Tag Archives: Pharmaceutical

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. Netherland
  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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MCO 2.0 Updates For Night Markets + Businesses

There have been some updates to the MCO 2.0 SOP, allowing night markets and timber operations, and extending business hours!

 

MCO 2.0 Updates For Businesses

On 28 January 2021, the Malaysia National Security Council (MKN) announced the extension of business hours and timber operations.

From 29 January 2021 onwards, all permitted retail and service businesses will be allowed to open from 6 AM until 10 PM.

  • Supermarkets and shopping malls
  • Groceries and convenience stores
  • Pharmacies
  • Veterinarian clinics and pet food stores
  • Laundromats and optical stores
  • Petrol stations

The government is also allowing logging operations to resume from 29 January 2021 onwards, as well as all timber-related businesses.

 

MCO 2.0 Updates For Night Markets

MKN also introduced changes to the MCO 2.0 SOP on 27 January 2021, allowing night markets to open from 4 PM until 10 PM.

Needless to say, sellers and visitors at these night markets will have to register with MySejahtera, and follow the SOP to protect themselves, namely :

  • wear a face mask at all times
  • maintain physical distancing of 1-2 metres
  • maintain good hand hygiene

 

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MOH : No Change In Pfizer Vaccine Delivery, No Approval Yet

The Malaysia Ministry of Health just announced that there is no change in the delivery schedule of the Pfizer COVID-19 vaccine. However, there is no approval yet…

 

Pfizer COVID-19 Vaccine : What Is It?

The Pfizer COVID-19 vaccine is an mRNA vaccine called BNT162b2 designed by BioNTech.

It uses messenger RNA technology to teach our cells to create the SARS-CoV-2 spike proteins.

The presence of these spike proteins triggers the body’s immune system, training it to create antibodies that target the actual SARS-CoV-2 virus.

If we actually get infected by SARS-CoV-2 after being vaccinated, those antibodies will immediately attach to the virus particles :

  • preventing them from infecting our cells
  • cause the virus particles to stick together (agglutinate), making them easier targets
  • identifying the virus particles as targets for phagocytic cells to destroy

The immune response to the spike proteins will also train memory cells, so that they can respond to a future COVID-19 infection weeks or months after vaccination.

Recommended : Pfizer + Moderna mRNA Vaccines : How Do They Work?

 

MOH : No Change In Pfizer Vaccine Delivery

On 27 November 2020, Malaysia announced the purchase of 12.8 million doses of the Pfizer COVID-19 vaccine.

They also announced that Malaysia will receive the Pfizer COVID-19 vaccine in four tranches over the whole year :

  • Q1 2021 : 1 million doses
  • Q2 2021 : 1.7 million doses
  • Q3 2021 : 5.8 million doses
  • Q4 2021 : 4.3 million doses

But after the Wall Street Journal wrote about a 50% cut in 2020 production of the Pfizer vaccine, there were concerns that we may not even get the vaccine in Q1 2021.

The Malaysia Director General of Health, Tan Sri Dr. Noor Hisham Abdullah, clarified on 6 December 2020 that the NPRA (National Pharmacutical Regulatory Agency) has not received any notification of vaccine delivery issues from Pfizer.

He assured the public that KKM is always monitoring developments, and receives advanced notice on the Pfizer COVID-19 vaccine.

Therefore, as far as they are concerned, there has been no change in the delivery schedule.

Recommended : Pfizer COVID-19 Vaccine : 2020 Production Cut Explained!

 

MOH : No Approval Of Pfizer Vaccine Yet

The Malaysia DG Health also announced that the NPRA (National Pharmaceutical Regulatory Agency) has yet to approve the Pfizer COVID-19 vaccine for use in Malaysia.

In fact, they have yet to receive any documents from Pfizer for the evaluation of the registration and testing of the BNT162b2 vaccine.

Regardless of what the Pfizer vaccine delivery schedule is like, it must first be evaluated, tested and approved by KKM and the NPRA, before it can be used in Malaysia.

 

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Pfizer COVID-19 Vaccine : 2020 Production Cut Explained!

Find out why Pfizer slashed by half their 2020 mRNA vaccine production, and what it means for the fight against COVID-19!

 

Pfizer BioNTech COVID-19 Vaccine : 2020 Production Cut By Half

On 3 December 2020, the Wall Street Journal revealed that Pfizer and BioNTech slashed by half the COVID-19 vaccines they were going to manufacture in 2020.

Instead of 100 million doses, they would only be able to manufacture 50 million doses of their BNT162b2 vaccine by the end of 2020.

That is only good enough to vaccinate up to 25 million people, because every person requires two doses.

That immediately knocked down Pfizer and BioNTech’s share prices by 2%, before recovering slightly.

 

Pfizer COVID-19 Vaccine : 2020 Production Cut To 50 Million Doses

Pfizer and BioNTech originally hoped to roll out 100 million doses of their COVID-19 vaccine candidate – BNT162b2 vaccine – by the end of 2020.

But they were forced to announce a reduced goal of 50 million doses in their 9 November 2020 press release :

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

 

Pfizer COVID-19 Vaccine : 2020 Production Cut Explained!

The Wall Street Journal report was not incorrect, but many readers misinterpreted the change to be new.

The article came out almost a month AFTER the 9 November Pfizer press release.

Here are the reasons why Pfizer and BioNTech were forced to cut their production forecast, and what their 2021 production forecast is like.

The Clinical Trial Took Longer Than Expected

Their Phase 3 clinical trial, which started on 27 July 2020, took longer than anticipated. Ironically, this was due to its effectiveness.

The trial required a minimum of 164 confirmed COVID-19 cases, which they did not achieve when they announced the reduced production goal on 9 November 2020.

That milestone was only achieved in mid November, and announced on 18 November 2020.

Recommended : Pfizer + Moderna mRNA Vaccines : How Do They Work?

Raw Materials Failed To Meet Standards

As explained in the WSJ article, Pfizer started to work on the COVID-19 vaccine supply chain in March, sourcing raw materials from suppliers in the US and Europe.

However, “early batches of the raw materials failed to meet the standards“, said a person directly involved in the development of the Pfizer vaccines.

And even though they fixed the problems, they “ran out of time to meet this year’s projected shipments“.

This Was Much Faster Than Usual

As WSJ also pointed out – pharmaceutical companies do not typically set up supply chains and manufacturing lines for a product that has not yet been approved.

So even the ability to produce 50 million doses by the end of the year is phenomenally fast, especially when the BNT162b2 mRNA vaccine was only approved by the UK MHRA, and has yet to be approved by the US FDA or EU EMA.

This was only possible because Pfizer set up their supply chain early, while the early trials just started.

1.35 Billion vs 1.4 Billion Difference

While their 2020 production goal was slashed by half to 50 million doses, that isn’t a big difference in the grand scheme of things.

Pfizer says that they are on track to produce 1.3 billion doses in 2021. So the production difference by the end of 2021 is really 1.35 billion versus 1.4 billion – a shortfall of 3.6%.

The problem with the Pfizer-Biontech and Moderna mRNA vaccines really isn’t how many they can produce in 2020. It’s how few they can actually produce in 2021.

Recommended : Why Pfizer + Moderna mRNA Vaccines Are Not Good Enough

Changes In Vaccine Shipment Schedule?

Is there any change in Pfizer’s vaccine shipment schedule? That depends.

If the delivery schedule was announced before 9 November 2020, it is likely to be affected somewhat.

But if delivery was announced after 9 November 2020, then it stands to reason that it would be based on the current 50 million dose forecast for 2020.

Take, for example, Malaysia’s purchase of 12.8 million doses on 27 November 2020. The scheduled delivery of 1 million doses in Q1 2021 should not be affected by the 9 November 2020 announcement.

 

COVID-19 : How To Keep Safe!

Here are a few simple steps to stay safe :

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