To survive COVID-19 we need vaccine diplomacy
By: Neha Mukherjee
Tags: International Relations, Cooperation, Vaccine Development, Covid 19 Crisis, Covid 19

In the age of COVID-19, the historical successes and failures point to the need to implement vaccine diplomacy in every aspect: discovery, production, and distribution. On January 10th, China and Australia shared the genome of the virus with the Center for Structural Genomics and Infectious Disease which includes over 40 countries.

A Nature article discusses how this discovery process led to different countries agreeing to “take snapshots” of different proteins which they would then focus on in order to isolate the antigen of interest.

First, it is critical to understand the science of a vaccine. A vaccine introduces a weakened version of the virus to the human body so that the body can build immunity when it encounters the virus in the future.

This immunity is gained in the form of antibodies, a protein released by B cells, which recognize various parts of the virus. Targeting different viral proteins and antigens, is traditionally a slow and laborious process. This includes determining which part of the virus needs to be targeted as a patient’s outcome can depend on which viral protein their body’s immune system targets.

As Dr. Gait Alter put it in a lecture for Brown University, it is not the number of antibodies that will determine immunity but rather the type or “flavor” that is important. Most scientists have now decided to move forward with vaccines targeting the “spike” protein of the Coronavirus.

The main point is that it is critical to understand the full genome of the virus so that scientists can design a vaccine that will target the correct protein, a process that requires extensive lab work and can be accelerated with shared data among labs.

Once scientists determined that this spike protein should be targeted, different companies embarked on several ways to actually produce a vaccine. This includes a variety of approaches such as whole inactivated virus vaccines, gene-based vaccines, and other genetic techniques that strive to elicit an immune response by introducing the virus or parts of the virus into human cells.

The Center for Disease Control outlines their trial process in six stages: Exploratory, Pre-Clinical, Clinical, Regulatory Review and Approval, Manufacturing, and Quality Control.

Within the Clinical Development Stage there are four phases. In Phase I small groups of people receive a trial vaccine. Phase II the vaccine is given to a larger sample of people but is expanded to those that have specific characteristics of interest. In Phase III the vaccine is tested for safety and efficacy in a trial that includes thousands of people. Phase IV is an ongoing stage that studies long term effects after approval.

An interactive tool from the New York Times shows that with academic research, pre-clinical work, clinical trials, factory building, manufacturing and distribution it would take the vaccine around 16 years to produce and release into the world.

Commonly, vaccines take 10–15 years to produce. To date the fastest vaccine to be produced is the Mumps vaccine which was done in a record time of five years in 1967. Thus the proposed 12–18 month timeline for a COVID-19 vaccine would be unprecedented.

Yet in a panel discussion published by the New York Times Magazine, panelists, all experts of science and vaccine production, note that with an unprecedented timeline they have also seen a new wave of collaborative efforts in COVID-19 vaccine production.

George Yancopoulos, the co-founder and President and Chief Scientific Officer at Regeneron said “Whether it’s scientists in academia, whether it’s people at biotech and pharma companies, whether it’s the doctors and health care workers who are at the epicenter at hospitals like Mount Sinai or Columbia in New York City, whether it’s the F.D.A. — we are all coming together, and things are happening at unprecedented rates because we realize that we have a common enemy.”

He is right. When China and Australia shared the vaccine genome this significantly shortened the academic research stage. What would usually take more than two years to discover a genome and understand the virus was able to be done in a matter of months as companies all over the world use the genome presented in the Center for Structural Genomics and Infectious Disease.

As we moved into pre-clinical and clinical phases, we again saw signs of diplomacy both across companies and countries. Marcus Spiller, Associate Director, FM and MRO Procurement at a leading pharmaceutical company says “Aggregating and using collective clinical and research data from around the world has been unprecedented and one of a series of initiatives to speed up research to treatment for Covid-19.”

As of July 14th, the RNA vaccine created by BioNTech (German), Pfizer (American), and Fosun Pharma (Chinese) is in Phase 1/II trials. The non-Replicating Viral Vector vaccine created by University of Oxford and AstraZeneca (Swedish) has entered Phase II and III trials in South Africa, Brazil, and England.

These are just a few examples of the 23 candidate vaccines in clinical evaluation by the World Health Organization. Through the sharing of information, pooling of resources, and movement to a parallel structure of phases, these clinical development trials which usually take over a decade to complete are also slated to be finished within months. But as more vaccine candidates move into Phase III trials and further into manufacturing, which is also happening in conjunction with late stage clinical trials, it will be essential that we consider equitability.

If we have learned anything from the responses of Ebola, Zika, and H1N1, it is that when we do not come together, scientifically, politically, and financially, a vaccine response will not be fast enough to truly help people in all parts of the world.

In the case of COVID-19, major steps have already been taken to share scientific knowledge and it is this principle that must continue as we strive to manufacture and distribute the vaccine. To continue to innovate, pharmaceutical companies and governments cannot endure significant losses on the production of vaccines, even when we are in a global crisis. This is not due to a lack of humanitarian purpose, but rather from a realistic, financial standpoint.