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

By CodeBlue | 27 November 2020

The Pfizer-BioNTech mRNA vaccine is priced at US$19.50 per dose, which would amount to US$249.6 million (RM1 billion) for 12.8 million doses; it’s unclear how much the Malaysian government is paying for the vaccine.

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KUALA LUMPUR, Nov 27 — Malaysia has signed its first Covid-19 vaccine agreement, purchasing 12.8 million doses of the Pfizer-BioNTech vaccine to immunise 20 per cent of the population.

Prime Minister Muhyiddin Yassin said under the Malaysian government’s preliminary purchasing agreement with US pharmaceutical giant Pfizer, the Covid-19 vaccine — a two-dose regimen — will be given to 6.4 million Malaysians starting next year.

“Through this arrangement, Pfizer has agreed to deliver one million doses in the first quarter of next year, followed by 1.7 million doses in the second quarter, 5.8 million in the third quarter and 4.3 million doses in the fourth quarter,” Muhyiddin told a media briefing.

According to BioSpace, the Covid-19 vaccine by Pfizer and German partner BioNTech is among the most expensive vaccines in Phase 3 trials, priced at US$19.50 per dose for the first 100 million doses; which is the price sold to the US. This amounts to US$249.6 million (RM1 billion) for 12.8 million doses; it is unclear how much the Malaysian government is paying for Pfizer’s vaccine.

The cold chain delivery of Pfizer’s Covid-19 vaccine — which requires ultra-cold storage of minus 70 degrees’ Celsius — poses significant distribution and logistical challenges in a tropical country like Malaysia, with large swathes of rural areas that do not have high concentration of health facilities, particularly in Sabah and Sarawak. It is unknown how many public hospitals or clinics — assuming that the Ministry of Health (MOH) takes charge of Covid-19 vaccination — have ultra-cold freezers.

Ghows Azzam, an associate professor of Universiti Sains Malaysia who is currently working as a science advisor at the Ministry of Science, Technology and Innovation (MOSTI), tweeted today that “Pfizer will handle delivery”. He also claimed that ultra-cold freezers are available in Malaysia, without specifying further.

Pfizer Malaysia and BioNTech said in a joint statement that their Covid-19 vaccine supply to Malaysia depended on Malaysia’s approval, noting that their vaccine is not currently approved for distribution anywhere in the world. Pfizer and BioNTech applied for emergency-use authorisation from the United States’ Food and Drug Administration (FDA) last November 20 for their coronavirus vaccine.

“Pfizer and BioNTech plan to submit the study’s safety and efficacy data for peer review to a scientific journal once the data analysis is complete.”

Another complication with Pfizer’s vaccine is its two-dose regimen that requires two doses to be administered three weeks apart, a tight timing considering that the company’s special cold boxes can only store its Covid-19 vaccine on dry ice, which must be replenished, for 15 days.

Besides the human resources issues in under-staffed public health clinics and hospitals in Malaysia, purchasing ultra-cold freezers to cover the entire country will also add cost. Although the government has allocated RM3 billion to buy Covid-19 vaccines, it is unclear if this amount also covers the costs of distribution and logistics.

Pfizer-BioNTech’s final data analysis on their Covid-19 vaccine has found that the vaccine is 95 per cent effective in preventing Covid-19. Pfizer’s vaccine harnesses messenger-RNA (mRNA) technology that uses genetic material to cause the body to produce a version of the spike protein from the coronavirus, preparing the body’s immune system to produce antibodies and immune cells. Pfizer’s vaccine requires a storage temperature of minus 70 degrees’ Celsius below, as the mRNA can break down if it’s not kept at an extremely cold temperature, making the vaccine unusable.

An anesthesiologist from the University of Southern California said that the mRNA tends to be more fragile, hence, it has to be stored at a low temperature to maintain its stability. Otherwise, it would disintegrate and the body may not recognise or have the correct immune response to it, CNBC reported.

Pfizer’s global supply communications manager Francesca Marzullo said that to transport the vaccine, the company would utilise temperature-controlled thermal shippers that use dry ice to maintain a temperature of approximately minus 70 degrees’ Celsius, up to 10 days.

The recipient of the vaccine, according to Pfizer, can store it in an ultra-low temperature freezer, which provides it with a shelf life up to six months. It can also be stored — only up to five days — at fridge temperature of two to eight degrees’ Celsius.

If medical facilities do not have subzero facilities, they can keep the vaccine in Pfizer’s thermal shipper as well, filled with dry ice for up to 15 days, as an impromptu storage unit. According to Business Insider, the dry ice stock for the vaccines can be replenished safely three times during the 15 days when the special cold box can last, following strict guidelines, like not opening it more than twice a day, and closing it within one minute once it’s opened.

Business Insider also reported that the trickiest part of the cold chain will likely be the end in clinics or pharmacies, as Pfizer’s special cold boxes are designed to ship the Covid-19 vaccines in batches of at least 1,000 doses at a time. This may complicate delivery of the vaccine to rural areas with sparse populations.

The portal also reported that a break in a link in the cold chain could make the mRNA vaccine unusable, with UBS Bank analysts projecting that about 5 to 10 per cent of the Pfizer vaccine could be made ineffective “due to inadequate storage conditions”.

Some of this waste could go undetected too, Business Insider said, leading to people getting ineffective shots and insufficient protection from the coronavirus.

30% Of Malaysians Will Get Access To Covid-19 Vaccines

Besides ensuring access to the vaccine, Muhyiddin said that the government has also made an agreement with Pfizer to ensure that Malaysia can have access to clinical trial data to evaluate the quality, safety, and efficacy of the vaccine.

“However, the company still needs the approval of the United States’ Food and Drug Administration (FDA) and regulatory approval from the producing country, in addition to obtaining approval from our health ministry’s National Pharmaceutical Regulatory Agency (NPRA) before it can be used in Malaysia.”

Muhyiddin also pointed out today that 30 per cent of Malaysians are expected to have access to Covid-19 vaccines through Pfizer’s agreement and the country’s participation in the global vaccine access plan, the COVAX Facility. The prime minister confirmed that the Malaysian government, represented by Health Minister Dr Adham Baba, signed an agreement with the COVAX Facility on November 22.

Malaysia has chosen the Optional Purchase arrangement under the COVAX Facility to gain access to Covid-19 vaccines under the COVAX portfolio for 10 per cent of the population. The Optional Purchase arrangement allows participating economies to choose which vaccines they wish to buy for their population.

Besides that, Muhyiddin said MOH, through a government-to-government initiative with China, will begin phase three vaccine clinical research for a Covid-19 vaccine being developed by the republic’s Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS).

A total of 3,000 participants will be part of the clinical research which is expected to start in December 2020.

“The vaccine safety profile will be first reviewed by the NPRA to obtain the Clinical Trial Import License, and will be studied by the Medical Research and Ethics Committee to ensure that the study is conducted in accordance with health ministry’s guidelines,” Muhyiddin said today.

Free Vaccine For Malaysians, Foreigners Will Have To Pay

The prime minister also announced that the Covid-19 vaccine will be free for all Malaysians. On the other hand, foreigners can take the Covid-19 vaccine at a rate which will be determined by MOH.

The vaccination process, Muhyiddin said, will be conducted in phases, prioritising high-risk groups, including frontliners, the elderly, and patients with non-communicable diseases such as heart disease, diabetes, and chronic respiratory diseases, among others.

Earlier this week, Khairy, who is the co-chairperson Covid-19 Vaccine Supplies Access Guarantee Special Committee (JKJAV), said that children below the age of 12 years will not be getting the vaccine next year citing that most of the candidate vaccines have yet to be tested on children below the age of 12.

CNN reported that Pfizer had vaccinated children as young as the age of 12 to study the effectiveness of the vaccine on their age group.

On November 30, Sabah’s state government had said that a total of 3,030 babies and children below the age of 12 had contracted the coronavirus as of November 19 which translates to 12 per cent of Sabah’s overall cases as of November 19 .

Update on Nov 28: This article was updated with Pfizer Malaysia and BioNTech’s joint statement, in paragraphs 7 and 8.

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