EU medicines agency sets December 29 date for Pfizer approval decision as it insists cyberattack targeting covid data will not affect its vaccine delivery
The European Medicines Agency, has announced that a decision for approval of the Pfizer vaccine will be made on December 29, despite the cyberattack targeting coronavirus vaccine data.
The EMA, which is currently weighing up whether to give special approval for several coronavirus vaccines, announced the cyberattack on Wednesday, but said it will not affect the timeline for approval of the vaccines.
Pfizer-BioNTech also said documents relating to its regulatory submission were illegally accessed.
The European Medicines Agency announced the cyberattack on Wednesday but said it will not affect the timeline for the delivery of vaccines
The Amsterdam-based international body said the decision on coditional approval for Pfizer-BioNTech's Covid-19 vaccine will be made on December 29, while a ruling on Moderna's vaccine will follow on January 12.
EMA chief Emer Cooke told a European Parliament committee said: 'We have been subject of a cyberattack over the last couple of weeks.
'This is being investigated.
'I can assure you that this will not affect the timeline for the delivery of vaccines and that we are fully functional.'
EMA added it was probing the hack 'in conjunction with experts from cybersecurity authorities across the EU, and with the criminal authorities and the Dutch police.'
Hacking attempts against healthcare have intensified during the pandemic as cyber criminals scramble to obtain the latest information about the outbreak.
Hackers linked to North Korea, Iran, Vietnam, China and Russia have on separate occasions been accused of trying to steal information about the virus and its potential treatments.
The EMA chief said that based on the data so far, 'the safety and efficacy look very promising'
The EMA chief said based on the data so far, 'the safety and efficacy look very promising'
'We have a data set of over 30,000 subjects who have been followed through the clinical trials.
'This gives us a very robust data set on which to make a decision, both on safety and efficacy,' she said at a committee meeting of the European Parliament.
She added that EMA analysts are also checking data on possible side effects after two people had reactions in the UK since the rollout of the Pfizer/BioNTech vaccine began.
AstraZeneca and Johnson & Johnson are expected to submit in the first quarter of next year their applications for a marketing authorisation of their COVID-19 vaccine candidates.