Experts are warning the US federal government against rushing out a coronavirus vaccine before testing has shown it’s both safe and effective – past vaccine disasters could prove they are right.
FDA (Federal Drug Administration) Commissioner Dr Steven Hahn said that his agency could consider an emergency use authorisation (EUA) for a Covid-19 vaccine before late-stage clinical trials are complete as long as the data showed strong enough evidence it would protect people.
The commissioner has the authority to allow unapproved vaccines when there are no adequate or approved alternatives. An EUA is not the same as full approval and it can be withdrawn at any time. That’s what happened with hydroxychloroquine and chloroquine. The FDA granted an EUA to the drugs and was much praised by President Donald Trump on March 28. However, it subsequently revoked its EUA in June after studies showed they were not effective and could even potentially cause serious heart problems.
Generally, for a vaccine to be FDA approved, scientists must collect enough data through clinical trials in large numbers of volunteers to prove it is safe and effective at actually protecting people against a particular disease. Once the data is collected, FDA advisers usually spend months considering it, here is where doubts are raised over the vaccine’s effectiveness and safety.
Vaccines normally have had to go through an entire clinical trial process and FDA approval process, which can take months or years. History has shown that when the vaccine making process has been rushed, there have been some seriously bad outcomes…
The Cutter Labs Incident
On April 12, 1955, the government announced the first vaccine to protect children against polio and within days, labs had made thousands of samples of the vaccine. Batches made by one company, Cutter Labs, accidentally contained live polio virus and it caused a serious outbreak. More than 200,000 children got the polio vaccine, but within days everyone knew something had gone drastically wrong.
“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 paediatrician and a distinguished professor. The government suspended the vaccination programme until it could determine the exact source of the problem.
The US will not join the WHO’s coronavirus vaccine effort
The US will not participate in a worldwide effort to develop and distribute a coronavirus vaccine. The White House said this was in part because the initiative is being led by the World Health Organisation.
President Trump has expressed confidence in US efforts to develop a vaccine and has been harshly critical of the WHO, criticising them for their ‘China-centric’ approach to the pandemic. White House spokesman Judd Deere said: “Under President Trump’s leadership vaccine and therapeutic research, development, and trials have advanced at unprecedented speed to deliver groundbreaking, effective medicines driven by data and safety and not held back by government red tape.”