Is the Pfizer vaccine suitable for Malaysia?

As the issue of a COVID-19 vaccine has become very controversial and emotional, we may need to pre-qualify ourselves on who we are, our knowledge, track record, beliefs and principles on this issue.

Our group was the first in the world to publish an “Open Letter To The Suffering People Of Wuhan” on 11 February, 2020 even before the pandemic engulfed the world. We called for global solidarity and co-operation to deal with the novel coronavirus which respects no borders and does not discriminate its victims on grounds of race, religion, ideology or gender.

Most of our predictions in this open letter and subsequent press articles and statements have come true, especially on the global spread of COVID-19 and how the disease, its origins, vaccines being developed, treatment and certain control measures such as wearing of face masks, have been heavily politicised and corrupted by certain powers such as the United States (US) government under President Donald Trump.

In March 2020, we were amongst the first in the world to set up a special think tank unit to undertake social research, analysis and forecast important issues related to COVID-19.

From March 2020, we were the first group in Malaysia to come out publicly to explain, educate and advocate the importance of wearing face masks in public places, which was finally made mandatory in the country on 1 August, 2020.

We are not anti-vaxxers. Neither do we believe in conspiracy theories, especially those without any hard evidence. We believe in scientific and evidence-based approaches and learning from the past.

We support the procurement of safe, suitable (considering our hot climate), effective, durable and affordable vaccines. We are not against new vaccine technology as long as it is applied in the right context and with sufficient period of testing and trials and with full transparency and disclosure of the safety risks involved.

We also believe in taking a more holistic approach to dealing with COVID-19 such as improving our body immunity via various means, herbal and other natural treatments and living a healthier lifestyle.

Until the pandemic is over, we subscribe to certain control measures still needed such as social distancing, wearing of face masks and frequent washing of hands but without disrupting our economic activities too much and implementing very targeted Movement Control Orders (MCOs).

We are also open to the idea, which is gaining more credibility now in the scientific community that, the world may be able to achieve the natural herd immunity needed to end the pandemic, without the heavy cost of human lives and suffering like what happened during the Spanish Flu of 1918-19.

READ MORE: Where are we in the COVID-19 vaccine race?

The Malaysian government has, so far, been committed to three COVID-19 vaccine procurement schemes – COVAX, coordinated by the World Health Organization (WHO) with a pool of nine vaccine candidates, at least two China vaccines (using the old tried and tested attenuated vaccine technology) and the Pfizer mRNA vaccine.

Amongst the three, the Pfizer mRNA vaccine has been the most controversial whilst the other two have been generally welcomed by the public here but more transparency and information is needed.

The government’s recent decision to sign a preliminary agreement to purchase 12.8 million doses of the Pfizer mRNA vaccine for 6.4 million people (based on dual dosage) or 20 percent of the population has raised important questions. Malaysia seems to be the first Asian country to sign such a deal.

There are basically two types of vaccine technologies for COVID-19.

The old tried and tested vaccine technology which normally takes 5 to 10 years to develop, uses an attenuated or inactivated natural virus to be injected into our bodies, to induce or train our bodies to fight such “weaker and maybe more friendly antigens” by triggering a response from our bodies’ antibodies and killer T-cells.

So, when a real and harmful antigen (virus) enters our body, it is already prepared and ready to take on this “invading enemy”.

READ MORE: US FDA authorizes Pfizer COVID-19 vaccine for emergency use

The Pfizer vaccine on the other hand, like the vaccine developed by another US biotech firm Moderna, uses a new messenger RNA technology of injecting synthetic RNA molecules, coated with a delivery vehicle made of lipid nanoparticles into human cells.

Once inside, the RNA functions as messenger RNA and the human cells are then programmed to make their own “vaccine” inside the body to mimic the form of a safe spike protein similar to that of the COVID-19 virus. This would then trigger an immune response.

The three biggest issues that many people in the know are most concerned about when it comes to the procurement of Pfizer mRNA vaccine are safety, efficacy and suitability for use in our hot country. Then, there are also the issues of transmissibility, durability, cost and government transparency.

Pfizer’s and other vaccine developments in the US were fast-tracked under immense pressure from President Donald Trump who needed a COVID vaccine badly as a political weapon for his November 2020 presidential re-election.

The three phases of human clinical trials for both, Pfizer and Moderna took only several months. A normal vaccine trial would take several years as there are several aspects of side effects and complications which may take a long time to be expressed.

The fastest vaccine to be developed and approved so far (before the Pfizer vaccine) in human history, was for mumps and it took four years. The most recent vaccine for Ebola took five and a half years.

During the clinical trials for these two mRNA vaccines, there were the expected side effects such as muscle pains, chills and headaches. But it is too soon to be sure if there would be more harmful effects later on. This is typical in many drug-development processes.

The US FDA (Food & Drug Administration) reported on 9 December that the Pfizer vaccine is generally safe and effective, even though six people who participated in the clinical trials died, two from the vaccine group (from “serious adverse events”) and four from the placebo group.

Meanwhile, on the same day, Britain’s medicine regulator advised that people with a history of allergies should not get this vaccine after two people reported severe adverse reactions on the first day of rollout.

There have been published reports that suggest that the Pfizer vaccine may not stop the transmission of the virus and only suppresses the symptoms and the protection provided by the vaccine may not be very long.

Safety is still the most important and often the most difficult issue to address.

Normal medicines are administered to people who are already sick and who may not mind taking some risk associated with the medicine concerned. But a vaccine is given to healthy people, including children. Even if there is a very small chance (say 0.5 percent) of causing harm, it would be unacceptable.

The risk versus gain analysis for a vaccine is rather complicated as it is extremely difficult to develop a safe, effective and durable vaccine.

That is why, if clinical trials and the approval process for a vaccine are rushed or politicised, the safety aspects may be compromised.

Ken Frazier, CEO of pharma giant Merck and a leading global authority on vaccine developments, had in July 2020, cautioned on the danger of rushing the current vaccine development process. Here is what he said: “Well, first of all, it takes a lot of time…Why? It requires a rigorous scientific assessment.

And here we didn’t even understand the virus itself and how it affects the immune system…what we are hoping to be able to do is to create a vaccine that can be both safe and effective and can be durable. Those are three different issues. What worries me the most is that the public is so hungry, so desperate to go back to normalcy, that they are pushing us to move things faster and faster.

There are a lot of examples of vaccines in the past that have stimulated the immune system, but ultimately didn’t confer protection. And unfortunately, there are some cases where it stimulated the immune system and not only didn’t confer protection, but actually helped the virus invade the cell because it was incomplete in terms of immunogenic properties.

We have to be very careful. In the last quarter century, there have only been seven, truly new vaccines introduced globally at the clinical practice…We have been trying to get a HIV vaccine since the 1980s and we’ve been unsuccessful.

When people say that there’s going to be a vaccine by the end of 2020, they do a grave disservice to the public. We don’t want to rush the vaccine before we’ve done rigorous science.

We’ve seen it in the past, for example, with swine flu. The vaccine did more harm than good. We don’t have a history of introducing vaccines quickly in the middle of a pandemic.”

In another example on vaccine safety, on 29 November, 2017, French drugmaker Sanofi Pasteur released a statement stating that their dengue vaccine, Dengvaxia, used in the Philippines in 2015, the first Asian country to approve the use of the vaccine on its people, posed risk to individuals vaccinated without having a prior dengue infection. This came after reports circulated of children dying allegedly from complications associated with the vaccine.

Many experts and people in the know are naturally concerned about what seems to be happening now, on the very rushed and politicised vaccine developments like the Pfizer vaccine.

The current euphoria (which is boosting stock markets in the West) over the high efficacy of more than 90 percent for the two mRNA vaccines, is clouding the more important issue of longer-term safety. This is the problem with unfettered capitalism where extreme greed often supersedes the safety and welfare of people.

There have been several past lawsuits in the US against Pfizer in the last few decades in which its US FDA Approved drugs (meaning certified safe for public consumption) such as Protonix, Prempro, Chantix, Lipitor and Effexor, have been alleged to cause harmful side effects including death. It was reported that the total penalty paid by Pfizer since 2000 for various offenses is US$4.7 billion.

The most notorious scandal took place in Nigeria in 1996 when Pfizer conducted unauthorised clinical tests on 200 children with its antibiotic drug, Trovan. The trials led to the deaths of 11 children. Pfizer paid a huge compensation and set up a special fund for those affected by Trovan but it could not bring back to life the children who died.

Our government should be very concerned with the safety and corporate ethics records of any COVID vaccine supplier and it should not just brush it aside with a flippant and irresponsible answer like “That is for Pfizer to answer”.

Granted that there are a lot more investments in COVID vaccine developments and that Pfizer’s vaccine uses a new digital technique (which has been around for some time now) to quicken the pace to develop and produce the vaccine at the laboratory level. But when it comes to human clinical trials, the human body has not changed over the centuries and it is not a digital robot. There must still be sufficient time given to allow our bodies to react and respond to the vaccine concerned.

Therefore, even if there are no harmful side effects during the few months of clinical trials, there are no guarantees that a year or two from now, there won’t be any harmful consequences for taking the vaccine.

Again, this new mRNA technology has never been used on humans before, so, no one can guarantee that there will be no longer term side effects such as autoimmunity, reactogenicity and other more harmful and unpredictable symptoms.

The nano-particles’ coating, not just the mRNA itself, may also produce some undesirable and unexpected side effects later on. We also do not know what other secret ingredients or adjuvants are being mixed with this vaccine. There seems to be too many unknowns.

On 2 December 2020, Britain became the first country in the world to approve the Pfizer vaccine for public use.

This decision by the Medicines and Healthcare products Regulatory Agency (MHRA) to approve the vaccine for emergency use in Britain in such a rushed manner (apparently, without going through the due process of properly analysing data from the clinical trials) created a backlash from its European and US counterparts.

Furthermore, the decision by the MHRA to grant civil immunity to Pfizer against legal suits, has raised some questions about the vaccine. If the vaccine is so safe and effective, why the need for immunity for Pfizer, which has faced many legal suits in the past.

Many analysts suspect that Prime Minister Boris Johnson, with his current popularity rating at a new low, due to his perceived mishandling of the pandemic, may be trying hard to gain back some public support.

We are not saying that the Pfizer mRNA vaccine is unsafe but merely expressing a genuine concern shared by many people on the rushed clinical trials using a completely new technology that has not been tested on humans before.

Even if the Pfizer mRNA vaccine is deemed safe and effective for use in our country, there is another major challenge here – operational feasibility as a result of our hot tropical climate.

We are talking about implementing a mass vaccination programme in Malaysia using a vaccine which must be stored at -70 to -80 degree Celsius with two doses per person to be injected, about 21 days apart.

Pfizer would only be responsible for storage and transportation (from one of its manufacturing sites in Michigan or Belgium) up to the ports of entry and would not be able to do much beyond that. Pfizer is supplying the special cold boxes (thermal shippers) filled with dry ice with 1,000 to 5,000 doses per box and they must be store in ultra-cold freezers.

A 23 November, 2020 CNBC documentary highlighted the extreme complexity of the logistical operations required for the Pfizer vaccine, even in the highly advanced US with all the technical expertise and resources at its disposal.

If in the cold US, they are only allowed to open the thermal boxes twice a day (one minute each time), in hot tropical Malaysia, we probably have 10 seconds each time. Each box must be replenished with new vaccines in 15 days. Once the vaccine thaws in a normal refrigerator, it has a shelf life of five days to be used. Remember that this is a two-dose regimen with 21 days apart.

The government of Malaysia has stated that it has at least 125 ultra-cold large freezers around the country in public universities and research institutes. There are three problems here.

Firstly, the capacity of these freezers is almost filled up and there is not much space left. Remember, we are talking about four large shipments of 500,000 doses in the first quarter of 2021, 1.7 million in the second quarter, 5.8 million in the third quarter and 4.3 million in the fourth quarter.

Secondly, the vaccine in thermal boxes should not be mixed with other drugs or products that are being store in the ultra-cold freezers.

Thirdly, all these ultra-cold freezers are manufactured overseas and there is a shortage around the world at the moment with a long waiting list. They are also very costly.

The strength of a supply chain system is as strong as its weakest link and the last mile to administer the vaccine at clinics, hospitals and health centres, especially in the rural areas, would be the biggest challenge.

Already our public health clinics and hospitals are understaffed. The Pfizer scheme would require training and management of the inventory and IT systems to monitor the delivery and vaccination at each chosen health centre.

Do we have such expertise, resources and capability? Another major problem would be the diversion of our limited and much needed healthcare human and other resources from their current essential tasks.

British Professor Richard Wilding, the world’s foremost supply chain expert, in quoting former US President Dwight Eisenhower that “wars have been won or lost primarily because of logistics”, said that the same principle applies to the supply and distribution of COVID vaccines.

He was commenting on the complexities of the logistics and distribution of the Pfizer vaccine’s rollout on 9 December in Britain.

The supply chain and logistical constraints listed by Professor Wilding for the immunisation of the Pfizer vaccine, appear highly challenging even for a well-organised, trained and high-tech healthcare infrastructure like what Britain has.

Indonesia (which is far more advanced in vaccine development than Malaysia with its own human vaccine manufacturing facilities) has declined the use of this vaccine, stating that it does not have the cold chain capabilities needed and it would be hazardous if the vaccine is not stored at the proper temperature.

On the costs involved in the various vaccine schemes, the government should be more transparent, once a deal has been done. The people have the right to know how public funds – RM3 billion (US$739.4 million) – is being allocated and spent.

Has the government already signed or intends to sign away civil immunity to Pfizer against legal action if something were to go wrong after taking the vaccine?

As the government has not been transparent enough, even on the main costs involved in the Pfizer scheme, it only has itself to blame for all kinds of speculation and rumours in the market.

Once a deal is done, even for the initial phase, using the NDA (Non-Disclosure Agreement) signed with vaccine suppliers, is no longer a valid reason for not being transparent on the main costs and key terms involved. The government, is first and foremost, answerable and accountable to its citizens and not overseas suppliers, who may not have the best interest of the people at heart.

NDAs are meant in the corporate world to protect trade secrets and sensitive details, and not as a tool for any government to hide behind or to avoid transparency.

Finally, if the government insists on going ahead with the Pfizer scheme, then its ministers, promoters and key supporters must lead by example by being the first to be administered publicly with this mRNA vaccine.

The Covid Research Centre is a Kuala Lumpur-based independent think tank unit set up in March 2020, which includes highly qualified local and overseas experts, to undertake social research and analysis on important COVID-19 related issues.

Professor Mustafa Ali Mohd is a clinical pharmacologist and toxicologist, former professor and Deputy Dean of the Faculty of Medicine, University of Malaya and Fellow, Malaysian Academy of Sciences.

Source: The ASEAN Post