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Pandemic vaccine research requires both  scientific & ethical standards, says Kimmelman

4/16/2020

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#Covid19PandemicVaccine; #Research; #RedTape; #ScietificEvidence; Ethics; #ClinicalTrials

New York, Apr 16 (Canadian-Media): In an effort to end the humanity's lockdown globally, accelerated efforts are being made by at least 70 research teams, including some in Canada, to develop a potential pandemic vaccines within a year by bypassing some of the usual red tape that slows down the vaccine approval process, media reports said.
Picture
Pandemic Vaccine Research. Image credit: Facebook page
Scientists said the goal of the vaccine is to expose our immune system to part of the virus so our antibody fighters can prepare to attack the virus that causes COVID-19, since in a pandemic, no one has immunity to the virus because it is new. 

Dr. Scott Halperin, of the Canadian Immunization Research Network, stressed the importance to have  multiple versions of the vaccine that achieve the same purpose but work in different ways.

He said with the first phase of clinical trials focused on safety, with about 30 to 50 volunteers testing out different doses of shots, next step of Phase 2 trials is critical as it involves larger number of people and takes about from seven to 10 years normally for the vaccine to go from the lab to the arms of patients.

"What's mainly being accelerated are the various administrative steps, not the safety steps," he said and added Canadian researchers hope to have some potential vaccines in clinical trials within the next four to six weeks.

​However, Jonathan Kimmelman, a biomedical ethics professor at McGill University in Montreal, who watches both scientific and ethical standards are followed was concerned that in a hurry to develop a vaccine, we may be tempted to tolerate less than optimal science and said, 


"That to me seems unacceptable. The stakes are just as high right now in a pandemic as they are in non-pandemic settings."​

To show how long the process can take, Kimmelman points to the example of the ongoing search for an effective HIV vaccine that began in the 1990s

In the meantime second phase of testing a vaccin, adapted from the company's Ebola research is being started by China's CanSino Biologics, according to China's Ministry of Science and Technology. Still another vaccine candidate is in Phase 1.

In the U.S., Pennsylvania-based Inovio Pharmaceuticals began last week a Phase 1 trial of its vaccine candidate that uses the DNA sequence extracted from the key spike protein of SARS-CoV-2, the virus that causes COVID-19.

On Mon., April 6, we initiated our COVID-19 DNA vaccine Phase 1 clinical study with the first participant dosed with our investigational DNA vaccine INO-4800. Read more in @NYTimes (click control/command F + INOVIO to view): https://t.co/co3gMAOJv1 #DNAVaccines #DNAMedicines pic.twitter.com/k4fw4XTHW9

— INOVIO Pharmaceuticals (@InovioPharma) April 14, 2020
Earlier this week, the first person received a second dose of another potential U.S. vaccine from the National Institutes of Health (NIH) and Massachusetts-based biotech company Moderna Inc.
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