IN EVERY PARTS OF THE WORLD, EVERY MINISTERS AND MEDICAL OFFCIERS ARE TIRED. TOO MANY WORK FOR THEM THIS YEAR ALONE. WHATEVER FOR TOMORROW WILL STILL CARRY ON, BECAUSE TOMORROW IS ANOTHER DAY.
WE HAVE TO BRAVE OURSELVES FOR WHATEVER CIRCUMSTANCES THAT WE CANNOT CONTROL.
China grants conditional market approval for its first homemade COVID-19 vaccine
China on Thursday announced that it has granted market approval attached with conditions for its first homemade COVID-19 vaccine, which was developed by Sinopharm, marking a monumental step in the battle against the pandemic that has killed 1.79 million globally.
The inactivated vaccine developed by Beijing Biological Products Institute under Sinopharm’s subsidiary China National Biotec Group (CNBG), got official authorization from China's National Medical Products Administration on Wednesday,Chen Shifei, deputy head of the National Medical Products Administration, said at Thursday's press conference.
The move came one day after the institute announced that the vaccine showed 79.34 percent efficacy and a 99.52 percent antibody positive conversion rate, according to interim results of the Phase III clinical trials.
The results are better than the 50 percent standard of the World Health Organization (WHO) and Chinese authorities, according to the institute. The vaccine also showed a good safety level, its producers noted.
A vaccine has to undergo strict review by each country's national drug administration before being authorized for public use. All data and processes are reviewed by professional third-party committees, CNBG's chairman Yang Xiaoming told the Global Times in a recent exclusive interview.
Yang was inoculated with a CNBG vaccine in March with hundreds of his colleagues. He said they had tested the level of antibodies six months after vaccination and the results were good.
Yang noted that data on safety and efficacy collected so far in the Phase III clinical trials is better than expected
Reported side effects of the vaccines are also milder than expected, Yang said. The side effects of CNBG's inactivated vaccines include aches or redness at the injection site, fever, muscular soreness, sickness and headache.
A representative of Sinopharm told the Global Times on Wednesday that the interim results are mainly based on data from trials conducted in the United Arab Emirates, the vaccine's largest test base. The Chinese regulator uses a very rigorous standard - stronger even than the international criteria - in reviewing the number of confirmed infected cases in the double-blind placebo-controlled trials for understanding the efficacy of the vaccine.
The Beijing institute's vaccine was approved in the UAE and Bahrain earlier this month.
Sinopharm's two inactivated vaccines have been administered to nearly 1 million people for emergency use and no serious adverse reactions have been reported. About 70,000 volunteers have participated in the phase-III clinical trials in more than 10 countries.
So far, at least 10 provinces in China, including East China's Jiangsu Province and South China's Guangdong Province, have officially announced a vaccination plan for local residents.
To form an immunology barrier it requires at least 700 million Chinese residents to be vaccinated, which means at least 1.4 billion doses, Yang said.
Normally there would only be 500-700 million doses of vaccines available on the Chinese market every year, Yang said, noting that it would be a big challenge for China to conduct mass vaccination in such a short time.
According to Yang, CNBG's production capacity of COVID-19 inactivated vaccines has reached 120 million doses by the end of the year and it will expand to one billion doses per year in 2021.
Yang noted that China has established a complete cold-chain industry for vaccine delivery. The only potential problem may lie in the imbalance between different areas such as developed coastal areas and central and western areas that are comparatively less developed.
Tao Lina, a vaccine expert in Shanghai, said that the approval demonstrated that China has created a "miracle" by creating a vaccine within one year.
Pfizer and Moderna have announced 95 percent efficacy for their mRNA vaccines, which was beyond predictions and drove up the public's expectation for Chinese inactivated vaccines.
Tao noted that despite the high efficacy, the US mRNA vaccines have shown more side effects as well as acute allergy occurrences. The mRNA vaccines also have more strict requirements for transportation.
Tao suggested that the inactivated and mRNA vaccines can both help human beings to resist the novel coronavirus. But both are early-stage products and more improved ones are expected, which will offer more balance between efficacy, safety and transportation requirements.
Posted by UlarSawa > Dec 31, 2020 11:13 AM | Report Abuse X
Are you sure? Dont think so lah. Pfizer vaccines first batch arrvd Spore on 22nd Dec and yesterday started using on front line staff. No issue at all. Msia also can get on feb 2021. Wake up lah. moderna n pfizer using mRNA tech only. Oxford one not same lah. Msia Covax agreement also supply by oxford on top of new order with total 20% lah. Oxford one either end of 1st qtr or latest 2nd Qtr some shpt arrv Msia. China and russia vaccines not concluded yet how to ship to msia. Correct?
Posted by samo50sg > Dec 30, 2020 11:38 PM | Report Abuse
Pfizer was never meant for our whole country as a whole. If you stay in kl. Then good. What about the rest of peninsula, Sarawak and Sabah? Do we have the logistics to get to the rural area? Within 5 days. The accident in korea should be a lesson that we cannot afford that mistake. Astral was our biggest hope but somehow their trials got delayed. Now supply is also affected. Thats means we covax, pfizer and astral won't reach general population until june. That leaves Sinovac,Sinopharm as the only one that could reach us by March hopefully.
Maybe Kanger is even not distributing the vaccine, which is why they have not come up with any statement despite so many positive news on this China vaccine. If kanger is distributing, why isnt it make any press statement on the progress of its venture?
" At least two countries in the Middle East have authorized the Sinopharm vaccine for emergency use for healthcare workers and other priority individuals. The United Arab Emirates was the first to do so, in September, while the kingdom of Bahrain granted approval in November. In Bahrain 7,700 people had participated in the clinical trials there, and as of this month the vaccine is available to frontline healthworkers, according to a government spokesperson. "
" KUALA LUMPUR (Dec 29): To overcome the Covid-19 pandemic, Malaysia is looking forward to intensifying efforts on vaccine development with the United Arab Emirates (UAE), said the Yang di-Pertuan Agong, Al-Sultan Abdullah Ri’ayatuddin Al-Mustafa Billah Shah.
In an exclusive interview with Emirates News Agency (WAM), Sultan Abdullah said UAE has demonstrated itself as a friend of Malaysia during this difficult period.
"Both countries could explore and intensify relations in the field of Covid-19 vaccine development and strengthen post-pandemic collaboration in the fields of health, education, food security, agriculture, future technology, renewable and clean energy, halal industry and tourism, just to name a few," he was quoted as saying in WAM’s report yesterday (Dec 29). "
If we collaborate the two articles as shown above, our DYMM AGONG; Yang di-Pertuan Agong, Al-Sultan Abdullah Ri’ayatuddin Al-Mustafa Billah Shah. is very keen to use SINOPHARM COVID 19 Vaccines as such, not surprised to us that MALAYSIA WILL ULTIMATELY APPROVE THE USAGE OF SINOPHARM VACCINE IN MALAYSIA VERY SOON. JUST WAIT AND SEE.... rather than we argue so much about this issue.
Any other company would seize the moment to holding a press conference informing what their plans are now that vaccine has been approved. But Kanger is suspiciously quiet on this. Maybe they will announce later as their MOU require them to sign a formal distributorship agreement.
There doesn't seem to be any further news regarding GI Healthcare either. All we know at the moment is that they are planning to sponsor 10,000 vaccines for frontliners. No mention about GI healthcare distributing the vaccines. Besides, i wouldn't be too worried as GI Healthcare is not a public listed company and also it is a new joint venture company just set up this year only.
It appears Sinopharm approval is not complete but conditional. Will our Government MOH accept this conditional approval?
"A Sinopharm company executive said Thursday the vaccine's Phase 3 trials covered more than 60,000 people, while detailed data will be released later and published in scientific journals at home and abroad.
An official with China's drug regulator said the vaccine's clinical trials are still ongoing, and its manufacturer will be required to submit follow-up data to authorities."
Shouldnt be an issue. Even Pfizer vaccine was given conditional approval by EMA and UK. Likewise Malaysia will also be giving conditional approval for Pfizer vaccine.
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....
pineapple123
2,472 posts
Posted by pineapple123 > 2020-12-31 09:16 | Report Abuse
TODAY IS THE FINAL DAY OF 2020. THE THE FINAL DAY OF EVERYBODY'S LIFE. SO COUNT YOUR BLESSING THAT YOU'RE STILL ALIVE. IF NOT INFECTED IS LAGI BAGUS.
TO THOSE NOT YET INFECTED, BEST TO ADHERE TO VACCINATION SOON AND BEST TOO TO WAIT FOR SINOPHAM, WHILE YOU DUDUK DIAM-DIAM AT HOME.