Topic: General Studies 2:
- Government policies and interventions for development in various sectors and issues arising out of their design and implementation.
- Health related issues
COVID-19: The race to find a cure
Context: The novel coronavirus has infected more than 4 lakh people worldwide and has led to the deaths of more than 17,000.
- The epicentre of the pandemic has now shifted from China to Western Developed countries
- With no specific therapy available at present, there is an increased pressure on world scientific community to fast-forward the development of vaccine
- As per WHO reports, nearly 20 vaccine candidates are in advanced stages of development and will be ready for Phase-I safety trials.
- In USA: Phase-I safety trials of an experimental vaccine (mRNA-1273) has already been administered to healthy volunteers for its safety and immunogenicity.
- In China: Another vaccine jointly developed by China’s Academy of Military Medical Sciences and CanSino Biologics has reportedly been cleared for early-stage clinical trials on more than 100 healthy volunteers
- The Serum Institute of India has also announced its readiness to start safety trials of a drug following animal experiments
Challenges of Vaccine Discovery
- Side Effects: The immune response induced by experimental vaccination may lead to any disease enhancements.
- Duration of immunity: If the immunity induced due to vaccination is transient, then humans will be susceptible to reinfections. Thus, a longer test period is required
- Lengthy Process: It will not be possible to roll-out any efficacious vaccine for at least another year, considering the complexity and the lengthy regulatory process involved in vaccine development
- Scientists and pharmaceutical companies have thus rushed to investigate and use drugs that have already been approved by regulatory authorities.
- With the available biological information about the virus protein & its mechanism of infection, the re-purposing of existing drugs to treat COVID-19 patients has already been started in many countries
- However, without any appropriate controls, careful dosing and safety concerns, such small experiments can do more harm than good
Controlled randomised trials
- It is a study in which people are allocated at random (by chance alone) to receive one of several clinical interventions (in this case the experimental vaccine)
- Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome. This speeds up the process to understand the drug’s efficacy without undermining safety standards.
- Solidarity Project: It is an initiative by WHO whereby four drugs or drug combinations will be tested randomly in many countries around the world.
- It includes the anti-Ebola drug, Remdesivir, Chloroquine, anti-HIV drugs, and the Ritonavir/Lopinavir combination, with or without Interferon-beta.
- The European counterpart of the trial, Discovery, will also conduct such trials in countries including France, Spain, Germany and the U.K.
- The pharma company Roche has also decided to initiate large, randomised Phase-III trials of its arthritis drug Actemra for its safety and efficacy in adult patients with severe COVID-19 pneumonia.
Hopefully, these trials will lead to tangible drug therapies against COVID-19.
Connecting the dots:
- Generic drugs and Branded drugs