85. ANSWERS NEEDED ON PURCHASE OF PFIZER VACCINE
Date: 7 December 2020
PRESS STATEMENT BY TENGKU RAZALEIGH HAMZAH
The government has recently announced a preliminary agreement to purchase 12.8 million doses of Pfizer mRNA vaccine for 6.4 million people (20 percent of the population) of Malaysia, perhaps the first country in the developing world to do so. This deal has raised several important questions.
The deal is rumoured to cost the government (taxpayers) more than RM 2 billion just for the purchase of the vaccine alone. The cost for the special storage and distribution facilities required in keeping the vaccine refrigerated at minus 80 degree Celsius could cost another RM 1 billion. The government has so far, not divulged the price that it is committed to Pfizer for this vaccine and the costings required for the special storage and logistics, so naturally, there would be lots of speculation. Would there be additional costs involved in filling and finishing the vaccine locally?
With an allocation of RM 3 billion for procurement of vaccine for the entire country, the Pfizer deal, only covering 20 percent of the population, seems to have used up the entire allocation. Perhaps the minister in charge of vaccine procurement should explain the price and estimated costings involved in the Pfizer deal.
As stated in my previous statements regarding the Covid-19 pandemic, I am a believer of using a safe and effective vaccine, based on tried & tested technology, to end this devastating pandemic.
However, there are several experts who now feel that we should consider other alternatives to end the pandemic. Examples given are improving our body immunity via various means, living a clean & healthy lifestyle, treating the disease with more holistic, herbal and complimentary medicine and continuing to adhere to necessary social measures such as wearing face mask and social distancing. Even the former VP of Pfizer Dr Mike Yeadon, believes that people around the world are acquiring the natural herd immunity needed and there is no need for any vaccines to bring the pandemic to an end.
The 3 most important factors to consider before taking a vaccine are: Safety, Safety and Safety. Efficacy and durability of a vaccine should only come next.
To trigger an immune response (of antibodies and killer T-cells), the old tried and tested vaccine technology which normally takes 5 to 10 years to develop, uses a weakened or inactivated natural virus to be injected into our body, to train our body on how to fight such “safe antigens”. So when a real and harmful antigen (virus) enters our body, it is already trained and ready to take on this “external enemy”.
The Pfizer vaccine, like the one developed by Moderna, uses a messenger RNA technology of injecting synthetic RNA (created at the lab), coated with a delivery vehicle made of lipid nanoparticles to inject 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 in the form of a safe spike protein similar to the spike protein of the Covid-19 virus. This would then trigger an immune response.
Pfizer’s and other vaccine developments were fast tracked under immense pressure from President Trump who needed a Covid vaccine badly as a political weapon for his November 2020 presidential re-election.
The 3 phases of human clinical trials for both Pfizer and Moderna took only several months of what should have been several years in order to ensure that there are no harmful side effects some years from now. During the trials, there were side effects such as muscle pain, chills and headache.
There are reports that suggest that the Pfizer vaccine may not stop the transmission of the virus and only suppress the symptoms and the protection provided by the vaccine may not be long (durability). Therefore, what is the purpose of this vaccine if it cannot stop the spread of Covid-19 and the MCOs would still need to be enforced, which would continue to drag down the economy?
In the meantime, the MCOs should be more targeted at susceptible groups or areas in a more localized manner instead of across some states in a blanket manner.
As this mRNA technology has never been used on humans before, no one can guarantee that there would be no middle and long 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 & unexpected side effects later on. We do not know what other secret ingredients are involved.
In an interview in July 2020, the CEO pharma giant Merck and a leading authority in the world on vaccine developments, Ken Frazier, had cautioned us about trying to rush the current vaccine development process:
“Well, first of all, it takes a lot of time. The fastest vaccine ever brought to market was the mumps vaccine. It took four years. Our most recent vaccine for Ebola took five and a half years. And why does it take so long? First of all, 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. No one knows for sure whether or not any of these vaccine programmes will produce a vaccine like that. 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.”
The current euphoria (boosting stock markets in the West) of the two mRNA vaccines over the more than 90 percent efficacy, has clouded the more important issue of long term safety, which is the biggest concern.
There have been many past lawsuits 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.
The most notorious drug 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.
There is no free lunch in this world. Covid vaccines have been heavily politicized by President Donald Trump. What is the real motive for Pfizer to do a deal with Malaysia and why didn’t Pfizer conduct any of its clinical trials here? Why did our government rush into this deal and commit practically all our financial allocation for vaccines when there are other safer, much cheaper and more practical options (without the special refrigerated storage and logistics)? If the Pfizer vaccine is so safe and effective, why has the UK Government just announced that it has granted immunity to Pfizer from legal action (by consumers)? Has our own government already signed or intend to sign away such an unjust & irresponsible clause?
Oxford University/Astra Zeneca’s adenovirus vector vaccine, also at its Phase 3 trials, seems much safer as the technology used been tried and tested before, such as for MERS and Ebola outbreaks. China has developed two vaccines (Sinovac and Sinopharm), also in the final Phase 3 using the safer old tried & tested technology.
I am not saying that Pfizer would not be doing its best on safety. But, how can they or anyone (based on Ken Frazier’s comments) GUARANTEE safety using such a new technology and on such a rush job.
While I have full confidence on our healthcare front liners, does our country have the high level expertise on vaccine R & D to be able to analyse the data properly from the short periods of clinical trials?
If the government refuses to reconsider or review the Pfizer deal, I would like to suggest that in order to lead by example and show sincerity, Cabinet members and senior officials who are medically fit, to be administered with this vaccine first before giving it to the others.
I would also like to propose that those medical representatives, health analysts, writers and academics who are very supportive of this Pfizer deal should also be mandated to be given this vaccine first.