"COVID-19 için Olası Önlemeler ve Tedavilere İlişkin Düzenleyici Terminolojiyi Anlama"; Kaynak: https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19
NORMAL ZAMANDA BİLİM:
Bence de hayati. Ve bu nedenle de çoğumuz, bu konuları anlamaya çalışırsak, yaşam hepimiz için çok daha kolaylaşabilir:
(1): Prof.Dr.Mehmet Aktekin: “Müdahale (Deneysel) Araştırmalar
Müdahale Araştırmalarının Avantajları
Derleyen: A.Şükran Demiralp, 26 Mayıs 2020
*"Avrupa Nükleer Araştırma Merkezi CERN'ün Başkanı Prof. Dr. Rolf Heuer ODTÜ'de açılan ‘Bilimi Hızlandırıyoruz’ adlı serginin açılışı için Türkiyede'ydi.
Prof. Dr. Rolf Heuer: "Bence Bilim ve Toplum faaliyetleri sadece önemli değil, aynı zamanda hayati de. Bir çok insan günlük yaşantısıyla bilim arasında bağlantı kuramıyor ve bu yüzden bilimin gerekli olmadığını düşünüyor. Aslında çevremizdeki bir çok şey bilime dayanıyor. Bu yüzden bilim konusundaki farkındalık artırılmalı. Bilimin öneminin farkedilmesi için sık sık bilimin üzerinde konuşmamız, tartışmamız gerekiyor. Bilim konuşmayı bırakıp sadece araştırma yapmak yeterli değil. Böyle yaparsak zaman içinde bu araştırmaların niye yapıldığını fark etmeyen, önemini idrak etmeyen bir toplum oluşur ki bu bir noktada araştırmaların sona ermesine kadar gider. Bu konuda toplumu suçlayamayız. Şimdiye kadar ziyaret ettiğim tüm ülkelerde bilime merak duyulduğunu gördüm. Suç biraz da bilim insanlarında. Araştırmacılar toplumla bağ kurmayı ihmal etmemeli."
- Speech by
- Stephen M. Hahn, M.D.Commissioner of Food and Drugs - Food and Drug Administration
Thank you for being here today for this important conversation, and to be sharing the computer screen with our colleagues under the HHS umbrella, all of them with unique health-related obligations and individual responsibilities to the public.
I think my HHS colleagues would agree, working together tirelessly on COVID-19 has further strengthened our already close working partnerships, which will benefit public health for years to come.
For the better part of the past year, the SARS-CoV-2 virus has reshaped our lives, forcing us to adapt the way we live and work, producing enormous economic hardships, disrupting families and communities, and causing profound personal pain and tragedy.
As we continue to battle this novel virus, we will no doubt face even more adversity before we can resume life as we once knew it. The just commenced holiday season, which I’m sure you agree is one like no other in recent memory, offers an example. But it is important that for the foreseeable future we continue to be vigilant and safe in our response to this disease, to meet it with responsible behaviors and action that help keep us safe.
The good news is that we are making important scientific progress. Each day brings greater knowledge and new understanding of this novel virus, and with it increased promise of meaningful treatments and preventive measures that will keep us safer.
The FDA has been working non-stop since the beginning of this pandemic to help gain greater understanding of this COVID-19. I am extraordinarily proud of the hard work demonstrated by the Agency’s committed public health professionals.
The FDA has applied enormous resources and tools in our search for solutions and to support the nation’s medical needs.
The FDA staff has engaged in this ‘round-the-clock work even as they have remained focused on meeting the FDA’s regular, mission-critical public health responsibilities.
Of course, COVID-19 continues to be a primary focus of our work. And it’s no surprise that the FDA has responded so effectively to this emergency.
One important tool we have used to great effect during this pandemic, is the Emergency Use Authorization (or EUA), created by Congress specifically to provide us with the means to respond quickly during a public health emergency.
Congress developed the EUA after the terrorist attacks of 9/11 to ensure that potentially lifesaving medical products could be available to people in medical need before the products had been studied fully and to the same level as approved products..
FDA represents science in action. Often, we must make real-time decisions based on ever evolving data concerning a previously unknown, highly contagious virus that we are still learning about. And sometimes it is necessary to reverse decisions as new data emerge. This is inherent in the Emergency Use Authorization (EUA) process and is akin to how a doctor might approach a patient in an emergency situation constantly updating a treatment plan as new data emerge.
Regarding any Emergency Use Authorization for a vaccine, we will approach it in our customary way, carefully considering the benefits and risks.
Since the start of this emergency, the FDA has been able to use the EUA to provide a speedy response to the nation’s unprecedented demand for diagnostic tests, PPE, and other medical products.
We have seen an approximate doubling of our work at FDA. Overall, during the pandemic, we’ve authorized more than 300 Emergency Use Authorizations (EUAs) covering more than 600 products. That’s more than 10 times the amount of EUAs issued for all previous public health emergencies combined.
As you are aware, much of the current focus around the nation involves the development of a safe and effective vaccine. The FDA continues to facilitate expedited vaccine development and to provide rapid feedback and technical advice to sponsors and researchers regarding the data needed to support the manufacturing, clinical development, and approval or authorization of COVID-19 vaccines.
In recent weeks, we’ve seen some very promising developments. Two manufacturers have submitted requests to the FDA to authorize the emergency use of vaccines that have completed stage 3 clinical trials. Others are moving through the pipeline.
I can’t speculate what will happen on this or any product that is submitted, as all the data must first be reviewed by FDA’s career scientists. But I can say, with complete assurance, that they will receive the most careful scrutiny.
While speed in reviewing these products is important, so is ensuring that any approval or authorized vaccine meets the Agency’s rigorous standards for safety, accuracy and effectiveness. And we will not authorize or approve any COVID-19 vaccine until such an approval or authorization meets the relevant statutory standard.
Additionally, we are committed to being as transparent as possible about the scientific basis for EUAs, in order to promote public confidence in the FDA’s scientific review process and ultimately in ensuring that the authorized products are used appropriately.
One way we have advanced this transparency is to make clear, through several guidances, the information a developer should provide to us so that we can review and approve or authorize a vaccine.
Another way is by having any vaccine submitted for authorization reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
This advisory committee consists of external experts who provide non-binding recommendations to FDA related to data concerning the safety and effectiveness of vaccines and other biological products.
They currently have two meetings in open session scheduled -- on December 10 and December 17 -- to discuss the requests for Emergency Use Authorization (EUA) of the Pfizer-BioNTech and Moderna COVID-19 vaccines, respectively.
We believe this transparency should help reassure the public regarding FDA’s commitment to ensuring that any vaccine meets its rigorous standards for quality, safety and efficacy.
Still another way we are strengthening our work, both in our response to the pandemic and for future preparedness, is through our efforts to increase the diversity of participants in clinical trials.
While this has a been an FDA focus for a number of years, it is especially important when trying to find treatments and cures for new diseases like COVID 19, in which certain segments of the population, including older adults, pregnant women, children, and racial and ethnic minorities, have been affected differently.
And this last point is especially important as you all read the news of vaccine authorizations coming out of Europe. While we all desire the successful and speedy development of these products, we cannot and will not shortcut the essential review our scientists must undertake to ensure the safety and effectiveness of any treatment or vaccine.
Speed in reviewing these products is important, but so is ensuring that the review meets the Agency’s rigorous standards for safety, accuracy and effectiveness.
Therefore, our Agency wants to make the following commitments today to the American public and this Committee.
• FDA will not authorize or approve any COVID-19 vaccine or therapeutic before it has met the Agency’s rigorous standards for safety and effectiveness;
• Decisions to authorize or approve any COVID-19 vaccine or therapeutic will be made by the dedicated career staff at FDA through our gold standard review processes; and
• Science and data will guide our decisions and FDA will not permit any pressure, from anybody, to change that.
FDA will fight for science; FDA will fight for the scientific integrity of the Agency and we will put the interests of the American people ahead of anything else.
I hope we can count on your support. From our vantage, the FDA will continue to apply its energy, resourcefulness, and scientific rigor to address these continuing challenges so that we can return to a more normal, healthier daily life.
Thank you, and I look forward to answering any of your questions. "
Kaynak: https://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-hahn-national-academy-medicine-town-hall-covid-19-vaccine-12042020#:~:text=And%20we%20will%20not%20authorize,meets%20the%20relevant%20statutory%20standard.&text=We%20believe%20this%20transparency%20should,for%20quality,%20safety%20and%20efficacy
