The vaccines for Covid are experimental. They have not been tested on pregnant women and have not been tested long term. They also are not FDA approved. The reason they are available is because they received emergency approval not because they passed animal testing or long term testing.
Animal Testing skipped,
A clinical trial for an experimental coronavirus vaccine has begun recruiting participants in Seattle, but researchers did not first show that the vaccine triggered an immune response in animals, as is normally required.
Now, biomedical ethicists are calling the shortcut into question, according to Stat News.
"Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct," Jonathan Kimmelman, director of McGill University’s biomedical ethics unit, wrote in an email to Stat News. "Often our decision to do so seems unwise in retrospect."
Typically, vaccine development can take 15 to 20 years, start to finish, Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat News. The lengthy process requires that scientists first give the vaccine to animals to determine whether it's safe and effective at preventing the disease in question. Only after passing through iterative tests in animal models, and being adjusted along the way, can a formulation be tested in human trials.
"When you hear predictions about it taking at best a year or a year and a half to have a vaccine available … there’s no way to come close to those timelines unless we take new approaches," Feinberg said.
What we don't know:
There are several things we don't know about these vaccines. Why shouldn't pregnant women get the vaccine? Could the vaccine cause sterility? Could the vaccine cause antibody dependent enhancement? This vaccine is experimental and has never been used on a human being before 2020.
After WWII 23 German doctors were tried for experimenting on human subjects without their consent. Of the 23 defendants, seven were acquitted and seven received death sentences; the remainder received prison sentences ranging from 10 years to life imprisonment. Their crimes involved everything from freezing subjects to dropping objects on their heads and everything between.
1. Don’t test on pregnant women.
2. Later when there are problems, don’t pay. Big Pharma is now 40x bigger since govt. granted no liability for vaccine manufacturers.
Previous Coronavirus Vaccine Efforts Have All Failed
In my May 2020 interview above with Robert Kennedy Jr., he summarized the history of coronavirus vaccine development, which began in 2002, following three consecutive SARS outbreaks. By 2012, Chinese, American and European scientists were working on SARS vaccine development, and had about 30 promising candidates.
Of those, the four best vaccine candidates were then given to ferrets, which are the closest analogue to human lung infections. In the video below, which is a select outtake from my full interview, Kennedy explains what happened next. While the ferrets displayed robust antibody response, which is the metric used for vaccine licensing, once they were challenged with the wild virus, they all became severely ill and died.
The same thing happened when they tried to develop an RSV vaccine in the 1960s. RSV is an upper respiratory illness that is very similar to that caused by coronaviruses. At that time, they had decided to skip animal trials and go directly to human trials.
“They tested it on I think about 35 children, and the same thing happened,” Kennedy said. “The children developed a champion antibody response — robust, durable. It looked perfect [but when] the children were exposed to the wild virus, they all became sick. Two of them died. They abandoned the vaccine. It was a big embarrassment to FDA and NIH.”
“In the interim, WHO recommends not to use mRNA-1273 in pregnancy, unless the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks, such as in health workers at high risk of exposure and pregnant women with co-morbidities placing them in a high-risk group for severe Covid-19,” the guidance said. The agency said its recommendations would be updated as more data become available.
Covid-19 mRNA vaccines aren’t made from live virus, and the mRNA, or messenger RNA—named after the molecular couriers that deliver genetic instructions—doesn’t itself enter the cell’s nucleus and is degraded quickly, the WHO said. Developmental and reproductive toxicology studies in animals haven’t shown any harmful effects, the WHO added.
At the same time, there aren’t enough data on actual pregnant people to assess the vaccine’s effectiveness or risk in pregnancy, the agency said. Pregnant women should be given information and counseling on the lack of safety and efficacy data, it said.
Neither Moderna nor Pfizer enrolled pregnant women in their Covid-19 vaccine trials. Moderna says it plans to establish a registry to study pregnancy outcomes in mothers and infants. Pfizer says it intends to start a maternal vaccine study in the future.
Research has shown that pregnant women are at higher risk of having a severe case of Covid-19 than those who aren’t pregnant, and Covid-19 may be associated with a higher risk of preterm delivery. The Centers for Disease Control and Prevention sayspregnant people may choose to be vaccinatedif they wish, adding that a conversation with a patient’s clinical team can help. Source
