Tag Archives: Pharmaniaga

1.28 Million Sinovac Vaccine Doses Ready For Distribution!

1.28 Million Sinovac Vaccine Doses Ready For Distribution!

1.28 million doses of Sinovac CoronaVac vaccine bottled by Pharmaniaga is now ready for distribution!

Here are the latest details…

 

1.28 Million Sinovac Vaccine Doses Ready For Distribution!

Finally, 73 days after Pharmaniaga received 200 litres of the bulk CoronaVac vaccine from Sinovac, the 1.28 million doses they bottled are ready for distribution!

Each single-use vial was bottled in four batches over five days, under NPRA’s scrutiny at the Pharmaniaga LifeScience factory in Puchong, Selangor.

17 quality control tests were conducted after the bottling process for 14 hours a day, before these vaccine doses were approved.

As of yesterday, a total of 1,284,147 doses – enough for about 642,000 people – are ready to be distributed across Malaysia.

Pharmaniaga said that they have the capacity to bottle up to two million doses per month.

 

Pharmaniaga Sinovac COVID-19 Vaccine : A Quick Primer!

Sinovac CoronaVac an inactivated virus vaccine made from actual SARS-CoV-2 virus grown in Vero cells, and killed using β-propiolactone.

Once injected into the body, the antigens on the inactivated SARS-CoV-2 virus triggers the body’s immune system.

Pharmaniaga LifeScience imported 200 litres of the CoronaVac bulk vaccine, which arrived on 27 February 2021.

Once bottled, those 200 litres of bulk vaccine should produce over 300,000 CoronaVac doses – enough to vaccinate approximately 150,000 people.

The Minister of Science, Technology and Innovation, Khairy Jamaluddin, said that the government is paying Sinovac less for the vaccine because bottling is done by Pharmaniaga.

However, he declined to disclose more information, so it is unknown how much the government is saving, once the costs of Pharmaniaga’s bottling and distribution are included.

Recommended : CoronaVac Vaccine By Sinovac : Your Questions Answered!

 

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Malaysia Approves Sinovac Vaccine Finished By Pharmaniaga!

Malaysia has conditionally approved the Sinovac COVID-19 vaccine filled and finished by Pharmaniaga!

Find out this means for the COVID-19 vaccination program in Malaysia!

 

Malaysia Approves Sinovac Vaccine Finished By Pharmaniaga!

On 23 April 2021, the Malaysia Ministry of Health announced that the Sinovac COVID-19 vaccine finished by Pharmaniaga LifeScience received conditional approval from the NPRA (National Pharmaceutical Regulatory Agency).

CoronaVac Suspension for Injection COVID-19 Vaccine (Vero Cell), Inactivated
Registrant : Pharmaniaga Lifescience Sdn. Bhd.
Manufacturer : Sinovac Life Sciences Co. Ltd., China

This conditional approval would allow the Sinovac COVID-19 vaccine filled and finished by Pharmaniaga LifeScience to be used in the Malaysia COVID-19 vaccination program.

 

Pharmaniaga Sinovac COVID-19 Vaccine : A Quick Primer!

Sinovac CoronaVac an inactivated virus vaccine made from actual SARS-CoV-2 virus grown in Vero cells, and killed using β-propiolactone.

Once injected into the body, the antigens on the inactivated SARS-CoV-2 virus triggers the body’s immune system.

Pharmaniaga LifeScience imported 200 litres of the CoronaVac bulk vaccine, which arrived on 27 February 2021.

Once bottled, those 200 litres of bulk vaccine should produce over 300,000 CoronaVac doses – enough to vaccinate approximately 150,000 people.

The Minister of Science, Technology and Innovation, Khairy Jamaluddin, said that the government is paying Sinovac less for the vaccine because bottling is done by Pharmaniaga.

However, he declined to disclose more information, so it is unknown how much the government is saving, once the costs of Pharmaniaga’s bottling and distribution are included.

Recommended : CoronaVac Vaccine By Sinovac : Your Questions Answered!

 

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Malaysia Approves AstraZeneca + Sinovac COVID Vaccines!

Malaysia has conditionally approved the AstraZeneca and Sinovac finished vaccines against COVID-19!

This does NOT include the bulk Sinovac vaccine that will undergo fill and finish by Pharmaniaga.

Find out this means for the COVID-19 vaccination program in Malaysia!

 

Malaysia Approves AstraZeneca + Sinovac COVID Vaccines!

On 2 March 2021, the Malaysia Ministry of Health announced that the AstraZeneca and Sinovac vaccines against COVID-19 received conditional approval.

  1. AstraZeneca COVID-19 Vaccine Solution for Injection
    Registrant : AstraZeneca Sdn. Bhd.
    Manufacturer : Medimmune Pharma B.V., Netherlands
  2. Sinovac CoronaVac Suspension for Injection
    Registrant : Pharmaniaga Lifescience Sdn. Bhd.
    Manufacturer : Sinovac Life Sciences Co. Ltd., China

These conditional approvals would allow the AstraZeneca and Sinovac finished vaccines to be used in the Malaysia COVID-19 vaccination program.

However, please note that the conditional approval is only for the finished vaccine from Sinovac.

The NPRA is still evaluating the CoronaVac vaccine that is being filled and finished by Pharmaniaga LifeScience Sdn. Bhd.

Hence, the bulk CoronaVac vaccine that recently arrived in Malaysia has NOT been approved for use yet.

They also gave conditional approval to a second source of the Pfizer COVID-19 vaccine.

  1. COMIRNATY Concentrate for Dispersion for Injection
    Registrant : Pfizer (M) Sdn. Bhd.
    Manufacturer #1 (drug product and final release) : Pfizer Manufacturing Belgium NV, Puurs, Belgium
    Manufacturer #2 (final release) : BioNTech Manufacturing GmbH, Mainz, Germany

The Pfizer COMIRNATY vaccine had earlier been approved. This additional approval allows vaccine doses from the BioNTech manufacturing facility in Germany to be used in the Malaysia COVID-19 vaccination program.

The NPRA is still evaluating the Sputnik V vaccine, also known as Gam-COVID-Vac, from Russia’s Gamaleya Research Institute.

 

AstraZeneca + Sinovac Vaccines : A Quick Primer!

The AstraZeneca COVID-19 vaccine, codenamed AZD1222, is a viral vector vaccine.

It uses a chimpanzee adenovirus – ChAdOx1 – which has been modified to prevent replication, to introduce a DNA sequence of the SARS-CoV-2 spike protein.

Once injected, the vaccine enters the cell and “teaches” it to produce the SARS-CoV-2 spike proteins and express them on its surface.

These spike proteins triggers the immune response to create antibodies that will protect you against the real SARS-CoV-2 virus.

The Sinovac COVID-19 vaccine, branded CoronaVac, is an inactivated virus vaccine.

It uses actual SARS-CoV-2 virus grown in Vero cells, and then killed using β-propiolactone.

Once injected into the body, the antigens on the inactivated SARS-CoV-2 virus triggers the body’s immune system.

Recommended : CoronaVac Vaccine By Sinovac : Your Questions Answered!

 

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Sinovac Vaccine Arrives In Malaysia, But Not Approved Yet

The first batch of the Sinovac COVID-19 vaccine – CoronaVac – just arrived in Malaysia.

There was not much fanfare, because the Sinovac vaccine has NOT actually been approved for use in Malaysia.

 

Sinovac Vaccine Arrives In Malaysia!

The first batch of the Sinovac vaccine – CoronaVac – arrived at the KL International Airport aboard MH319 at 8:47 AM on 27 February 2021.

Unlike the Pfizer-BioNTech COVID-19 vaccine, the Ministry of Health obtained CoronaVac through Pharmaniaga Lifescience Sdn Bhd – an intermediary company.

Hence, the Sinovac vaccine arrived in the form of 200 litres of CoronaVac bulk vaccine, which would then have to be bottled by Pharmaniaga.

Once bottled, these 200 litres of bulk vaccine should produce over 300,000 CoronaVac doses – enough to vaccinate approximately 150,000 people.

The Minister of Science, Technology and Innovation, Khairy Jamaluddin, said that the government is paying Sinovac less for the vaccine because bottling is done by Pharmaniaga.

However, he declined to disclose more information, so it is unknown how much the government is saving, once the costs of Pharmaniaga’s bottling and distribution are included.

 

Sinovac Vaccine Not Approved In Malaysia Just Yet

While the CoronaVac vaccine has arrived in Malaysia, we should point out that it has not been approved by the National Pharmaceutical Regulatory Agency (NPRA).

Therefore, the CoronaVac vaccine will not be used just yet in the Malaysia COVID-19 vaccination program.

According to the Science, Technology and Innovation Minister, Khairy Jamaluddin, this is because the CoronaVac vaccine has not been bottled.

One of the criteria for approval by the NPRA is the evaluation of the bottling process by Pharmaniaga. Until that happens, the CoronaVac vaccine cannot be approved for use in Malaysia.

It should be pointed out that China only just approved this Sinovac vaccine for general use on 6 February 2021.

 

Sinovac COVID-19 Vaccine : A Quick Primer

Developed by Sinovac, CoronaVac is an inactivated virus vaccine – an older method of creating vaccines.

The SARS-CoV-2 viruses are cultured (grown) in Vero cells, and inactivated (killed) before being administered as a vaccine.

The CoronaVac vaccine only needs to be refrigerated at 2–8 °C (36–46 °F), which makes it easy to distribute.

This is a 2-dose vaccine, which the second dose delivered 14 days after the first.

Its Brazil clinical trial results showed that the CoronaVac vaccine was 50.4% effective in preventing COVID-19, just crossing the 50% mark for regulatory approval.

It was about 78% effective in preventing “mild to severe” COVID-19 disease, which is nevertheless good news.

Recommended : CoronaVac Vaccine By Sinovac : Your Questions Answered!

 

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