The speed with which the biopharmaceutical industry marshaled its resources last March to attack the coronavirus pandemic was unprecedented. Working with the NIH, FDA and CDC, the industry has produced dozens of vaccines and therapeutics which have the potential to prevent and/or treat Covid-19. This response has not been lost on the public. Despite the fact that people haven’t been holding the industry in very high esteem, recent surveys have indicated biopharma’s pandemic efforts have improved its image, something the industry hopes will continue.
(Photo by Pete Marovich/Getty Images)
Especially important has been the race to bring a Covid-19 vaccine to the world. Companies like Pfizer, Moderna, J&J, Sanofi and others have been very aggressive in their planning not just in putting multiple vaccine candidates into clinical trials but also building manufacturing capabilities at risk to be ready to mass produce a vaccine when one has been successfully shown to be both safe and effective. Each late stage clinical trials that are being run involve 30,000 patients. This is relatively small for most vaccine phase 3 trials which usually recruit as many as 100,000 patients. However, given the pandemic, both industry and government agencies believe that a vaccine can be approved on the smaller set of patients, provided that the data support such action and that studies on these vaccines continue post-approval.
Now, however, the FDA Commissioner Dr. Stephen Hahn has said that the agency might consider emergency use authorization (EUA) of a vaccine before these trials are complete. This has alarmed many who believe that cutting corners to make a vaccine available sooner would be a big mistake. These views were voiced in an op-ed by Dr. David Aronoff, director of the Infectious Diseases Division of Vanderbilt University, who believes that “This is a risk I do not think that the FDA should take.” He goes on to make the following points.
“[Vaccines] must go through large phase III studies that provide critical information regarding safety and efficacy. Releasing a vaccine that is either unsafe or ineffective would be a major setback… A barrier to immunization uptake has been the rise of vaccine hesitancy, based on unfounded concerns of safety (such as the long-debunked role of immunizations in the development of autism spectrum disorders). What we do not need is the release of a vaccine with a lopsided risk-benefit ratio that exacerbates general fear of this vital method of disease prevention.”
Historically, the time to discover and develop a new vaccine could be as long as a decade. The speed that the industry-government partnership has used to bring forward a Covid-19 vaccine has been stunning. However, you still must complete these 30,000 patient phase 3 trials to have a reasonable sense of the risk-benefit of these vaccines. A premature EUA for such a vaccine isn’t a good idea.
It is likely that political pressure will continue to build for such a premature EUA. In this situation, it is imperative that companies unite and simply refuse to accept such an approval and instead wait for the trials to complete and for the data to be properly reviewed by regulatory agencies. Such a firm stance will not be easy and will likely be assailed by government officials as being unpatriotic. However, Aronoff’s view are right on the money. The risks of premature approval are too great not just to patients but also to the industry and its reputation as well.
The biopharma’s mantra should be: “We will issue no vaccine before its time.” The public can only benefit from this position.
Read Again https://www.forbes.com/sites/johnlamattina/2020/09/02/pharma-companies-should-not-manufacture-covid-19-vaccines-prematurely/Bagikan Berita Ini
0 Response to "Pharma Companies Should Not Manufacture Covid-19 Vaccines Prematurely - Forbes"
Post a Comment