COVID-19 vaccine development: Fast doesn’t mean unsafe
As the possibility of a COVID-19 vaccine dominates political discussions, a physician who has been tracking pandemic information for months believes the biggest challenge lies ahead - persuading people to take the vaccine when one is ready.
"There is a lot of vaccine shyness in the United States,"
says Thomas Huth, M.D., Vice President of Medical Affairs for Reid Health. He
notes that vaccines alone can be controversial with some, pointing out that in
a normal flu season only about half the high-risk people get a flu shot. "so
it's understandable that people have concerns about a brand new vaccine that
will have been developed very quickly."
A recent national poll by CBS News indicated only 21 percent
of those asked said they would get a vaccine.
"As health leaders, we have a lot of work to do to reassure
people that a vaccine for COVID-19 was properly tested and is safe," Dr. Huth
He noted that the pausing of an AstraZeneca vaccine trial on
30,000 subjects because of a possible reaction in one of the people is not
alarming. "This is actually a common occurrence in pharmaceutical research."
The trial was restarted this week in England after a review panel found that
the illness in one subject was not related to the vaccine.
Pausing such a study is a normal part of the process, he
said. "I think some people's concern about safety is fueled by the fact that
Russia cut an important corner in the development of their vaccine by skipping
the very important Phase 3 trial, in which a large number of people are tested
for safety and effectiveness, including people with a variety of underlying
In fact, for the U.S. work, early safety data from Phase 3
trials "is apparently so good they are adding subjects with certain immune
system disorders. You would think that if there were significant concerns about
safety, they would not include people whose immune systems are especially
Addressing concerns about the speed of the work, Dr. Huth says
the process has been expedited not by cutting corners but by:
- Pausing research on other less urgent topics and concentrating scientific, technological and regulatory resources onto this effort
- Building on past research into coronavirus vaccines, rather than starting from scratch
- Overlapping, rather than skipping, development phases.
- Streamlining the regulatory bureaucracy so that review and approval can happen in days or weeks rather than months or years.
- Pre-investing in production capability so that vaccine can be rapidly shipped once approved
- Developing multiple vaccines so that if one or two have to be stopped, others will continue
"If a vaccine is
available as soon as it looks like it might be, I will be first in line for a
shot, if they'll let me. Having carefully watched this process with a
knowledgeable eye, I'm confident it will result in a properly tested vaccine
that will be better than risking a serious COVID-19 illness," Dr. Huth said.
"If a vaccine is available as soon as it looks like it might be, I will be first in line for a shot, if they'll let me. Having carefully watched this process with a knowledgeable eye, I'm confident it will result in a properly tested vaccine that will be better than risking a serious COVID-19 illness." - Thomas Huth, M.D.