Philadelphia Medicine Fall 2020 - 8

p h i l a m e d s o c .org

cover story continued
countermeasure candidates and providing coordinated government
support.
The OWS allows companies leeway in determining how the
evaluations will go, but the Food and Drug Administration wants
to see larger numbers over a variety of trials to assess the date and
determine efficacy.
According to Marks at the FDA, manufacturers of these vaccines
agreed to do trials of about 30,000 individuals, at least for three of
them. Another trial involves about 60,000 individuals.
Having lots of patients "gives us large safety data sets and will
hopefully get us answers in terms of these event-driven trials toward
whether or not they are effective as well as safe," Marks said.

Avoid repeating history
Marks wants to have careful evaluations of all candidates before
CDC approval, in light of what happened years ago to a promising
vaccine.

Get Your
Marketing
in Shape

Advertise in
Philadelphia Medicine

For advertising information
call 610.685.0914 Ext 1

www.HoffPubs.com
8

Philadelphia Medicine : Fall 2020
Fall/Winter 2019-2020 : Philadelphia Medicine

"It all has to start with manufacturing quality," he said. "That is
so fundamental here. And if you think about probably the worst
event in vaccine history, from the standpoint of the FDA, it was the
Cutter Incident in 1955 in which it was ultimately a manufacturing
quality issue, where an inactivated polio vaccine was not inactivated
adequately and children got polio from the vaccine that was supposed
to prevent it. We can't ever have anything like that happen."
In late April of 1955, according to the website, historyofvaccines.
org, just a few weeks after the landmark press conference announcing
success of the vaccine trials, an Idaho doctor reported a case of
paralytic polio in a recently vaccinated girl. Over the next few weeks,
similar reports trickled in to local health authorities. All involved a
disturbing detail: paralysis began in the vaccinated arm, rather than
in the legs as was more common.
It soon emerged that most of the cases of paralytic polio occurred
in children inoculated with vaccine produced by Cutter Laboratories
in California.
The FDA has addressed its own resources to deter negative
impacts in manufacturing.
"We spend a lot of time making sure we do not let history repeat
itself, and we care a lot about manufacturing quality," Marks said.
"We care about safety and efficacy, and in this case, post-market
surveillance, important for vaccines, will take on a heightened
importance for a COVID-19 vaccine."

Who receives the vaccine?
Who receives immunization will depend on the role of, first,
health care and emergency response providers in addition to longterm care professionals.
That will evolve over time, according to Messonnier.
"Our partners in Operation Warp Speed assure us that some
vaccine will be available this calendar year in 2020," Messonnier
said. "But we expect the quantities of vaccine will be limited and
therefore it will be important to target the vaccine."
https://philamedsoc.org/ http://wnfg.com http://www.HoffPubs.com
Philadelphia Medicine Fall 2020

Table of Contents for the Digital Edition of Philadelphia Medicine Fall 2020
