The mRNA-based platform for delivering vaccines has been shown to be safe in humans, but this COVID-19 vaccine has not. And in the United States, the biotechnology company Moderna in Norwood, Massachusetts, has shipped an experimental vaccine based on messenger RNA to the US National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, for testing in a clinical trial. My worry is that this could mean a vaccine is administered before its efficacy and safety have been fully evaluated in animal models or clinical trials. Funders should beware of hype, and release more grants for appropriate tests for coronavirus drug and vaccine development.Ĭhina is advancing several COVID-19 vaccines of different types, and has announced plans to have products in human tests or emergency use in healthy people in April. They must also be careful to assess healthy human volunteers for antibodies against any coronaviruses before enrolling them in safety trials. Regulators must continue to require that vaccine developers check for potentially harmful responses in animal studies. Similar phenomena have been seen in animal studies for other viruses, including the coronavirus that causes SARS ( Y. By contrast, Ebola virus has very high fatality rates (averaging around 50%, but varying from 25% to 90%), yet is less contagious, so vaccination can be more targeted.ĭecades ago, vaccines developed against another coronavirus, feline infectious peritonitis virus, increased cats’ risk of developing the disease caused by the virus ( T. That means many people - perhaps the majority in hotspots - would need to be vaccinated to stop the spread and prevent deaths. The fatality rate is low (3.4% by the World Health Organization’s latest estimate, although this is highly uncertain), yet transmission rates are high and the spread is difficult to track. But combating this disease demands a vaccine that is safe and potent. Governments are understandably desperate for anything that would forestall the deaths, closures and quarantines resulting from COVID-19. Also, some viral protein fragments can elicit more potent or less risky immune responses than others, and it makes sense to learn this in animal studies before trying them in people. Work with the SARS virus shows that worrying immune responses were seen in ferrets and monkeys, but not in mice. They should also demand strong preclinical evidence that the experimental vaccines prevent infection, even though that will probably mean waiting weeks or even months for the models to become available.
Before allowing use of a COVID-19 vaccine in humans, regulators should evaluate safety with a range of virus strains and in more than one animal model. In my view, standard protocols are essential for safeguarding health. I have worked to develop vaccines and treatments for coronaviruses since 2003, when the severe acute respiratory syndrome (SARS) outbreak happened. Vaccines for measles, mumps, rubella, polio, smallpox and influenza have a long history of safe use and were developed in line with requirements of regulatory agencies.
Make no mistake, it’s essential that we work as hard and fast as possible to develop drugs and vaccines that are widely available across the world. Groups in the United States and China are already planning to test vaccines in healthy human volunteers. Around the world, I am seeing efforts to support ‘quick-fix’ programmes aimed at developing vaccines and therapeutics against COVID-19.
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