JAKARTA, Indonesia, November 9, 2020 / PRNewswire / – In an effort to support the government’s plan to develop a Covid-19 vaccine in Indonesia, Badan POM is revealing three vaccine development priorities: Safety and Effectiveness And Quality As part of the Committee on Covid-19 Handling and National Economic Recovery (KPCPEN), the top priorities in the Covid-19 vaccination plan will be implemented by Badan POM in order to ensure a prudent approach as per President Joko Widodo’s instructions.
“As a government agency responsible for preserving the safety of medicines and food, Badan POM is taking strategic measures to ensure the availability of the Covid-19 vaccine while giving priority to public health,” Dra Toge J Apartment Hotadjolo MHA, Interim Deputy for Medicines, Narcotic Drugs and Psychotropic Substances, Precursor Medicines and Additives In Badan POM
Badan POM added that the Covid-19 vaccine will undergo proper and appropriate research before it is announced that it is ready and safe for the public.
Vaccine development must comply with appropriate drug development methods (Cara Pembuatan Obat yang Baik / CPOB)
Under certain circumstances, vaccine approval in the form of an Emergency Use Authorization (EUA) EUA may be a special registration mechanism during emergencies, as is the case in the current Covid-19 pandemic according to WHO guidelines, he said. Touji: « The decision to grant emergency use permission must be made with the understanding that the benefits outweigh the risks. »
Badan POM added that the EUA can provide a certain amount of flexibility. ”So, for example, for safety, we might accept results from Phase 1 and clinical trials II in the meantime, for their efficacy, in addition to obtaining data on device response Immunocompromised After vaccination, we may accept the results of the three-month interim report data. Of course, clinical trials are expected to continue while Badan POM continues to provide monitoring.
Based on WHO data as of October 19, 2020, 154 vaccines are currently in the pre-clinical testing phase and 44 candidate Covid-19 vaccines have entered the clinical trial phase Clinical trials are testing the efficacy of new drugs in humans Before this phase, the drug underwent For preclinical testing through animal trials, clinical trials are conducted to ensure efficacy and safety, as well as to detect potential side effects in humans.
A number of candidates for Covid-19 vaccines have entered the third phase of clinical trials, including those developed by Sinopharm, Sinovac Biotech, AstraZeneca, University of Oxford, Novavax, Modern, Pfizer and Bio-Ntech, in addition to the Aesthetics Research Institute « Indonesia conducts clinical trials of the Covid vaccine -19 developed by Sinovac. The interim results will be completed for a period of three months by the end of the year, and the report will be submitted to the POM in early January 2021 and Tuji explained that this clinical trial has already been conducted in Brazil.
When the time comes to distribute the Covid-19 vaccine, Badan POM will continue monitoring the distribution chain to ensure the quality of the vaccine Toji said: “When starting the vaccination process, Badan POM will continuously oversee the safety of the vaccine through the side-effects monitoring program known as pharmacovigilance.
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For effective monitoring, Badan POM hopes for the proper cooperation and participation of all health workers in this field as well as the pharmaceutical industry. According to Tuji, health workers can monitor and report adverse events after immunization that the community suffers after receiving the vaccine if there is an increase in Frequency of side effects, Badan POM has the right to review the effectiveness and safety aspects of vaccines and then review the results of this monitoring by experts
The government ensures that approval for vaccine distribution has gone through a series of comprehensive research and testing. By prioritizing the prudent approach, all efforts are made for vaccines to provide the best effectiveness for the general public
Based on the consideration that dealing with the Coronavirus Disease 2019 (Covid-19) and the recovery of the national economy must be in line with one integrated and inseparable strategic policy, President Joko Widodo issued Presidential Regulation (Berbers) No 82 of 2020 regarding the Committee Patriot Act for Covid-19 and Economic Recovery (KPCPEN) on July 20, 2020
KPCPEN’s priorities respectively are Indonesia SEHAT (priority for people to be safe from Covid-19 and reform of health services), Indonesia BEKERJA (priority to empower and accelerate employment), and Indonesia TUMBUH (priority for national economic recovery and transformation)
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Pfizer stock rose early Monday after the pharmaceutical giant said its coronavirus vaccine was more than 90% effective in the Phase 3 study
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Cruise operator shares rose Monday, as investors cheered news of Pfizer Inc and BioNTech Inc. The candidate for a COVID-19 vaccine « hit » in an interim analysis from the Phase 3 study Carnival Corps. Shares jumped 29 shares of Royal Caribbean Group rose 5% in pre-trading Active market with 211% and Norwegian Cruise Line Holdings Ltd. up 246% Cruise operators have been among the hardest hit by the COVID-19 pandemic, as they have struggled to resume operations amid government restrictions in the US and abroad. Investor celebration has not been limited to the cruise sector, as it has soared. Dow Jones Industrial Average futures over 1,500 points, or 55% pre-open
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Financial stocks rose on Monday, amid positive news from Pfizer and BioNTech SE over a possible COVID-19 vaccine that gave investors hope for a rapid recovery in the economy The SPDR Financial Sector Financial Determination Fund ran 74% in pre-market trading, with a surge All 65 components of stocks and American Express was the biggest gainer, stock rose 189% as travel services company and consumer credit cards had a lot to gain from the economic transition Among the most likely components of financial ETFs, JS shares of Morgan Chase & jumped 92%, Bank of America Corp. ran 92%, Citigroup Inc rose 89%, Wells Fargo & rose 85%, Berkshire Hathaway Inc of Warren Buffett rose 54% after the company reported an 82% jump in third-quarter earnings. The rise in financial stocks was part of a big boom. In the broader stock market, the Dow Jones Industrial Average futures rose 1541 points, or 55%
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Vaccine, Food and Drug Administration, Emergency Use Permission, Coronavirus
World News – GB – Covid-19 Vaccination Plan: Badan POM is set to ensure safety, efficacy, protection, and quality of the Covid-19 vaccine
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