Commission president says contract for up to 300 million doses of Pfizer/BioNTech vaccine will be authorised

LAST UPDATE | 10 Nov 2020

EUROPEAN COMMISSION PRESIDENT Ursula von der Leyen has said the Commission will tomorrow authorise a contract for up to 300 million doses of the BioNTech and Pfizer vaccine.

The announcement follows news from the two companies yesterday that the vaccine was 90% effective in its Phase 3 trial, which involved more than 40,000 participants.

Von der Leyen today described the vaccine as “the most promising so far”. 

“Once this vaccine becomes available, our plan is to deploy it quickly, everywhere in Europe. This will be the fourth contract with a pharmaceutical company to buy vaccines. And more will come. Because we need to have a broad portfolio of vaccines based on different technologies,” she said.

“We have already started working with Member States to prepare national vaccination campaigns.

“We are almost there. In the meantime, let us be prudent, and stay safe.”

The Commission has also reached agreements with three other companies that have a vaccine in development:

• It agreed with AstraZeneca to purchase 300 million doses with an option to buy 100 million more.
• It signed a contract to purchase up to 300 million doses of the Sanofi-GSK vaccine.
• It approved a contract with Janssen Pharmaceutica NV to purchase 200 million vaccines with the possibility to purchase a further 200 million.

All of these agreements are on the basis that the vaccine has been proven to be safe and effective once it has gone through regulatory assessments.

The announcement yesterday was cautiously welcomed by world leaders and health officials who described it as a positive step.

At yesterday’s Department of Health Covid-19 briefing, Chief Medical Officer Dr Tony Holohan said it is “certainly night time for celebration” yet as the trial is not yet complete and regulatory authorities will still have to inspect the data when it is published.

Dr Cillian de Gascun, director of the National Virus Reference Laboratory (NVRL) said the news is “positive”, but there will still be practical challenges to work out with any vaccine.

“Over 90% effective – if that holds true in the real world – will be a very good start from a vaccination perspective. Obviously, it’s a two dose schedule so there’s some potential logistical challenges around that,” he said.

“The duration of protection, obviously is something we don’t yet know. Similarly, we know from the media reports this vaccine requires an ultra cold chain of minus 80 degrees. So, again, logistically it could be difficult to roll it out so it’s not going to be the global solution, but certainly it’s very positive first step.”

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Suspension of Sinovac candidate

The World Health Organisation has said 44 candidate vaccines are in clinical evaluation with 10 of those at the final Phase 3 clinical stage.

One of these candidate vaccinations, from Chinese pharmaceutical company Sinovac, hit a roadblock on the same day Pfizer/BioNTech were hailed for their success so far. 

Brazilian regulators halted trials of Sinovac’s vaccine in the South American country citing an “adverse incident” involving a volunteer recipient.

Health regulator Anvisa said it could not give details on what happened because of privacy regulations.

The public health centre coordinating the trials of the vaccine in Brazil, the Butantan Institute, said yesterday it was “surprised” by the decision. The institute “is investigating in detail what happened,” and “is at the Brazilian regulatory agency’s disposal to provide any clarification necessary on any adverse incident the clinical trials may have presented,” it said.

This morning Sinovac said it is “confident in the safety of the vaccine”. The company also said the adverse incident in one of its trial volunteers was “unrelated to the vaccine”.

- With reporting from AFP.