@UlarSawa NPRA, KKM usually relies on stringent regulatory authorities such as USFDA, European Medicines Agency and World Health Organization during the assessment of the clinical data. Sinopharm vaccine will not only apply for China National Medical Products Administration (Chinas' FDA) but World Health Organization vaccine pre-qualification as well which will ensure that it is on par with international standards such as USFDA and European Medicines Agency. Sinopharm has been working very closely with the World Health Organization during the development and clinical trial phase of Sinopharm Vaccine. So chances of obtaining approval from World Health Organization is very high.
Even the evaluation by China National Medicinal Products Administration is stricted than western countries.
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"Our data is evaluated by relevant departments following protocols even stricter than in some Western countries, and we are in close communication with the WHO," the company representative further said.
EU criticises ‘hasty’ UK approval of COVID-19 vaccine European Medicines Agency says its approval process is more appropriate, as German politician calls UK move ‘problematic’.
European regulators have issued caution over the United Kingdom’s move to approve Pfizer-BioNTech’s COVID-19 vaccine for widespread use, saying their longer approval process was safer.
In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by the UK.
The agency said on Tuesday it would decide by December 29 whether to provisionally authorise the vaccine from US drugmaker Pfizer and its German partner BioNTech.
A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.
The EMA’s comments came hours after the UK became the first country in the world to approve the drug developed by Pfizer and BioNTech for use.
Long term risks of mRNA vaccines like Pfizer and Moderna vaccines are unknown and need to be monitored closely for several months to a year.....
------------ But he acknowledged that there are unique and unknown risks to messenger RNA vaccines, including local and systemic inflammatory responses that could lead to autoimmune conditions.
An article published by the National Center for Biotechnology Information, a division of the National Institutes of Health, said other risks include the bio-distribution and persistence of the induced immunogen expression; possible development of auto-reactive antibodies; and toxic effects of any non-native nucleotides and delivery system components.
Noor Hisham says no to emergency use of Covid-19 vaccine, after UK move
PUTRAJAYA: Health director-general Dr Noor Hisham Abdullah has clarified that the government will not approve the Pfizer Covid-19 vaccine for emergency use in Malaysia.
His comments come after the UK government authorised the vaccine for emergency cases earlier today, becoming the first country in the world to do so.
“The Medicines and Healthcare products Regulatory Agency in the UK has approved the use of the vaccine, but that does not mean it has been registered. They are only using it for emergencies.
“In Malaysia, we will not make any exceptions to use the vaccine for emergencies. This is to ensure the safety of all,” he said at a press conference today.
Prime Minister Muhyiddin Yassin said regulatory clearance from the US Food and Drug Administration and Malaysia’s National Pharmaceutical Regulatory Agency will be required before the vaccine can be used here.
Kanger's core bamboo business will be on track to making profit with the bright outlook on China's economic growth in 2021
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OECD lifts global economic outlook on vaccine progress, sees China driving recovery
China to drive global recovery
The OECD said the economic recovery would be uneven across countries, however, “potentially leading to lasting changes in the world economy.”
It said China was expected to account for over one-third of world economic growth in 2021, while the contribution of Europe and North America “will remain smaller than their weight in the world economy.”
The OECD said it sees China, which started recovering earlier than its peers, recording economic growth of 1.8% this year. It remains the only major economy expected to record economic growth in 2020.
The world’s second-largest economy was projected to record real GDP growth of 8% next year and 4.9% in 2022.
By comparison, the U.S. was expected to record an economic contraction of 3.7% in 2020, before posting growth of 3.2% in 2021 and 3.5% in 2022.
The euro area was seen reporting real GDP of -7.5% this year, 3.6% in 2021 and 3.3% in 2022.
“Despite the huge policy band-aid, and even in an upside scenario, the pandemic will have damaged the socio-economic fabric of countries worldwide,” the OECD said in its report.
“People living in poverty and usually less well covered by social safety nets have seen their situation deteriorate even further. Children and youth from less well-off backgrounds, and less qualified adult workers have struggled to learn and work from home, with potentially long lasting damage.”
The OECD said governments would need to use their policy instruments to actively ensure those hit hardest by the coronavirus crisis receive the support they need.
Egypt begins process to contract 20 million doses of COVID-19 vaccine
In addition to developing its own vaccine, Egypt’s VACSERA struck a deal in September with China’s Sinopharm to conduct human trials of the Chinese company’s vaccine. No reports have been released from these trials.
Galvez added during the government's Laging Handa briefing that his group is also in talks with China's Sinopharm, which could also produce vaccines in the next three months.
is vaccine lucrative as gloves? Ask yourself. vaccine one time use and glove daily usage. which one generate more profit? dont expect much can earn from vaccine as one time use only and the government said will fixed the selling price. correct?
Pressure now on China with Pfizer's approvals. If Sinopharm dont announce any data about efficacy of its vaccine, it will confirm what the West already been peddling - that China vaccine is not tested for success
Sinopharm is one of the best companies that exist worldwide. It is the seventh largest producer of vaccines internationally. The vaccine that we have chosen is an inactivated one, it is one of the most conventional and safest methods. It is like the flu vaccine, the polio vaccine and the diphtheria vaccine. Those are inactivated vaccines that have been effective for years and years", he added.
Chinese vice premier underlines progress in COVID-19 vaccine development
BEIJING, Dec. 2 (Xinhua) -- Vice Premier Sun Chunlan on Wednesday said China has achieved major progress in the research and development of COVID-19 vaccines, with five vaccines having entered phase-III clinical trials.
Sun made the remarks as she and State Councilor Wang Yong inspected the work on COVID-19 vaccine development and production in Beijing.
Sun said 14 vaccines developed from five technological routes have entered clinical trials, five of which have entered phase-III clinical trials.
Emergency use and preparation for the production of the vaccines are progressing smoothly, she said.
Sun called for consistent efforts to carry out phase-III clinical trials of the vaccines with a scientific and rigorous approach, and ensure they meet relevant laws and regulations and international standards.
The vaccines should be developed safely and effectively and be able to withstand tests in various aspects, she noted.
Efforts should go into the preparation for mass production and the drafting of distribution plans when the vaccines are available for the public, Sun said.
China has timely released the latest vaccines information, China’s vaccines are gaining international steam and a growing number of states are following up to obtain them. Whilst the achievements of Moderna and Pzifer are widely lauded, in the end, these companies only complete a part of the jigsaw in ending the COVID-19 crisis. Not everyone has the privilege or infrastructure to buy them. Therefore, the accomplishment of SinoVac, CanSino, and SinoPharm are set to play a significant role in making a difference for billions of people around the world.
@UlarSawa Did you read my sharing above? As i mentioned Malaysia also accepts World Health Organization pre-qualification of vaccines, not just US FDA or European Medicines Agency.
Frankly speaking without US FDA or Europe approval. You dare to use the China vaccine? Now we are talking about competition among US and Europe vs China Vaccines. Whoever can sell first will get the bulk of the early bird plump profit. You guess those Western Countries will let China become the first to sell their vaccines with US FDA and Europe Regulator approval? correct?
At 0947... Vol merely 53k lot shares.....good siign..ppl holding fast..normally 1 hr aftrr mkt open it touches half million lots ..but not today.....enm
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This book is the result of the author's many years of experience and observation throughout his 26 years in the stockbroking industry. It was written for general public to learn to invest based on facts and not on fantasies or hearsay....
UlarSawa
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Posted by UlarSawa > 2020-12-02 22:41 | Report Abuse
Sinopharm only apply China FDA approval. not even US or Europe approval. Correct?