On 2/4/2021 3:59 PM, Gary Jones wrote:
The experimental vaccines from both Pfizer and Moderna utilize mRNA
(messenger ribonucleic acid) which instructs the body’s cells on
manufacturing proteins.* It is technology that has not “ever been
approved for any disease, or even entered final-stage trials until
now.”* There have been no independently published animal studies on any
of the vaccines, and it is not yet known what effects they will have on
the elderly, the very young, or women who are pregnant or might become
pregnant in the near future.* I’d say those are important groups whose
safety is critical.

https://www.americanthinker.com/blog...accines.h tml


For background, I think it's important to note that:

(a) Ad Fontes Media rates American Thinker as hyper-partisan right in
terms of bias and as somewhat unreliable in terms of reliability.

(b) According to the American Thinker entry in Wikipedia, "David Solway,
in the months following the 2020 presidential election, contributed
seven articles perpetuating the myth of a stolen election based on
evidence such as "Biden’s rallies routinely featured twenty or so
vehicles in a car park. That alone tells us that Biden was never in the
game."

Now, to address your concerns:
(1) Absence of animal models - It's been well documented that there is
no universal "best" animal model for reliably predicting the effect(s)
of drugs and biologics on the pathogens and other disease processes the
affect humans. Models are tested and either adopted or discarded based
on past experience with similar diseases processes and a lot of trial
and error. Depending on the specific circumstances, the FDA encourages,
but doesn't always require preliminary animal trials to precede human
trials to be included in applications submitted to it for emergency use
and/or licensing. Moderna did test its vaccine on pregnant rats and
found no adverse effects on either the mother rats or their offspring.
Pregnant animal studies are on-going at Pfizer.

(2) The decision to Approve and/or use drugs and biologics, both from a
regulatory and clinical frame of reference is predicated on risk vs.
benefit. The effects of COVID-19 infection on the elderly, the very
young, and women who are pregnant was known adequately when the FDA
issued the emergency use authorizations for both the Pfizer and the
Moderna vaccines to enable the FDA to authorize vaccine administration
to those groups. The risks of COVID-19 infection were devastating on
the elderly and although rarer, almost equally devastating when they
affected pregnant women. The CDC web site includes the following:
"Observational data demonstrate that, while the chances for these severe
health effects are low, pregnant people with COVID-19 have an increased
risk of severe illness, including illness that results in ICU admission,
mechanical ventilation, and death compared with non-pregnant women of
reproductive age. Additionally, pregnant people with COVID-19 might be
at increased risk of adverse pregnancy outcomes, such as preterm birth,
compared with pregnant women without COVID-19." There was insufficient
data to authorize the vaccines for the very young, who seem to have a
much lower incidence of clinical symptoms (i.e., risk) when proven to be
infected. Therefore, the vaccines were only authorized for the cohort
ages that were used in the Phase I, II, and III trials. Trials are
ongoing at both Moderna and Pfizer to test the safety and efficacy of
their vaccines in a well controlled cohort of younger people. In
simpler terms, pregnant women, just as with the elderly are at much
greater risk of severe outcomes from a COVID-19 infection. Therefore,
the risk vs. benefit assessment strongly favors benefit for those
groups. Therefore, the FDA allows the vaccines to be administered to
pregnant women after they are given pregnancy-specific detailed
information about the known risks and benefits in consultation with
their obstetrician.

In conclusion, what is your point? Are you suggesting that tens of
thousands or possibly hundreds of thousands of additional people,
possibly including your own loved ones, friends, etc. or even yourself
should die without the opportunity to be vaccinated until what endpoint
of certainty are you suggesting be reached prior to vaccine approval?
Personally, I think the currently approved vaccines met an appropriate
balance of risk vs. benefit to warrant their release under the currently
issued emergency use authorization.