Earlier this week, leading health experts, donors and scientists from around the world came together at the World Health Organization (WHO)’s Geneva office to understand the epidemic of COVID-19 — the disease caused by the novel coronavirus — and look at developing treatment options. They discussed diagnostics, drugs and vaccines that could work against the disease.
The treatment options to fight COVID-19 are limited, as it happens with most novel infectious diseases. Public health experts say in the absence of sustained investments by governments — and the lack of interest by pharmaceutical companies to find a cure for infections that impact middle- and low-income countries the most — responses to an epidemic such as COVID-19 become largely episodic.
Yet, this time, weeks after the world woke up to the coronavirus epidemic, public health institutes, not-for-profit drug-discovery agencies and even emerging biotech companies have fast-tracked their COVID-19 vaccine candidates into clinical trials.
Thanks to the genetic data about the virus, there are already 10 vaccine candidates in various stages of clinical trials. Norway-based Coalition of Epidemic Preparedness for Innovations (CEPI), US government’s Biomedical Advanced Research and Development Authority and National Institute of Health as well as India’s Department of Biotechnology are hoping to find ways to treat the disease.
“When you start developing vaccines,” says Gagandeep Kang, the executive chair and board member of CEPI, “you don’t know if it is going to work. What you have to do is try different approaches. You keep killing projects at different stages so that you wind up with at least one successful project. But it needs to start with seven or eight projects.”
Researchers are experimenting with several pathways — from extending vaccine platforms of other infectious diseases to using the antibodies produced by an infected human body — to fight novel coronavirus. For example, US-based Inovio is looking to extend its vaccine candidate for Middle Eastern Respiratory Syndrome that strengthens the body’s immune system to fight a disease. Known as “immunotherapy”, this pathway has become a common theme in new cancer medicines.
The University of Queensland is working on a “clamping” platform, which stabilises proteins that help the immune system identify foreign elements and trigger a fight against them. Serum Institute of India is teaming up with the US-based biotech company Codagenix. Live-attenuated vaccines, like the ones developed by Codagenix, are ideal in outbreak scenarios as these can be manufactured rapidly and generally require only modest amounts of active ingredients, says J Robert Coleman, CEO of Codagenix.
Since the outbreak of coronavirus was announced on December 31, the confirmed cases now stand at more than 66,000, with 1,523 deaths. In India, the three students who tested positive for the virus in Kerala have recovered, but three new cases were reported in Kolkata this week.
As Indian officials scan airports for infected passengers, the Department of Biotechnology (DBT) is busy on the discovery side. Renu Swarup, secretary of DBT, says they are looking at putting together a group to expedite the research for a vaccine. It is also giving top-up funding to Indian drug makers applying for CEPI research grants to find a vaccine.
Despite the rapid developments on the vaccine side, scientists say it will take at least a year for a vaccine to be licensed. So if coronavirus becomes a pandemic — which means a disease spreading to large parts of the world — the world would have no cure. WHO had said the virus was now being considered to be an epidemic with multiple locations. Anthony S Fauci, head of the National Institute of Allergy and Infectious Diseases, who is leading the applied research on infectious diseases such as Ebola, Zika and HIV AIDS, says once a vaccine candidate reaches phase-2 (it takes four months to get to that stage) it will still take eight months to see if it is effective. “Even though we go into trial in three months, a vaccine as a deployable countermeasure is not in the scenario for at least one year,” Fauci said.
It took four years for the Ebola vaccine to get licenced, says Kang of CEPI. “In Ebola, we got our first answer with a very tiny number of patients because of the ring vaccination strategy (a strategy to inhibit the spread of a disease by vaccinating only those who are most likely to be infected),” Kang explains. If the coronavirus crisis turns serious, she says, regulators around the world will need to rethink their requirement on the number of trials needed to approve a vaccine.
The current regulatory requirement to check the effectiveness of a vaccine is to administer it to hundreds of patients. However, scientists are debating whether it is ethical at all to continue trials on larger population during epidemics.
Another problem is that even if there is a vaccine candidate out there, companies might not be ready to make it. Companies like GlaxoSmithKline had taken a financial hit while trying to make Ebola vaccines. In 2019, GSK gave away the Ebola vaccine candidate to Sabin Vaccine Institute. In India, too, after the H1N1 virus outbreak, several companies had to destroy their inventories as the virus had died down by the time the vaccines were ready. For drug companies, developing vaccines during an epidemic does not make financial sense.
Ronald Klain, who led the Ebola Task Force for the US government, said at a session of the Aspen Institute’s conference that companies lose money while trying to make vaccines for such epidemics. “It is the global health organisations that have to step up to de-risk the situation. Because this is an international problem.”
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