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110. Is Pfizer vaccine safe, suitable for us?


AS the issue of Covid-19 vaccine has become controversial and emotional, we may need to pre-qualify ourselves on who we are (footnote), 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 February 11 even before the pandemic engulfed the world.

We called for global solidarity and cooperation to deal with this novel coronavirus, which respects no borders and does not discriminate its victims on grounds of race, religion, ideology and sex.

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 masks, have been heavily politicised and corrupted by certain powers, such as the US government under President Donald Trump.

In March, we were among the first in the world to set up a think-tank to undertake social research, analysis and forecast important issues related to Covid-19.

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

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 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 masks and frequent washing of hands but without disrupting too much our economic activities and implementing targeted movement-control orders.

We are also open to the idea (not saying that we agree yet), 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.

The Malaysian government has, so far, been committed to three Covid-19 vaccine procurement schemes – Covax, coordinated by the World Health Organisation (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.

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

The government’s 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% of the population has raised important questions.

Malaysia seems to be the first Asian country to sign such a deal. (The Philippines was the first Asian country to use the dengue vaccine Dengvaxia in 2015.)

There are basically two types of vaccine technology for Covid-19.

The old tried-and-tested vaccine technology which normally takes five to 10 years to develop, uses an attenuated or inactivated natural virus to be injected into our body, to induce or train our body to fight such “weaker and maybe more friendly antigens” by triggering a response from the body’s 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”.

The Pfizer vaccine, on the other hand, like the vaccine developed by another US biotech firm Moderna, uses a new messenger RNA technology (never used before on humans) of injecting synthetic RNA molecules, coated with a delivery vehicle made of lipid nanoparticles into the 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 procurement of Pfizer mRNA vaccine are safety, efficacy and suitability for our 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 Trump who needed a Covid-19 vaccine badly as a political weapon for his November presidential re-election.

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

The fastest vaccine in human history to be developed and approved so far (before the Pfizer vaccine), was for mumps and it took four years. The most recent vaccine for Ebola took 5½ years.

During the clinical trials for these two mRNA vaccines, there were the expected side effects, such as muscle pain, chills and headache. 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 Food & Drug Administration has just come out with a report (on Wednesday) saying that the Pfizer vaccine is generally safe and effective, even though six people who participated in the clinical trials had died, two from the vaccine group (from “serious adverse events”) and four from 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 would be more questions raised on the two who died in the US during the trials after taking the Pfizer vaccine and two in Britain who developed adverse reactions.

There have been published reports that suggested 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 (durability).

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 small chance (say 0.5%) 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 the clinical trials and the approval process for a vaccine are rushed or politicised, the safety aspects may be compromised. This is more so in this case where we witnessed two deaths in the Pfizer trials on the subjects taking the vaccine.

Ken Frazier, CEO of pharma giant Merck and a leading global authority on vaccine developments, in July cautioned on the danger of rushing the current vaccine development process. Here is what he said (from the horse’s mouth) which our government and all of us must listen carefully:

“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 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 it 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 an HIV vaccine since the 1980s and we’ve been unsuccessful.

“When people tell the public 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 the swine flu, that that 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 November 29, 2017, French drug maker 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 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% 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 safety and welfare of people.

There have been several past suits 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 & Effexor, have been alleged to cause harmful side effects, including deaths. It was reported that the total penalty paid by Pfizer since 2000 for various offences is US$4.7 billion (RM19.3 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 those children who have died.

Our government should be very concerned with the safety and corporate ethics’ records of any Covid-19 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-19 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, our 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 body 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 guarantee 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 would 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 December 2, 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 to approve this vaccine for emergency use in Britain in such a rushed manner (apparently, without going through the due process of properly analysing the data from the clinical trials) created a backlash from its European and even American counterparts.

Furthermore, the agency’s decision 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 by many people on the rushed clinical trials using a completely new technology that has not been used 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 climate.

We are talking about implementing a mass vaccination programme in Malaysia using a vaccine which must be stored at -70° to 80° 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 November 23 CNBC documentary report highlighted the extreme complexity of the Pfizer vaccine logistical operations, even in highly advanced US with all the technical expertise and resources at their disposal.

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

The government 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.

First, the capacity of these freezers is almost being 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 next year, 1.7 million in second quarter, 5.8 million in thirrd quarter and 4.3 million in fourth quarter.

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

Third, 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 costly.

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

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? Please be honest about it. 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 from 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-19 vaccines.

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

The supply chain and logistical constraints listed by 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 our country 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 public has the right to know how public funds (of RM3 billion of taxpayers’ money being allocated) are being spent or committed.

Has the government signed or intend 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 can only blame itself for giving rise to 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 the vaccine suppliers, is no longer a valid reason for not being transparent on the main costs and key terms involved.

NDAs are meant in the corporate world to protect trade secrets and sensitive details, not a tool for any government to hide under or to avoid transparency in spending away taxpayers’ money.

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. – December 11, 2020.

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

* Prof Mustafa Ali Mohd is a clinical pharmacologist and toxicologist, former professor and deputy dean of Faculty of Medicine, Universiti Malaya and fellow, Malaysian Academy of Sciences.

* This is the opinion of the writer or publication and does not necessarily represent the views of The Malaysian Insight.

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