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Continuous R&D must

The last decades have seen myriad vaccines in progress trailing off after outbreaks of diseases which were Coronavirus cousins, like the SARS and the MERS, fizzled out

When the new Coronavirus genome sequence was posted on an online databank in January, scientists in several biotechnology laboratories around the globe saw its close similarity to the SARS (Severe Acute Respiratory Syndrome) virus and thereby several teams started work on vaccine development. Internationally, experts are of the opinion that the world will “need the vaccines” to contain the current pandemic as it is very possible that this outbreak will not just fizzle out (considering its epidemiology and pattern) like the outbreaks of the last few decades but could return. In fact, it could come back with a vengeance (with mutations and antigenic shifts and drifts).

Large pharmaceutical companies such as Merck, Johnson & Johnson and Sanofi, as well as comparatively lesser-known biotechnology firms like Gilead, Regeneron, Inovio and Moderna, are pursuing vaccines and chemicals to fight the Coronavirus and the estimate is that at least 40 other biotechnology companies, small and big, are on one or the other research and development (R&D) mission for a vaccine or a drug to save the world at this time of a crisis. During the SARS pandemic, a research team at Boston was able to secure investments and thereby work progressed to clinical trials. The team, in all likelihood, could have accomplished all the phase trials for vaccine development. And had that been done during the 2002-2003 epidemic, we could have potentially been equipped with a vaccine to use in China in the initial days of the outbreak. This could have saved the world from the current pandemic and its resultant fallouts.

“This is the problem with the whole vaccine infrastructure, it is reactive and not enough anticipatory. Oh, SARS is gone now, let’s forget the fight we were on and just move on to other projects”, says one of the prominent scientists from the biotechnology industry.

The last decades have seen myriad vaccine R&D work in progress trailing off after outbreaks of infectious diseases which were Coronavirus cousins, like the SARS and the Middle East Respiratory Syndrome (MERS), fizzled out. Whenever a “mysterious” new illness emerges and public alarm is at its peak, there’s a race to develop a way to prevent or treat the disease. But by the time a promising candidate is ready, it’s often too late and the outbreak is on the wane. The world has seen this happen with the outbreaks of Zika, Ebola, SARS, MERS interspersed between epidemics of H5N1 and H7N9 avian, swine and H1N1 influenza.

The reasons for such incomplete work are varied — the potential patient pool for clinical trials dries up once an infectious outbreak subsides and the pool of medical customers for a drug also disappears as an epidemic disappears quite unpredictably, offering little chance to recover an investment of what could be hundreds of millions of dollars. Currently, various R&D works have been going on in parallel. The one at the most advanced stage is at its first human trial in Kaiser Permanente Washington Health Research Institute in Seattle, where four patients received jabs — the first being a 43-year-old mother of two.  This vaccine developed at Moderna therapeutics uses pre-existing technology and is made to a very high standard. The company claims it can’t cause the disease as genetic code copied from the virus that causes the disease is used and not a “real virus” extract. It is named Mrna-1,273 Vaccine and is very unlike the usual vaccines in use that are prepared from weakened (live) or killed viruses.

Scientists working at Moderna say the vaccine has been made using a tried and tested process. And at the same time experts reiterate that it will take many months to know if this vaccine has served the intended purpose or not. The main goal of this first set of tests is to find out if the vaccine is safe. If it is, later studies will determine how well it works. Such rapid development of a potential vaccine is unprecedented, and it was possible because researchers were able to use what they already knew about related Coronaviruses that had caused SARS and MERS.

Besides this advancement, there are others on the job for the benefit of humanity. In a suburb south of Boston, robots are manufacturing a potential vaccine. Another candidate vaccine —development work for which started when SARS terrified the world in early 2000s — sits in deep freeze in a repository ready to be thawed and formulated into thousands of vials for further testing. Yet another is being put together at facilities in San Diego and Houston, with projections that it could be tested on people by the summer of 2020. Another laboratory in San Diego, the Inovio, is using a new type of DNA technology to develop a potential vaccine. It is named INO-4,800 and is planned to enter human trials by the summer.

For any vaccine to be deployed after development takes at least a year because of the time needed to run clinical trials and attain regulatory permissions. Hence in all probability there may be an approved therapeutic drug (to treat COVID-19) long before scientists actually arrive at a licenced, marketable vaccine.

Several drug makers, most prominently Gilead Sciences (California) —an anti-HIV drug company and Toyama Chemical (Japan) are testing medicines developed for other diseases as a possible Coronavirus treatment. The most promising, broad spectrum anti-viral drug that has come up is Remdesivir, the same drug that was tried in controlling the Ebola virus outbreak with poor results.

Gilead and health authorities in China are racing to test it on people in controlled trials. This US-based biotechnology company had already shipped this drug to China to be used on the patients even without FDA approval on requests from treating physicians.

Another drug Kaletra — a combination of two anti-HIV drugs from pharma group AbbVie is in trials. The anti-malarial drug Chloroquine is another relatively safe drug with high activity against the Coronavirus, though this needs some definitive clinical trials to mark its efficacy.

The laboratory of Beth Israel in collaboration with Janssen is working to accelerate another vaccine. This laboratory is using a common cold virus to deliver a Coronavirus antigen into cells to stimulate the immune system. This laboratory has earlier used a similar approach to make over a million doses of a vaccine for the Ebola virus that has yet to be licenced. The work done against Coronavirus is in the stage of testing multiple versions of the vaccine on mice, ferrets and Rhesus monkeys exposed to the Coronavirus within a research facility.

Historically, the promise of breakthrough medicines and treatments appears to rest with private companies, and not the federally-sponsored manufacturing sites. Drug companies are often seen to be reluctant to develop vaccines because more often than not such epidemics dissipate long before a vaccine can pass through the regulatory lines and be approved. And the financial implications of such R&D work are too high on the companies to handle, once the disease and the customers dissipate quite suddenly.

Charitable donations are being used to support prominent pharma groups and promising projects and the leading player in this is the Coalition for Epidemic Preparedness Innovations (CEPI). This is supporting Inovio and Moderna groups for vaccine development and its co-founders are the Governments of Norway and India, the Bill and Melinda Gates Foundation and the Wellcome trust.

For future disaster preparedness against infectious disease outbreaks we need funds from Governments and philanthropic organisations to support pharmaceutical groups not just in their basic research but for the late stage developments as well.

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