If there is a common theme in US response errors to Covid-19, it has been a real surprise of squandering. Our leaders spent time, as well as public trust and people’s economic and emotional resources. And they shook up the opportunity to do good science – testing drugs and vaccines in a way that serves the public interest rather than the interests of pharmaceutical companies.
There is no question that Covid-19 vaccines and treatments will save many lives. But we are not doing the kinds of scientific studies needed to determine the best vaccines and treatments to save lives and reduce the weeks we suffer with unprecedented social and economic constraints. It is not too late to change course.
It is not too late, for example, to test the potential that some have built up that their normal return could improve by months if the Pfizer vaccine is given as a single shot. Although clinical trials concluded safety and efficacy for two images, supply is running short and there is little evidence that one image provides some protection.
The company could test the idea by selecting a group of volunteers early in the release to get one picture, and compared to those who get two, says Peter Bach, physician and director of the drug pricing laboratory at the Sloan Kettering Memory Cancer Center. Testing is the only way to justify by giving people one view.
He says he also stands by a recommendation he made in September, that vaccines should be tested against each other. There is a lot of valuable data that can be quickly collected as there are over 40 vaccines at the test stage, with many different technological approaches. Some use inactivated viruses, others virus fragments and others viral DNA encoded in different types of harmless viruses. Then there are the two front runners, which use messenger RNA.
As researchers told me last spring, some of these vaccines may be better at preventing high – risk people from getting fatal cases, but some may other to be better for keeping people at low risk from spreading the virus. Some will be cheaper and easier to make. Some will encourage fewer side effects. Pfizer product requires extreme cooling; others are not. One candidate may even act as an oral vaccine rather than an injection.
The first vaccines over the finish line of FDA approval may not be the best for achieving worldwide immunity. As STATnews reported in September, a number of the “tortoises” in the race, from Merck and Sanofi, look very strong.
“You won’t lose anything if you make fifty thousand people with Pfizer against J&J,” said Bach. “It’s not like scrubbing Pfizer vaccines. “Trials like this would be in the public interest, ensuring we get the maximum amount of data in the shortest possible time.
As clinical trials typically work, companies design their own trials within certain constraints established by regulators such as the FDA. But that doesn’t have to be the case. In this never-before-seen situation, we should have a much more uniform standard for scientific experiments. In fact, last June, the FDA issued some standardized test guidelines for vaccine manufacturers, Bach said. “That didn’t quite work.”
Mandatory status may provide us with much-needed information on how well the newly approved Pfizer and Moderna vaccines protect against asymptomatic disease and thus help us all to herd protection. to achieve. Regular testing of subjects for Covid-19 would have told us this, but Pfizer and Moderna did not collect that data. The AstraZeneca trial collected data on asymptomatic cases, although the trial was fatalized by a dosing error. And communication by finding topics may help us learn if vaccinated people can pass silent diseases on others. These are not normal procedures, but they are not standard procedures.
The other nearby secret is how long immunity to a vaccine lasts. The best way to learn about safety and long-term effectiveness is to keep the placebo-controlled trials going. But Pfizer is already talking about ending its lawsuit by giving the vaccine to the people in the control arm. The move may seem altruistic, but there is a self – serving side to it: It reinforces the ability to keep receiving data and discovering less common safety issues.
The same idea applies to a drug that can treat Covid-19, which should be tested in a standard system designed for our benefit. Last spring, the antiviral drug Remdesivir was approved, for example, with very little data on efficacy, timing and dosing. It is a disappointment.
The general public is so tired that we are thankful for any ray of hope, and were unwilling to question something that would end the pandemic – even if pharmaceutical companies getting a great deal from here. They deserve some praise, but not as much as the public deserves the best public health campaign. That was not at its normal level in 2020, but it is not too late to make it better.
Bloomberg