LETTER | Concerns raised over safety of Covid-19 vaccines and the response

LETTER | The following is a part of a media statement by the Muslim Consumer Organisation Malaysia, Persatuan Patriot Kebangsaan (Patriot), Covid Research Centre of the Think Tank Unit and the Asian Heritage Museum Group on their concerns over the safety of the Covid-19 vaccine rolled out in Malaysia.

It is published along with a response by Dr Musa Nordin, a specialist paediatrician and founder of the government-linked initiative on vaccine and immunisation education, Immunise4Life.

The concerns raised by the NGOs are in bold.

1. Members of the public have the right to know about the risk and safety aspects of Covid-19 vaccines.

Based on latest news reports and after consulting some experts, we believe that we have not been told the full story on the safety aspects of the mRNA vaccines, especially the ultra-sensitive and highly unstable mRNA vaccine developed by the US-based multinational biotech firm Pfizer, which would require refrigeration of minus 70 degrees to 80 degrees Celsius.

There is a lot of literature in the public domain. Many who have made similar complaints on Facebook, Instagram, YouTube etc have not even bothered to do their homework and read the voluminous reading material available.

In fact, the United States Food and Drug Administration (FDA) did their deliberations online and everyone can access and ask questions.

Unfortunately, most are not interested in real serious discussion and prefer to dwell in social media being fed with fake news, misinformation and conspiracy theories.

Below are the three large trials by researchers who studied the three vaccines licences under Emergency Use Authorisation (EUA), namely Pfizer and BioNTech, Moderna and the US National Institute of Health and AstraZeneca, and the University of Oxford.

In total there were about 100,000 volunteers in these trials. The scientific papers on the trials can be read in the articles below:

- Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (New England Journal of Medicine) 

- Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK (The Lancet) 

- Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine (New England Journal of Medicine) 

2. Non-disclosure of all relevant facts on safety aspects is worse than spreading false news.

Diverting attention, covering up the safety aspects of the mRNA vaccine, and only giving selective information or playing down on the serious adverse events (including deaths) caused by the vaccine is unethical and even criminal.

If the vaccine concerned were to cause serious side effects later on, who will be held responsible, since the vaccine producer would likely be given social immunity here?

If you read the three scientific papers, then you will get most of your answers. If you’ve read the Pfizer and Moderna vaccine dossiers submitted to the FDA for EUA, all the relevant facts which you seek are answered.

To even suggest otherwise is an admission of total ignorance of the bare facts that are in the public domain.

To allege unethical practice and criminal intent is not the decorum of healthy discourse and engagement of minds to seek solutions!

Kindly peruse the FDA Briefing Documents on the Pfizer and Moderna vaccines and if you still have enquiries we can have a conversation. 

3. We must learn from the anti-dengue vaccine Dengvaxia Scandal in the Philippines in 2016, which was approved by the World Health Organisation (WHO), where more than 130 children died after being vaccinated.

The case is being investigated for criminal negligence and possibly, greed and corruption as well.

Twenty government officials and medical experts have so far been indicted in the Philippines in 2019 for homicide charges related to the rushed approval process and for carrying out the vaccination in “undue haste”.

The Dengvaxia issue in the Philippines is totally mired in ugly national politics. So being a scientist I am not in the least interested to dwell on this subject, whether political, legal, criminal or whatever. I will stick to the science and move on.

4. Safety is far more important than efficacy. It is meaningless having a 100 percent effective vaccine today but later report serious side effects, including deaths.

Unlike medicine, a vaccine is given to healthy people including children so the threshold for safety is very high.

Also, unlike medicine or a drug, a vaccine tends to stay in our body for a long time, even forever. So the propensity for a new and unverified vaccine to cause harm is great.

This question sounds like a more useful discussion. You seem to give the impression that only you are interested in the safety of the vaccine and the scientists who designed the vaccine and the researchers who painfully undertook the pre-clinical trials, phases 1, 2 and 3 trials don’t really give a damn about safety.

And to say safety is far more important than the efficacy of the vaccine is simplistic thinking, missing the true understanding of the science of vaccinology.

This science has come a long way since the first smallpox vaccine was discovered in 1796. Just to illustrate the criticality of vaccine efficacy (VE), it is this very property that led to the eradication of smallpox in 1980.

A safe vaccine with no significant efficacy would not have achieved this outstanding public health achievement.

Scientists are unanimous in their conviction that any candidate vaccine must be rigorously investigated in double blind placebo controlled, randomised control trials with many thousands of volunteers for at least two months to uncover more than 90 percent of the major side effects.

These criteria have been met by the three candidate vaccines which involved at least 100,000 volunteers.

These numbers are much more than previous trials with the Pneumococcal Conjugate Vaccine (PCV) and Human Papilloma Virus (HPV) vaccines which recruited 52,000 and 27,000 volunteers respectively and where there were no major Adverse Effects Following Immunisations (AEFI).

Similarly, there were no significant major AEFIs in all three Covid-19 vaccines.

In the Pfizer trial, the major AEFI was one percent in both the placebo and the vaccine arms of the trial.

Even the most severe AEFIs presented within the first 30 minutes of the administration of the vaccines, not three or 30 years later as some you may be led to think. And these are the anaphylactic reactions.

With the Pfizer vaccine, the incidence was 11 per one million and 2.5 per one million with the Moderna vaccine.

You may be horrified by these numbers but let me put these figures in perspective.

Since the data collection in the US by the Centre for Disease Control of Prevention (CDC) is complete and transparent, I think it best for me to refer to their data.

I would have loved to illustrate with our national data but I am afraid not much is available in the public domain to speak of.

I think instead of ranting at the safety and efficacy data, you will be more useful as an agent of change if you can convince the Health Ministry and the National Security Council (NSC) to be more forthcoming with our Covid-19 national data.

Risk of dying with Covid-19 in the US is one in 780. Risk of Moderna anaphylaxis in the US is one in 400,000. Risk of Pfizer anaphylaxis in the US is one in 91,000.

So the risk of dying with Covid-19 in the US is 513 times and 117 times higher than the risk of anaphylaxis with the Moderna and Pfizer vaccine respectively.

You choose which one is safe now. This is what we call risk benefit analysis. Welcome to life. We all have to make choices in life. And hopefully our choices are informed choices, based on good science and not misinformation and conspiracy theories.

5. Even the 95 percent efficacy claimed by the US-based mRNA vaccine producers (Pfizer and Moderna) has been challenged by a world-renowned scientist, Peter Doshi, associate editor of the highly respected British Medical Journal in an article dated Jan 4, 2021.

Much of the efficacy claims would depend on the criteria and protocol used during the clinical trials which may vary from one vaccine developer to another.

This one guy wants to dispute the recommendations of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The VRBPAC is the expert committee that reviews all vaccines before making a recommendation to the FDA for approval or non-approval. It is made up of experts in vaccines, public health, and statistics.

There are around 30 individuals on the committee including one vaccine industry expert (a clinical physician-scientist, not some highly-paid executive) and one consumer representative, in this case, a respected attorney who concentrates on healthcare issues.

These are scientific experts with educational and research backgrounds far beyond Doshi’s anthropology degrees and conspiracy theories. Why does Doshi think he’s smarter than these experts?

If the Covid-19 pandemic weren’t so dangerous, I would laugh at Doshi for being another one of those anti-Covid-19 vaccine grifters.

Dr Anthony Fauci, probably the world’s leading expert on infectious diseases, has spent nearly 50 years studying medicine, immunology, infectious diseases, and public health. He has published over 300 articles on diseases.

Fauci endorses the 95 percent effectiveness level, although he has shared the same concerns about the length of time of the studies as many of us have.

Fauci has spent hours and days pouring over the data from both clinical trials (and I know he has done the same with several other clinical trials).

Fauci and members of VRBPAC are real authorities in science, not false ones like Peter Doshi, anti-vaccine shill.

They are authorities not only as a result of their academic degrees and years of research into vaccines but also as a result of relying upon unbiased and independent research over the years.

None of these real vaccine experts noted the unsupported complaints that Peter Doshi listed in his non-peer-reviewed blog article.

If Doshi’s critiques were valid, then these experts would have been all over it, even now. But his critiques are invalid, which means it could lead to lower Covid-19 vaccine uptake if people accept what he’s claimed. And that will lead to more deaths.

The science does not support Doshi. I have attached the full rebuttal of Doshi here. And I have attached another critique refuting Peter Doshi’s claims doubting trustworthiness and meaningfulness of COVID vaccines here too. 

6. We cannot assume that the vaccines are safe just because the US government has given approval, or tacit approval from the WHO.

The vaccine producers must provide all the clinical trials data for our regulatory authority, the National Pharmaceutical Regulatory Agency (NPRA) for a thorough professional evaluation based on data, facts and news reports from around the world so far, on all adverse and unexpected side effects, including deaths, for those people taking the vaccine concerned.

The approval process must not be rushed or compromised by political pressure as it involves the safety and the lives of our people. Again, let’s learn from the Dengvaxia Scandal in the Philippines involving a vaccine developed by a leading global biotech MNC.

The NPRA has approved the Pfizer vaccine. I hope you will now encourage your members to have the vaccine when their time is due.

I understand that AstraZeneca, Sinovac and Sinopharm have also submitted their vaccine dossiers for consideration by the NPRA.

This is very encouraging because we must lay our hands on as many safe and efficacious vaccines in order to build herd immunity which is probably around 70 percent of the population.

Again you have brought again up the issue of the Dengvaxia vaccine in the Philippines, suffice for me to say:

a. There is no causal link between the deaths reported in the Philippines and the vaccine. Findings from an independent expert body on vaccine safety, the WHO Global Advisory Committee on Vaccine Safety (GACVS), determined that there was insufficient evidence to establish a causal relationship between the death cases reported in the Philippines and the vaccine.

b. The conclusions of the Department of Health in the decision denying the appeal on the revocation of the Dengvaxia license state that “the safety of the vaccine is not at trial.” The conclusions from our own assessment are also in alignment with these findings.

c. No causal-related deaths were reported in 15 countries after clinical trials conducted for more than a decade with 41,000 subjects involved. There continues to be no evidence that any deaths have been causally linked to the dengue vaccine.

d. In the over a million people who have received at least one dose of the dengue vaccine, the most frequently reported adverse events have been fever, headache, dizziness, vomiting and rash.

e. The WHO and the vaccine manufacturers have a global pharmacovigilance system that collects information on adverse events reported in vaccinated individuals. The system is designed to carefully assess and evaluate the full documentation on AEFIs in order to assess any possible or causal association between these events and vaccination.

7. There are two processes involved in developing and producing a vaccine. The first part is on research and development (R&D) and production of the untested “rough cut” vaccine using the latest high tech, which can take place at lightning speed.

This is fine as we are not against using high tech or technological progress as long as it does not harm innocent people.

But the second and most important part of the process is to conduct preclinical trials (on animals) first and then, the human clinical trials with the vaccine concerned.

The human clinical trials must not be rushed as our human body is not a high tech robot and it needs a minimum of three to five years to respond (vaccine and its ingredients would normally stay in our body for a very long time).

On another safety aspect, the promoters of the mRNA vaccine claimed that once the mRNA vaccine has done its job in our body to instruct our designated cells to make the "friendly antigen" to stimulate the antibody response needed, the mRNA vaccine (it's not actually a vaccine by strict definition) would then break up and it would be destroyed, that is the end of the story. This is highly misleading.

What they do not tell you is that the by-products of the break up, may stay in our body for a very long time, may interact with other cells and may cause harm to our body later on.

There are just too many unknowns here with this new and not properly tried and tested technology, so taking an attitude of "ignorance is bliss" or “you must trust this huge global MNC biotech firm” for injecting an unverified and unstable vaccine to healthy people is irresponsible and dangerous.

So you think you know better than the likes of Fauci and Paul Offit who have spent virtually their entire professional career dealing with vaccines to ensure they are safe and effective for use in humans.

Maybe you should share with us your credentials with us so that we know exactly your expertise and compare them with Fauci and Paul Offit whom you dispute.

I shall list here the minimum that is expected so that we can judge them objectively. For most of us, an authority in vaccines requires actual studies in some, if not all, of the following fields:

• immunology – the study of the immune system

• biochemistry – the study of chemical processes in biological systems

• cell biology – the study of the structure and function of the cell

• virology – the study of viruses and virus-related diseases

• microbiology – the study of microorganisms, which include viruses (which is often broken out into a separate field of study), parasites, and bacteria

• physiology – the study of functions and mechanisms of living systems, generally, in this case, humans

• epidemiology – the study of patterns and distribution of diseases and medical conditions in a population

• pharmacology – the study of the mechanism of action of drugs and medications

• public health – the study of the science of preventing disease and promoting human health through organized efforts

• statistics – a mathematics discipline that focuses on the collection, organization, analysis, and interpretation of data

• pediatrics – the branch of medicine that involves the treatment and care of infants, children, and adolescents

8. The same people in the US, including health officials such as Dr Anthony Fauci, who are now aggressively promoting the US mRNA vaccines, have lost credibility over the Face Mask Scandal in the West last year.

It resulted in huge and uncontrolled infections and many fatalities in the West. These government officials and experts were either dishonest or they were so stupid and living in denial, when the pandemic was already full-blown in the US and elsewhere, to refuse to change their illogical, unscientific and self-contradictory policy of “no-necessity to wear face mask in public places”, until much later on and after many more people became infected and died.

First, they said that the face mask was not at all effective at protecting anyone from sending and receiving the virus but they also said that due to a shortage of face mask then, it should be reserved for frontline workers only.

So if it could work for protecting frontline workers, how come it could not work for others? No answers from them.

Then they used that racist narrative (promoted by their then President Donald Trump) that wearing a face mask was an Asian culture (which their adversary China is a major part of and a global manufacturing centre for face mask). So, how could they bring themselves to follow the inferior Asian culture? Well, they reap what they sow!

I am not interested in politics in the US. For your information, our Health Ministry similarly held to the CDC rule that the use of masks should then, early in the pandemic be prioritised for the healthcare workers and the frontliners.

Then there was an acute shortage of masks. What was the stand of you four NGOs then? Did you shout out this discrepancy on the use of face-masks?

I cannot speak for others but I stuck out my neck and rallied for #Mask4all. A colleague in Penang phoned me repeatedly to tell the Heath Ministry and the health minister to make the use of masks mandatory in Malaysia.

I tweeted “Back to Basic Public Health” on March 31, 2020. Were your four NGOs advocating for the use of masks, too, then?

This is what I wrote then: Rule 7: Go for #Mask4All

I know I am treading on soft ground here. The CDC and WHO guidelines are against the liberal use of face masks.

They are however not based on good science except to save the masks for use by healthcare providers in the midst of severe shortage.

This rule has had the unintended result of stigmatising the mask wearers as either being contagious or a mask hoarder.

It is all about crowd psychology. If everyone wears a mask, the hesitant sick person will now be more willing to put on a mask because there will be no more stigma.

The face mask blocks the big projectile droplets that land in the nose or throat and cause the spread of Covid-19 infection. Like social distancing and handwashing, the #Mask4All policy has somewhat contributed to Asia better flattening the epidemic curve.

Fast forward, #Mask4All policy may be the middle ground policy to harmonise between total lockdown that hurts the economy and total freedom with the risk of Covid-19 resurgence.

It is also time to do without handshakes, hugs and kisses and do the hola, namaste, eyvallah and elbow bumps instead. You can check this out with all the associated diagrams:

I note that you have made many allegations, insinuations, even heaped scandalous accusations of individuals in your letter.

But after reading and answering the first eight questions I have yet to see any reference or attachment to validate or verify your claims. This is akin to the Malay proverb "Baling batu, sembunyi tangan".

This is not the tradition or adab of a good Muslim individual or NGO, since one of the signatory NGOs of the long letter represents Muslim consumers.

Maybe we all need to be reminded of the verse of the Quran from Surah Yusuf: 108 which states:

Say (to them, O Messenger): "This is my way: I call to God on clear evidence and with sure knowledge – I and those who follow me. All-Glorified is God (in that He is absolutely above having any partners) – and I am not one of those who associate partners with Him." 

9. Uncertainty about the long-term side effects regarding mRNA vaccines makes it impossible to conduct a proper ‘risks versus benefits’ analysis.

I have earlier alluded to the severe AEFI following the mRNA vaccines. Virtually all of these would appear within the grace period of two months.

This has been the window period since we made vaccines in a big way with DTP (diphtheria, tetanus, pertussis) and smallpox in the 1950s - unless you have any specific long term AEFI which the vaccinologists are not aware of or familiar with.

Please do not hide behind big words like long term side effects, be more specific.

Up until 10 months of use with millions of doses administered, there have been no safety signals except for anaphylaxis.

Anaphylactic shock is probably the most severe AEFI that appeared within 30 minutes, not 30 day or 30 weeks or 30 years as some microbiologists tried to hint on television recently.

Because we are aware of this AEFI, clear guidelines were in place and none of the vaccinees who had this AEFI suffered any short or long term complications, and if I may emphasise, none died.

The other was intussusception with the rotavirus vaccine, where the intestine telescopes into the adjacent gut. This occurred within 21 days, not 21 weeks or 21 years.

The offending Rotashield vaccine was removed from the market promptly and replaced with the safer Rotarix and Rotateq vaccine with an incidence of one intussusception per 100,000 cases.

It protects from rotavirus, which causes 111 million episodes of gastroenteritis (diarrhoea, vomiting and dehydration), 25 million clinic visits, two million hospitalisations, and 352,000–592,000 deaths in children under the age of five.

Which would you prefer your child or grandchild to have, the rotavirus vaccine or risk severe illness and death?

10. One main component of the very unstable mRNA vaccine, polyethylene glycol (PEG) coating of nanoparticles, is already suspected to cause many reported severe side effects on those who have taken the vaccine.

A scientific article on Dec 21, 2020 in the highly respected Sciencemag.org reported that “suspicions grow that nanoparticles (PEG) in Pfizer’s Covid-19 vaccine trigger rare allergic reactions”.

Health authorities in the US are concerned enough to study the matter further.

Finally, we are talking some sense.

There are not many AEFI associated with PEG. It is the suspicion of scientists that PEG is probably the chemical that is triggering the anaphylaxis seen with both the Pfizer and Moderna vaccines. Kindly tell us, which are the other “reported severe side effects” (besides anaphylaxis)?

I note that you are fond of lapsing into the anti-vaccine tactic of exaggerating and sensationalising AEFIs of mRNA vaccines. We cannot have a healthy discourse if you very quickly blow up issues instead of stating the facts.

In fact, the manner in which the PEG is reconstituted as the nanoparticle enveloping the mRNA may be the reason why different rates of anaphylaxis is reported between Moderna and Pfizer mRNA vaccines at the rate of 2.5 per one million and 11 per one million, respectively.

11. On Jan 7, it was reported that the US CDC admitted that it was carefully monitoring allergic reactions to the vaccines from Pfizer and Moderna and urged individuals who had a serious reaction not to get the second dose.

What is even more alarming is that the CDC in the same press report said that allergic reactions are occurring at a rate of 11.1 per 1 million vaccinations, compared with flu vaccines, in which such reactions occur at a rate of 1.3 per one million shots.

Basically for the mRNA vaccines, the allergic reactions, so far, are nine times more than the flu vaccines.

You conveniently mentioned the Pfizer AEFI (11 per million) to contrast with the flu vaccines but selectively did not mention the lower AEFI of Moderna 2.5 per million, or the zero anaphylaxis of AstraZeneca DNA vaccines thus far. Tell me, who is now selectively misinforming?

I have from the outset been upfront with all the trial data and with the pharmacovigilance data.

This culture of selective misinformation is a prominent trait of anti-vaxxers, conspiracy theorists, multi-level marketing of alternative medicines sellers by individuals and NGOs, namely those who promote mega-doses of vitamins, minerals, supplements (all of which they do not undertake randomised controlled trials [RCT] to prove whether they are safe or effective, but the peddlers insist that all drugs and vaccines must undergo years and years of RCT). Talk of double standards!

I am sure you know how the rakyat have suffered from Covid-19 because of the double standards practised by the privileged and connected in our country.

12. Some high-profile cases so far, among people who have died or suffered serious side effects just after taking the Pfizer mRNA vaccine are:

• A healthy Mexican female doctor, 32, hospitalised (in ICU), Jan 3;
• A healthy US doctor, 56, died on Jan 3;
• A healthy Portuguese nurse, 41, died on Jan 4; and
• A total 29 nursing home residents in Norway have died, so far.

It was reported on Jan 12 that over 12,000 people in Israel were tested positive for Covid-19 after receiving the Pfizer vaccine.

More and more news reports from around the world are coming out on people who have died and who are suffering severe unexpected side effects after taking the unverified and unstable mRNA vaccine.

Yet again, you do not exhibit the decorum or adab that is expected of a good Muslim or Muslim NGO or plainly a fair and just human being. I think this verse from Surah al-Hujurat sums it all: Oh believers, if an evildoer brings you any news, verify 'it' so you do not harm people unknowingly, becoming regretful for what you have done (49:6)

You act as though you have performed the forensic investigations and did the autopsies to determine the cause of the deaths or the cause of the associated events post immunisation.

Undoubtedly, the mRNA is in the spotlight and every little thing that goes wrong is immediately attributed to the vaccine.

If you’d only be patient then you will soon learn that the 33 elderly, frail residents in home care died due to their pre-existing comorbidities. Not my word but that of the Minister of Health of Norway, who added that 45 of them die each day from pneumonia, septicaemia (blood poisoning) strokes, heart attacks, and other non-Communicable diseases.

The death of the Portuguese nurse was not linked to the vaccine. This in medicine is known as Temporal Association (coincidental), not Causal Association (not the cause of the death).

The ITP in the US doctor and the sick Mexican doctor are still being investigated.

Why must you jump the gun and be the judge, jury and executioner all in one? This is a very dangerous and irresponsible approach.

Again, I have attached the evidence for your kind perusal:

• Mexican doctor
• US doctor
• Portuguese nurse
• Norway nursing home

Regarding the Israel cases, the rise in infections, despite the lockdown and vaccinations, has been attributed to virus mutations and disregard by some people of restrictions on assembly.

So they were either incubating the virus prior to the mRNA vaccine or they disregarded masking and distancing and were infected prior to the Pfizer being protective in 52 percent of case happening at two weeks after immunisation. And the full protection (95 percent) which is only achieved after the second dose.

These are readily explained by the researchers and the implementers of the vaccination programme.

You also deliberately avoided the fact that there was a significant 60 percent drop in the hospitalisation rates for the elderly thus reducing the burden on the hospital capacity and the overstretched healthcare workers.

The Pfizer mRNA must surely be effective to achieve this remarkable feat. I hope you’d be more patient and do not rush with your conclusions, do a bit more reading and fact-checking. Otherwise, you will fall flat on your face.

13. In order to protect the safety of our people, we would like to warn certain local doctors, health interest groups and academics, who may have been compromised and are trying to divert attention away to other issues and cover-up on the severe side effects from taking the mRNA vaccine, that we are monitoring what they do and say.

We would not allow such dishonest people to mislead or deceive the public on the safety aspects of the mRNA vaccine and to put our people in harm’s way.

I wonder, who are these doctors, health interest groups and academics, who are compromised, and whom you are closely monitoring? Are you threatening them and/or us?

I have in my earlier answers explained all the AEFIs of the mRNA. Are there any other AEFIs which we have not covered, or which you only know and which the scientists at the cutting edge of mRNA technology are not aware?

It is difficult to have a healthy conversation if you hide behind big words like “severe side effects” and do not disclose what exactly you mean.

Since you are a Muslim NGO, then I will engage you in the basics of Islamic jurisprudence and research ethics.

A maxim in Islamic law states that in matters that concern muamalat (social and human affairs), the default rule is “everything is permissible unless proven otherwise.

In the absence of clear textual evidence (ayat-ayat qati’) to the contrary, everything is permissible (halal). Permissibility (halal) does not require textual evidence.

Even silence in the Quranic texts and in the authentic traditions of the Prophet Muhammad (peace be upon him) means permissibility or an opportunity to make ijtihad.

To say that any intervention, in this case, vaccines are not allowed, has severe side effects etc requires textual evidence.

The burden of proof that vaccines are haram (forbidden), the side effects are severe etc, falls on those who repudiate it and not on those who affirm it.

14. We would like to know why Pfizer has insisted or demanded governments around the world to give social immunity against legal suits for adverse and serious side effects (including deaths) caused by the vaccine.

You obviously have a short term memory on the history of vaccines. Maybe I will jolt your memory bank and then you might be able to realise the concept of the vaccine court.

In the 1980s, US parents claimed that the Diphtheria, Tetanus, Pertussis (DPT) vaccine caused severe side-effects which damaged the brains of their children.

They sued the DPT vaccine manufacturers and were awarded large sums by the jury, which virtually bankrupted most of the DPT vaccine manufacturers. All of them stopped making DPT vaccines except for one.

It was later revealed that all the children actually suffered from a congenital disorder which made them brain injured and it was not related to the vaccines at all.

The National Vaccine Injury Compensation Program (NVICP) was established in 1986 in order to restore the supplies of life-saving vaccines which would threaten the herd immunity against many fatal vaccine-preventable diseases.

Claims against vaccine manufacturers can only be heard in the US Court of Federal Claims, sitting without a jury.

Only scientifically-proven injuries caused by vaccines would be compensated by the US Court of Federal Claims, better known as the vaccine court. Justice is therefore served to both the vaccine manufacturers and the vaccine.

Imagine if the threat of a multi-million dollar suit is hanging over the necks of vaccine manufacturers in their attempts to make a vaccine against a novel coronavirus, then we will not see anyone of them interested in making a life-saving vaccine. And as we speak 102 million persons have been afflicted by the coronavirus with 2.2 million deaths.

A Covid-19 vaccine is the only other tool that is available to reduce the numbers of Covid cases, Covid deaths and to end the pandemic.

I think this vaccine court is a fair and just solution to the unceasing battle between the injured vaccines users and the vaccine makers.

The NVICP is funded by a US$0.75 excise tax on all vaccines recommended by the CDC.

It is high time that the MOH consider this option to allay the anxieties of the potential vaccine users.

15. Why are the top management of Pfizer unwilling so far, to be given their own vaccine? What kind of confidence and leadership by example are they showing on their own product?

That is a question that you should ask the Pfizer top management.

By the way, I am sure you are fully aware of the principle of individual autonomy, which is a fundamental component of medical ethics - it is a respect for competent and informed decisions by adult patients to determine their own medical care.

You are obviously infringing on the personal autonomy of the Pfizer top management, which any medical practitioner would never do. This is far and above, and separate from your questioning of their leadership qualities.

You obviously have little grasp of the philosophy of medical ethics and medical law. The former is about doing the right things (for example, taking the vaccine) and the latter is about doing things rights (for example, respecting the right of the Pfizer executives to refuse the vaccine)

(Editor’s Note: Pfizer CEO Albert Bourla said he has not been given the vaccine because he and other Pfizer executives and board members do not want to jump the queue of vaccine recipients. He said there are limited doses, so the CDC recommends them prioritised for healthcare workers and long-term care residents.)

16. The mRNA vaccine (that our country has ordered 25 million doses for 12.5 million people) is developed by a company with a total penalty of US$4.7 billion since 2000 for various crimes committed including bribery.

It has a terrible track record on safety and integrity, including the death of 11 children in Nigeria in 1996 due to botched clinical trials on 200 children for their antibiotic drug called Trovan.

This as I mentioned previously is politics, which I am not the least interested in. I am only interested in science.

I dissect the evidence in relation to the efficacy and safety of the mRNA vaccines and that they meet the benchmarks set by the regulatory agencies and that the vaccines are offered to mankind at affordable prices. All else is irrelevant to my scientific research and inquisitiveness.

(Editor’s Note: Pfizer, a manufacturer of more than 300 pharmaceutical products including Advil, Robitussin and Viagra, has faced numerous lawsuits over some of its products, but thousands of those lawsuits have also been dismissed by courts.

The company has also settled various lawsuits and cases involving fraud and illegal healthcare marketing.

In 2009, it paid US$2.9 billion in fines in the United States for illegal promotion of four drugs - antipsychotic drug Geodon, antibiotic Zyvox, anti-epileptic drug Lyrica and Bextra, which is used to treat osteoarthritis.

By 2012, it had paid more than US$1 billion to settle lawsuits by 10,000 women over the hormone-replacement drug Prempro, which the woman said caused breast cancer.

The US Food and Drug Administration (FDA) still lists Prempro as a recommended drug to deal with menopause but notes that hormone medicines can cause other illnesses including breast cancer.)

17. To understand the confusion and misinformation about vaccines out there being spread by certain parties with vested interest, we need to understand that our country is part of the global market of the new "vaccine cold war' which has already begun, between three main power blocs - US, China and Europe.

The approach used by China and the Europeans to promote their vaccines seems to be more ethical, equitable, fairer and sensitive to the needs of poorer countries.

Our country must not be used as guinea pigs or a pawn by any powers in this global vaccine cold war.

Consideration for procurement of any covid vaccines must not be based on political coercion or pressure but solely on merit, especially safety.

I totally agree with the last sentence. Herewith, I furnish the evidence.

The ball is now in your court to show your evidence for the China and Russian vaccines. I may have missed if it was published in the Mandarin or the Russian language, which you may have access.

First, we must agree on some back to basics of vaccinology. I have outlined them here:

To start with, the WHO and FDA have decided that the vaccine must be at least at least 50 percent efficacy.

The vaccines must be proven to be safe. This seems to be the primary concern of most people.

Vaccine trials have been ongoing since the 1950s. It has been established in the science of vaccinology that more than 90 percent of AEFI would be unravelled within two months of the vaccine trials.

Thus the FDA has mandated that there should not be any safety signals for at least two months of the use of the vaccines in the trials.

The candidate vaccines must have undergone Phase 3 clinical trials with sufficient numbers in both the treatment and placebo groups, to be sufficiently powered to drive significant conclusions on the efficacy and safety of the vaccines.

The Phase 3 vaccine trials must be able to be validated and verified by the scientific fraternity and must be published in peer-reviewed scientific journals.

The candidate vaccines must meet the stringent criteria set by the national regulatory bodies and if proven efficacious and safe, will be licensed for Emergency Use Authorisation (EUA) by the respective national regulatory agencies.

The candidate vaccines will be reviewed by the Strategic Advisory Group of Experts (SAGE) on Vaccines of the WHO for consideration of pre-qualification status for global use.

All of the abovementioned criteria is best illustrated and examined in the table below (under response for Concern 18), where I have contrasted the new technology mRNA (Pfizer and Moderna) versus the old tech vaccine inactivated (Sinovac, Sinopharm) and proteins (Novavax, Russian EpiVacCorona).

While the world is becoming a global village, with increased collaboration, cooperation and solidarity in the face of global threats like climate change and the pandemic, WHO solidarity trials to test drugs against Covid-19 ( like hydroxyl chloroquine, antiviral drugs, repurposed drugs etc), sharing the genomic sequence of the coronavirus, sharing research on various aspects of the pandemic from masking, distancing, ventilation, therapeutics, rapid diagnostics and vaccine, you are still frozen in the Cold War of yesteryears.

Like the mRNA vaccine, which needs to be thawed from arctic -70 degree Celsius to be jabbed into the deltoids of mankind to offer protection to the human race, you need to thaw yourselves to be relevant to contemporary societies.

By the way, Novavax is based in Maryland in the US. Unlike what you suggest, the US is collaborating with the UK and South Africa. This does not match the vaccine cold war narrative which you state.

Novavax just released its trial findings in the UK among 15,000 volunteers with vaccine efficacy (VE) of 89.3 percent and South Africa with a lower VE of 60 percent against their more transmissible strain.

The Pfizer and Moderna vaccines have maintained their VE against both the Kent B117 (UK) and South Africa strains.

A 30,000-person Phase 3 trial in the United States was delayed because of problems with manufacturing the doses required for the study.

It finally launched on 28 Dec, 2020. So there is no trans-Atlantic cold war as you make it to be.

18. While we may oppose the use of mRNA vaccine until our questions are answered transparently and we have more information and certainty on its longer-term safety aspects, we wish to show that we are constructive.

There are much safer, effective and cheaper alternatives, home remedies and practices. We can also learn from China on how they could overcome the pandemic last year, within their borders, without resorting to a vaccine. Some of the safer alternatives are as below: such as:

• Other safer vaccines such as Oxford University/AstraZeneca vaccine (using new but tried & tested technology) and the proven technology of using attenuated or inactivated virus from nature such as China’s Sinovac vaccine called CoronaVac.

It looks like I have to illustrate the data for AstraZenca and Chinese vaccines data since none is forthcoming from you guys except for big words in capital letters but without content nor substance.

Sources: CNN, Moderna, Pfizer, The New York Times, Biopharma-reporter.com, The Guardian.

Here are a few salient features to assist you to make an informed choice.

This conversation has always been about sharing the latest information so that one is able to arrive at the best possible decisions for one’s choice of vaccine uptake.

There is no compulsion nor is there coercion as you try to make it out to be. This, in medicine, is well described as individual autonomy.

It is worth noting that only the “new” vaccines using mRNA and DNA have been published in scientific journals.

None of the old technology vaccines has been published scientifically. They have only been revealed in press releases.

Thus we are unable to verify the claims of the makers of the old vaccines.

The mRNA and DNA vaccines have superior efficacy when compared to the classic "old technology" vaccines. The mRNA vaccines have a 95 percent efficacy rate.

Except for one case in the Pfizer trial, none in the remaining five percent who received the vaccines, developed severe Covid-19 disease.

This would have the knock on effect of preventing the recipients of the mRNA vaccines from being hospitalised, let alone occupy an ICU or a ventilated bed.

The Israeli have immunised just under 50 percent of their population. Even prior to the administration of the second dose of the Pfizer vaccine, they have observed a 60 percent reduction in the hospitalisation rates of their vaccine recipients, who are older than 60 years old.

This is a most welcome benefit of the mRNA vaccines and would contribute immensely towards the protection of the capacity of the healthcare facilities and prevent them from being overwhelmed.

Except for the very low rates of anaphylaxis in the mRNA vaccines (see table), the new MRNA and DNA vaccines are Safe.

There are no published reports of the safety aspects of the older technology vaccines. This aspect of a vaccine is critical and one must be fully convinced with sound safety data before even allowing any vaccine to be rolled out.

The three mRNA and DNA vaccines have about 90,000 volunteers tested in their trials. This compares against 31,856 in the older technology vaccines trials.

Numbers are crucial to scientifically ensure that the trials are sufficiently powered to make sound conclusions on efficacy and safety.

All three newer technology vaccines have been licensed for Emergency Use Authorisation (EUA) since Dec 2020. They have been approved more widely in more countries.

The older technology Chinese vaccines Sinovac and Sinopharm were approved for early and limited use by the Chinese government in June 2020, whilst they were still in Phase 1 or 2 of trials.

This is unthinkable and unprecedented according to the scientific fraternity because safety and efficacy had not been fully established then.

There should not be any short cuts in the scientific trials. This would have the effect of releasing to the vaccinated population vaccines which have not been fully studied and may risk unknown safety concerns and may not even be shown to be effective.

This will adversely affect vaccine confidence amongst both the scientists and the general public.

Similarly, the Russian vaccine EpiVacCorona, was granted early and limited use by Russia in Oct 2020, while it was still being studied in Phase 1 or 2 trials.

Only one vaccine has been granted EUA by the WHO. This is Pfizer’s mRNA vaccine. The other two new technology vaccines are being considered for EUA by the WHO.

• Ivermectin, an antiparasitic and antiviral drug in tablet form, which has been proven to be very safe.
  
  It has just been reported on Jan 22 that our Ministry of Health said Ivermectin is “cheap, easily available and safe for us” and that the MOH would be developing clinical trials in Malaysia to determine its efficacy in treating Covid-19.
  
  [Editor’s Note: Health director-general Dr Noor Hisham Abdullah on Jan 21 actually debunked claims that Ivermectin can be used to treat Covid-19. 
  
  He said there is not enough evidence for this, but there is potential to study the drug, typically used to treat parasite infestations like scabies.]
  

This is good and welcomed news. But we would like to propose a step further.

Our MOH and NPRA should quickly approve Ivermectin for public use, over the counter but still, continue with the clinical trials to test its efficacy.

Ivermectin was developed by the Japanese in the 1970s and was used very successfully in the 1980s to treat the parasitic river blindness (Onchocerciasis) in rural areas such as in Africa, a disease which had before that crippled whole communities.

For the last 30 years or so, more than three billion people have taken Ivermectin with not a single reported case of death or adverse side effects.

Recently, there have been many studies overseas to show that it can help to prevent and treat covid-19.

The new Pfizer mRNA vaccine was quickly approved by our NPRA without any clinical trials being done here.

In fact, the clinical trials in the US for mRNA vaccines were incomplete by normal protocol and were done in a rush of eight months instead of the normal period of three years (minimum), but they were approved for public use by the US FDA under Emergency Authorisation.

So why can't our NPRA approve Ivermectin (under Emergency Authorisation, too) for public use first and still do the clinical trials to test its efficacy? What have we got to lose?

In view of the current critical healthcare crisis, time is of the essence in dealing with Covid-19 with every available “safe weapon” that we can get hold of.

We are aware that certain parties with vested interest in certain medical products are now trying to discredit this godsent medicine but we must fight this in the interest of the public.

No one is discrediting this supposedly “godsent medicine”. You need to look at yourselves in the mirror and pose the same benchmarks you mandate upon mRNA vaccines, to be now mandated upon Ivermectin.

That is to say, Ivermectin must be scrutinised by the scientific discipline of placebo-controlled, randomised controlled trial (RCT) as much as mRNA vaccines were examined recruiting 73,000 volunteers between them, with interim analysis published in peer-reviewed journals and to be continued for a total of 30 months, to prove efficacy against Covid-19.

By the way, hydroxychloroquine was touted as a “godsent medicine” by no other than then US President Donald Trump himself and what happened?

This is what the WHO Solidarity Trial concluded:

“World Health Organisation expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19).

“These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalised patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.” 

The issue of Ivermectin has similarly been brought to the attention of the scientific fraternity. The US National Institute of Health issued the following recommendations:

“The Covid-19 Treatment Guidelines Panel has determined that currently there is insufficient data to recommend either for or against the use of ivermectin for the treatment of Covid-19.

“Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of Covid-19.    

• Anti-viral Nasal Spray just developed by Canadian firm Sanotize, has been tested and approved by Health Canada. Convenient and relatively cheap to use. It is found to be effective and safe in preventing and treating Covid-19. This seems to be another godsend product which may face similar hurdles like Ivermectin from parties with vested interest who would oppose it.

[Editor’s Note. On Jan 11, the Canada-based Sanotize Research and Development initiated clinical trials of its nasal spray against Covid-19in Surrey, UK. The trials are ongoing.

Health Canada did not approve the drug for use against Covid-19, as claimed. Instead, the nasal spray’s makers said Health Canada approved a Phase 2 efficacy study on 210 people. The trial is ongoing.]

• Increase intake of (anti-Covid-19) Vitamin C with Zinc, Vitamin D, minerals and trace elements to boost body immunity.

• Drinking warm water more frequently, controlled steam inhalation and gargling the throat with saltwater and mouthwash.

• Various reliable or proven herbal or natural products to improve our body immunity

• Have enough exercise, sleep or rest and live a more hygienic and healthier lifestyle

[Editor’s Note: Fact-checkers at the AFP found there is no evidence to suggest that drinking warm water more regularly, steam inhalation or gargling with salt water and mouthwash stops the virus from entering the lungs. 

The Malaysian MOH on Jan 13 debunked claims that gargling with mouthwash can cure Covid-19 but said it can be used as a prevention, similar to regularly washing hands with soap or sanitiser. 

Similarly, the WHO said vitamins and mineral supplements cannot cure Covid-19 but can play a role in health and well-being.

The WHO maintains a website which debunks myths about Covid-19 and purported therapies. 

19. Until the pandemic is over, we must continue to adhere to control measures such as social distancing, wearing face masks in crowded places and frequent handwashing.

I think we all agree on these well-proven measures. Masking has been shown to be 60 percent protective whilst physical distancing has been shown to be 90 percent protective.

The 3Cs (avoiding close conversation, crowded spaces and closed spaces with limited ventilation), 3Ws (wearing a face mask, washing hands and warnings or regular reminders on preventive measures) and ensuring good ventilation in indoor spaces are a few others.

The last needs to be better understood by all so that outdoor activities are encouraged since the risk of transmission indoors is 18 times that of outdoors.

This apart from a breath of clean, fresh air and to reboot our mental status. 

The views expressed here are those of the author/contributor and do not necessarily represent the views of Malaysiakini.