Jen Christensen, CNN: Past vaccine disasters show why rushing a coronavirus vaccine now would be ‘colossally stupid’…

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Excerpts:

1. The vaccine may not be safe.
2. If it is not safe, people will lose faith in vaccines.
3. If a vaccine doesn’t offer complete protection, people will have a false sense of security and increase their risk.
4. If a substandard vaccine gets an EUA, a better vaccine may never get approval, because people would be reluctant to enroll in trials and risk getting a placebo instead of a vaccine.

There would be unnecessary deaths.

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Past vaccine disasters show why rushing a coronavirus vaccine now would be ‘colossally stupid’

By Jen Christensen, CNN

Updated 1534 GMT (2334 HKT) September 1, 2020

Vaccine experts are warning the federal government against rushing out a coronavirus vaccine before testing has shown it’s both safe and effective. Decades of history show why they’re right.

Their concern that the FDA may be moving too quickly heightened when FDA Commissioner Dr. Steven Hahn told the Financial Times that his agency could consider an emergency use authorization (EUA) for a Covid-19 vaccine before late stage clinical trials are complete if the data show strong enough evidence it would protect people.

Vaccine approval

For a vaccine to be FDA approved, scientists must gather enough data through clinical trials in large numbers of volunteers to prove it is safe and effective at protecting people against a disease. Once the data is collected, FDA advisers usually spend months considering it.

An EUA is much quicker. Only once before has the FDA given a vaccine this lesser standard approval of an EUA, but it was in an unusual circumstance. Soldiers had sued, claiming a mandatory anthrax vaccine made them sick, and a judge put a hold on the program. The Department of Defense asked for an EUA that then overrode the court ruling in 2005, so it could continue vaccinating military personnel — this time on a voluntary basis.Otherwise, vaccines have had to go through the entire clinical trial process and FDA approval process, which can take months or years.When the vaccine making process has been rushed, there have been bad outcomes.

The Cutter incident

On April 12, 1955 the government announced the first vaccine to protect kids against polio. Within days, labs had made thousands of lots of the vaccine. Batches made by one company, Cutter Labs, accidentally contained live polio virus and it caused an outbreak.More than 200,000 children got the polio vaccine, but within days the government had to abandon the program.

“Forty thousand kids got polio. Some had low levels, a couple hundred were left with paralysis, and about 10 died,” said Dr. Howard Markel, a pediatrician, distinguished professor, and director of the Center for the History of Medicine at the University of Michigan. The government suspended the vaccination program until it could determine what went wrong.

However, increased oversight failed to discover another problem with the polio vaccine.From 1955 to 1963, between 10% and 30% of polio vaccines were contaminated with simian virus 40 (SV40).

The epidemic that never was

In 1976, scientists predicted a pandemic of a new strain of influenza called swine flu. More than 40 years later, some historians call it “flu epidemic that never was.”

Ford made the decision to make the immunization compulsory.The government launched the program in about seven months and 40 million people got vaccinated against swine flu, according to the CDC. That vaccination campaign was later linked to cases of a neurological disorder called Guillain-Barre syndrome, which can develop after an infection or, rarely, after vaccination with a live vaccine.

“Unfortunately, due to that vaccine, and the fact that it was done so hastily, there were a few hundred cases of Guillain-Barre, although it’s not definitive that they were linked,” Kinch said.

Markel said people’s mistrust of the system makes the idea that the FDA would rush this process before late stage clinical trials are complete”colossally stupid.””This is one of the most ridiculous things I’ve heard this administration say,” Markel said. “All it takes is one bad side effect to basically botch a vaccine program that we desperately need against this virus. It’s a prescription for disaster.”

One, the vaccine may not be safe. Two, if it is not safe, people will lose faith in vaccines. Three, if a vaccine doesn’t offer complete protection, people will have a false sense of security and increase their risk. Four, if a substandard vaccine gets an EUA, a better vaccine may never get approval, because people would be reluctant to enroll in trials and risk getting a placebo instead of a vaccine.”People are going to die unnecessarily if we take chances with this,” Kinch said. “We’ve got to get this right.”

CNN Health’s Jamie Gumbrecht contributed to this story.

https://edition.cnn.com/2020/09/01/health/eua-coronavirus-vaccine-history/index.html

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