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The highly anticipated results of phase 3 clinical trials for the Pfizer-BioNtech vaccine were published Thursday in the medical journal. New England Journal of Medicine (NEJM), when the scientific commissions of drug regulatory agencies in the United States and Europe are apparently ready to give you the green light for emergency use. One fact that stands out is that the side effects, when registered, seem a little milder in older people.
The European Medicines Agency (EMA) should give the green light to the Pfizer-BioNtech vaccine “no later than December 29,” he said Thursday at a hearing at the Committee on the Environment, Public Health and Safety. The director of the EMA of the European Parliament, Emer Cooke. This authorization will be valid for all 27 countries of the European Union at the same time.
To EMA Director, Emer Cooke
DR
The decision on Moderna’s vaccine, also based on messenger RNA – a new technology, which until now has never been used for vaccines – should be cleared at an expert meeting on January 12, Cooke specified. In the United States, the Food and Drug Administration, the body that regulates the drug market, promotes this Thursday at a meeting of the scientific committee that is evaluating the Pfizer vaccine, and the decision should be made this week. Regarding Moderna’s vaccine, a decision is due on December 17.
The EMA is even working overnight shifts, Emer Cooke said, so the entire evaluation process is sped up. This was only possible because pharmaceutical companies were sharing the results of clinical trials with the regulator, in an ongoing evaluation process.
The EMA is evaluating two other vaccines, but they are lagging behind: those from Janssen and those from the University of Oxford-AstraZeneca. It is not yet possible to advance specific dates, but Emer Cooke is convinced that they can still be authorized “during the first quarter of 2021”.
Results published Thursday by BioNtech scientists in NEJM, who developed the vaccine that Pfizer will manufacture and distribute throughout the world, confirm that it has a high degree of safety and efficacy, and that it begins to confer immunity 12 days after the first dose, but only reaches its maximum effectiveness (95%) a week after the second, that is, 28 days after the first dose. The team acknowledges the limitations of the study (duration and number of people in the subgroups) “to detect less common adverse effects in a guaranteed way.” The most common were fatigue and headache, and were most frequently reported at the age of 55.
Emer Cooke promised, before MEPs, that authorization to commercialize covid-19 vaccines “will only be given when the data clearly shows that the benefits outweigh the risks.” He also assured that EMA will make available in its site, “Within three days” after approval, all the documents relied upon to conduct the assessment. That will include the results of clinical trials, he said.
“The authorization that will now be issued is not final, it is conditional. It will have to be renewed within a year, and it will continue to be evaluated, it can be revoked at any time. It will be up to the Member States to monitor possible adverse effects and insert them into the system, ”Cooke warned.
Concern for transparency has to do with the need to promote the acceptance of drugs and vaccines for covid-19, and counteract the misinformation that runs very easily on social networks, Emer Cooke explained. Therefore, the EMA is organizing this Friday a session, on the Internet, in its site, between 12 noon and 3:30 in the afternoon, to explain how the approval process for these vaccines is progressing. Anyone can watch and hopefully ask questions. “We need to understand people’s concerns and questions,” he concluded.
