News of what is apparently planned as the world’s largest vaccine trial (by far) to take place in Malaysia was dropped casually on Friday, thanks to none other than a statement by the Palace about the Agong’s sudden travel plans to visit his old friend the Crown Prince of Abu Dhabi (‘MBZ’).
Sarawak Report immediately queried what appeared to be a global bombshell. According to the statement, also reported by the Malaysian news agency Bernama, The two royal personages are seemingly in negotiations to trial no less than 500,000 Covid 19 vaccine doses on Malaysian citizens (or perhaps it is migrant workers who will be targeted in the ‘voluntary’ scheme?).
“The main agenda of this special visit involves discussions between Al-Sultan Abdullah and Sheikh Mohamed Zayed and the top leadership of the UAE government regarding their intention to donate 500,000 doses of Covid-19 vaccine to Malaysia for the purpose of the third phase of the clinical test in the country,” [translation Malay Mail]
So far the ramifications of this astonishing news have gone virtually unremarked in the Malaysian media – despite the likelihood of a planned announcement of some kind of agreement at the end of this visit.
However the people of Malaysia need to be aware that if this HUGE planned vaccine trial in their country goes ahead as described it will be over TEN TIMES larger than any of the other on-going vaccination trials by global companies. By comparison, the already licensed Pfizer/Biontech vaccine enrolled 43,998 participants and the Astra Zeneca and Moderna models involved a mere 30,000 each.
Speaking to Sarawak Report on condition of anonymity one of Britain’s top infections diseases experts said that such a large trial would not only be unprecedented it would be unnecessary and hard to justify “most vaccine trials involve up to 40,000 volunteers” he confirmed.
Sarawak Report’s investigation of the Abu Dhabi initiative appears to confirm that the vaccine in question is being developed by China and is not projected to complete its trials until September 2021.
An Emirati company, Abu Dhabi Health Services Company, is working as a so-called “collaborator” in a trial sponsored by Chinese state owned giant Sinopharm/China National Biotec Group (CNBG) with the Wuhan Institute – one of many across the world in the race to corner the vaccine market.
News releases have not specified whether the Emirate has invested in the project with a view to lucrative rewards, however it has been reported that Abu Dhabi is conducting tests locally for the Chinese sponsors. According to published Stage 3 trial specifications the number of participants involved is officially expected to be only 45,000 – a far cry from the half million tests being touted by the Royal leaders to now take place in Malaysia!
So, on what grounds and for what purpose has this sudden off-shoot enterprise, involving half a million ‘donated’ trial vaccines been devised separately for Malaysia? Is this apparent Royal intervention in a medical trial meant to hopefully ‘benefit’ Malaysians on the basis that the vaccine may turn out to be effective or are there also politics in play?
The matter is hugely significant because in no country in the world, of course, are such initiatives on health supposed to be made on the prerogative of a political leadership as opposed to the objective and professional health authorities.
Indeed, in a shocking development on late on Monday afternoon the Malaysian Director General of Health confirmed to journalists at a press conference that as far as his ministry is concerned this plan has so far not been addressed at all by the proper regulatory bodies.
Dr Noor Hisham Abdullah was further forced to admit that whilst he had heard of the royal announcement about the vaccine “donation” (touted as the main purpose of the King’s five day visit to Abu Dhabi) the matter remains “hearsay” as far as he is concerned!
Health director-general Dr Noor Hisham Abdullah said he had “heard” about it but called it “hearsay”. This is because no documents about the vaccine candidate had been submitted to the National Pharmaceutical Regulatory Agency (NPRA) for review yet.
“We heard about the donation (where) about 500,000 vaccines will be donated to our country, but more importantly, it has to go through the NPRA registration (process). Once we get the registration, then only we will allow the vaccine to be used in this country,” Hisham answered during a press conference in Putrajaya this evening. [Malaysiakini]
Commenting on the situation the UK expert responded “It seems appalling, what can I say?”
Most Malaysians are well aware of the political incentives that appear to lie behind this apparent gesture of medical charity towards Malaysians by the Crown Prince of Abu Dhabi.
A case is currently pending before the UK Supreme Court which was brought by the previous Malaysian government alleging that decision makers in the Emirate engaged at the highest levels in the 1MDB fraud and subsequent cover-up, in return for kickbacks amounting to at least a billion dollars.
Malaysian prosecutors have estimated that the cost to Malaysia has totalled at least $3.5 billion – money that Abu Dhabi therefore owes Malaysia. Enough cash, in fact, to purchase 300 million doses of already certified Pfizer vaccines, which are marketing at €12 each as the most expensive of the several completed vaccines already coming available to buy.
It would therefore seem to be a poor exchange to be fobbed off with a quarter of a million unconfirmed trial doses (plus the same numbers in placebo) if this ‘donation’ is to be presented be part of an expected ‘Royal Deal’ with Abu Dhabi to close the case.
Nevertheless that scenario seems glaringly on the cards as the planned outcome of this visit, given the statement by the Royal Palace and recent actions.
One of the first quiet decisions by the new Malaysian government after Muhyiddin’s surprise appointment by the new Agong was to suspend the legal proceedings and enter into negotiations with Abu Dhabi about the case, which Abu Dhabi has fought tooth and nail to keep out of the London courts.
The PN government has every reason to wish to return to the cover-up over the settlement with Abu Dhabi by ex-PM Najib, not least because the Crown Prince is one of the Agong’s most valued friends. In a recent recording Najib’s proxy Jho Low claimed one billion dollars was the amount stolen by collaborators of the prince’s brother Sheikh Mansour ($160 million of which was used to buy Sheikh Mansour’s super yacht).
Meanwhile, Najib himself is now back as a key voting member of the government which boasts a majority of 3.
Yet by engaging in such diplomacy the new Agong appears once more to have dramatically over-stepped the boundaries of his constitutional role.
It’s not the first time, of course. Over the past month the new Agong has controversially demanded that MPs to accept a budget that he claimed to have overseen, drawn up not by an elected Finance Minister but by his own close friend, in turn controversially appointed to that post by a prime minister the Agong had personally selected over the expressed wishes of MPs after Harapan was toppled.
It is argued the Agong has also repeatedly manipulated his constitutional role by delaying audiences with party leaders in order to prop up the prime minister he selected over recent weeks and months.
Spearheading medical decisions affecting the health of millions in a pandemic represents a new departure altogether on the other hand. Experts point out that the Sandhurst educated military man is now promoting an unfinished vaccine that lags behind several others emerging onto the world market in terms of proven data.
The UK infectious diseases expert who spoke to Sarawak Report confirms that while headline press releases have claimed good results so far for the Sinopharm vaccination trials it has been widely observed by the medical community that no published data has so far been made available to confirm these claims.
“This is a traditional old-style vaccine, based on dead virus. It may be a perfectly reasonable vaccine, but there is no data published or accessible on public regulator websites like there is available for the Moderna and Pfizer. Oxford have published their stuff as well. All we see for vaccines like the Sinopharm and Russian models are headlines – I can’t see any published results anywhere. We do see such headlines perhaps a couple of weeks in advance but then the data should become available with peer reviews”
The same infectious disease expert raised a far more pressing concern which reflects today’s statement by the Director of Health. For Malaysia to approve any participation in such trials he said “the Malaysian regulatory authority must have this data about the safety and effectiveness and efficacy of this vaccine on which to base a decision about its use”.
“No head of state has the authority to influence the medical regulators in any country. The agencies are supposed to be entirely independent of outside influence. Their only remit is that the vaccines are safe, work and reliable for the people. That is a medical and scientific judgement, nothing to do with political or financial influence. Even if it is registered in Abu Dhabi the Malaysian authorities have to assess it first”.
Most Malaysians are likely to agree, which makes the present situation particularly questionable and concerning where a senior medical officer has been forced to admit the King has just touted a vaccine proposal without consulting his ministry and in the absence of any data. After all, Peru has just suspended its own trials of the same drug following adverse reactions.
There is a further eyebrow raising concern arising from these apparent negotiations between royals. Abu Dhabi’s role not as a sponsor of the vaccine but only as a collaborator on the trials means that it has no status to offer the uncompleted drug for testing in other countries, according to the expert.
“China’s Sinopharm as the sponsor has the legal obligation and responsibility for the trial and to ensure it is implemented to the right ethical and clinical standards. Collaborators carry out the trial on the ground according to an agreement with the sponsor, however the overall responsibility and ownership remains with Sinopharm as Abu Dhabi clearly doesn’t make the vaccine. Therefore it is critical to ask what is their [Abu Dhabi’s] locus standi in this whole business?”
The point being that legally Abu Dhabi’s royal prince has no business to be offering separate trials to Malaysia of a drug that is the responsibility of another party. The vast quantities being spoken of and resulting huge management issues just add to the controversial nature of the proposition.
A number of Arab countries have indeed initiated trials of Chinese drugs, connected largely to Road and Belt initiatives in what has been described in as ‘Vaccine Diplomacy” by China. Abu Dhabi itself is reported as having authorised ’emergency use’ of the Chinese vaccine within its own jurisdiction despite the trials not yet having been completed.
However, the UK expert also points out that reputable international organisations, including the Global Alliance for Vaccines and Immunisations (GAVI) and others, have been engaged in accredited programmes to ensure equitable distribution of safe and fully tested vaccines across the world. High middle income countries like Malaysia ought also be well positioned to buy fully tested vaccines already on the market for its citizens.
So why the experimental route with an unproven product by-passing the Malaysian authorities and credible international bodies? Perhaps a further statement from the palace following the Agong’s discussions with the Crown Prince of Abu Dhabi will enlighten Malaysians further on the royal plans?