By Dvorah Richman, Heartland Institute
Growing concerns about the federal government’s COVID-19 shot approvals, policies, and pressure tactics have led Florida Gov. Ron DeSantis and others to push back with legislation and recommendations.
The U.S. Food and Drug Administration (FDA) approved new versions and dosing of Moderna’s Spikevax and Pfizer’s Comirnaty COVID shots for people aged 12 and older, and gave “Emergency Use Authorizations” (EUA) for children aged 6 months to 11 years, on September 11.
The FDA’s approval was based on “manufacturing data and non-clinical immune response data.” Moderna announced non-peer-reviewed clinical trial data for Spikevax, “confirming” an increase in neutralizing antibodies against currently circulating COVID variants.
Florida became the first state to recommend against COVID-19 boosters for anyone under age 65, on September 13.
Untested on Humans
Questions regarding Moderna’s shot are “still looming,” and Pfizer’s version has “zero efficacy data,” “has not been tested on humans at all,” and only has data “about antibody protection from 10 mice,” wrote Marty Makary, M.D., M.P.H.and Tracy Beth Høeg, M.D., Ph.D. in the New York Post on September 14.
Despite the lack of clinical evidence, the FDA and Centers for Disease Control and Prevention (CDC) are vigorously promoting the new mRNA shots, say Makary and Høeg.
“The push is so hard that former White House COVID coordinator Dr. Ashish Jha and CDC head Mandy Cohen are making unsupported claims the new vaccine reduces hospitalizations, long COVID and the likelihood you will spread COVID. None of those claims has a shred of scientific support,” Makary and Høeg wrote.
Unlike Flu Shots
Scott Jensen, M.D., a physician, author, and a former Minnesota state senator and gubernatorial candidate who has been critical of government pandemic policies said it is “mindboggling” that the FDA claims “the public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality.”
Contrary to experience during the COVID-19 pandemic, the FDA assumes the mRNA vaccines have a safety profile similar to seasonal flu shots, says Jensen.
“The flu vaccine approval process, which doesn’t require clinical trials, shouldn’t be used for COVID shots,” said Jensen. “Flu vaccines have a long safety record, but COVID shots don’t. They have higher complication rates, including severe and life-threatening adverse events.”
Safety, Efficacy Questions
The FDA stated in its EUA announcement that it is “confident in the safety and effectiveness of the updated vaccines.”
However, COVID shots have been associated with a serious adverse event rate of one in 5,000 doses and serious events have been estimated to be as high as one in 556 recipients, according to studies cited by Makary and Høeg. The incidence of myocarditis for younger people is six to 28 times higher after the vaccine than after infection. There are also concerns about how multiple boosters impact the immune system.
Drug safety advisors and academics recently petitioned the FDA to amend COVID-19 shot labeling to reflect associated adverse events. The FDA denied virtually all the petitioners’ requests.
Research from 17 Southern Hemisphere countries and equatorial regions found “a definite causal link” between “many peaks in all-cause mortality and rapid vaccine rollouts” and fatal toxicity risk per injection that is “exceedingly large in the most elderly,” states a report published by CORRELATION Research in the Public Interest on September 17. The authors recommend elderly people not be prioritized for COVID-19 shots.
As for efficacy, Makary and Høeg say that follow-up studies of COVID vaccines in general reveal that mild efficacy against infection is transient, “lasting just a few months.”
In advising against the shots for individuals age 65 and under, Florida Surgeon General Joseph Lapado, M.D., Ph.D. noted the insufficient safety and effectiveness data and lack of any “meaningful booster-specific clinical trial data performed in humans.”
Lapado urged those over age 65 to discuss the booster with a health care provider. Specifically, Lapado mentioned concerns about the ineffectiveness of the shots after 4 to 6 months, the increased risk of infections, the risk of myocarditis and other heart conditions, and elevated levels of spike proteins from the shots for indefinite periods of time.
“I will not stand by and let the FDA and CDC use healthy Floridians as guinea pigs for new booster shots that have not been proven to be safe or effective,” said DeSantis, regarding Lapado’s announcement.
Not Just Shots
Despite evidence that masks are ineffective against COVID-19 and potentially harmful, a growing number of universities, businesses, and hospitals are reinstituting mask mandates and other restrictions.
Florida enacted legislation banning various COVID mandates, empowering doctors, and prohibiting gain-of-function research. Other states and cities have also banned various COVID-19-related restrictions. At the federal level, “Freedom to Breathe” legislation prohibiting mask mandates in various settings has been introduced in the U.S. Senate and House of Representatives.
Furthermore, doctors say it has become harder to distinguish COVID from allergies or the common cold.
John Salop, a patient of the Virginia-based Inova Hospital System, said he sought advice from his Inova physicians.
“Particularly considering treatment for my blood disorder, I need nuanced answers,” said Salop. “Instead, I’ve only been told ‘We follow CDC guidance.’”
Media outlets attacked DeSantis, contending his policy is political, intended to distinguish his presidential campaign from Donald Trump’s.
Paragon Health Institute Senior Policy Analyst Drew Keyes said “It should come as no surprise that state leaders are stepping into the void that federal missteps have opened.”
Those who say this is all about politics are “dead wrong,” says Jensen.
“We’re dealing with serious, complicated and difficult issues,” said Jensen. “Collectively, we must have the courage, even in this charged environment, to stand up and counter government presumptions with facts and concrete arguments.”
Dvorah Richman, J.D. (firstname.lastname@example.org) is a life sciences regulatory attorney with extensive industry and law firm experience focused on government laws, regulations and policies regarding a wide variety of products and topics.