FDA: FAILING TO MONITOR VACCINE SAFETY

Despite the fact that the COVID-19 vaccines in circulation were rushed into use through the Emergency Use Authorization Act and are using a new type of mRNA encoding technology, The New York Times published an article on 12 February with the headline: 

As Millions Get Shots, F.D.A. Struggles to Get Safety Monitoring System Running

At the time, some 35 million vaccinations had been administered in the U.S., yet the system set up to document ill effects and life-threatening reactions to the vaccines “won’t be capable of analyzing safety data for weeks or months, according to numerous federal health officials.”  
The article points out, “For now, federal regulators are counting on a patchwork of existing programs that they acknowledge are inadequate because of small sample sizes, missing critical data or other problems.”
The FDA tracking system touted during the vaccine trials is called the Biologics Evaluation Safety Initiative (BEST), but it hasn’t even gone past its developmental stage. Dr. Ashish K. Jha, dean of Brown University School of Public Health, made his concerns clear: “We knew these vaccines were coming for at least several months before they got authorized, so we really should have had a well-developed system.”
The article quotes an official from the CDC who chose not to be identified: “It’s been a puzzle to me. The FDA talks about this in a way that is really unclear as to what is up and ready to go and what isn’t.”
The article goes on to state that because the COVID-19 vaccines are free, the normal database for adverse reactions, which would be reported through health insurance claims, isn’t available. 
Dr. Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, pointed out, “The current safety surveillance system in the U.S. is dependent on health insurance claims data and electronic health records. If the vaccine data information doesn’t get into the safety system, then that safety system is unable to function.”
The FDA would not commit to when it would develop an accurate monitoring system to handle over 100 million medical records and have the ability to detect any safety issues. Indeed, the article points out that “critics say it is folly for the FDA to be launching a new system in the midst of a pandemic. And several CDC officials said the FDA was not giving them a real sense of when the complex system would begin to work.”  
TRENDPOST: As with the bureaucracies of the world, most are a “folly,” but they do as they wish, and the majority public believe what the government agencies promote. Indeed, the NYT article reported “turf wars and bureaucratic hurdles had slowed BEST’s progress,” and “federal regulators are counting on a patchwork of existing programs that they acknowledge are inadequate because of small sample sizes, missing critical data or other problems.”
TRENDPOST: The U.S. government sells the lie, and the media promotes it that the COVID vaccination is “free.” The fact is that Washington paid Pfizer Inc. nearly $2 billion for 100 million additional doses of its COVID-19 vaccine.
Where did they get the $2 billion? They took if from the pockets of We the People, i.e., taxpayers.
Moreover, the profits the drug lords are making from the vaccine that We the People paid them to develop and produce will make them billions.
As noted in our 2 February Trends Journal, we quoted USA Today, which reported:
“Governments have poured billions of dollars into helping drug companies develop vaccines and are spending billions extra to purchase doses. However, the particulars of these offers largely stay secret, with governments and public well-being organizations acquiescing to drug firm calls for secrecy.”
On the making-money side of the drug deal, we quoted an article published in The Guardian on 10 November:
“The US drugmaker Pfizer and the German biotech firm BioNTech stand to bring in nearly $13 billion in global sales from their coronavirus vaccine next year, which will be evenly split between the two companies, according to analysts at the US investment bank Morgan Stanley.”
TRENDPOST: Washington signed contracts offering Big Pharma “liability shields” that protect the drug manufacturers in case their vaccines turn out to cause severe health consequences. 
The contracts also give drug companies favorable ownership rights through lucrative patents and provide language stating a commitment to keep the details secret.

Comments are closed.

Skip to content