Yesterday was the 59th anniversary of the first American manned space flight by Alan Shepard. Now imagine that NASA was granted the power to demand that EVERY AMERICAN take a space flight starting on May 6th, 1961. THAT's the COVID vaccine. For some, the vaccine might be a giant leap for health. For others? A Challenger far worse.
Pro-vax. Anti-vax. Doesn’t matter. Bloomberg is telling you that safety for a product already exempt from liability, safety is not the very first priority. Anyone who takes the new vaccine will be participating in the world's largest clinical trial. "Vaccine trials normally start by looking at safety, but in order to hasten the development of a Covid-19 vaccine, the drugmakers are looking at both safety and the immune-system response from the experimental shots."
In March, Wayne Rohde wrote an article for us titled Meet The PREP "Public Readiness and Emergency Preparedness" ActMeet The PREP "Public Readiness and Emergency Preparedness" Act: Here is the definition of the act. The Public Readiness and Emergency Preparedness Act (PREP Act) added new legal authorities to the Public Health Service (PHS) Act to provide liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. It also added authority to establish a program to compensate eligible individuals who suffer injuries from administration or use of products covered by the PREP Act’s immunity provisions.
Bloomberg News published an article yesterday about the race to bring COVID-19 vaccines to market. Below is an excerpt and link. And I've taken a screen shot to preserve the critical phrasing.
Pfizer Starts U.S. Trials of Experimental Covid-19 Vaccine By Cynthia Koons
...New York-based Pfizer is working with BioNTech SE of Germany. The companies started testing the inoculations in patients in Germany in late April. Vaccine trials normally start by looking at safety, but in order to hasten the development of a Covid-19 vaccine, the drugmakers are looking at both safety and the immune-system response from the experimental shots.
Pfizer and BioNTech are in a race with companies including Johnson & Johnson, Moderna Inc. and dozens of other biopharmacuetical outfits and academic groups to come up with a safe and effective vaccine against the illness within the next year to 18 months. A handful are in human trials already, including Moderna’s and ones from CanSino Biologics Inc., the Beijing Institute of Biotechnology and Inovio Pharmaceuticals Inc.
Pfizer’s U.S. trial will involve 360 patients in two age groups: 18 to 55, and 65 to 85, though trials in the older population will start only after safety and immune response are established in the younger group. The University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center will eventually provide testing sites for the vaccines as well.
“In an early vaccine trial, you actually monitor for a lot of potential reactions, you cast a very wide net, you actually ask the people to report to you everything they’re feeling,” said Pfizer’s Phil Dormitzer, chief scientific officer for viral vaccines. “You don’t know for sure until you’ve looked at a very large number.”
Given what has happened with the development of other vaccines in the past, there is a risk that the new inoculation could actually make patients more susceptible to severe illness.
“Knowing there’s a potential risk, we’re going to proceed as though that’s a real risk,” Dormitzer said. “If it were to happen, we’ll detect it as soon as possible”
Pfizer and BioNTech are looking at four different shots -- and at a variety of doses and schedules -- and will decide as the trials proceed which is the most effective. The aim is to have a shot ready for emergency use by the fall. The companies are also sharing data with regulators in real time, instead of analyzing it themselves before submitting it and applying for approval from regulators...