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EU medicines regulator says data 'looks robust' as it plans toward Pfizer vaccine approval by end of month

A decision on the approval of the Pfizer/BioNtech is due on 29 December.
Dec 10th 2020, 4:31 PM 12,490 8

THE DIRECTOR THE European Medicines Agency has said that the information from Pfizer/BioNtech vaccine looks robust so far but they can’t promise approval for distribution in the EU. 

Emer Cooke told a European Parliament committee that the 29 December will be the latest that the EU regulatory body will announce it’s approval for the Pfizer/BioNtech vaccine, while a decision for Moderna’s vaccine is due on 12 January at the latest. 

Cooke said a positive outcome on approvals cannot be guaranteed at this stage as there are still issues the EMA needs to resolve.

“Our experts are going back and forth, they’re questioning the data, there’s a large set of data, we have to make sure that we really analyse that data correctly.”

However, based on the data for the two vaccines so far, “the efficacy and safety look very promising, and we have not seen the adverse events coming up that would be a concern.”

The Amsterdam-based agency, which is evaluating requests for conditional marketing authorisation for coronavirus vaccines, said it is taking into consideration the adverse reactions which prompted the allergy warning from UK regulators.  

The warning came after two NHS staff members who received the jab on Tuesday had allergic reactions after being given the Pfizer/BioNTech vaccine.

Two health workers, who are understood to both have a history of severe allergic reactions, were among thousands to receive the vaccine on the first day of the Covid-19 mass vaccination programme.

The EMA received case reports on the two adverse reactions in the UK yesterday and experts are currently reviewing the data to see if could be predicted or whether it is directly linked to the vaccine. 

Cooke said the EMA is working closely with the 27 member states to ensure any that any future adverse vaccine reactions are collected and reported, “and they will be contributing to the overall assessment.”

She acknowledged that the vaccines have not yet been studied in pregnant or breastfeeding women but said this area will be required to be studied post-authorisation of the vaccines.

Likewise, she said more studies are needed on children under the age of 16.

Cooke said as part of the EMAs marketing authorisation procedure, companies are required to submit a paediatric investigation plan where they outline the studies that they will perform in children, following the collection of the full data on adults.

She added that plans are in place for these subsequent studies to be done in a phased manner. 


She said that safe and effective Covid-19 vaccines will become a key component in overcoming the virus, but they alone will not be “the silver bullet that will allow us to return to normal life”.

Cooke stressed that a combination of the current social distancing, facemasks, tracking diagnostics, together with other public health measures will still be needed to control the spread of the pandemics for several months as vaccinations are taking place.

Last night, the EMA was targeted in a cyberattack, but Cooke said the timeline for the delivery of vaccines will not be affected as its operations have been able to continue. The incident is currently under investigation. 

“We are we are investigating the cyber attack in conjunction with experts from cybersecurity authorities across the EU, with the criminal authorities and the Dutch police,” said Cooke. 

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It would not be the first time an entity linked with coronavirus vaccines has been targeted by cybercriminals.

Last month, Microsoft said it had detected attempts by state-backed Russian and North Korean hackers to steal valuable data from leading pharmaceutical companies and vaccine researchers.

Microsoft said most of the targets – located in Canada, France, India, South Korea and the United States – were “directly involved in researching vaccines and treatments for Covid-19″.

The EMA is also in the early stages of carrying out reviews of vaccines developed by Oxford University-AstraZeneca and Johnson & Johnson.  

The Irish government has signed up to six advance purchase agreements of vaccines from Moderna, AstraZeneca, Jansen, Sanofi, CureVac and Pfizer.

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