EU defends its slower vaccine authorisation

“The promise of vaccines is phenomenal [and] the reward is potentially game-changing,” World Health Organization (WHO) regional director for Europe Hans Kluge said on Thursday (3 December), as the UK became the first Western country to approve a vaccine.

However, recent WHO studies indicate that about half of the population in some European countries are unsure about vaccination against Covid-19.

For Kluge, “it’s understandable to be concerned about vaccination in the current circumstances in which much is still unknown” – such as which vaccines will eventually be licensed, when they will be available and their potential side effects, if any.

The reassurance comes a day after the UK became the first Western country to approve a vaccine and the first in the world to give the green light to the vaccine jointly developed by US’s firm Pfizer and Germany’s BioNTech – with the UK’s rollout expected to at least begin next week.

The UK’s medicines regulatory agency announced the decision on Wednesday, just weeks after the companies released first data from the final stage of their clinical trial.

The procedure followed by the British authorities, however, gives the companies complete immunity from legal liability in civil cases.

The license, known as an “emergency use authorisation,” has been traditionally used to allow medical products under emergency conditions which have not been already approved by the European Medicine Agency (EMA).

Under EU law, all member states can opt for this approach.

However, a commission official said on Thursday that for member states, it is important that the vaccine approval goes through the EU agency, since the trust of citizens is at stake.

Nevertheless, Hungary may end up using this opt-out approach for the roll out the Russian-made vaccine Sputnik V.

UK vs EMA

Meanwhile, the EMA is carrying out a fast-track but standardised regulatory process for the approval of two vaccines candidates, developed by Pfizer/BioNTech and Moderna, which have applied for EU-wide authorisation.

Under this approach, the same standards of quality, safety and efficacy for the approval of all EU medicines will apply to Covid-19 vaccines.

The Amsterdam-based agency, which moved from London after Brexit and is responsible for the scientific assessment of the data of all clinical trials, said this is the “most appropriate” method to approve the vaccine.

Data has been examined as it becomes available in order to accelerate the process.

After monitoring the results, EMA has to issue a scientific opinion that the commission uses to discuss with member states and give the official green light to the authorisation.

This final step by the commission, which can take up to 67 days, will be reduced to three days to ensure a quick distribution.

For the Pfizer/BioNTech vaccine, EMA expects to have a scientific opinion no later than 29 December – meaning that distribution could start early January.

The “conditional marketing authorisation” that companies will receive, which is foreseen under public health emergencies, holds the company accountable for the safety of the product – even after the approval is granted.

Moreover, the companies are responsible for monitoring the safety vaccines, reporting suspected adverse reactions to EMA and keeping product information up to date, while conducting safety and effectiveness studies regularly.

Hacked

The commission, on behalf of member states, has sealed deals with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech/Pfizer and CureVac for up to two billion vaccine doses.

The EU executive said that once a vaccine is authorised, EU countries will get access to purchase the vaccines at the same time, on a population-based pro-rata basis.

Member states can also donate the vaccines to lower and middle-income countries or to re-direct it to other neighbouring countries.

Meanwhile, the commission’s taxation and customs department has been targeted by hackers who have launched a “global phishing campaign” to gain insights about the Covid-19 vaccine ‘cold supply chain’, tech giant IBM revealed on Thursday.

Understanding how to build a secure cold chain may be key for the storage and distribution of vaccines like the one of BioNTech/Pfizer, which needs to be stored at minus 70 degrees to avoid spoiling.

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