From previous clinical data and trials, one can notice and understand that it takes around 10-15 years for the development of any vaccine against a virus or disease. In case of the Covid-19 vaccine, the limitations caused due to the extended waiting period for the vaccines in general had to be broken by developing essential solutions that could be accepted by all. The scientific community realised early on that this task cannot be achieved by working in isolation. It has to be an integrated effort by everyone connected to and responsible for the virus research. To find effective solutions, the key stakeholders had to work in close coordination with the government, regulators, ethics committees, sponsors, investigators, or patients as the need may be. The situation also demanded effective partnership between private pharmaceutical corporate bodies, public health administrators, and key research labs and universities.
A responsible government
The barriers of national borders or political ideologies did not come in the way towards combating the pandemic. The governments all over have been working towards a robust solution that focussed on:
1) Devising effective control mechanisms to restrict the spread of the Covid-19 virus within their country through lockdowns and restricted travel.
2) To declare road-maps and schedules either for the development of vaccines in close co-ordination with the pharmaceutical companies, on one hand, and research labs on the other.
3) Procure vaccines from other countries who have essential facilities to respond to the situation effectively.
For example, the U.S. government names the efforts to develop a vaccine as Operation Warp Speed, which brought together various national bodies such as the Department of Health and Human Services, Food and Drug Administration, and the Department of Defense, solely to help pharmaceutical companies not only to develop the vaccine but also to strategise the launch and distribution through the length and breadth of the U.S.
Similarly, the European Commission also funded various candidates by pledging over $8 billion for vaccine research alone in European Union region.
Breakthrough for Covid-19 vaccine
The world-wide endeavour to develop vaccines has already started bearing fruit. Few countries, including India, have successfully developed the vaccines and have been authorised to start vaccination drives and share the vaccines with other countries that lack the necessary facilities and infrastructure to develop the same. Various tracking mechanisms are in play to effectively monitor and control the flow for those countries that have achieved approval for vaccine manufacture. They also track the progress of companies that are in various phases of vaccine development with clinical trials and other related developments.
Role of pharmaceutical companies and research laboratories
The vaccine has now been developed to suit the phase-wise trial requirements. Safety and efficacy are essential to be adhered to. Any slack in this area might lead to a shift in the risk versus benefit mindset leading to catastrophic outcomes. The conventional time-consuming process of vaccine development, and the development of vaccines using genetic engineering methods—which are much faster—both the methods have been chosen.
Pharmaceutical companies and research laboratories have responsibly taken the onus towards the development of safe and effective vaccines. They are handling the pressure of expediting regulatory approvals after every stage of trials along with managing the production of safe and effective vaccines on or before the scheduled date of trial completion. Researchers have successfully shortened the pre-clinical phase considerably to initiate clinical phase trials ahead of time.
Flexible regulations
Though the commitments to avoid accidents due to vaccinations remains the core concern for all stakeholders, yet, both the regulators and the ethics committee released new guidelines. Few of those guidelines include:
1) Necessary freedom to be flexible regarding the enforcement of general requirements.
2) As long as the alternative procedure devised for vaccine development was keeping up to the requirements of normal regulations, all other parameters of regulations were negated, to enable faster development of safe and effective vaccines.
3) Regulators also followed necessary norms for giving permissions at various stages of vaccine development, based on their inspection of every aspect of the trial. The regulators went out of the way to guide the researchers in the right direction.
Challenge for the Sponsors and CROs
The Sponsors and CROs have taken a plunge to catch up with the expedited timeline to overcome operational challenges. Some of the tasks include:
1) Severely compressed timeline with no scope for extension.
2) Remotely assessing the huge data getting generated was a bigger challenge, thanks to various electronic gadgets and tools which were enabled.
3) The erratic spread of the virus affecting the trial sites posed irresolvable challenges.
4) Implementation of electronic connectivity at all location, spread over various geographies was very challenging.
5) For pivotal studies, it was recommended that the trial be conducted—At multi-centric location within a nation, and also at a multi-national level.
Every adverse event was adequately reported for analysis and interpretation by the medical monitors on a real-time basis. Monitoring of logistical factors in cold conditions have been extremely important as it has a direct impact on the efficacy of the vaccines.
Massive amount of various data which were generated during the process of trials underwent continuous cleaning without damaging the required data and locking the same after the final trial for each patient. After this, the final data with its outcome had to be analysed, and the outcome to be shared with all concerned for relevant actions subsequently. The timely availability of finances for expediting all trials has also been very crucial.
The technological advancement facilitated due to the IT revolution and opening of the economy due to globalisation efforts, combined with the collaborated efforts of all stakeholders, has been of great help in the transfer of information and subsequent management of the same effect in the development of vaccines at the fastest rate possible.
It was also very essential to be vigilant, especially through certain encoded systems, to monitor the effect of vaccinations and to analyse them diligently and continuously. This vigilance mechanism helps in modulating the formulations to create corrective actions with near cent-percent success.
Accelerating a safe and effective Covid-19 vaccine
The availability of safe and effective vaccines, production in mass-scale at a rapid rate, and creating effective logistical patterns to dispatch the vaccines from every nook and corner are the major challenges that need to be addressed. The vaccine is the only solution seen to contribute towards the control of the pandemic. The challenges posed by the Covid-19 virus are major and extraordinary. WHO has been working effectively in facilitating necessary collaboration by and between various factors associated with vaccine development, with accelerated efforts at a scale, something that has not been seen before by humanity.
Highlights of the current Covid-19 scenario
The fast-track development of vaccines for the Covid-19 virus by the effective application of genetic engineering has enabled the world research and scientific community to usher into a new era of vaccine development. Conducting clinical trials for the vaccines has been the most difficult task during the lock-down period since it was highly impractical for one to predict the outbreak of the virus and develop trial sites based on this factor.
Further, with the high mortality rate of Covid-19 affected patients, the general public is apprehensive to volunteer to allow the researchers and scientists to take a trial of vaccines. On getting positive results for the trial of vaccinations done on humans, the production capacity of the vaccines was enhanced causing a heavy inflow of funds. Organising financers and government sanctions is another deterrent factor that has to be faced.
The pandemic has created a simultaneous demand for vaccines all around the world. A globally fair vaccine allocation system needs to be established and put into place which shall enable the distribution of vaccines to the targeted community based on the risk level.
In the eventuality of the seriousness of the virus getting reduced around the time, the vaccines are developed, the manufacturing activities of safe and effective vaccinations should be continued with stockpiling options. To achieve this goal, a global financing system also needs to be developed to facilitate large-scale manufacturing and deployment of vaccines, to avoid financial losses for the manufacturing partners. Preparedness for future outbreaks could be redeemed through this process.
Views are personal. The author is Director, SIRO Clinpharm.
