Episode #17 - COVID-19 - Vaccine approvals

18 December 2020 | Science conversation

Vismita Gupta-Smith

Hello and welcome to Science in 5, WHO’s conversations in science.

I'm Vismita Gupta-Smith. As countries move forward with National approval of vaccines, what does this process mean? Explaining this today is WHO’s Dr Mariangela Simao. Welcome Mariangela.

Dr Mariângela Simão

Thank you.

Vismita Gupta-Smith

Mariângela, please explain the National approval process for us.

Dr Mariângela Simão

There are different ways that a product, a health product, can enter a country. In normal times, we call it a licensing authorization by the National regulatory authority. Each country has a National regulatory authority and it may be guided by different regulations, although the vast majority of them follow internationally agreed parameters.

Then when you have situations like we have right now with the pandemic, many countries have what's called an emergency use authorization, which is an emergency use authorization for products that are still being finalized in tests or are being brought into the market for specific situations.

No vaccine gets into a country without some authorization by the National regulatory authority.

Vismita Gupta-Smith

Mariângela, explain the process of emergency approvals of these vaccines and how is safety ensured in this process?

Dr Mariângela Simão

It's very important to highlight that no vaccine candidates should be used or issued an emergency approval at country level if it has not finished phase three trials. And why do we say that? Why does WHO keep saying that? Because it's during Phase 3 trials that you do the assessment of efficacy and safety.

When it comes to the assessment of the authority, it has already data on both efficacy and safety. The job is not finished yet because after this, in order to authorize at country level, you need to assess whether the vaccine was “well made”. If it complied to what we call the good manufacturing practices and quality control and so on.

And after it comes into the country, it's also monitored for any potential side effects, anything that relates to additional information that didn't come through clinical trials.

So this is to say that by the time it's authorized the country level, it has gone through a lot of scrutiny. So it's very good to highlight that safety and efficacy will be guaranteed by the process that we have put in place.

Vismita Gupta-Smith

Mariangela, WHO also has its own approval process for vaccines. How does that work with national approval processes and what does that mean for manufacturers and countries?

Dr Mariângela Simão

In the case of the COVID vaccines, WHO has issued what we call an expression of interest for an emergence use listing and potentially, in due time, to a pre-qualification of vaccines.

Why is this important? It's important because there are many National regulatory authorities, there are many, many countries that don't have the technical capacity to do the full assessment. And also when you have an international procurer, traditionally, the UNICEF buys vaccines for the world and PAHO buys for the Americas.

So which assessment do they rely on in terms of quality assurance of safety, efficacy - they rely on WHO’s pre-qualification program. So this is a very fast moving process, usually, to ensure that once a vaccine is proven to be safe and effective, that actually there are no regulatory barriers for these vaccines to enter, to be deployed at country level, no matter whether this is a very mature National regulatory authority or a less mature National regulatory authority.

So reliance on WHO’s process is very important for many countries in the world.

Vismita Gupta-Smith

Thank you, Mariângela. There you have it, Dr Mariângela Simão, explaining the approval process for vaccines. If you find this information useful, please share with your friends and your networks. Remember, there's a lot of misinformation about vaccines out there.

So be the source of scientific, evidence-based information. Until next time then, stay safe, stay healthy and stick with signs.