Posted by MZM2511 > 2021-06-05 17:30 | Report Abuse

Tambahnya, setakat ini, terdapat enam produk vaksin Covid-19 yang telah selesai dinilai oleh NPRA dalam masa yang ditetapkan dan telah mendapat kelulusan pendaftaran bersyarat daripada PBKD.

Katanya, pihak NPRA juga sedang menilai BEBERAPA PERMOHONAN BAHARU bersyarat vaksin-vaksin Covid-19 pada masa ini.

“Permohonan ini juga akan disegerakan dengan kaedah yang sama. NPRA sememangnya sentiasa terbuka menerima pandangan pelbagai pihak,” katanya

Source: https://www.kosmo.com.my/2021/05/25/npra-nafi-lewat-lulus-produk-vaksin-covid-19/

Posted by MZM2511 > 2021-06-06 04:38 | Report Abuse

UPDATED NEWS...

KJ sahkan ada pihak tempatan cuba daftar vaksin Sinopharm

Menteri Penyelaras Program Imunisasi COVID-19 Kebangsaan sahkan terdapat beberapa pihak tempatan yang sedang cuba mendaftarkan vaksin Sinopharm dihasilkan syarikat farmaseutikal dari China. Vaksin sinopharm tidak termasuk di dalam Program Imunisasi COVID-19 Kebangsaan (PICK). Kata Khairy Jamaluddin, perkara berkenaan adalah dibenarkan dan pihaknya mengalu-alukan perkara tersebut. (May 21, 2021)

Sumber: https://www.astroawani.com/video-malaysia/covid-19-kj-sahkan-ada-pihak-tempatan-cuba-daftar-vaksin-sinopharm-1905361

Posted by MZM2511 > 2021-06-06 20:28 | Report Abuse

Kelulusan WHO tingkatkan keyakinan terhadap vaksin Sinovac - Khairy (2 Jun 2021)

Kelulusan Pertubuhan Kesihatan Sedunia (WHO) terhadap vaksin COVID-19 Sinovac akan meningkatkan keyakinan terhadap pengambilan vaksin tersebut.

Menurut Menteri Penyelaras Program Imunisasi Covid-19 Kebangsaan (PICK) Khairy Jamaluddin Abu Bakar, ini membuktikan vaksin tersebut selamat dan berkesan.

Sumber: https://www.astroawani.com/berita-malaysia/kelulusan-who-tingkatkan-keyakinan-terhadap-vaksin-sinovac-khairy-301080

Posted by MZM2511 > 2021-06-08 14:40 | Report Abuse

WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendations

7 May 2021 News release Reading time: 3 min (917 words)

WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG).

Posted by MZM2511 > 2021-06-09 19:29 | Report Abuse

Diketepi dari MKN, menteri tegur cara k'jaan kendali vaksin, PPV

"Contoh kalau dunia boleh menerima penggunaan vaksin menerusi EUL (Senarai Kegunaan Darurat) dari negara asalnya dan WHO, kita harus menggunakannya untuk mendapatkan bekalan vaksin yang lebih beragam.

"Kita tak boleh hanya bergantung pada Covax dan NPRA untuk meluluskannya. Contoh hari ini ada vaksin lain seperti Sputnik V dan Sinopharm," tambahnya.

https://www.malaysiakini.com/news/578265

Posted by MZM2511 > 2021-06-22 09:49 | Report Abuse

An update on the prospect of Kanger to be involved as the distributor of Sinopharm Covid-19 vaccine in Malaysia:

Report 1: 9 March 2021.

Kanger International Bhd will receive 10,000 doses of a Covid-19 vaccine developed by state-owned China National Pharmaceutical Group Corp (Sinopharm) for trial purposes.

In a bourse filing today, the group said the 10,000 doses of the vaccine will be for trial purposes and that it will be getting the necessary approvals from the relevant authorities.

“The first batch of vaccines is expected to arrive in May 2021,” Kanger stated.
Sinopharm has Covid-19 vaccine candidates that are undergoing stage 3 clinical trials

Source: https://www.theedgemarkets.com/article/kanger-receive-10000-doses-sinopharm-covid19-vaccine%C2%A0-may-trial-purposes

Report 2: 21 May2021.

The government is open to any party that has the capability and clinical data of the Sinopharm Covid-19 vaccine to register it with the National Pharmaceutical Regulatory Agency (NPRA), says Khairy Jamaluddin (pic).

The National Covid-19 Immunisation Programme coordinating minister said that this DID NOT HAVE TO GO THROUGH PHARMANIAGA, the local registration product holder for the Sinovac vaccine.

He said there were several parties interested in bringing the Sinopharm vaccine from China.

“It can go through anybody else who wants to try and bring in the vaccine. It can be registered with the NPRA,” he said in a video late Thursday (May 20) to address several allegations made by Opposition leader Datuk Seri Anwar Ibrahim about the immunisation programme.
Source: https://mywinet.com/covid-19-those-who-want-to-bring-in-sinopharm-vaccine-can-register-it-with-npra-says-khairy/

Report 3: 27 May2021.
“the process of registering the Sinopharm vaccine (with NPRA) has started and we hope to receive some good news on its approval soon.”
Source: https://www.freemalaysiatoday.com/category/nation/2021/05/27/sabah-signs-mou-with-private-firm-to-obtain-sinopharm-vaccine/

MY FINDINGS:
1. Kanger planned to bring Sinopharm Covid-19 vaccine for trial purposes.

2. Until 21 May 2021, the Sinopharm Covid-19 vaccine was not registered with NPRA yet.

3. There will be a big probability that the report by Kanger official is true. The company has started to register the said vaccine with NPRA.

Posted by MZM2511 > 2021-06-22 09:50 | Report Abuse

On the Sputnik Covid-19 vaccine produced by Russia, Khairy said that Duopharma Biotech Bhd’s wholly-owned subsidiary, Duopharma (M) Sdn Bhd (DMSB), which holds the distribution rights to the product, has three months to register the vaccine with the National Pharmaceutical Regulatory Agency (NPRA), after inking an agreement with the government earlier this month.

He said that the NPRA still requires further information on the vaccine.

“However, NPRA also said that it would simplify the registration process if Sputnik gets emergency use (status) from the World Health Organisation (WHO). Sputnik has not received the EUL from WHO yet,” he said, referring to the Emergency Use Listing.

Source: https://www.malaymail.com/news/malaysia/2021/06/21/khairy-cansino-vaccine-to-arrive-in-malaysia-next-month-no-updates-yet-on-j/1983852

Posted by MZM2511 > 2021-06-22 09:50 | Report Abuse

“However, NPRA also said that it would simplify the registration process if Sputnik gets emergency use (status) from the World Health Organisation (WHO).
--------------------
I want to stress on this.

If the Sinopharm was truly just registered with NPRA, the process of approval should be more shorter in time compared with the vaccine candidate which not been approved by WHO yet.

Note: Sinopharm vaccine has been approved by WHO.

Posted by MZM2511 > 2021-06-23 12:45 | Report Abuse

1. Until 21 May 2021, the Sinopharm Covid-19 vaccine was not registered with NPRA yet.

As per report on 21 May 2021: "The government is open to any party that has the capability and clinical data of the Sinopharm Covid-19 vaccine to register it with the National Pharmaceutical Regulatory Agency (NPRA)", says Khairy Jamaluddin.

2. The earliest registering date with NPRA can posibly be done after 21 May 2021.

3. Reports by Kanger official on 27 May 2021 stated that Kanger has started the process of registering the Sinopharm vaccine with NPRA.

As per report: “the process of registering the Sinopharm vaccine (with NPRA) has started and we hope to receive some good news on its approval soon.”

Source: https://www.freemalaysiatoday.com/category/nation/2021/05/27/sabah-signs-mou-with-private-firm-to-obtain-sinopharm-vaccine/

Posted by MZM2511 > 2021-07-15 20:58 | Report Abuse

Dr Noor Hisham: NPRA set to announce Sinopharm’s inclusion in Covid-19 immunisation plan

“Tomorrow the NPRA will meet and we will consider the Sinopharm vaccine, which was approved by the World Health Organisation.

“Their company just sent their dossiers to us, and in less than a month we have evaluated and will give our decision on the conditional approval tomorrow,” he said.

Source: https://malaysia.news.yahoo.com/dr-noor-hisham-npra-set-111805262.html

Posted by MZM2511 > 2021-07-19 17:41 | Report Abuse

The Board of Directors of Kanger (“Company”) wishes to announce that Kanger Medical International Sdn. Bhd., a wholly-owned subsidiary of the Company had, on 19 July 2021 entered into Head of Agreement with Sparmak Medical Equipment Trading LLC for purchase of inactivated SARS-COV-2 Vaccines (Vero Cell) vaccine developed by Beijing Institute of Biological Products Co. Ltd., an affiliate of SINOPHARM CNBG.

Please refer to the full announcement as attached.

This announcement is dated 19 July 2021.

Source: https://www.bursamalaysia.com/market_information/announcements/company_announcement/announcement_details?ann_id=3176295

4.1 Quantity and specification of the Products
Quantity: Five Million (5,000,000) doses with an option to buy an additional Five Million (5,000,000) doses.
Specification: SARS COV-2 vaccine (Vero cell) inactivated, 6.5 U/0.5ml in prefilled syringe or vial (as per availability) and pack size either 2 doses per vial per box or Single dose per vial per box (as per availability). The Product is manufactured by Gulf Pharmaceutical Industries Julphar in the United Arab Emirates (HAYAT-VAX), i.e. G42 Medications Trading LLC (“Manufacturer”).

Posted by MZM2511 > 2021-07-19 17:42 | Report Abuse

Earlier this year, Sinopharm entered into a joint venture with UAE-based G42 to produce the Sinopharm Covid-19 vaccines in the country under the Hayat-Vax brand.

The made-in-UAE vaccine was the first Covid-19 vaccine to be produced in the Arab world.

"The Hayat-Vax vaccine is essentially the same Sinopharm Covid-19 vaccine, manufactured in the UAE. Hence, we are confident that it will be well-received and accepted by the Malaysian people as an effective vaccine towards the global fight against the Covid-19 pandemic," said Kuah.

Kanger has also been authorised by G42 to be the product registration holder and distributor of the Hayat-Vax vaccine in Malaysia.

On behalf of G42 Medications, Kanger said it had submitted applications to obtain the required approvals from the National Pharmaceutical Regulatory Agency for the Hayat-Vax vaccine to be used in Malaysia.