epa08600537 A handout photo made available by the Russian Direct Investment Fund (RDIF) shows containers with a new two-vector COVID-19 vaccine at Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia, 06 August 2020 (issued 13 August 2020). Russia registered the new called Sputnik V vaccine against coronavirus Sars-Cov-2 and opens the stage of its massive testing. EPA/RDIF HANDOUT NO RESTRICTIONS, ALLOW TO USE IN SOCIAL NETWORK HANDOUT EDITORIAL USE ONLY/NO SALES
Photo: ΑΠΕ-ΜΠΕ
Για να ξεκινήσει η παραγωγή σε μεγάλη κλίμακα και η ευρεία διάθεση στην παγκόσμια αγορά ένα εμβόλιο θα πρέπει να λάβει άδεια από τις εγκριτικές αρχές που είναι ο Οργανισμός Φαρμάκων και Τροφίμων (FDA) στις ΗΠΑ και ο Ευρωπαϊκός Οργανισμός Φαρμάκων (ΕΜΑ) στην Ευρώπη.
Σύμφωνα με τον Παγκόσμιο Οργανισμό Υγείας αυτή τη στιγμή βρίσκονται υπό αξιολόγηση περισσότερα από 170 υποψήφια εμβόλια. Τα 138 βρίσκονται σε προ-κλινικές δοκιμές. Τα 24 αξιολογούνται ως προς την ασφάλειά τους στους ανθρώπους σε μικρές μελέτες φάσης 1. Τα 14 βρίσκονται σε μελέτες φάσης 2 με περισσότερους εθελοντές και αξιολογούνται ως προς την αποτελεσματικότητα και την ασφάλεια. Εννέα εμβόλια βρίσκονται υπό αξιολόγηση σε μεγάλες μελέτες φάσης 3 που, εφόσον έχουν ενθαρρυντικά αποτελέσματα αποτελεσματικότητας και ασφάλειας, πρόκειται να οδηγήσουν σε έγκριση από τις ρυθμιστικές αρχές.
Για να ξεκινήσει η παραγωγή σε μεγάλη κλίμακα και η ευρεία διάθεση στην παγκόσμια αγορά ένα εμβόλιο θα πρέπει να λάβει άδεια από τις εγκριτικές αρχές που είναι ο Οργανισμός Φαρμάκων και Τροφίμων (FDA) στις ΗΠΑ και ο Ευρωπαϊκός Οργανισμός Φαρμάκων (ΕΜΑ) στην Ευρώπη. Προς το παρόν, κανένα εμβόλιο δεν έχει λάβει έγκριση, ενώ η Ρωσία έδωσε επιταχυνόμενη έγκριση σε εμβόλιο με βάση τα αποτελέσματα μελετών φάσης 2. Ανά τον κόσμο, 3 εμβόλια έχουν λάβει πρώιμη ή/και περιορισμένη έγκριση για χρήση στους ανθρώπους, 1 στη Ρωσία και 2 στην Κίνα.
University of Oxford/AstraZeneca
epa06118564 (FILE) - A file photo dated 02 March 2010 showing the company sign outside the Pharmaceutical company AstraZeneca research and development plant in Lund, Sweden. Anglo-Swedish pharmaceutical company AstraZeneca said 31 July 2017 the US regulators had given AstraZeneca's Imfinzi immunotherapy drug what is called the 'Breakthrough Therapy Designation' by the US Food and Drug Administration (FDA) for patients with locally-advanced unresectable non-small cell, non-metastatic lung cancer. The company said that following the 'Breakthrough Designation' it hopes to bring the drug treatment to patients as soon as possible. EPA/DRAGO PRVULOVIC SWEDEN OUT
Photo: ΑΠΕ-ΜΠΕ
BioNTech/Fosun Pharma/Pfizer
epa07131323 (FILE) - A view of a sign at Pfizer's headquarters in New York, New York, USA, 11 July 2018 (reissued 30 October 2018). Pfizer on 30 October 2018 reported their third-quarter 2018 earnings saying their net income in 3rd quarter stood at 4.11 billion USD, an increase of 45 percent. Pfizer further said a part of the revenue growth in Innovative Health sector were offset by the loss of exclusivity of Viagra in the U.S. in December 2017 and the resulting shift in the reporting of Viagra revenues in the U.S. and Canada to the Essential Health business at the beginning of 2018. EPA/JUSTIN LANE
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Sinovac
epa08628351 Sinovac's COVID-19 vaccine candidate CoronaVac (C) is displayed among other vaccines at the company's headquarters in Beijing, China, 26 August 2020 (issued 27 August 2020). Chinese company Sinovac Biotech is developing the COVID-19 vaccine candidate called CoronaVac. EPA/ROMAN PILIPEY
Photo: ΑΠΕ-ΜΠΕ
CanSino Biological Inc./Beijing Institute of Biotechnology
Yu Xuefeng, co-founder, Chairman and CEO of CanSino Biologics Inc., poses during the ceremony for the listing of Chinese hotpot chain Haidilao at the Hong Kong Stock Exchange (HKEX) in Hong Kong, China, 28 March 2019.
Shares in Chinese biotech firm CanSino Biologics Inc. were set to open at HK$21 ($2.6) in their Hong Kong debut on Thursday (28 March 2019). CanSino made headlines in 2017 when Chinas regulator approved its vaccine for the deadly Ebola virus that ravaged parts of Western Africa in 2014 and 2015. That vaccine was co-developed with the Chinese military and was one of a number of similar products being created globally to fight the disease.
Photo: AFP
Gamaleya Research Institute
6328005 09.09.2020 A medic holds the Russian coronavirus vaccine developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology during the third phase of the post-registration clinical trials at a clinic, in Moscow, Russia. On August 11, Russia became the first country in the world to register a vaccine against COVID-19. Vladimir Pesnya / Sputnik
Photo: AFP
Wuhan Institute of Biological Products/Sinopharm
epa02173781 An employee works at Wuhan Institute of Biologic Products in Wuhan, Hubei province, central China on 26 May 2010. The institute started recalling a batch of rabies vaccine for human use due to quality defects, media reported on 26 May. EPA/SHEPHERD ZHOU
Photo: ΑΠΕ-ΜΠΕ
Beijing Institute of Biological Products/Sinopharm
epa08628133 A Sinopharm company logo is displayed at the company's headquarters in Shanghai, China, 25 August 2020 (issued 27 August 2020). According to media reports, Sinopharm, major state-owned Chinese pharmaceutical company, plans to have a COVID-19 vaccine on the market by the end of 2020. EPA/ALEX PLAVEVSKI
Photo: ΑΠΕ-ΜΠΕ
University of Melbourne/Murdoch Children's Research Institute
epa08473177 A laboratory employee works in a Laboratory at the Institute of Virology at the University in Marburg, Germany, 08 June 2020. The Philipps University of Marburg, the German Centre for Infection Research (DZIF), the Ludwig Maximilian University of Munich (LMU) and the University Medical Centre Hamburg-Eppendorf (UKE) are jointly researching a vaccine against the SARS-CoV-2 coronavirus. Countries around the world are taking increased measures to stem the widespread of the SARS-CoV-2 coronavirus which causes the Covid-19 disease. EPA/RONALD WITTEK
Photo: ΑΠΕ-ΜΠΕ
Moderna/NIAID
epa08247565 Signs at the main entrance for the biotech firm Moderna, are seen outside the company's Norwood facilities in Norwood, Massachusetts, USA 25 February 2020. Moderna has announced that they have shipped mRNA Vaccine Against Novel Coronavirus (mRNA-1273) to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) to be used in the planned Phase 1 study in the United States. EPA/CJ GUNTHER
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