Abstract. On 31/12/2019, World Health Organization (WHO) was informed of cases of pneumonia of unknown cause in Wuhan City, China, that was placed under lockdown on the 23 January 2020. But almost half of the population of the city (total 11 million) was already on the move across the country to enjoy the festivities with their families (the Lunar New year, Chinese traditional festival, marking the end of winter and the beginning of the spring season), a season in China that is also the largest annual human migration on the planet. On 11 March 2020, the rapid increase in the number of cases led WHO to announce that the outbreak as a pandemic. Now (15 December 2020) there are 73,2 million cases of infection, 1,629,949 deaths, 51,4 million of infected people recovered. Of infected patients 20,1 million (99,5%) are in mild conditions, and 106,430 (0.5%) in serious or critical conditions (15.12.2020). From the beginning of the pandemic, researchers worldwide and big pharmaceutical companies started working around the clock to find a vaccine against the COVID-19 pandemic. This international effort, never before in the human history, means that a fast-tracked vaccine could come to market in the end of 2020 to the middle of 2021. As of December 2020, there were more than 200candidates for vaccines intended to provide acquired immunity against COVID‑19. The 44 vaccine candidates were in clinical research: namely 34 in Phase I–II trials and 10 in Phase II–III trials under varied technology platforms. The WHO has established the Coalition for Epidemic Preparedness Innovations (CEPI), and the Gates Foundation (GF) are committing money and organizational resources for the prospect that several vaccines will be needed to prevent continuing COVID‑19 infection. The CEPI, is a US$2 billion worldwide fund for rapid investment and development of vaccine candidates. On 4 May 2020, the WHO organized a telethon which received US$8.1 billion in pledges from 60 countries to support rapid development of vaccines to prevent COVID‑19 infections. The WHO also announced the deployment of an international “Solidarity trial” for simultaneous evaluation of several vaccine candidates reaching Phase II–III clinical trials. On 4 June 2020, a virtual summit of private and government representatives of 52 countries (35 heads of state from G7 and G20 nations), to raise US$8.8 billion in support of the Global Alliance for Vaccines and Immunization (GAVI) to prepare vaccinations of 300 million children in under-developed countries. Contributions US$1.6 billion from The Gates Foundationand £330 million pounds (for 5 years by UK government.This review presents all aspects of regulations for safety and efficacy of present vaccines for COVID-19 and their progress through clinical trials for phase III.
Challenges for Delivering Succesful Vaccines. Clinical safety, quality and effectiveness before a COVID-19 vaccine is granted regulatory approval
Dec 17, 2020