- The US sets forth on an unprecedented effort to come up with vaccines in record time.
- It is dubbed “Operation Warp Speed” by the Trump administration.
- One approach is more typical, and involves each company working independently on its own trial.
- The second is it involves several vaccine developers working in one large trial.
A recently published article by Elizabeth Cohen,
A join venture to fight coronavirus
According to two members of the Accelerating Covid-19 Therapeutic Interventions and Vaccines group, or ACTIV, there are plans to work together for finding a vaccine for coronavirus.
Bioethicist Art Caplan said it’s unprecedented that a plan for competing US vaccine companies to work together in one large trial is even being considered. “This is all very recent,” he said.
“There haven’t been any final decisions as of yet on which approach ACTIV will take,” NIH spokeswoman Renate Myles told CNN in an email. Members of ACTIV’s clinical trials working group are expected to discuss the options on a call Wednesday. Those members include representatives from the vaccine companies.
“I’m hoping we’ll have more to share in the coming weeks since things are moving very quickly,” Myles wrote.
Companies testing their vaccines on individual basis
- Three US companies are already testing their vaccines on humans, according to the World Health Organization.
- They’re still in phase 1 or phase 2 trials, which typically involve giving the vaccine to dozens or hundreds of study subjects.
- Moderna, based in Massachusetts, is working on a vaccine with the National Institute of Allergy and Infectious Diseases, a part of the NIH.
- Pfizer is working with German company BioNTech, and Pennsylvania-based Inovio is also in clinical trials.
- A fourth US company, Johnson & Johnson, announced last week that it plans to start clinical trials in September.
The most efficient way to do
Phase 3 of vaccine trials typically involve thousands of study subjects, some of whom are randomly assigned to get the vaccine, and others who are randomly assigned to be injected with a placebo, a substance that does nothing. The researchers then wait and see if there is a difference in Covid-19 infections rates between the vaccine group and the control group.
If the vaccine developers band together in one large phase 3 trial of all of their experimental vaccines, they could all use the same placebo group and wouldn’t have to recruit their own.
“Certainly, this is the most efficient way to do it,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, and a member of the ACTIV group.
But another member said there are advantages to each company doing its own trial, since each company is currently at a different stage.
Did you subscribe to our daily newsletter?
It’s Free! Click here to Subscribe!
Source: CNN