Friday

12th Apr 2024

EU defends its slower vaccine authorisation

  • The procedure followed by the British authorities gives the companies complete immunity from legal liability in civil cases (Photo: Nathan Forget)

"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.

Read and decide

Join EUobserver today

Get the EU news that really matters

Instant access to all articles — and 20 years of archives. 14-day free trial.

... or subscribe as a group

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.

EU commission keeps vaccine price secret

The European Commission is about to sign a fourth contract for hundreds of millions of vaccine doses against Covid-19. The contracts include non-disclosure clauses, meaning things like price or even where they will be produced remains confidential.

EU seeks new deal for '90% effective' Covid-19 vaccine

After an experimental Covid-19 vaccine developed by the American giant Pfizer and its German partner BioNTech was found to be more than 90 percent effective, the EU announced that it will sign a contract for up to 300 million doses.

EU leaders to discuss vaccine roll-out this month

EU leaders regularly held video-conferences to coordinate the pandemic reaction last year, but countries and EU institutions recently began a blame-game over the sluggish roll-out of vaccines.

Opinion

Calling time on Amazon's monopolism and exploitation

As Amazon's founder Jeff Bezos just reclaimed the title of the richest person on Earth, its workers cannot even take a bathroom break under the pressure of meeting inhumane performance targets.

Opinion

This 'deregulation' lobbying now threatens EU economy

Next week's EU summit (17-18 April) will discuss the strategic agenda for the next five years. The current "competitiveness agenda" is to a large extent driven by a big lobbying campaign — so far, not well covered by the media.

Latest News

  1. UK-EU deal on Gibraltar only 'weeks away'
  2. Belgium declares war on MEPs who took Russian 'cash'
  3. Brussels Dispatches: Foreign interference in the spotlight
  4. Calling time on Amazon's monopolism and exploitation
  5. Resist backlash on deforestation law, green groups tell EU
  6. China's high-quality development brings opportunities to the world
  7. Ukraine tops aid list again, but EU spending slumps
  8. Who did Russia pay? MEPs urge spies to give names

Stakeholders' Highlights

  1. Nordic Council of MinistersJoin the Nordic Food Systems Takeover at COP28
  2. Nordic Council of MinistersHow women and men are affected differently by climate policy
  3. Nordic Council of MinistersArtist Jessie Kleemann at Nordic pavilion during UN climate summit COP28
  4. Nordic Council of MinistersCOP28: Gathering Nordic and global experts to put food and health on the agenda
  5. Friedrich Naumann FoundationPoems of Liberty – Call for Submission “Human Rights in Inhume War”: 250€ honorary fee for selected poems
  6. World BankWorld Bank report: How to create a future where the rewards of technology benefit all levels of society?

Stakeholders' Highlights

  1. Georgia Ministry of Foreign AffairsThis autumn Europalia arts festival is all about GEORGIA!
  2. UNOPSFostering health system resilience in fragile and conflict-affected countries
  3. European Citizen's InitiativeThe European Commission launches the ‘ImagineEU’ competition for secondary school students in the EU.
  4. Nordic Council of MinistersThe Nordic Region is stepping up its efforts to reduce food waste
  5. UNOPSUNOPS begins works under EU-funded project to repair schools in Ukraine
  6. Georgia Ministry of Foreign AffairsGeorgia effectively prevents sanctions evasion against Russia – confirm EU, UK, USA

Join EUobserver

EU news that matters

Join us