Efforts are underway to develop a vaccine for Coronavirus on an urgent basis, but it’s a long-drawn process
Countries across the world today are working assiduously to contain the spread of Coronavirus. While effective containment strategies may have slowed the spread of the respiratory disease in Wuhan, China, mass production of a vaccine is the only way to completely forestall its further spread. It should be noted, however, that antibiotics don’t work against viruses. Antiviral drugs do.
Over 35 companies and biomedical institutes are in a race today to develop a vaccine for COVID-19, with some countries like the US and China even claiming to have entered clinical trials. Estimated to take around two years, these efforts are supported by an enormous amount of investment. Boston-based biotech firm Moderna will enter human trials imminently. Created 42 days after the genetic sequence of the virus was released by Chinese researchers in mid-January, the first vials were sent to the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in Bethesda, Maryland, for human testing.
The manufacture of a vaccine, however, is a long-drawn process, as there’s a great amount of meticulous testing and approval protocols involved. A vaccine has to succeed in clinical trials to get necessary approvals from drug authorities before it is market-ready. Experts feel it can take anywhere between two years or longer for a vaccine to move from the lab to the public. Vishal Sehgal, medical director, Portea Medical, an in-home healthcare service provider, explains how a vaccine goes through at least six stages of development before it can be made available for use. “The first stage is the most research-intensive and identifies the natural or synthetic antigens that might help prevent or treat a disease. The second stage involves testing to understand whether the candidate vaccine will produce immunity. In the clinical development stage, a sponsor submits an application for an Investigational New Drug (IND) to the US Food and Drug Administration (FDA).
Under this, there are three sub-phases. Once a vaccine passes through all three phases, the vaccine developer submits a Biologics License Application (BLA) to the FDA. The next step involves manufacturing and the last one is quality control. However, each of these stages requires inputs from numerous stakeholders, including lab researchers to policymakers and medical professionals. This timeline can change in the event of a pandemic, but it is imperative that we account for the minimum time frame,” he says.
Vaccines are developed, tested and regulated in a more thorough manner than other drugs. “Vaccines are more thoroughly tested than non-vaccine drugs, as the number of human subjects in vaccine clinical trials is usually greater. Also, post-licensure monitoring of vaccines is closely examined by the Centres for Disease Control and the FDA. The global push to make a Coronavirus vaccine is accelerated at all levels. Safety trials will begin as soon as a dozen of healthy volunteers in Seattle, Washington, receive a vaccine in a phase 1 safety trial sponsored by the US government. The key questions about how our immune system fights off the virus—and how to safely trigger a similar immune response with a vaccine—remain unanswered. If vaccine candidates released on an accelerated schedule turn out to be ineffective or unsafe, it could end up delaying the development and widescale rollout of an effective vaccine. So these trials seek to answer questions like how do people develop immunity and how long does it last?” says Dheeraj Jain, founder, Redcliffe Lifesciences, a molecular genomics diagnostic service provider.
The National Institutes of Health and Baylor University in Waco, Texas, say they are working on a vaccine based on what they know about coronaviruses in general, using information from the SARS outbreak, but it may take a year or more to develop. “Doctors are using different drug combinations, but there is a need to adopt unconventional ways of healthcare delivery to minimise the spread. Telehealth services can be utilised to ensure most patients with moderate symptoms stay at home and only the ones in a serious condition are brought to hospitals for better utilisation of resources,” says Vikram Thaploo, CEO, telehealth, Apollo Hospitals Group.
Till a vaccine comes to the market, containment and mitigation might be the only strategy.