"We've been anticipating this for many months now," he tells AFN. "We knew it was going to come out likely between August and December. So, [we're] pleased that the FDA – after reviewing hundreds of thousands of pages they say of information coming from Pfizer about follow-up of the study groups – felt that they had what they needed for this formal approval of the vaccine."
But not everyone is convinced the formal approval of the Pfizer shot – or any COVID-19 shot – will mean anything. The founder of Citizen's Council for Health Freedom argues that many people understand it is a "political decision" only. Some individuals and organizations say people were injured or have died after getting the COVID-19 shot(s). Others doubt whether the COVID-19 shots will be effective against the variants blamed for the increase in case numbers.
Staver: Maybe not so 'safe' as we're told
President Joe Biden, acting FDA Commissioner Dr. Janet Woodcock, and others maintain the COVID-19 shots are safe and effective.
"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said Woodcock. "While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the FDA's gold standards for safety, effectiveness, and manufacturing quality that we require for an approved product."
AFN talked to Mat Staver, founder and chairman of Liberty Counsel, a law firm speaking out against vaccine mandates. He argues that FDA approval doesn't necessarily mean "safe," offering as proof what he calls "a sordid history" of the FDA that goes back many years.
"The Journal of American Medical Association issued an article in 2017 that said between the years 2001 and 2010 … one third of all the FDA-approved drugs had safety problems and many of them had to get FDA back involved because of these safety problems," the attorney reports. "So, there is a long history of FDA-approved drugs that cause serious injury and death."
FDA Commissioner Woodcock, however, points out that millions of individuals have already safely received COVID-19 vaccines. "[But] we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," she continued. "Today's milestone [FDA approval] puts us one step closer to altering the course of this pandemic in the U.S."
But Staver says otherwise: "The history of the Pfizer shot indicates that over 9,000 people have already died, just since it was deployed in December 2020. This is a very dangerous drug – and we now know that it no longer has the effectiveness that it has claimed to have once had."
CMDA's message: No more excuses
"… In the history of vaccination," says CMDA leader Chupp, "there has not been such a large population of people vaccinated with an mRNA vaccine like this; [there's] no vaccine in history in such a short period of time in which we had data to document its safety."
He continues: "We have so much documentation of its efficacy that it is working to reduce severe COVID, represented by hospitalization and ICU admissions and deaths. And therefore, those who have been hesitating because of being told that they're being experimented upon I think that now formally can be taken away as an excuse."
As outlined on the FDA's website, the vaccine that has been known as the Pfizer/BioNTech COVID-19 vaccine will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Another serious concern
Meanwhile, concerns over the Pfizer shot have resurfaced over use of cell lines from aborted babies during its testing. In an interview with AFN, Dr. Tara Sander Lee of the Charlotte Lozier Institute explains.
"We know that they did not use any aborted fetal cell lines to produce the vaccine or to make the vaccine that's actually injected into you," she reports, "but there was some post-production testing that was done using aborted fetal cell lines."
So according to Lee, neither the Pfizer shot nor the Moderna shot contain the cell lines. But to appease those with concerns about testing using the cells, she suggests both companies should change their approach.
"It really does put the user in a vulnerable position choosing whether to accept a vaccine that had any connection with abortion-derived cell lines or not being vaccinated," she notes. "We need to consider people's consciences when it comes time to accepting these vaccines – especially when there's a connection with abortion-derived cell lines."
The Charlotte Lozier Institute points out that alternative cell lines – such as from monkeys or Chinese hamster ovaries – can be used instead of human cells derived from aborted infants. The Institute maintains a chart on its website that reviews all known vaccines and whether abortion-derived cell lines were used.