Albert Burla, president and CEO of the American company Pfizer, who announced positive and effective results from the third and final phase of the Corona vaccine trials, revealed that it is not possible to apply for an emergency use permit from the Food and Drug Administration. US based only on these efficacy results, it is also needed for additional safety data, saying, “We are continuing to collect this safety data as part of our ongoing clinical trial.” .
In a statement via the company’s official website, Burla explained that an average of two months of safety data was estimated after the second and final dose of the candidate vaccine required by FDA guidelines. (FDA) A possible emergency use license will be available by the third week of November.
He added: “The advanced phase of the study of our potential coronavirus vaccine was found to be 90% more effective in preventing corona in participants with no evidence of previous infection with SARS-CoV-2 In the first interim analysis of effectiveness.
Confirming that the results show that the vaccine-based mRNA It can help prevent Coronavirus in most people who receive it, and that means taking one step closer to providing people around the world with a much-needed hack to help end this global pandemic..
Noting that data is provided to demonstrate that the vaccine can be continuously manufactured to meet quality standards, beyond that efficiency, safety and consistent manufacturing are the three requirements before applying for authorization..
Announcing that in the coming weeks we will see further updates on vaccine trials and communication with regulatory agencies to confirm safety and efficacy.
On the other hand, Anthony Fauci, director of the American National Institute of Allergy and Infectious Diseases, said: “It is indeed a good day for biomedical research after reaching the results of the trials of the possible Pfizer vaccine for Corona, which has turned out to be over 90%, which is unusual and will have a big impact on everything we do. ” As for the coronavirus “.
According to a report from the Bloomberg agency, Fauci has made it clear that more data will emerge in the coming weeks that may not be pleasantly positive. The vaccine may work better in some groups than in others. There may be safety concerns limiting its use, including side effects. The rare one that takes two to three months to appear and the vaccine must be stored at extremely low temperatures, a logistical challenge that will make distribution more difficult and slower..
And according to the report, the director of the National Institute of Allergy of America explained, regardless of the obstacles, it’s better to have a vaccine that appears to be more effective than an inactive vaccine and the belief that there is a vaccine on the way that allows people to all over the world to foresee the end of social distancing actions and sacrifices and wear a mask for a few months. Others, not yet for a few years.