Coronavirus vaccine: US skips 'crucial' animal trials, to start testing experimental drugs on human
The US has kickstarted its first clinical trial on a coronavirus vaccine. One healthy individual has volunteered to receive experimental doses of the vaccine, a source told AP news.
According to reports, 45 healthy volunteers are expected to join the study that is being conducted at the Kaiser Permanente research facility in Washington state. But even after the first trial passes, the vaccine could still take at least a year before it is made available.
Funded by the National Institutes of Health (NIH), this first human vaccine trial is evaluating a vaccine developed by a Massachusetts-based biotechnology company named Moderna.
The company has bypassed a crucial step in the development of vaccines: animal trials. At this step, researchers evaluate how animals respond to the vaccines before moving to human trials.
“I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial", Tal Zaks, chief medical officer at Moderna, told STAT. He added that scientists at the NIH are working on nonclinical research — test on animals and other lab tests — in parallel.
"This is very unusual,” Akiko Iwasaki, a Yale University microbiologist told STAT. “It reflects the urgency to develop vaccines to counter the Covid-19 pandemic," he added.
Trump recently urged pharma companies to fast-track work on vaccines. He said the work is “moving along very quickly” and he hopes to see a vaccine “relatively soon.”
"In the next, I would say four weeks or so, we will go into what is called a phase one clinical trial. There are probably at least 10 or so candidates to evaluate that are at various stages of development," Dr Anthony Fauci, the director of the US' National Institute of Allergy and Infectious Diseases (NIAID) said during a hearing on March 11.
In April, another American biotech company, Inovio Pharmaceuticals, will evaluate the safety of its candidate vaccine candidate on a few volunteers in the US, China and South Korea. If the trial succeeds, the company will make a million doses of the vaccine before the end of the year.
Johnson & Johnson (J&J) is another important player. The company is partnering with the US Department of Health & Human Services (HHS) to speed up the process.
“This partnership will ensure that vital research is made possible at rapid speed and underscores the importance of public-private partnerships to tackle the worldwide novel coronavirus epidemic. We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world," Paul Stoffels, Vice Chairman of the Executive Committee, said in a statement.
'Americans First'
The Trump administration has tried to lure a German-based pharma company to move their research to the US. This is to get Americans exclusive access to a potential vaccine, reports suggest.
On March 2, the White House met with the chief executive of the German pharma company named CureVac, Daniel Menichella, according to The New York Times.
“We are very confident that we will be able to develop a potent vaccine candidate within a few months,” Daniel Menichella said in a statement on the day of the meeting.
According to Reuters, the Trump administration had offered a huge sum of money to the company to secure exclusive rights over the vaccine. The German government, for their part, is doing everything they can to retain them.
“The German government is very interested in ensuring that vaccines and active substances against the new coronavirus are also developed in Germany and Europe," a German Health Ministry spokeswoman, confirming a quote in the newspaper, told Reuters.
In response, a US official said, “This story is wildly overplayed... We will continue to talk to any company that claims to be able to help. And any solution found would be shared with the world.”
After heading the company for two years, Menichella left the company a few days ago. "The company rejects current rumors of an acquisition," a statement from the company read.