<p>The data submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna for their Covid-19 vaccine candidates is "very robust", its executive director said on Thursday.</p>.<p>"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," Emer Cooke said at a committee meeting of the European Parliament.</p>.<p>The agency is expected to complete reviews by Dec. 29 for the Pfizer/BioNTech vaccine and by Jan. 12 for the Moderna vaccine "at the latest".</p>.<p>Cooke said that the approval decision dates could change, depending on the assessment.</p>.<p><a href="https://www.deccanherald.com/international/covid-vaccine-coronavirus-vaccine-live-updates-today-pfizer-moderna-sputnik-v-astrazeneca-oxford-bharat-biotech-covaxin-covishield-919242.html" target="_blank"><strong>Follow latest updates and developments on the coronavirus vaccine here</strong></a></p>.<p>"We cannot guarantee that there will be a positive outcome at this stage" Cooke said, adding that the agency's experts had to examine very large data sets.</p>.<p>"We have to make sure we analyse those data correctly," she said.</p>.<p>Cooke added that EMA analysts were also checking data against the new information that emerged in Britain on Wednesday when two people had anaphylaxis and one a possible allergic reaction after the rollout of the Pfizer/BioNTech vaccine began.</p>.<p>She added that she expected AstraZeneca and Johnson & Johnson to submit in the first quarter of next year their applications for a marketing authorisation of their Covid-19 vaccine candidates.</p>.<p>The agency has been assessing preliminary data of the AstraZeneca shot since early October, and Johnson & Johnson's data since early December.</p>
<p>The data submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna for their Covid-19 vaccine candidates is "very robust", its executive director said on Thursday.</p>.<p>"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," Emer Cooke said at a committee meeting of the European Parliament.</p>.<p>The agency is expected to complete reviews by Dec. 29 for the Pfizer/BioNTech vaccine and by Jan. 12 for the Moderna vaccine "at the latest".</p>.<p>Cooke said that the approval decision dates could change, depending on the assessment.</p>.<p><a href="https://www.deccanherald.com/international/covid-vaccine-coronavirus-vaccine-live-updates-today-pfizer-moderna-sputnik-v-astrazeneca-oxford-bharat-biotech-covaxin-covishield-919242.html" target="_blank"><strong>Follow latest updates and developments on the coronavirus vaccine here</strong></a></p>.<p>"We cannot guarantee that there will be a positive outcome at this stage" Cooke said, adding that the agency's experts had to examine very large data sets.</p>.<p>"We have to make sure we analyse those data correctly," she said.</p>.<p>Cooke added that EMA analysts were also checking data against the new information that emerged in Britain on Wednesday when two people had anaphylaxis and one a possible allergic reaction after the rollout of the Pfizer/BioNTech vaccine began.</p>.<p>She added that she expected AstraZeneca and Johnson & Johnson to submit in the first quarter of next year their applications for a marketing authorisation of their Covid-19 vaccine candidates.</p>.<p>The agency has been assessing preliminary data of the AstraZeneca shot since early October, and Johnson & Johnson's data since early December.</p>