Health

COVID-19: Extensive research underway; how much will it help?

As many as 42 vaccines were in preclinical stage and two vaccines in Phase I clinical trials as of March 20, according to WHO  

 
By Vibha Varshney
Last Updated: Monday 06 April 2020
Medicine tablets. Source: Public Domain Pictures

Most of the world’s population is adversely affected by the novel coronavirus disease (COVID-19) pandemic and the subsequent public restrictions to contain it. But the pandemic has set the ball rolling for multiple companies to test and make drugs, vaccines and diagnostics.

According to the World Health Organisation (WHO), as many as 42 vaccines for the virus SARS-CoV-2 were in preclinical stage and two vaccines in Phase I clinical trials as of March 20, 2020.

Similarly, a pipeline assessment of diagnostics by Foundation for Innovative New Diagnostics, a global non-profit organisation that drives research on diagnostics 36 molecular assays 38 immunoassays, are in development.

Data from a coronavirus treatment acceleration program run by United States Food and Drug Administration to support new therapies showed that 10 therapeutic agents were in active trials and another 15 therapeutic agents in planning stages.

Profits are at the centre of these endeavours. Wall Street is already monitoring biotech companies involved in making these products. According to Nasdaq, Dynavax Technologies Corp, a California-based company that makes adjuvants used to make vaccines effective at lower doses, will invest in the venture.

The company is working with University of Queensland and has secured funding from Oslo-based non-profit, Coalition for Epidemic Preparedness Innovations (CEPI).

CEPI has deployed up to $29.2 million in the search for a COVID-19 vaccine. The organisation hopes to fund at least three vaccine candidates and estimates it would need an investment of $2 billion to develop a vaccine ready for global deployment.

At present, most research on drugs, vaccines and diagnostics is being carried out by small biotech companies and universities who would end up selling their knowhow to the big four — GlaxoSmithKline, Sanofi, Merck and Pfizer — which control as much as 85 per cent of the vaccine market.

Many of these small companies are using novel techniques to develop vaccines. For example, Boston-based Moderna is working with National Institutes of Allergy and Infectious Disease (NIAID) — under the United States health department — on a Ribonucleic acid-based vaccine which codes for spike protein on the virus.

The company has already shipped doses of the vaccine to the NIAID Vaccine Research Center for the Phase I safety trial, which is likely to begin in April. However, it is not likely that the vaccine would be ready anytime soon. NIAID director Anthony Fauci recently reported to US senators that it would take at least a year-and-a-half to have a vaccine.

After this, it would need to be seen if these can be manufactured in sufficient quantities and are available at an affordable price.

A spokesperson for GAVI, the vaccine alliance, told DTE that the organisation has taken steps to help strengthen the preparedness of health systems in lower-income countries. Under this, countries that qualify for GAVI support will be able to quickly reallocate up to 10 per cent of grants extended to them to respond to the threat posed by SARS-CoV-2.

GAVI is an international organisation created in 2000 to improve access to new and underused vaccines for children living in the world's poorest countries.

GAVI said: 

GAVI will continue to monitor the pandemic as it evolves to understand how to best leverage the alliance’s expertise in delivering affordable vaccines at scale and to the most vulnerable.

As many as four clinical trials are being carried out across the world to test the efficacy of the BCG vaccine against the virus. It has been shown that the vaccine trains the innate immunity in a person.

When a person is attacked by a microbe, the body's innate immune system kicks in. Monocytes, a type of white blood cell, penetrate the infected tissue, convert to macrophages and provide the first line of defense.

Mihai Netea, a researcher at the Radboud University in the Netherlands has shown that the innate immune system has a memory. The genetic material in immune cell remains in a state of high alert for several months following an infection and can offer protection from new infections.

Other than this, existing experimental vaccines against Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) are also likely to work.

The University of Oxford recently received permission to test the vaccine, ChAdOx1 nCoV-19, in humans. The vaccine is based on an adenovirus vaccine vector and the COVID-19 spike protein, and is an extension of the group’s work on MERS vaccine.

Similarly, Maryland-based Novavax Industries Corp is working on vaccines against SARS and MERS and expects to complete animal testing soon and move to the first phase of human trials by the end of spring 2020.

Existing drugs are also being rapidly tested against SARS-CoV-2. Antimalarial drug chloroquin is being used in combination with the antibiotic azithromycin for their protective effect.

Another drug, Remdesivir, was developed and patented 10 years ago by Gilead Sciences, a research-based biopharmaceutical company, against the Ebola virus. A recent study showed that this drug was useful against MERS coronavirus, suggesting that it could work on COVID-19 too.

Gilead is carrying out clinical trials of the same drug in China in collaboration with the Chinese government. The earliest results from these trials are expected in April 2020.

Other drugs being experimented with are the antivirals Lopinavir and Ritonavir (sold together as Kaletra for HIV/ AIDS patients) and influenza drugs like Oseltamivir. A recent study showed that camostat mesylate, a drug approved for pancreatitis in Japan, blocks SARS-CoV-2 infection of cells and could be another off-label drug choice.

Most of these drugs are off patent and manufacturing capacities already exist.

“Since the composition of matter for these compounds has long since passed into the public domain, any subscription could be made for another use that would get around the patent,” said James Leahy, professor at the Florida Center of Excellence for Drug Discovery & Innovation, Department of Molecular Medicine, University of South Florida.

Leahy is also optimistic that the industry life threatening illnesses will be as susceptible to price gouging by the industry as more lifestyle-type drugs like for ED or psoriasis.

“Once an approved treatment plan is in place, many organisations will start manufacturing drugs. For the older ones, the process will be simple. For the newer ones, I expect that countries such as India would allow for patent invalidation in the interest of public need,” Leahy added.

Proposed drugs and vaccines need to be tested properly.

An experimental SARS vaccine had earlier aggravated symptoms in animals. Though it was later modified to eliminate the problem, this was the same vaccine that has been repurposed for SARS-CoV-2.

Stringent safety tests are therefore needed. According to Shibo Jiang, professor of virology at the School of Basic Medical Sciences, Fudan University, Shanghai, testing vaccines and medicines without taking the time to fully understand safety risks could bring unwarranted setbacks during the current pandemic.

“The public’s willingness to back quarantines and other health measures to slow the spread tends to correlate with how much people trust the government’s health advice. A rush into potentially risky vaccines and therapies will betray that trust and discourage work to develop better assessments. Despite the genuine need for urgency, the old saying holds: Measure twice, cut once,” he wrote.

 

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