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The World’s Greatest Race

June 18, 2020

BY CHRIS GUINTHER

 

The race to develop a Covid-19 vaccine is on… and we are optimistic about a solution within a year. With more than 6 million confirmed Covid-19 cases worldwide and the number increasing daily, the race for a Covid-19 vaccine is moving at full speed. Globally, there are more than 100 vaccines in development — with nine of them in human clinical trials. We expect the development efforts to intensify in the coming months and it’s likely that more companies will enter clinical trial Phase I, where the vaccine is tested in a small sample of healthy humans with moderate doses.

And what’s better than Phase I trials? Well, Phase II trials. We anticipate more companies advancing to Phase II, where a larger sample of subjects of different age groups are tested for safety, efficacy, and determining the right dosing so they can move to Clinical Phase III rapidly. In Phase III trials, more complex and rigorous tests are performed on a much broader population with more than 10,000 patients.

We hope you keep your spirits high and look forward to some major breakthroughs in the coming months. Let’s review a couple of the leading candidates.

Pfizer (PFE), in a collaboration with BionTech (BNTX) and separately, Moderna (MRNA), are focusing on a messenger-Ribonucleic acid (mRNA) vaccine, a novel technology, where an information carrying biomolecule instructs body cells to make copies of the S protein of the virus, recognize it and build antibodies to fight the virus once it attacks the body.

Although Moderna has taken an early lead, two other pharmaceutical companies, Johnson & Johnson (JNJ) and Pfizer (PFE), are well positioned to win the race. Both companies are working on potential vaccines, they have leading candidates, and are deploying massive resources for R&D and manufacturing to produce hundreds of millions of doses even before trials are completed. JNJ is entering into strategic collaborations and investing massively to provide an affordable vaccine on a massive scale. JNJ also has ambitious manufacturing goals of rapidly supplying more than a billion doses of vaccine.

Merck (MRK), although not part of the nine companies conducting clinical trials yet, is engaged in research efforts for both the development of medicines and a vaccine for Covid-19. In recent months, MRK announced research collaborations with the Institute for Systems Biology and the non-profit scientific research organization IAVI to define the molecular mechanisms of Covid-19 and work on its vaccine development efforts, respectively. Through the collaboration with IAVI, Merck aims to jointly develop a vaccine candidate using the virus technology that is the basis of its Ebola Zaire vaccine.

Regeneron (REGN) has created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral ‘escape,’ a critical precaution in the midst of an ongoing global pandemic. REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick. This treatment could be available much sooner than a vaccine. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines. Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches.

There are too many potential solutions to mention them all, but out just this week, Dexamethasone, a cheap and widely used steroid, has become the first drug shown to save lives among Covid-19 patients in what scientists hailed as a “major breakthrough”. Results of trials announced on Tuesday showed Dexamethasone, which is used to reduce inflammation in other diseases, reduced death rates by around a third among the most severely ill Covid-19 patients admitted to hospital. The results suggest the drug should immediately become standard care in patients with severe cases of the pandemic disease, said the researchers who led the trials.

The RECOVERY trial compared outcomes of around 2,100 patients who were randomly assigned to get the steroid, with those of around 4,300 patients who did not get it. The results suggest that one death would be prevented by treatment with dexamethasone among every eight ventilated Covid-19 patients, Landray said, and one death would be prevented among every 25 Covid-19 patients who received the drug and are on oxygen. Among patients with Covid-19 who did not require respiratory support, there was no benefit from treatment with dexamethason.

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