Are Investigational New Drug Trials in India A Positive Sign For Healthcare
Are Investigational New Drug Trials in India A Positive Sign For Healthcare: The Researchers Perspective
With the new virus variant causing a surge in infections, India has been crippled by the pandemic. Apart from the shortage of medicines, oxygen and healthcare staff, several states in India face a shortage of vaccines – one of the most effective tools to end the pandemic.
As of 5 May 2021, 1.1 billion COVID-19 vaccine doses have been administered. However, only 0.3% went to low-income countries. Experts predict that if the vaccine production and distribution are not ramped up, it may take a minimum of 2 years for most income countries to be vaccinated.
In October last year, around 100 countries, led by India and South Africa, requested World Trade Organization members to agree on a time-limited waiver of COVID-19-related intellectual property (IP) rights. As per the request, the vaccine suppliers should share their knowledge so that more countries, especially low-income countries, can start producing vaccines on their own. Waiving the IP is expected to increase the production and the global coverage of COVID-19 vaccines.
The US until now had opposed the plan to waive the IP related to COVID -19 vaccines, but in a dramatic turn of events, on 5 May 2021, the US trade representative, Katherine Tai, announced that the US would support a proposal to waive patents on COVID-19 vaccines considering the urgent need for more global supply.
The pharmaceutical industry and others have opposed the decision to lift patent protections on COVID-19 vaccines. The opponents argue that waiving patents on COVID-19 vaccines may not ramp up production quickly and could compromise vaccine quality. However, supporters of the waiver disagree and point out that generics drug developers have been supplying the world with high-quality vaccines and drug products for years.
Experts suggest that there is a high probability of a third wave of the pandemic in India. Developing affordable generic vaccines can increase vaccine accessibility and help the country prepare for the next surge. If the patents are lifted, it will undoubtedly mean expanding the scale of production and speeding vaccine rollout.
Manufacturing vaccines is a complex process and is easier said than done. Though the IP waiver may be game-changing, many experts believe that IP is not the real hurdle. Manufacturers in developing countries need to be supported with the technology to actually produce the vaccines. This applies particularly to innovative vaccines such as mRNA. A majority of the COVID-19 vaccines involve an element of genetic manipulation, a highly complex procedure, which may be difficult to reverse engineer.
Manufacturing equipment and raw materials are other bottlenecks. It also requires highly trained staff and the establishment of workflows with stringent quality control.
While the US has proposed to support patent waiver, the export of vital raw materials is still blocked as per the country’s Defense Production Act, which grants US vaccine makers priority access to specialised materials such as filters, tubing and specialised disposable bags essential to making vaccines.
Lastly, any vaccine which is manufactured will have to go through the final step of clinical trials to get regulatory approvals.
Vaccine manufacturers who reverse engineer COVID-19 vaccines will have to run the vaccines through clinical trials once again. Clinical trials are necessary to evaluate the reverse-engineered version’s immunogenicity and efficacy.
Sharing of technology and IP could increase global vaccine coverage, which would likely increase public and private investment in developing countries like India.
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