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
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.
Note: This is a shelf company without any paid up capital. It is also not registered for commencement of business. The above info is obtained from SSM Company Search.
We are finalising Sinovac, CanSino and Gamaleya because these will not just be vaccine purchases but will also include fill & finish capacity (putting the vaccines in the vials) in Malaysia and potential R&D tie ups.
Malaysia's portfolio of vaccines at the current moment with local value-add on three of the vaccine manufacturers (subject to final agreement signing) from Sinovac, CanSino and Gamaleya, which includes fill and finish, R&D and possible manufacturing.
James89 We are finalising Sinovac, CanSino and Gamaleya because these will not just be vaccine purchases but will also include fill & finish capacity (putting the vaccines in the vials) in Malaysia and potential R&D tie ups.
Malaysia's portfolio of vaccines at the current moment with local value-add on three of the vaccine manufacturers (subject to final agreement signing) from Sinovac, CanSino and Gamaleya, which includes fill and finish, R&D and possible manufacturing.
Sad to see that the current situation is so unclear to the stock traders because the govt does not announce how the vaccine that the govt dealt directly will going to be distributed, making everyone guessing. The PN govt seems keeping people under suspend. Why???
KUALA LUMPUR: Two government-linked companies (GLC) which are also pharmaceutical manufacturing facilities have been identified to do the "fill and finish" process for the Covid-19 vaccine once it's available.
PUTRAJAYA (Dec 23): Malaysia had opted for the Covid-19 vaccine produced by United Kingdom (UK) pharmaceutical company AstraZeneca through negotiations under the COVAX facility that will ensure supply for another 10% of the country’s population.
Science, Technology and Innovation Minister Khairy Jamaluddin said this will see supply from AstraZeneca increase to 20% after an earlier procurement of 10%through direct negotiation with the company.
“AstraZeneca’s delivery of the vaccine through COVAX is being finalised but we have been told it is between March and June next year.
“Through the direct negotiation, meanwhile, (Malaysia) will receive the first shipment in April or May 2021,” he told a media conference on the development to procure Covid-19 vaccines here today.
Malaysia previously joined the COVAX facility under the ‘Optional Purchase Arrangement’ agreement which allows the government to select vaccine-manufacturing companies that participate in COVAX to obtain supplies for 10% of the country's population.
Khairy, who is also the co-chairman of the Covid-19 Vaccine Supplies Access Guarantee Special Committee (JKJAV), said the Government had also consulted with pharmaceutical company Pfizer on the option of adding another 20% vaccine supply if needed.
“The reason why (is) because in the United States only two types of vaccines have been approved, which are Pfizer and Moderna and we know it is a sure thing,” he said.
Khairy said Malaysia had previously finalised the supply agreement for 12.8 million doses of COVID-19 vaccine produced by Pfizer which is expected to arrive in the country in stages from February 2021.
On the new mutation of the COVID-19 virus in the UK, he said Pfizer was monitoring the effectiveness of its vaccine and needed six weeks to make changes if it is found to be less effective against the new strain.
Khairy said the Government was also in the final stages of negotiations with three other COVID-19 vaccine manufacturing companies, Sinovac and CanSinoBIO from China and the Gamaleya National Centre from Russia, provided those companies could add value to the country's vaccine development.
"This includes carrying out the fill-finish (bottling) process, so we buy the vaccine in bulk, bring it here and the bottling is done here. This is an important process before we have the capacity to carry out the entire vaccine development process," he said.
Khairy said the Government was also looking at companies which could forge partnerships in research and development (R&D) as well as technology transfer with local companies.
He said the Government is negotiating for access to 14 million doses of COVID-19 vaccine from Sinovac and 6.4 million doses from Gamaleya, both of which are two-dose vaccines, while the agreement with CanSinoBIO involves 3.5 million single-dose vaccines.
Overall, Khairy said all the agreements would cover 82.8% of Malaysia's population, involving a total cost of RM2.05 billion.
On Malaysia's delay in getting the COVID-19 vaccine compared with some countries such as Singapore and Canada, he said the country's financial position was not on par with other developed countries.
“No company can provide 100% supply to Malaysia because developed countries bought (the vaccines) earlier than us as they can offer more and they can make decisions because their budgets are much bigger than ours.
“Canada, for example, has bought enough vaccines to give to its people five times over. They have 500% population coverage. Our pockets are not that deep," he said.
PUTRAJAYA (Dec 23): The Ministry of Health (MoH) is seeking to reduce the time needed to evaluate the safety and efficacy of the Covid-19 vaccine produced by US pharmaceutical giant Pfizer to less than 90 days, so a conditional approval for the drug may be granted before next March.
In normal circumstances, just the first phase of the five-phase evaluation process — which involves going through the documentation of the vaccine development process — may take between 90 and 120 days, said Health director-general Tan Sri Dr Noor Hisham Abdullah.
Evaluation of the vaccine has already started as the first scientific documents, also known as dossier, for its registration were received by the National Pharmaceutical Regulatory Agency (NPRA) on Dec 15, he said.
"So we will try our best to carry out the processes that have been identified so that we can reduce the time for us to conditionally register the vaccine within a period of less than 90 days.
"If everything is in order, maybe we will be able to conditionally approve the vaccine before March," he told reporters during the daily MoH Covid-19 press conference today.
Conditional approval with rolling submissions A conditional approval means the vaccine will be allowed to be administered in Malaysia but with monitoring by the ministry for a period of one year, said Noor Hisham.
Pfizer will also be bound by the practice of "rolling submissions", meaning the company is required to continue submitting the latest data from its clinical trials for the NPRA to continuously review them.
"The company will have to submit their latest data for us to examine whether they are effective in cases with mutations [in the coronavirus], and whether there are complications or side effects and so on. So we will monitor adverse events following immunisation," Noor Hisham said.
By granting the conditional approval, Noor Hisham said the ministry may still override its decision, based on the latest data it reviews from the administration of the vaccine.
On Nov 24, the government, through the MoH, signed a preliminary purchasing agreement with Pfizer to obtain 12.8 million doses of its Covid-19 vaccine to meet the immunisation needs of 20% or 6.4 million Malaysians.
Under this agreement, Pfizer has pledged to deliver one million doses of its vaccine in the first quarter of 2021, 1.7 million doses in the second quarter, 5.8 million doses in the third quarter, and 4.3 million doses in the final quarter.
The Malaysian government has also inked an agreement with the United Kingdom's AstraZeneca to purchase its Covid-19 vaccine to meet the immunisation needs of 20% of the people in the country.
This is Malaysia's third agreement after the government signed with Covax to buy 10% of its vaccine needs and with Pfizer to cover 20% of Malaysia's requirements last month.
Prime Minister Tan Sri Muhyiddin Yassin has also said the government is in the final stages of negotiation with Sinovac, CanSino and Gamaleya to secure the supply of vaccines to more than 80% of the country's population.
Pfizer vaccine comes in vial which contains 7 doses. There will be left over in every vial. Therefore gov may opt to refill it to ease medical official job and saving.
may be the big fish accumulate enough ticket after pressing price low recently n now the time to release its potential. haha..my 2 cents joke..
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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
https://www.bloomberg.com/news/articles/2020-12-12/pfizer-covid-vaccine-wins-u-s-fda-emergency-use-authorization