Fast And Fabulous: How The COVID-19 Vaccines Got Approved So Quickly
By Sally Bathgate - AMWA Member. 17 March, 2021
Before 2020, I’m not sure many people really cared how the government regulators evaluated the quality, safety and efficacy of new medicines.
We were happy to have new medicines, of course. But we weren’t that engaged in the process of how they came to us.
Skip to 2021: now lots of people have an opinion on how medicines are developed and how regulators evaluate them. And there are lots of big questions around how the new COVID-19 vaccines could be developed and approved so quickly.
Continuing AMWA’s webinar series ‘COVID-19 Vaccine — Your Questions Answered’, Associate Professor Jo Kirman, from the Department of Microbiology and Immunology at the University of Otago, gave us her expert tour of the some of the drug regulators. And showed us how and why the COVID-19 vaccines got approvals so quickly.
Who are the drug regulators?
- The Food and Drug Administration (FDA), USA
- The European Medicines Agency (EMA), evaluating medicines for members of the European Union.
- The Therapeutic Goods Administration (TGA), Australia
- Medsafe, New Zealand
She noted that one of the criticisms of the drug approvals process is that evaluations seem essentially duplicated, with the same data sets,
over scores of different countries:
“A lot of people think, ‘Oh, if it's already been approved by the FDA or the EMA, why are we bothering to go through with our own approval process? Isn't it just slowing things down?’”
But it’s more complex than that.
Why can’t a single regulator give the green light for the whole world?
As Kirman explains:
“Each of these regulatory bodies actually enforces a different local legislation. So, for example, the FDA has the Centre for Biologics Evaluation and Research, and they are the entity that enforces the [US] legislation.”
Despite the product data being essentially the same, the legislative requirements in each country are not. This means each country needs to approve medicines within their own legislative framework.
For instance, national regulators ensure the product being imported (or manufactured) in the country meets the requisite national quality standards. You can hear more about these standards—illustrated by a delightful Milo® analogy—in the recording of the webinar.
What’s more, the medical contexts of different countries are not the same – particularly with this pandemic.
Both the US and the EU are in “emergency situations”, with huge numbers of infections and death. Even though there is still urgency, Australia and New Zealand are not experiencing the pandemic in this way.
When “emergency” criteria are met – this triggers changes to the normal regulatory review process.
Provisional approval, interim approval, emergency approval, oh my!
Each regulator has a process by which it can fast-track—or prioritise—the data review. This process can be sought by the manufacturer whenever there is an urgent medical need for a product.
And COVID-19 vaccines are by no means the first pharmaceutical products to receive fast-track reviews.
Such reviews go quickly because they can allow things like:
- Concurrent exploration of drug safety and efficacy (preclinical and clinical studies)
- Submission of data in batches (rolling submission), rather than as one complete package
- Allowing a product review to ‘push ahead’ of other applications in the queue.
So, the regulators are prepared for emergencies like this, and the vaccine reviews are being done according to the normal legislative framework of the regulators.
Kirman uses the TGA as an example:
“The TGA has been using something called the provisional approval pathway for the [COVID-19] vaccines, which follows these five steps:
- First, there is a provisional determination [allowing the drug to be reviewed on this pathway]
- The next thing is the pre-market registration [supplying and evaluating the evidence]
- And then the provisional registration period gets approved. At the moment you've got two vaccines approved: the Pfizer in Astra Zeneca vaccines. Provisional registration lasts for two years.
- Provisional approval is contingent on these manufacturers providing additional information, particularly as more data comes to light - that will constantly need to be provided for evaluation by the TGA.
- And then if they provide all of the necessary information, they're able to transition to full registration.
So, there's a lot of engagement with the regulatory body going on. Even after this provisional registration.”
In addition, the TGA allowed rolling data submission, exceptional expert review committee meetings, as well as collaboration with regulators in the UK, Canada, Singapore and Switzerland (the Access Consortium).
All these factors expedited the usual TGA review time frame from 255 days to 54 days (for the Pfizer vaccine). You can listen to the recording to find out how Medsafe tackled their review.
Are the COVID-19 vaccines safe?
“It's important to recognise that the regulatory bodies want to keep the population safe. They don't want to hurt people,” says Kirman.
The regulators are not cutting corners, they look extremely closely at all the adverse events - both in clinical trials and in 'real-world' experience.
As Kirman explains, “The regulatory bodies don't rely on the interpretation of the company providing that data: they will look at the raw data, and they will draw their own conclusions about the efficacy and also about the safety.”
“The New Zealand and Australian authorities have shown that they can accelerate the approval process within their existing framework, without compromising the breadth and the depth of the evaluation processes. And it’s a dynamic ongoing process—so it's not over yet.
As I've shown you there's lots of post-market evaluation, as new information comes to light… so it's definitely been a fabulous process.”
Kirman is confident there is enough data to be sure the vaccines are safe and effective in the short term, with some open questions for some age groups, some people groups and some COVID-19 virus variants. The ongoing submission of data will answer most, if not all, of these questions.
AMWA member Sally Bathgate worked as a Regulatory Affairs professional in the pharmaceutical industry in Australia from 2001-2010. She’s had the privilege of shepherding many new drug and new indication applications through the TGA approval process.