulation, filling, packaging and distribution capabilities to ensure vaccines reach populations round the world in support of the global call to fight the pandemic [7]. This report outlines four key areas where DCVMN-affiliated manufacturers are engaged in vaccine research and development using various technology platforms, and could play a role in large scale manufacturing and supply capabilities, for supporting an efficient roll-out of potential vaccines against COVID-19.

II. Methodology
We conducted an online search, on COVID-19 vaccine research and development activity by DCVMN members, to compile an overview of initial efforts to date, combined with recent survey results on supply capacity as described in detail elsewhere [6],complemented with some data from 2019. stage that vaccination of all populations will be demanded, given the high level of contagion of the virus. It is conjectured that a number of vaccines will be necessary to supply the world's populations.
As yet, there is no determination as to whether any candidate vaccine will be universal or indicated for specific populations, how many doses will be required, nor of the likely container presentations: prefilled single dose syringes, single or multidose vials, nasal spray, micropatches or other delivery devices.

IV. Rapid Scale up and Large Scale Manufacturing
While broad research and development is key to achieving an effective safe vaccine, massive levels of manufacturing will be required to meet the presumed high demand. Speed of transitioning from a proven vaccine to large-scale manufacturing will be essential in order to commence immunization globally as soon as possible. Deploying available facilities, especially viral vaccine production capacity, will likely save time, resources and, importantly, lives, recognizing DCVMN members' capacities, both those with WHO prequalified vaccines and those certified by national regulatory authorities. [6].
According to an internal survey the total number of doses supplied collectively by 37 DCVMN members was around 3.5 billion in 2018/2019 ( vaccine into ten dose vials, as used in large immunization programmes, would imply that with filling 100 million vials, one billion doses could be supplied.
However, the exact available capabilities, for both antigen manufacturing and filling capacity, and the feasibility and timing of a manufacturing "switch" from currently produced antigens to produce potential COVID-19 vaccines, need to be carefully assessed in discussions with manufacturers on an individual basis.
Gavi, the Vaccine Alliance, estimated that the cost of manufacturing hundreds of millions of doses of a single product will range from $50 million dollars for companies with existing facilities and trained personnel, to about $700 million dollars for those starting from scratch [13]. barcoding traceability standards for international shipping/supply [16]. It will also help to secure the supply chain against substandard and falsified vaccines and provide visibility for all supply chain actors.

VI. Maintaining supply of other essential vaccines
An important concern is that efforts to make vaccines to halt this pandemic should not hamper other vital vaccine production. DCVMN members are engaged in the production or distribution of nearly 50 distinct vaccines with close to 200 products [6]. Ensuring the security of this supply to national and international destinations is central to the mission of DCVMN. The amount of spare capacity available at any time for the formulation or fill-finish of COVID-19 vaccines will depend on the specific situation of each member which is retained by them as confidential information.
Using spare capacity and/or expanding working operations, DCVMN members can support the manufacturing, fill-finish and distribution of COVID-19 vaccines, without jeopardizing the ongoing production of vaccines for national immunization programmes.