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COVID Update

Many people are wondering why we still don’t have a vaccine for the COVID-19 virus yet, and when we will finally get one.  Amid the hopeful headlines, we aren’t hearing much from the deep experts who are in the trenches trying to find an effective way to prevent the virus from lodging in our bodies.  What are they saying these days?

Dr. Peter Hotez, at the Center for Vaccine Development at Texas Children’s Hospital, notes that the current pandemic is actually our third major encounter with a coronavirus.   There was Severe Acute Respiratory Syndrome (SARS) in 2003, and the Middle Eastern Respiratory Syndrome (MERS) in 2012.  Like those other viruses, COVID-19 replicates in the upper airways of the human body and is being transmitted whenever people cough, sneeze, or even speak—whenever we aerosolize the virus into the air.  Inside the body, scientists have found that the virus makes us sick when it attaches to something called the ACE-2 receptor that is found in the heart and lung tissue (and also in parts of the nervous system).

An effective vaccine must trigger an immune response that will prevent the coronavirus from docking to very specific ACE-2 receptors in the body.  But how do you do that in a way that is safe and effective?  Hotez notes that 90% of all vaccines, for all diseases, never make it to the end of the clinical trial, often because safety concerns have emerged.  Testing the safety of a virus vaccine has always, in the past, required years of human trials—in fact, decades-long timelines are more normal.  The fastest vaccine ever developed in history was the mumps vaccine—which took four years.

Will we break that record?   The Russian Ministry of Health has approved one coronavirus vaccine already: something called Sputnik V, developed by the Gamaleya Research Institute in Moscow.  But many of the world’s health experts are concerned about the vaccine’s safety and efficacy, since it was rushed to approval before it had entered Phase 3 clinical trials.

The Healthline website, which tracks treatments and vaccine efforts around the world, notes that there are now more than 100 vaccine projects related to the COVID-19 virus, but most experts think the most likely timeline for a vaccine to come to market for widespread use is summer or fall 2021.  That timeline could be accelerated due to a “human challenge trial.”  In this trial, some 30,000 people in more than 140 countries have signed up to get various experimental vaccines and then voluntarily expose themselves to the coronavirus—rather than the usual trial, where people are vaccinated and then the researchers wait to see if they have contracted the virus by participating in normal life (whatever that means these days).

Several public/private partnerships are working on the problem too.  Operation Warp Speed is a collaboration of the U.S. Health and Human Services, the National Institute of Health and 18 biopharmaceutical companies.   The COVID-19 Prevention Trials Network combines clinical trial networks funded by the National Institute of Allergy and Infectious Diseases, the HIV Vaccine Trials Network, and the Infectious Diseases Clinical Research Consortium.  The World Health Organization has organized a Coalition for Epidemic Preparedness Innovations working with vaccine manufacturers Inovio, Moderna, CureVac, Institut Pasteur/Merck/Themis, AstraZenica, Novavax, the University of Hong Kong, Clover Biopharmaceuticals, and the University of Queensland, Australia.

Those hoping for an early breakthrough should know that the U.S. Food and Drug Administration has scheduled a public meeting of the Vaccines and Related Biological Products Advisory Agency to discuss what would seem to be an early stage of the approval process: the general development of COVID-19 vaccines.  This meeting will review the data that would be needed to facilitate the authorization or licensure of any vaccine that might be developed in the future; in other words, what the clinical trials should cover and what their results should be.  

This meeting is scheduled for October 22nd.  For those who believe that COVID-19 management is a bit of a political football, it should be noted that the meeting is being held 12 days before the general election.

Of course, even when scientists do develop a promising vaccine, it will take time to manufacture and distribute it around the world. To help prepare for this challenge, the federal government is making investments in the necessary manufacturing capacity at its own financial risk, giving firms confidence that they can invest aggressively in its development and allowing faster distribution of an eventual vaccine. Manufacturing capacity for selected candidates will be advanced while they are still in development, rather than scaled up after approval or authorization, to expedite the process.

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