The companies “Pfizer” and “Biontech”, recently, provided very positive data regarding the upcoming vaccine against the emerging corona virus, confirming that clinical trials have shown great efficacy in preventing the infection that causes “Covid 19” disease.
This announcement raised questions about the possible date of readiness for this vaccine, especially since the start of vaccinating people will mark the return to normal life, albeit gradually.
According to “CNN”, according to officials and health experts, the vaccine announced by “Pfizer” and was very welcomed, will not be ready until the second half of next December.
The vaccine, which was developed in a record period of time, requires this period, because it is required to obtain approval from one of the most prominent health and scientific institutions in the United States.
Experts say that the Pfizer / Biontech vaccine will not obtain the approval of the US Food and Drug Administration before the second half of December, meaning that it still takes several weeks.
Larry Curry, an academic at the University of Washington and a prominent member of the clinical trials of the Coronavirus vaccine, says that the US Food and Drug Administration will take approximately 10 days for it to review clinical trial data on the vaccine.
The American scientist added that the prestigious US agency will also look at the standards for producing this vaccine, in order to make sure that they comply with the required manufacturing specifications.
The researcher stated, “I am not sure how long this will take, but the matter may be completed in two weeks. This is reasonable.”
The Food and Drug Administration pledged to seek the assistance of the Advisory Committee on Vaccines and Related Biological Products in the United States, known as “VRBPAC”.
In the same direction, the researcher and member of this committee, Paul Offit, is likely to have the vaccine against the Corona epidemic ready in December.
The American academic indicated that the opinion of this advisory committee may be requested as early as next December.
But setting a date for vaccine readiness is not easy, because several companies began producing the vaccine before it received approval, in order to gain time, especially since this approval for use appears to be almost guaranteed.
On Monday, the “Pfizer” companies clarified that what they announced recently is included in the preliminary data only, but the latter cannot be sent to the Food and Drug Administration to obtain approval for emergency use.
The US Food and Drug Administration requires companies to wait two weeks for half of the volunteers to receive a second dose of the vaccine.
After waiting two weeks, the company can submit a formal application for the emergency use license.