ABSTRACT
Vaccine development usually takes around 7 y to come to the market after getting necessary regulatory approvals. But recent pandemics like Covid, Ebola, Swine Flu, have resulted in the collaboration of efforts between the government doing investments in vaccine development, academia, regulatory bodies, and industry. This has shortened the timelines for approval for vaccines. In 2009, HINI, Swine flu vaccines took 93 d for identifying the vaccine candidate for clinical trials. In 2014, for Ebola vaccine, it was deployed while the epidemic was still going on. Ebola vaccine was developed in 5 y. In case of Covid (SARS-CoV-2) clinical trials were approved when 2 mo of the pandemic onset. Within a time of 9 mo about 138 vaccine candidates are being reviewed for approval of EUA. This highly helps in the shortening of vaccine development and necessary approval. In this paper, we focused on the regulatory framework of vaccine development in INDIA, US and EU.Copyright © 2023 The Authors.
ABSTRACT
The earliest cases of COVID-19 disease in Africa were, in most cases, the result of imports from abroad. The Democratic republic of the Congo (DRC) identified the first case at the beginning of 2020. Two days after his return from France, the first patient was tested positively in the capital, Kinshasa. The travel restrictions and status of the state of emergency were announced on 24 March 2020. A lockdown followed. In June of the same year, 11 provinces were already affected by COVID-19 disease. The negative socio-economic impact has occurred and is similar to that in any other country. The DRC does not differ from other African countries or on the issue of infectious diseases such as HIV, malaria, cholera, measles or Ebola virus disease. Recurring Ebola epidemics are addressed by vaccination with Ervebo vaccine. Unlike Ebola, part of the population does not believe in the existence of SARS-CoV-2 and does not respect basic anti-epidemic measures. Medical capacities were very limited at the beginning of the SARS-CoV-2 epidemic, both in terms of diagnosis and testing and availability of treatment (60 ventilators to 83 million inhabitants). The situation is complicated as a result of 20 years continuing wars. Another African country, Guinea, is currently facing not only COVID-19, but also the zoonotic disease of Lassa fever, which has been detected in several patients. Copyright © 2021, Medakta s.r.o.. All rights reserved.