Conditional authorisation ‘most likely’ for COVID-19 vaccine, EMA says

EMA sources told EURACTIV.com that the most likely scenario in the EU would be a conditional marketing authorisation (CMA) for a COVID-19 vaccine. [Shutterstock/Alessandro Zappalorto]

The most likely scenario for COVID-19 vaccine candidates in the EU is a one-year conditional marketing authorisation (CMA), European Medicines Agency (EMA) sources have told EURACTIV.

conditional marketing authorisation allows the approval of a medicine or a vaccine that addresses an unmet medical need with a positive benefit-risk balance. It is based on less complete data than is normally the case, and with specific conditions to be met within defined timelines after authorisation.

The source added that CMAs are valid for one year and can be renewed annually.

In an interview with Italian daily Il sole24ore, the EU drug agency chief Guido Rasi said he is expecting to give to go-ahead to the first COVID-19 vaccine in December and start distribution in January 2021.

Rasi added that the effect of the vaccine on infection rates and deaths will only be visible after five or six months, which would land next summer.

He said in order to vaccinate everyone in Europe, 500 million doses will be needed. “If everything goes smoothly, at the end of 2021 we will have sufficient immunisation.”

He also projected that Europe might have up to seven COVID-19 vaccines approved in 2021.

Rasi emphasised that it would be crucial to monitor the course of the virus over the next 4-5 years. He foresees different potential scenarios, which include the eradication of the virus, or the mutation of the virus, either for better or worse.

“The virus could even become one of the components of the flu vaccine in the coming years,” Rasi said, referring to the influenza vaccine that is rolled out annually to those who are the most vulnerable.

Vaccine hesitancy creates concern in the fight against COVID-19

Scepticism about adverse effects and actual lack of efficacy in immunisation practices can become an important negative factor when a vaccine against coronavirus becomes available, according to the head of the EU’s medicines agency (EMA), Guido Rasi.

CMA does not mean less safety

Under normal circumstances, EMA has to finalise its scientific review process within 210 days. But in the case of COVID-19, the agency has put in place rapid review procedures.

Since CMAs are based on less comprehensive data than the normal procedure, EURACTIV also asked EMA if it sees any potential risk in authorising vaccine candidates, such as the Pfizer/BioNtech one, in this way.

If approved, this vaccine, of which the EU has ordered 300 million doses, would be the first of its kind as it is based on messenger RNA (mRNA), acting on the transfer of instructions from DNA to cells’ protein-making machinery.

“The safety requirements for COVID-19 vaccines are the same as for any other vaccine in the EU and will not be lowered in the context of the pandemic,” the EMA sources replied.

They added that the EU has a comprehensive safety monitoring system that allows measures to be put in place to minimise risk, detect any potential adverse effects, and introduce any necessary mitigating actions early.

“The authorisation is granted if the benefits of immediate availability also outweigh the risks related to more limited data, and on the condition that the company will supply the additional information requested within defined timelines, such as the results of further studies, once the vaccine is on the market,” the EMA sources explained.

Does fast-track drugs approval in EU run too fast?

More than two years after its launch, the EU’s fast-track approval process for marketing new drugs, called PRIME, is broadly welcomed by patients and industry, walking the fine line between patients’ safety and expediency, and between the need to foster innovation and remaining abuse-proof.

FDA and EMA

Asked if an earlier approval from the US Food and Drug Administration (FDA) would mount the “political” pressure on the EU to speed up approval procedures too, the EMA sources replied that the agency is a scientific body.

“Once data on a COVID-19 vaccine or medicine is submitted to EMA, the agency provides an independent recommendation, based on a thorough scientific evaluation of all available evidence on its safety, efficacy and quality.”

The sources added that EMA and FDA are conducting independent scientific assessments of vaccines and therapeutics, according to the regulatory and legal framework for medicines in the EU and the US respectively.

However, the two agencies have a longstanding agreement allowing the exchange of confidential information as part of their regulatory and scientific processes.

“In the context of COVID-19, EMA has almost daily interactions with the FDA on all aspects of COVID-19 treatments and vaccines, through informal and formal exchanges through ‘clusters’,” the sources added.

*Gerardo Fortuna and Natasha Foote contributed to this article

[Edited by Zoran Radosavljevic]

Subscribe to our newsletters

Subscribe
Contribute