By Dorothy Cummings McLean
The Unites States Food and Drug Administration has authorized the emergency use of a second COVID-19 vaccine.
The FDA granted an emergency use authorization (EUA) to Moderna, a Massachusetts-based biotechnology company, yesterday. Like the Pfizer/BioNTech vaccine approved for use on December 10, the Moderna vaccine uses messenger RNA.
The EUA comes as civil liberties advocates around the world raise concern over the possibility of “COVID passports” allowing people who receive a coronavirus vaccine to move around more freely than those who do not. It also comes as some physicians, such as America’s Frontline Doctors, have for months expressed their frustration over the FDA’s refusal to grant EUA to the drug hydroxychloroquine (HCQ), which has been around for decades to safely treat malaria and arthritis. America’s Frontline Doctors and others who have treated coronavirus patients say HCQ is effective at treating the disease.
On December 17, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend the vaccine 18-0, with one abstention. The Moderna vaccine is meant to be used on people aged 18 and over.
Yesterday the FDA released a press statement about the new vaccine, claiming that its availability is a “crucial step in the fight” against the COVID-19 coronavirus.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said Dr. Stephen M. Hahn, the FDA Commissioner.
Hahn claimed that the authorization of both vaccines, though “expedited” had been faithful to the “rigorous standards for safety” needed for an EUA.
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA,” he stated.
“These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”
Hahn stopped short of saying that the Moderna vaccine would certainly protect those injected from COVID-19, saying only that it “may be effective in preventing” the disease.
Another official stated in the press release that the EUA was not an FDA “approval.”
“Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDA’s expectations [ …] have been met,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.
According to the FDA, the new vaccine has a small piece of COVID-19 genetic material (messenger RNA) that “instructs” cells in the human body “to make the virus’s distinctive ‘spike’ protein.”
“After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2,” the FDA press release states.
According to The New York Times, an “early study” found that the Moderna vaccine protected volunteers from COVID-19 for three months. It is given in two injections 28 days apart. The New York Times also reported that Moderna plans to produce 20 million doses by the end of 2020 and up to a billion doses in 2021.
There is some debate concerning the moral use of the new Moderna vaccine, with Catholic bioethicists divided on the extent to which material derived from an aborted child was used in its development. Stacy Trasancos of the St. Philip’s Institute in Tyler, Texas revealed in the Catholic Register in November that HEK293 cells derived from a baby aborted in were “used for spike protein and mRNA expression to develop and test the [Moderna] vaccine.”
“In a patent Moderna filed in 2019 presenting similar technology with mRNA, they repeatedly describe the use of HEK293 cells, including in the development of the lipid nanoparticle delivery system,” Trasancos wrote.
“So, the claim that Moderna’s vaccine is ‘ethically uncontroversial’ because it has no connection to unethically derived materials does not seem to be supported as both the development of the spike protein sequence, the mRNA expression in testing, and the lipid nanoparticle delivery system are described as using the HEK293 cell line derived from an aborted fetus.”
The HEK293 (“Human Embryonic Kidney 293”) cell line was first produced in 1973 in the Netherlands from the kidney cells of an aborted girl. According to Dr. Alex van der Eb, who was involved in the cell line’s development, the unborn baby had been completely healthy before her death.
“So the kidney material, the fetal kidney material, was as follows: the kidney of the fetus was, with an unknown family history, obtained in 1972 probably,” Van der Eb testified before the VRBPAC in 2001.
“The precise date is not known anymore. The fetus, as far as I can remember, was completely normal. Nothing was wrong. The reasons for the abortion were unknown to me. I probably knew it at that time, but it got lost, all this information.”
Van der Eb also admitted, regarding a cell line he developed in 1985, to using the retina of a human baby aborted at 18 weeks’ gestation.
A number of experts have stated that mass vaccinations are not essential to end the coronavirus crisis. In October, Dr. Michael Yeadon, once Pfizer’s most senior researcher, wrote:
There is absolutely no need for vaccines to extinguish the pandemic. I’ve never heard such nonsense talked about vaccines. You do not vaccinate people who aren’t at risk from a disease. You also don’t set about planning to vaccinate millions of fit and healthy people with a vaccine that hasn’t been extensively tested on human subjects.
In an interview published earlier this month, Dr. Theresa Deisher, who holds a doctorate in Molecular and Cellular Physiology from Stanford, said that “this virus to date has less than a 0.03% fatality rate and most of those people, I believe it’s 92% or above, have other health problems; we’re making a vaccine at warp speed for a virus that doesn’t look like it’s going to need a vaccine.” Deisher also confirmed that refusing to take any COVID-19 vaccine was a rational decision.
“Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine associated risks in pregnancy,” the FDA’s fact sheet for healthcare providers states. It also says:
In clinical studies, the adverse reactions in participants 18 years of age and older were pain at the injection site (92.0%), fatigue (70.0%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23.0%), axillary swelling/tenderness (19.8%), fever (15.5%), swelling at the injection site (14.7%), and erythema at the injection site (10.0%).
The U.K. government, meanwhile, has advised that pregnant women should not receive the Pfizer vaccine, which it recently approved, and should avoid pregnancy for two months after receiving the jab.
LifeSiteNews has produced an extensive COVID-19 vaccines resources page. View it here.