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Fighting the COVID-19 virus: Clinical Trials open the second front! 1.0

March 26, 2020

Whatever led to Covid 2019 – there are conspiracy theories galore, evolution, mutation, climate change and more. As health workers worldwide battle with the seriously affected, another theatre opened last Monday. Along with the ICUs, laboratories carrying out Clinical Trials have joined in. Over 35 drug makers are fighting with millions of dollars at stake.

Most of the vaccine research under way globally targets a protein called ‘spike’ that studs the surface of the new coronavirus and lets it invade human cells. So, this is a race to develop a vaccine that succeeds in blocking spike – which will prevent people from getting infected.

Interestingly, researchers at the U.S. National Institutes of Health (NIH) have copied the virus’ genetic code that contains the instructions for cells to create the spike protein. This vaccine code-named mRNA-1273, was developed by the NIH and Massachusetts-based biotechnology company. Moderna Inc. encased that “messenger RNA” into a vaccine. The Seattle research institute is part of a government network that tests all kinds of vaccines and was chosen for the coronavirus vaccine study before COVID-19 began spreading widely in Washington state.

This vaccine code-named mRNA-1273, was developed by the NIH and Massachusetts-based biotechnology company. Moderna Inc. encased that “messenger RNA” into a vaccine.

The idea is to make a recipient’s body a mini factory, producing some harmless spike protein. When the immune system spots the foreign protein, it will make antibodies to attack – and be primed to react quickly if the person later encounters the real virus.

While there is no chance that the participants could get infected because the shots do not contain the coronavirus itself – Monday’s milestone marks the beginning of a series of studies in people needed to prove whether the shots are safe and could work. However, Dr. Anthony Fauci of the NIH has toned down any early expectations. According to him – even if the research goes well, a vaccine would not be available for widespread use for 12 to 18 months.

Starting what scientists call a first-in-humans study is a momentous occasion for scientists. Some of the study’s carefully chosen 45 healthy volunteers, ages 18 to 55, will get higher dosages than others to test how strong the inoculations should be. Scientists will check for any side effects and draw blood samples to test if the vaccine is revving up the immune system. Kaiser Permanente, a Health Maintenance Organisation (HMO), screened dozens of people, looking for those who have no chronic health problems and are not currently sick. Researchers are not checking whether would-be volunteers already had a mild case of COVID-19 before deciding if they are eligible.

Some of the study’s carefully chosen 45 healthy volunteers, ages 18 to 55, will get higher dosages than others to test how strong the inoculations should be.

But because vaccines are given to millions of healthy people, it takes time to test them in large enough numbers to spot an uncommon side effect, cautioned Dr. Nelson Michael of the Walter Reed Army Institute of Research, which is developing a different vaccine candidate.

There is hope also in the form of Artificial Intelligence. For instance, a supercomputer can test drug effectiveness very quickly by using machine learning and AI. The traditional drug discovery process can be notoriously lengthy. It can take 10 years for a new medicine to reach the market from the time it is discovered. Therefore, researchers are also examining the efficacy of existing drugs in treating COVID-19. “The logic is if any of these compound works, it would be much quicker than the typical drug development process to get approval and widespread use”, according to Jeremy Smith, Molecular biologist.

The traditional drug discovery process can be notoriously lengthy. It can take 10 years for a new medicine to reach the market from the time it is discovered. Therefore, researchers are also examining the efficacy of existing drugs in treating COVID-19.

Roche’s arthritis drug Actemra reportedly has the backing from Chinese authorities and has launched clinical trial. AbbVie’s HIV drug Kaletra, Japanese flu drug and China’s own homegrown drug trial is under way.

German newspaper Welt am Sonntag reported that the governments of Germany and USA are wrestling over the German-based company CureVac. It claimed that none other than the US President was offering large sums of money to German scientists working on a vaccine!

In this race to the finish, there is even an element of greed. The Intercept reports mounting pressure in the recent weeks from investment bankers on health care companies fighting the novel corona virus ‘to consider ways that they can profit from the crisis’. Gilead Sciences, the company producing remdesivir, the most promising drug to treat Covid-19, is one such firm facing investor pressure.

The Intercept reports mounting pressure in the recent weeks from investment bankers on health care companies fighting the novel corona virus ‘to consider ways that they can profit from the crisis’.

“In the past, we humans have learned to control the world outside us, but we had very little control over the world inside us”, observes Yuval Noah Harari in his seminal work 21 Lessons for the 21st Century. Will the hunt for a COVID-19 remedy lead us there? Well, as of now the focus has shifted from cyber hacking to the virus that has hacked humans!

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One Comment
  1. Walter permalink

    Very good article, Praveen! In the past, the United States would have taken a leadership role and collaborated with other countries in trying to find a cure. Scientists and health officials would have coordinated their efforts, probably when the virus first started to appear in China, to share data and knowledge that hopefully could have led to faster testing and then trials. Alas, the Trump administration’s “America First” policy does not inhibit global collaboration, which forces countries to work individually and not collectively as a group mind. In fact, Trump and his xenophobia and aversion to global institutions has probably hindered American efforts to suppress COVID-19. I specifically remember Trump at a G-7 summit tossing a piece of candy to Chancellor Angela Merkel and telling her, “Don’t say I never gave you anything.” It’s not surprising when Trump tried to buy those German scientists, Chancellor Merkel stepped in and told Trump to essentially, “Get lost!” As they say, payback is a bitch. If we learn anything from this terrible pandemic, it will be that humanity needs to work together on a planetary scale and to let go of these petty differences we continue to harbor against one another. In my opinion, the only way we can continue to survive as a species is by looking after one another and, more importantly, protecting and sustaining the planet we call home.

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