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How long does it take to develop a vaccine?
Guido Rasi, former director of EMA, the European drug agency, professor of microbiology at the University of Tor Vergata, responds: The variable and unpredictable weather. One year is enough for the flu because it starts from a technological platform where the changing virus is inserted. The hepatitis C vaccine has been tested for years and was as much a failure as for AIDS. 8 years were needed for anti-Ebola due to difficulties related to the short duration of the epidemics.
Why does anti Sars-CoV-2 arrive after one year?
There was no problem enrolling patients as the epidemic never stopped. It was easy to do the experimentation in a population highly exposed to the virus.
What else has accelerated the times?
Unprecedented sums were invested and technological platforms were used that brought together several research groups that worked on elements made available to the scientific community immediately. We work for large consortia and not for individual laboratories.
Did the vaccine travel the fast lane?
At Ema, a working group has been created that works only on Covid, made up of experts appointed by the network of national regulatory authorities. They are in charge of evaluating the data produced for the development of anti-Covid drugs and vaccines. The companies were allowed to submit the data as they had it and the working group reviewed it from time to time without having to wait for the entire dossier to be completed to obtain authorization. In this way, evaluation times are shortened: from 1 year to 3 months. Ema has been working for 3 months on vaccines from Astrazeneca, Moderna and Pfizer / Biontec.
What speed is achieved at the expense of safety?
No, they have not skipped steps, as virologist Anthony Fauci also stated. Only administrative and bureaucratic inefficiencies have been eliminated and companies have deployed all their forces.
Have phase 1 and phase 2 testing been simplified?
No. When it is said that phases 1 and 2 were carried out in parallel, it means that while one group of patients was observed with the methodology inherent in phase 1, another group was observed for the next phase. The risk of who produces the drug. If phase 1 goes wrong, the resources used in phase 2 would be wasted.
How many people have been vaccinated?
More than 130,000, including phase 3. Traditionally, between 300 and 3000 people are enrolled.
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Why have the trial results not yet been published, but have been previously announced by the companies?
It is not the first time that companies anticipate results, according to a commercial game that does not surprise, but this does not affect the regulatory authorities. It is up to them to request the data to be analyzed. The world of industrial communication and technicians do not meet. Anticipations sure create confusion. The official data from the pharmaceutical agency is published on Ema’s website and can be consulted by anyone, including the methodology and steps that led to the approval of individual products.
Did the three vaccines cause any side effects during the test?
Any vaccine develops side effects in 3-5% of those vaccinated: from swelling in the arm from the sting to a 2-day low fever
November 21, 2020 (change November 21, 2020 | 22:08)
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