[conspire] (forw) Re: (forw) Not an antivaxxer, nosirree

[Rick Moen]

Quoting tom r lopes <tomrlopes at gmail.com>:

> What about the 200+ million drug trial in the US, alone?  I think by now
> FDA approval would be certain.

KT was factually correct that FDA has not yet issued full approval for
any of the three, only EUAs.  Let's talk about differences.

An EUA is a remedy available in time of crisis, approval issued if there
are no adequate or approved alternatives, but the treatment's developer
must still prove safety and gather about three months worth of careful
test data with thousands of study particpants.

Full approval takes at least _six_ solid months of data and then it requires
at least six months for FDA to review it.  Pfizer so far is the only one
of the three to apply for full approval, which thus is highly likely to
happen later this year, in time for the fall school term.  Context
quotation from expert Dr. William Schaffner of Vanderbilt University:
"The only difference really between the emergency use and the licensure
is that volunteers are observed for a longer period of time to see the
duration of protection, and if there might be rare adverse events that
occurred down the road."

Consequences:  

1. Legally, schools and businesses will be able require students/employees 
   be vaccinated.  (Thus, students are requred to be vaccinated against,
   IIRC, Hepatitis B, diphtheria, measles, mumps, and rubella, among
   other diseases.)
2. Public confidence will doubtless increase.
3. Pfizer can then market directly to the public.  
4. EUAs for competing products are not valid for long after a 
   fully approved alternative comes onto the market (unless they
   _either_ likewise get full approval or show they are 
   particularly good in use-cases where the Pfizer vaccine
   is not, such as for particular sub-populations or against
   particular virus variants).
5. (I'm not sure about this one?)  It might be that employees who
   encounter side effects are more likely to get time off work.

Because Pfizer's original EUA was for age 16 and up, and only lately
has been extended to lower ages (EUA for ages 12-15 as of May 10th), the
full approval pending would also be for 16 and up, and approval for
younger kids will take longer, well into 2022.

Your point is an excellent one that we now have a stunningly successful
record of millions of Americans getting these vaccines, making vaccine
hesitancy utterly irrational.  The success ought to be embraced about as
joyfully as Americans embraced the Salk and Sabin vaccines against
polio, as this has been a huge victory, worth celebrating.  _However_,
millions of people having benefited from the vaccines is not quite the
same as rigourous clinical trials.

What was so amusing about KT saying "I'm not an antivaxxer or anything" 
is that he'd just trotted out two bog-standard antivaxx talking points
found among fundies and RWNJs (right-wing nutjobs) -- the "fetal
stem-cell cultures were used" and "they don't have full FDA approval"
excuses.

It's culture-war bullshit, but worse than most such bullshit, because it
kills people and ruins lives.


A fourth and fifth vaccine may be coming soon.  Novavax is applying for
EUA in 3rd Q 2021, and AstraZeneca is applying directly for full FDA
approval and skipping EUA.

To illustrate what is required for an EUA, here's what J&J (Janssen) had
to do, to get FDA's EUA on Feb. 28th for its single-shot COVID-19
vaccine:  

Safety
------

The available safety data to support the EUA included an analysis of
43,783 participants enrolled in an ongoing randomized,
placebo-controlled study being conducted in South Africa, certain
countries in South America, Mexico, and the U.S.  The participants,
21,895 of whom received the vaccine and 21,888 of whom received saline
placebo, were followed for a median of eight weeks after vaccination.
The most commonly reported side effects were pain at the injection site,
headache, fatigue, muscle aches and nausea.  Most of these side effects
were mild to moderate in severity and lasted 1-2 days.

Effectiveness
-------------

The effectiveness data to support the EUA included an analysis of 39,321
participants in the ongoing randomized, placebo-controlled study being
conducted in South Africa, certain countries in South America, Mexico,
and the U.S. who did not have evidence of SARS-CoV-2 infection prior to
receiving the vaccine.  Among these participants, 19,630 received the
vaccine and 19,691 received saline placebo.  Overall, the vaccine was
approximately 67% effective in preventing moderate to severe/critical
COVID-19 occurring at least 14 days after vaccination and 66% effective
in preventing moderate to severe/critical COVID-19 occurring at least 28
days after vaccination. 

Additionally, the vaccine was approximately 77% effective in preventing
severe/critical COVID-19 occurring at least 14 days after vaccination
and 85% effective in preventing severe/critical COVID-19 occurring at
least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at
least 14 days after vaccination, and 348 cases of COVID-19 in the
placebo group during this time period.  There were 66 cases of COVID-19
in the vaccine group that occurred at least 28 days after vaccination
and 193 cases of COVID-19 in the placebo group during this time period.
Starting 14 days after vaccination, there were 14 severe/critical cases
in the vaccinated group versus 60 in the placebo group, and starting 28
days after vaccination, there were 5 severe/critical in the vaccine
group versus 34 cases in the placebo group. 


Here is FDA's write-up about the EUA process, generally:
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained