CIU Discusses drug research and the applications in relation to the Covid-19 vaccine licensing

CIU Vocational School of Health Sciences, Pharmacy Services Program, gave information to students on the subject, “Drug Research and the Applications in Relation to the Covid-19 Vaccine Licensing”.

At the event, CIU Faculty of Pharmacy, Professor of Pharmacology, Prof. Dr. Osman Özdemir and Assoc. Prof. Dr. Fatoş İlkay Alp Yıldırım of Istanbul University, spoke about the development of new drugs, and the licensing of vaccines in connection to Covid-19.

Özdemir: “Developing drugs is a costly job”
Stating that developing drugs is an expensive job to undertake, Prof. Dr. Özdemir explained that due to the increase in costs, drug research is initiated by small companies, however after a certain point is reached, it is bought by larger drug companies.

Adding that during this process the effects are researched and that the application for the clinical research of the substances are made, Özdemir continued that in the event that these are accepted, Phase-1 of the work now begins.

Advising that in the following stage, the side effects upon humans are deciphered and thus the trustworthiness of the drug is evaluated, Özdemir noted that the successful ones are moved on to Phase-2, however 62% are unsuccessful in Phase-2, and that 42% of those that moved from Phase-2 to Phase-3 are unsuccessful.

Yıldırım stated that during the development of the Covid-19 vaccine, all bureaucratic processes were shortened

Stating that everyone is experiencing some uneasiness with relation to the vaccine, Assoc. Prof. Dr. Yıldırım went on to say, “As it takes about 5-10 years on average for a drug to be developed, the fact that the vaccine was found in a short time of 10 months has raised some debate”.

Speaking about the years long process of drug development, Yıldırım continued, “Here there is the bureaucratic part of the work. There are transactions such as the establishing of funding for research and the obtaining of permissions, however in this situation that involved the entire world, the processes were shortened”.

Stating that the most important part is in revealing the genetic sequence of the virus, Yıldırım went on to state, “We know the Sars-cov2 virus. Studies on this subject have been intensively progressing since 1960. With Sars in 2003, and Mers in 2012, our lives continually exist with Coronavirus".

Explaining that should the virus have been unknown, or had an unknown genetic sequence, years would have been required in such a case, Yıldırım elaborated, “After the approval of the Phase-3 studies, in order to obtain approval for full use, it would take close to 2 years to find out the length of time it took the vaccine to develop antibodies, or the length of time it protects the person. However, as we are not currently in that situation, the process only took 2 months”.

Stating that in the event that all the data is not available for full use authorization, an urgent use authorization is obtained, Yıldırım said that Pfizer/BioNTech both applied to WHO for full use approval and that for more than 6 months they have been used intensively for vaccination.

Saying that security-related processes are carried out transparently without skipping a step, Yıldırım concluded, “There are currently approximately 300 vaccine studies in the world. There are 6 vaccines that have received emergency use approval”.

In her speech, advising that it is necessary to give importance to the field of pharmacy, Yıldırım stated that it is important for us to produce our own vaccine.