UK set to approve Pfizer-BioNTech Covid vaccine within days

https://www.ft.com/content/ebd9ca50-c2d7-4b0e-afd5-e90e93c0c495

UK set to approve Pfizer-BioNTech Covid vaccine within days

https://www.ft.com/content/ebd9ca50-c2d7-4b0e-afd5-e90e93c0c495

mRNA vaccines eg Pfizer and Moderna vaccines seems safe and effective based on interim phase III clinical data. However, possible intense short term side effects and theoretical long term side effects will still need to be observed and monitored closely if it ever occurs after approval of the vaccine ie.during phase IV post marketing.

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After he got the second injection, his arm immediately swelled up to the size of a “goose egg,” Hutchison says. He can’t be sure he got the vaccine and not a placebo, but within a few hours, the healthy then-43-year-old was beset by bone and muscle aches and a 38.9°C fever that felt, he says, “unbearable.” “I started shaking. I had cold and hot rushes,” he says. “I was sitting by the phone all night long thinking: ‘Should I call 911?’”

Hutchison’s symptoms resolved after 12 hours. But, he says, “Nobody prepared me for the severity of this.”

He says the public should be better prepared than he was, because a subset of people may face intense, if transient, side effects, called reactogenicity, from Moderna’s vaccine. Some health experts agree.

Fewer than 2% of recipients of the Pfizer and Moderna vaccines developed severe fevers of 39°C to 40°C. But if the companies win regulatory approvals, they’re aiming to supply vaccine to 35 million people globally by the end of December. If 2% experienced severe fever, that would be 700,000 people.

“We suspect the lipid nanoparticle causes the reactogenicity, because lipid nanoparticles without mRNA in them do the same thing in animals,” Weissman says. “We see production, in the muscle, of inflammatory mediators that cause pain, [redness], swelling, fever, flulike symptoms, etc.”

Longer term side effects of mRNA vaccines remain theoretical. They include the possibility that people with lupus, whose disease is driven by antibodies against their own genetic code, could experience flare-ups because of the revved up immune response induced by the vaccines, says Sarfaraz Hasni, director of lupus clinical research at the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

https://www.sciencemag.org/news/2020/11/fever-aches-pfizer-moderna-jabs-aren-t-dangerous-may-be-intense-some

@DrHash https://www.facebook.com/DGHisham/posts/3875666502457209

@SleepingForest Yes, i shared the link above. Limited use refers to emergency use for high risk individuals and front liners. Full approval will be given soon so that the vaccine can be used for general public after National Medical Products Administration of China has reviewed the phase III clinical data and approved the vaccine.

https://www.facebook.com/DGHisham/posts/3875666502457209

@Jerry20 Btw, it is spelled as "pandemic" and not "pendemic". There is no such thing as "pendemic" lololol

@Jerry20 Dont come here and talk cock lol Go back to your AT and your Solution...

Apart from guaranteed efficacy and safety, Sinopharm Vaccine is also Halal. In my opinion, this is an important aspect of vaccines in Malaysia which is a muslim dominant country as remember that vaccine efficacy alone is not sufficient to ensure herd immunity. The vaccine need to be accepted by the community as Covid vaccine is not mandatory in Malaysia (only voluntary). Hence, higher vaccine acceptance will lead to higher vaccine adherence/ compliance. This will ensure vaccine effectiveness and success in achieving herd immunity in Malaysia.

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Bio Farma President Director Honesti Basyir said that the MUI is involved in the data examination process to ensure that vaccines produced by Sinovac, CanSino, and G24/Sinopharm are halal. “Abu Dhabi (UAE)’s ulema council has announce that there is no issue with the halal status of the G24 vaccine,”

Sumber: https://setkab.go.id/en/govt-involves-mui-to-ensure-halal-covid-19-vaccine/

Acquisition of Pfizer Covid-19 vaccine hinges on FDA, NPRA approval

The agreement to purchase 12.8 million doses of the Covid-19 vaccine with pharmaceutical company Pfizer Inc can be made void if the vaccine fails to be registered with the United States' Food and Drug Administration (FDA) and the Health Ministry's National Pharmaceutical Regulatory Agency (NPRA).

Muhyiddin also stressed that Pfizer still needs the approval of the FDA and regulatory approval from the producing country, in addition to the NPRA, before it can be used in Malaysia.

In further tweets, Dr Noor Hisham said Malaysia is NOT GETTING VACCINE SUPPLIES FROM JUST ONE COMPANY.

He was responding to a question from a Twitter user seeking clarification on why Malaysia is leaning towards Pfizer for vaccines, when the company is said to have a complicated vaccine storage mechanism when compared with other companies.

"WE ARE TRYING TO GET VACCINE SUPPLY FROM VARIOUS SOURCES. NOT JUST ONE COMPANY," HE SAID.

https://www.nst.com.my/news/nation/2020/11/645157/acquisition-pfizer-covid-19-vaccine-hinges-fda-npra-approval

Bye Sayonara....

@Tkeng Nobody is asking you to be here lol If you think this forum is too noisy then just leave lol

Cannot deny the fact that this company has also diversified into other sectors....

@Moneyfind44 Nobody is stopping you from sharing about bamboo LOL Kalau nak share la jangan cakap sahaja.

I like this statement given by Sinopharm. I have no doubt that the vaccines were developed and clinical trials conducted in line with international standards. I have also no doubt that Sinopharm vaccines will be able to obtain WHO pre-qualification once the vaccines have been approved by China's National Medical Products Administration. WHO pre-qualification is a big deal as it will prove that the vaccines meet internationally recognised standards.

"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," a representative of Sinopharm told the daily earlier."

https://www.newindianexpress.com/world/2020/nov/26/vaccine-updates-astrazeneca-manufacturing-error-clouds-study-resultssinopharm-to-go-for-chinese-g-2228282.html

Know all the 10 leading Covid-19 vaccine candidates that are now in the phase III clinical trials (Note Sinopharm vaccine is stated there). Also, i was right that Novavax vaccine is a protein-based vaccine. The previous KKM FB post mentioned that is is a VLP or virus like particle vaccine which is incorrect.

https://www.facebook.com/DGHisham/posts/3875666502457209

Due to the budget constraints, cost effectiveness of vaccines is rather crucial if we aim to cover a larger % of the population. We do not have the luxury of picking the most expensive vaccines.

@Ny036 No objections if they increase the budget allocation for Covid Vaccines. Currently, i would say the budget allocation is insufficient.

In my opinion, it is rather silly of our government to even consider Pfizer vaccine. The logistics and the supporting infrastructure expenses for ultra-cold storage of -70C and ultra-cold chain transportation and distribution will be a huge burden on MOH. This issue may cause urban areas to be prioritized over the rural areas. The allocated budget of 3 billion would certainly be insufficient unless we increase the budget allocation during next weeks budget debate. There is still another 40% of the population unaccounted for. Pfizer takes up 20%, Covax 10%, so the balance is still 40%.

Malaysia’s agreement with Pfizer void if Covid-19 vaccine fails to be registered with FDA, NPRA — health DG

Malaysia’s preliminary purchasing agreement with pharmaceutical company Pfizer will be void if the latter’s Covid-19 vaccine fails to be registered with the US Food and Drug Administration (FDA) and Malaysia’s National Pharmaceutical Regulatory Agency (NPRA), health director-general (DG) Tan Sri Dr Noor Hisham Abdullah said today.

Azrul said Galen is also concerned about the logistical burden to be shouldered by the MoH because the vaccine requires ultra-cold storage of -70°C, a capacity beyond most existing primary care healthcare facilities.

Therefore, the MoH would be reliant on the availability of suitable storage units at the state level to ensure that the vaccines' cold chain is not interrupted, according to him.

"We expect the most challenging part of the process to be the delivery of vaccines to rural areas. Due to limitations and pragmatic concerns, will urban areas end up being prioritised over rural areas?” Azrul asked.

Azrul said Malaysia needs to review its Budget 2021 allocations, especially those related to Covid-19 vaccination because the scheme involves more than just the cost of the vaccine but also supporting infrastructure expenses.

He said the country needs to ensure that the MoH gets the necessary funds and manpower needed to hit the ground running when the vaccine becomes available in 2021, especially since this vaccine has specific logistical and storage requirements which require investing in related infrastructure and training.

"Are we going to acquire Pfizer's special ice boxes? Have we allocated for the record-keeping system? As it stands, we do not believe that the existing allocations are adequate for the purpose. The health allocations need to be reviewed and increased," Azrul said.

https://www.theedgemarkets.com/article/health-dg-malaysias-agreement-pfizer-will-be-void-if-covid19-vaccine-fails-be-registered-fda

Malaysia’s agreement with Pfizer void if Covid-19 vaccine fails to be registered with FDA, NPRA — health DG

Malaysia’s preliminary purchasing agreement with pharmaceutical company Pfizer will be void if the latter’s Covid-19 vaccine fails to be registered with the US Food and Drug Administration (FDA) and Malaysia’s National Pharmaceutical Regulatory Agency (NPRA), health director-general (DG) Tan Sri Dr Noor Hisham Abdullah said today.

Azrul said Galen is also concerned about the logistical burden to be shouldered by the MoH because the vaccine requires ultra-cold storage of -70°C, a capacity beyond most existing primary care healthcare facilities.

Therefore, the MoH would be reliant on the availability of suitable storage units at the state level to ensure that the vaccines' cold chain is not interrupted, according to him.

"We expect the most challenging part of the process to be the delivery of vaccines to rural areas. Due to limitations and pragmatic concerns, will urban areas end up being prioritised over rural areas?” Azrul asked.

Azrul said Malaysia needs to review its Budget 2021 allocations, especially those related to Covid-19 vaccination because the scheme involves more than just the cost of the vaccine but also supporting infrastructure expenses.

He said the country needs to ensure that the MoH gets the necessary funds and manpower needed to hit the ground running when the vaccine becomes available in 2021, especially since this vaccine has specific logistical and storage requirements which require investing in related infrastructure and training.

"Are we going to acquire Pfizer's special ice boxes? Have we allocated for the record-keeping system? As it stands, we do not believe that the existing allocations are adequate for the purpose. The health allocations need to be reviewed and increased," Azrul said.

https://www.theedgemarkets.com/article/health-dg-malaysias-agreement-pfizer-will-be-void-if-covid19-vaccine-fails-be-registered-fda

Next week then

QR results released tomorrow?

Pfizer phase III clinical trials is currently still ongoing. Full data has not yet been released. Only the interim data has been released. The main reason for the deal with Pfizer was to ensure that the government had access to the interim data to assess the vaccine’s quality, safety and effectiveness. So Pfizer vaccine is still subjected to evaluation by NPRA and approval by the Drug Control Authority (DCA) before it can be distributed to 20% of the Malaysian population. It is not a done deal yet.

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Prime Minister Tan Sri Muhyiddin Yassin said the agreement, signed on Tuesday (Nov 24), aimed to ensure the government had access to data to assess the vaccine’s quality, safety and effectiveness while also ensuring access once it was ready for distribution.

"Pfizer on Nov 9 stated that the first interim data analysis showed that vaccine efficacy was at 95%.

https://www.theedgemarkets.com/article/malaysia-has-signed-initial-agreement-pfizer-procure-128-million-doses-covid19-vaccine

@Noobie123 Yes, Astrazeneca is currently lagging behind in the global vaccine race due to an anomaly in their results ie higher dose resulted in lower efficacy (62%) versus lower dose which resulted in higher efficacy (90%) which strangely was serendipitously discovered by luck due to a dosing error. The conclusion that the lower dose resulted in higher efficacy was unfortunately based on a subgroup analysis of a relatively small number subjects which is considered as "underpowered" for a clinical trial and hence unable to reliably conclude that the lower dose resulted in higher efficacy due to the small number of subjects. So now Astrazeneca will have no choice but to conduct a fresh clinical trial to prove the higher 90% efficacy of the lower dose.

https://techcrunch.com/2020/11/26/astrazeneca-says-it-will-likely-do-another-study-of-covid-19-vaccine-after-accidental-lower-dose-shows-higher-efficacy/

The minister added that Morocco had already decided to purchase COVID-19 vaccines produced by China's Sinopharm and UK-Swedish AstraZeneca, which were expected to arrive in the country in December, but the country continued to negotiate with other pharmaceutical companies.

"During the negotiations, we have selected several producers and, finally, opted for Chinese laboratory Sinopharm and Sinopharm and British-Swedish AstraZeneca. Their vaccines' clinical trials are very convincing. If everything is well, we will receive first arrivals by December. The negotiations on other laboratories are still continuing," Ait Taleb told Sputnik.

https://www.urdupoint.com/en/world/moroccan-health-minister-plans-to-discuss-spu-1098426.html

At the same time, the prime minister also stated that Malaysia can make its own bilateral agreements outside COVAX, such as with China’s state-owned pharmaceutical company Sinopharm or British-Swedish pharmaceutical company AstraZeneca, to obtain Covid-19 vaccines for Malaysia.

https://codeblue.galencentre.org/2020/10/13/malaysia-may-get-chinese-covid-19-vaccine-by-dec-pm/

https://www.scmp.com/news/asia/southeast-asia/article/3111692/coronavirus-malaysia-secures-128-million-pfizer-vaccines

Morocco Set To Start Shots With Chinese COVID-19 Vaccine In Mid-December - Health Chief

Morocco expects that the population will start receiving shots of a coronavirus vaccine developed by Chinese pharma giant Sinopharm's subsidiary, CNBG, in mid-December, Health Minister Khalid Ait Taleb told Sputnik in an interview

https://www.urdupoint.com/en/world/morocco-set-to-start-shots-with-chinese-covid-1098408.html

Malaysia Buying Pfizer’s Ultra-Cold Covid-19 Vaccine, Posing Major Distribution Issues

https://codeblue.galencentre.org/2020/11/27/malaysia-buying-pfizers-ultra-cold-covid-19-vaccine-posing-major-distribution-issues/

Next week vaccine theme will continue...

Yes Sinopharm vaccine is working quietly in the background and they know they are ahead of western vaccines. Western media only like to shout and bark loudly regarding western vaccines and act as though only western countries are producing vaccines.

Muhyiddin said the agreement with Pfizer is to ensure that the government has data access to evaluate vaccine quality, safety, and efficacy, apart from ensuring access to the vaccine once it is distributed by the company.

https://www.nst.com.my/news/nation/2020/11/644852/govt-inks-deal-pfizer-vaccinate-64-million-malaysians

@Goldencoins Yes, China has repeatedly assured Southeast Asia, including Malaysia that the vaccines will be affordable. It is part of their effort for global good. The price that is quoted in the articles is certainly not final. That price is most likely for developed nations, and not for developing or underdeveloped nations who will either be given heavily subsidized vaccines or even free vaccines.

Govt signs deal with Pfizer for 12.8 mil Covid-19 vaccine doses — PM Muhyiddin

https://www.theedgemarkets.com/article/malaysia-has-signed-initial-agreement-pfizer-procure-128-million-doses-covid19-vaccine

Yes, means guaranteed it will be effective in Asians.

Some are also being donated via a subsidized program, COVAX via the WHO. Countries that have ordered Chinese manufactured vaccines so far include Indonesia, Sao Paulo province in Brazil (despite disruptions from the central government), Mexico, Malaysia (donation), Turkey and the Philippines. The scope of countries to receive donations from Beijing is also likely to be ramped up as China intensifies its multilateral cooperation to fight the COVID-19.

https://www.theedgemarkets.com/article/why-chinas-vaccines-are-gaining-international-momentum

Covid-19 vaccine to be given free to Malaysians, says PM Muhyiddin

The Covid-19 vaccine will be given free to Malaysians but foreigners will have to pay a charge determined by the Ministry of Health, Tan Sri Muhyiddin Yassin said today.

The prime minister said the government has no plan to make the vaccination compulsory and the vaccine will be administered only to those who agree to take it voluntarily, particularly people at risk and prone to disease.

https://www.theedgemarkets.com/article/covid19-vaccine-be-given-free-malaysians-says-pm-muhyiddin

@Luckybull Pfizer only covers 20% of the population. Another 10% will be from Covax (Vaccine company not known). So balance will 40% unaccounted for.

@Loading China will be donating the vaccines to Malaysia dont worry

Govt signs deal with Pfizer for 12.8 mil Covid-19 vaccine doses — PM Muhyiddin

The Malaysian government, through the Health Ministry, has signed a preliminary purchasing agreement with pharmaceutical company Pfizer to obtain 12.8 million doses of Covid-19 vaccines to meet the immunisation needs of 20% or 6.4 million Malaysians.

Prime Minister Tan Sri Muhyiddin Yassin said the agreement, signed on Tuesday (Nov 24), aimed to ensure the government had access to data to assess the vaccine’s quality, safety and effectiveness while also ensuring access once it was ready for distribution.

https://www.theedgemarkets.com/article/malaysia-has-signed-initial-agreement-pfizer-procure-128-million-doses-covid19-vaccine

Govt signs deal with Pfizer for 12.8 mil Covid-19 vaccine doses — PM Muhyiddin

The Malaysian government, through the Health Ministry, has signed a preliminary purchasing agreement with pharmaceutical company Pfizer to obtain 12.8 million doses of Covid-19 vaccines to meet the immunisation needs of 20% or 6.4 million Malaysians.

Prime Minister Tan Sri Muhyiddin Yassin said the agreement, signed on Tuesday (Nov 24), aimed to ensure the government had access to data to assess the vaccine’s quality, safety and effectiveness while also ensuring access once it was ready for distribution.

https://www.theedgemarkets.com/article/malaysia-has-signed-initial-agreement-pfizer-procure-128-million-doses-covid19-vaccine

As predicted today will close at 0.185

Analysis: Questions over AstraZeneca's COVID-19 vaccine data risk delaying approval

https://uk.reuters.com/article/us-health-coronavirus-astrazeneca-data-a/analysis-questions-over-astrazenecas-covid-19-vaccine-data-risk-delaying-approval-idUSKBN2861WS

Trump says coronavirus vaccine deliveries to begin next week

https://www.thestar.com.my/business/business-news/2020/11/27/trump-says-coronavirus-vaccine-deliveries-to-begin-next-week

Today i predict closing price will be 0.185

@jutawansenyap Lol, i do not need to justify my investments to you. Your money your decide, my money i decide. End of story lol

@Mohd Akmal Hakim How to tell whether PP complete or not? How many more tranches/shares ?

@JK22 QR will be released on 29 November 2020 ?

Okay thanks for the information

DAP’s Loke explains why opposition MPs allowed budget to pass

He said this decision did not mean that the opposition supported the whole budget.

“There are things that we can agree and support, such as the payment of salaries for civil servants, special allowances for frontliners, cash assistance to the people, wage subsidies for employers.

“However, there are also many allocations that we rejected, such as the allocation of RM85 million for JASA, cutting allocations for schools and other issues raised by opposition MPs,” he said.

He added that the opposition will request for a bloc vote to reject the allocation for the communications and multimedia ministry as JASA is an agency under the said ministry.

He said the opposition parties will continue to fight in the committee stage debate on the budget from Monday.

https://www.freemalaysiatoday.com/category/nation/2020/11/26/daps-loke-explains-why-opposition-mps-allowed-budget-to-pass/