FDA intends to 'proceed towards an authorization' of Covid-19 vaccine, official says, as cases soar
(CNN)The FDA has informed Pfizer it intends "to proceed towards an authorization" of the manufacturer's Covid-19 vaccine, the US Health and Human Services Secretary told ABC on Friday morning, as the country is deep into a worsening health crisis.
The statement comes a day after an FDA panel recommended the agency grant an emergency use authorization for the Pfizer-BioNTech coronavirus vaccine.Other key steps remain, but if those hurdles are cleared, the first vaccinations in the US could happen early next week, HHS Secretary Alex Azar told ABC's George Stephanopoulos.
"The FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine," Azar told ABC Friday morning.
There are currently has a vaccine phase III test in 8 Malaysia hospitals. (Please refer to the following link). The vaccine is an inactivated virus vaccine that is developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) in Beijing (China). I strongly believed that the type of vaccine will benefit DPharma and Pharma. It is government to government base. I believe this type of vaccine will be free to Frontliners, children and elderly residents.
By the way, when the ZFLongkema put up the news of sending their research team to Malaysia for the phase III vaccine test. It will be the time that the distribution of vaccine to Malaysia will be nearby. The ZFLongkema developed by ZhiFei will benefit to MYEG. They are properly will benefit to Foreign Workers as MYEG is linked to Foreign workers.
Pfizer Vaccine Cleared in U.S., a Landmark in Covid-19 Fight
Pfizer Inc. gained emergency U.S. authorization for its Covid-19 vaccine on Friday, completing an unprecedented scientific sprint that could eventually help bring an end to a pandemic that has killed nearly 300,000 Americans
KUALA LUMPUR, Dec 12 — Malaysia will not rush the approval of Covid-19 vaccines for “emergency use” as some other nations have done, said Khairy Jamaluddin.
The Science, Technology and Innovation minister said the country would ensure that any vaccines procured would go through thorough evaluation by the authorities to ensure their safety.
“In Malaysia, there will be no political pressure and we will not use the emergency-use pathway.
“The clinical data of the vaccines we procure will be independently evaluated by the [Health Ministry’s National Pharmaceutical Regulatory Agency] NPRA before it can be registered and used,” he said.
The minister was commenting on a report of the US Food and Drug Administration expediting approval for the Pfizer-Biontech vaccine due to pressure from the outgoing Trump administration.
Donald Trump is pushing for the vaccine to be rolled out before the formal transition to President-Elect Joe Biden next year in order to claim credit for his administration.
Malaysia has ordered the Pfizer-Biontech vaccine and an alternative from COVAX that would roughly cover 30 per cent of the population, which will be delivered in batches next year.
However, no country has yet given full regulatory approval to any Covid-19 vaccine candidate so far.
This has led to some sections here in Malaysia and elsewhere to express concern over the potential dangers and side effects that may have been overlooked in the rush to produce a reliable vaccine against the world-stopping Covid-19 pandemic.
The Health Ministry has repeatedly assured Malaysians that any and all vaccines to be used here will be fully studied and evaluated to ensure they are safe to use.
Malaysia is grappling with a third wave of Covid-19 infections that has pushed the country’s total cases to over 80,000.
Bursa Malaysia expected to break 1,700 psychological level
Bursa Malaysia is expected to trend higher next week, with the key FTSE Bursa Malaysia KLCI (FBM KLCI) breaking the psychological level of 1,700, and poised to march into the new year with a big bang.
MUAR: Tan Sri Muhyiddin Yassin mengarahkan Kementerian Kesihatan agar penghantaran vaksin yang sepatutnya tiba pada Mac ini supaya dipercepatkan.
Perdana Menteri berkata, beliau telah mengarahkan dilakukan segera sama ada ia berkesan atau sebaliknya.
“Kalau hendak tunggu ujian macam vaksin biasa, mungkin dua tahun lagi tidak dapat bekalan. Saya sudah arahkan sama ada ia berkesan atau tidak berkesan agar dipercepatkan, jangan sampai rakyat marah Perdana Menteri.
“Jadi, saya minta kepada Menteri Kesihatan, Datuk Seri Dr. Adham Baba untuk pesan kepada pembekal agar mempercepatkan penghantaran vaksin yang sepatutnya tiba Mac ini,” katanya.
Beliau berkata demikian dalam Majlis Sambutan Deepavali Dewan Undangan (DUN) Gambir di Dewan Muniandy, Sagil di sini hari ini.
Pada 27 November lalu, Perdana Menteri mengumumkan kerajaan telah menandatangani perjanjian pembelian awal vaksin dengan Pfizer bagi membolehkan negara mendapatkan 12.8 juta dos bekalan.
Dalam pada itu, Muhyiddin berkata, beliau juga telah mengarahkan Dr. Adham dan Menteri Sains, Teknologi dan Inovasi, Khairy Jamaluddin agar melakukan rundingan agar stok vaksin ditambah daripada 30 peratus kepada 60 hingga 70 peratus.
Katanya, perkara itu atas atas nasihat Kementerian Kesihatan dan sekiranya jumlah berkenaan dapat dipertingkatkan, maka ia lebih terjamin agar rakyat dihadapi virus Covid-19.
“Itu kalau mahu belanjakan, kerajaan terpaksa guna peruntukkan RM3bilion, sekarang kita belanja sudah RM2 bilion, tetapi vaksin tak sampai lagi.
“Kalau hendak tunggu ujian vaksin macam biasa, mungkin dua tahun tidak sampai lagi, saya arahkan sama ia berkesan atau tidak maka ia perlu dipercepatkan penghantarannya,” katanya.-UTUSAN ONLINE
Bahrain approved the registration of the Sinopharm Group Co Ltd. vaccine against the coronavirus, about a week after the United Arab Emirates registered the Chinese-made vaccine.
“Results from Phase III clinical trials showed an 86% efficacy rate, a 99% seroconversion rate of neutralizing antibody and 100% effectiveness in preventing moderate and severe cases of Covid-19,” the National Health Regulatory Authority said in a statement Sunday.
Bahrain has participated in phase III clinical trials, in which more than 7,700 volunteers signed up. Bahrain had previously authorized the emergency use of the vaccine, which was provided to frontline workers in contact with coronavirus patients.
The UAE registered the Sinopharm vaccine after finding it had a 86% efficacy rate, paving the way for a full public use and allowing for a re-opening of the Gulf nation’s economy.
Egypt plans to start the process of inoculation against the coronavirus after receiving the first shipments of Sinopharm vaccine.
Govt to increase Covid-19 vaccine purchase to cover 60%-70% of M'sians — PM
The government has plans to increase its purchase of the Covid-19 vaccine to cover the immunisation needs of about 60%-70% of Malaysians compared with 30% currently.
Prime Minister Tan Sri Muhyiddin Yassin said this was because some nations had purchased doses exceeding their population.
“As for Malaysia, we have already got 30%. I have instructed Health Minister Datuk Seri Dr Adham Baba along with [Science, Technology and Innovation Minister] Khairy Jamaluddin Abu Bakar to negotiate and increase it from 30% to 60% or 70%.
COVID-19 vaccine is permissible for Muslim use, preservation of life is key consideration: MUIS
SINGAPORE: The Islamic Religious Council of Singapore (MUIS) said on Sunday (Dec 13) that it "holds the position that a COVID-19 vaccine is permissible for Muslim use".
"We would advise and encourage Muslims to be vaccinated once it is available and when the vaccine has been medically authorised as safe and effective, as this is a basic necessity to protect lives in the context of a global pandemic," said MUIS.
The council made its religious position on the vaccine known in a media release.
It said that the objectives of introducing a COVID-19 vaccine and the processes involved in producing vaccines are "largely aligned to established Islamic principles and values".
Islamic jurisprudence places great importance on the sanctity and safety of human life and the protection of livelihoods, it said.
Efforts to protect human life from any form of danger and harm, such as the development of vaccines, are therefore highly encouraged in Islam, it added.
Kuwait City: Kuwait’s Ministry of Health approved the emergency use of the Pfizer/BioNTech COVID-19 vaccine, local media reported. The Assistant Undersecretary for Drug and Food Control Affairs at the Ministry of Health, Abdullah Al Bader, said in a press statement that approval was granted after a committee conducted a comprehensive evaluation of the vaccine and reviewed the results of the clinical trials.
You know why price drop, even vaccine news everywhere. Because today price is overvalue. It is 6 month ahead during pendemic start. Once vaccine start to roll out. This stock will drop to their fair value.rm 2. Run before you lose your capital.
cannot fight trend in any stock. Have a plan always to win big and cut fixed loss to win in the end. Do not blame the stock if we fail. Improve ourselves to do the best.
Political instability is our biggest threat atm. 3rd round budget reading might turn sour today as things do not look too good for PN. Mahathir seems confident that the gov might be toppled today. If they fall, beneficiary GLC counters will be dragged along.
If the Political attempt is the reason for this down-slide, then there is no further issues to worry about. Regardless, of who's in power, the Medical Administration and execution remains the same, even during PH time.
Completely irrelevant reasoning, utterly rubbish, and totally illogical to compare prices of the past BEFORE any unprecedented, super-normal events.....such incomprehensible intelligence.
Most Gloves counters were struggling to survive pre-Covid and some were trading as penny stocks, as in March 2020, Supermax at RM0.70, Rubberex at 0.17, TG at 1.29. But their persistence, hard work and perseverance paid off. When the unfortunate event of Covid Pandemic struck worldwide, their product became GOLD. Their book-orders are fully filled till end 2021. Some are expecting Billions in profits, which is in line with Confirmed Sales. Do you expect the pandemic to end in a few months and their value/prices going back to pennies?
There are no "Vaccine" counters traded on KLSE. All are toilet paper MOU shouted to create romours for speculations.
However, there are on Pharmaceutical counters, under which some are retailing and others to be part of govt's networking, distribution and well laid infra-structure of public administration for decades. The pandemic has given some unexpected duties to be part of the govt's effort for mass immunisation, which might be performed by GLCs, thus a little more benefits. Do you expect the related "unexpected" requirement for healthcare is FREE of charge?
I wish to state I do not hold any stocks in Gloves. To each their own as money is yours to command, not advising nor solicitous.
Covid 19 virus still on scale of explosion over the world and all Vaccines still under third trials stage and not even enter Malaysia but some people already shouted post-Covid, what a ridiculous human...
Malaysia is expecting and schedule for some Pfizer in March, 2021, which some are still doubtful as the queue is long, demand is extremely high with supplies out-striped. Pfizer plant in Michigan is producing 500 million shots per year with their Swiss plant delivering 600 million shots. Their orders overshot their supplies.
Singapore as reported yesterday, shall be receiving their Pfizer-BioNTech Vaccines by end Dec, 2020. Their PM Lee and his colleagues in Cabinet is in line for the early shots to show their confidence for this EUA (Emergency Use Authorised) vaccine.
Pfizer Gen-2 vaccine which is still in the pipeline and shecduled release in 2Q, DOES NOT need -70 degrees storage and cold chain deliveries. It is at the same temperate as vaccines from Moderna, AstraZeneca and the Russian's Sputnik, which is at -2 to -4 degrees.
PM has ordered for additional procurement of Vaccines from SUPPLIERS. Govt has confirmed order for Pfizer (20% population) and COVAX (10%) and hope to increase herd immunisation to 70% population.
When KJ announced the purchase details which is "Delivered to Destination" That does not mean the vaccine is delivered to the hospitals, vaccination centers, rural clinics and out-of-reach villages. The vaccination process may take a whole year, given the supply shipments and the local networking. The govt may be providing FREE, but someone needs to settle the bills for the work to be done in handling, distributing and nurses. (Each Pfizer vial/bottle is good for 5 shots and needs to be diluted with Saline) PLEASE DO NOT TELL ME THEY WOULD COME FREE OF THE SERVICES?
To assist in the nationwide vaccination, and a piece of the pie, some Private hospitals are hoping that the govt would allow them access to whichever vaccine deemed to have NPRA, CTIL and MTEC, and even FDA approval, certification and accreditation. And there is only ONE company with INJECTABLE Drugs License in Malaysia to comply with just that.
These newly crowned Covid vaccines are for prevention and NOT a cure. It's to create herd immunity to break the chain and to prevent and contain the spreading. These vaccines are such precious commodities that some countries like India (has announced) and USA (Trump declared) that the supply needs to be for local injections before allowed to be exported to other countries.
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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....
NPRA1985
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Posted by NPRA1985 > 2020-12-12 02:26 | Report Abuse
FDA intends to 'proceed towards an authorization' of Covid-19 vaccine, official says, as cases soar
(CNN)The FDA has informed Pfizer it intends "to proceed towards an authorization" of the manufacturer's Covid-19 vaccine, the US Health and Human Services Secretary told ABC on Friday morning, as the country is deep into a worsening health crisis.
The statement comes a day after an FDA panel recommended the agency grant an emergency use authorization for the Pfizer-BioNTech coronavirus vaccine.Other key steps remain, but if those hurdles are cleared, the first vaccinations in the US could happen early next week, HHS Secretary Alex Azar told ABC's George Stephanopoulos.
"The FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine," Azar told ABC Friday morning.
https://edition.cnn.com/2020/12/11/health/us-coronavirus-friday/index.html