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COMMENTARY | The Covid-19 pandemic has surprised practically all nations without being prepared. The Global Health Security Alliance study in 2019 found that most nations’ pandemic preparedness plans fell woefully short.
Nonetheless, the scientific community has risen to the challenge and made great strides toward understanding the SARS-CoV-2 virus.
Apart from the public health measures of use of masks, physical distancing, personal and community hygiene, avoidance of 3Cs (crowded places, confined spaces and close conversations), meticulous attention to the test-trace-isolation-support quartet, accurate diagnoses , and safe and effective therapies, we urgently need Covid-19 vaccines to flatten the pandemic curve and end this global health crisis.
The World Health Organization (WHO) and Chinese health authorities first announced to the world the discovery of a new coronavirus, known as 2019-nCoV, on January 9.
Chinese authorities shared the complete sequence of the coronavirus genome on January 11 and 12. The sequencing of the SARS-CoV-2 genome is crucial for the development of specific diagnostic tests, potential therapies, and candidate vaccines.
The first human vaccine trials began in March and there are now 54 candidate vaccines in various phases of clinical trials. Of these, 12 are now in phase 3 clinical trials and six vaccines have obtained national authorization for emergency use (USA).
This is remarkable, considering that the average time required to develop a vaccine from the preclinical phase to license for use is at least 10 years. The history of vaccines also informs us that, of the potential vaccines that reach the preclinical phase, only seven percent are successful, while the odds of obtaining a license for their use are 20 percent if they become clinical trials.
The science of genetic vaccines is a breakthrough in the development of Covid-19 vaccines. There are no precedents for mRNA vaccines in our historic vaccine portfolio.
The technique involves the introduction of a selected mRNA sequence that encodes the coronavirus spike protein into the vaccine. The vaccine first produces the spike protein, which acts as the antigen that then triggers the proliferation of protective antibodies to neutralize it.
Pfizer and German drug makers BioNTech were the first to show that their vaccine was 90 percent effective. During their second announcement on November 18, they said their coronavirus vaccine was 95 percent effective and had no adverse effects after immunization (AEFI).
There were only eight cases of Covid-19 (one severe) in the vaccine group, compared to 162 cases in the placebo group (nine severe). They will then file with the Food and Drug Authority (FDA) to obtain the USA.
There is a lot of fake news on social media about the Moderna vaccine. Like Pfizer, they use mRNA technology. The US government invested $ 1 billion in Moderna’s research in partnership with the National Institute of Health (NIH).
Their preclinical studies showed that the vaccine protected monkeys from the coronavirus. In March, its scientists were the first to put the Moderna vaccine candidate into human trials.
Since July, they have evaluated 30,000 volunteers in their phase 3 clinical trials. On November 16, Moderna announced preliminary analysis of their clinical trial, which showed the vaccine was 94.5 percent effective.
Of the 95 participants who received Covid-19, 90 were from the placebo group and five from the vaccine group. Another promising result of Moderna’s trial was that the vaccine appears to protect participants from severe Covid-19 disease. The 11 volunteers who developed the disease severely belonged to the placebo group (not vaccinated).
The trial will continue and, in the meantime, they plan to submit a US application to the FDA. Moderna has signed agreements with several countries, including Canada, Japan and Qatar, to supply the vaccine if it is approved for the US. The United States government alone gave the company an additional $ 1.5 billion in exchange for 100 million doses.
The other candidate vaccines using mRNA technology are Zydus from India, which is a skin patch vaccine, Curevac Germany (in collaboration with Elon Musk’s Tesla), both in phase 2 trials, and Imperial College London (Morning Side Ventures) in phase 1/2 trials. There are nine others in Phase 1 trials.
The next group are the viral vector vaccines. About 12 candidate vaccines in clinical trials use viruses to deliver coronavirus genes that then instruct our human cells to make the SARS-CoV-2 protein. This stimulates our bodies to produce protective antibodies as an immune response.
CanSino Biologics in China uses the Ad5 adenovirus as a carrier virus. It is now in phase 3 clinical trials in Saudi Arabia, Pakistan, and Russia. The Chinese army approved its use as a “particularly necessary drug” among its soldiers.
The Russians used Ad5 and Ad26 as the carrier virus in their Sputnik5 vaccine. Published scientific data is scant, but they claim an efficacy rate of 92 percent, based on 20 Covid-19 cases among trial participants. They have expanded their trial participants to 40,000 in Russia, Belarus, the United Arab Emirates, Venezuela and, most recently, India, which has 9 million cases and 130,000 deaths.
Johnson and Johnson have developed Ad26 Ebola vaccines and are using it for their coronavirus vaccine candidate. Initially a single-dose vaccine, they are now testing it with a two-dose regimen and 60,000 volunteers have enrolled for their study.
In October, the trial was stopped for 11 days due to a suspected adverse reaction, which has since been clarified. The US and EU governments have booked 100 and 200 million doses, respectively.
AstraZeneca and the University of Oxford have developed a vaccine based on the chimpanzee adenovirus. The United States government awarded them US $ 1.2 billion instead of 300 million doses if they were successful.
Phase 3 trials are ongoing in England, India (known as Covishield), Brazil, the United States, and South Africa. The EU has made a reserve of 400 million doses. The AstraZeneca trial was paused for seven days in September, when one volunteer was diagnosed with transverse myelitis, which has since been ruled out as an unrelated event.
The third group contains viral proteins and no coronavirus genetic material. Proteins or fragments of the coronavirus are packaged into nanoparticles.
US-based Novavax has received funding from the US government and the Coalition for Epidemic Preparedness and Innovation (Cepi). They launched their phase 3 trials in England with 15,000 volunteers. They have an agreement with Serum Institute India to manufacture two billion doses a year.
In August, the Vector Institute, a Russian biological research center, registered EpiVacCorona for a phase 1/2 trial. In October, Russia granted regulatory approval for its early use, the second after Sputnik5.
Both vaccines were approved for use early before a phase 3 trial to show that they were safe and effective. Eighteen other candidate vaccines use this protein-based technology.
The fourth group is the tried and tested vaccine method using inactivated and attenuated viruses. Chinese state-owned Sinopharm has two candidate vaccines that use inactivated coronavirus as the antigen.
They launched their phase 3 trials in Peru, Morocco and the UAE. Both vaccines are approved for limited use in China and the UAE. None of the 56,000 people immunized with Sinopharm vaccines and who traveled abroad have been infected with Covid-19. A total of 100,000 have been immunized without significant AEFI. Sinopharm is preparing to manufacture up to 1 billion doses per year.
The sixth vaccine approved for limited use in China is Sinova Biotech’s Inactivated CoronaVac. Phase 3 trials have started in Brazil, Indonesia and Turkey. Seven other candidate vaccines employ this vaccine technique.
The Murdoch Children’s Research Institute in Australia is conducting a phase 3 trial to study whether the BCG vaccine protects against the coronavirus.
The explosive and brutal pace of the pandemic has claimed 1.3 million lives and recorded 55 million cases. Covax, an initiative of the WHO, Gavi, the Vaccine Alliance and Cepi, has the largest portfolio of 18 vaccines with various actions to end the pandemic as soon as possible.
Collaborations between governments, global health agencies, vaccine manufacturers, scientists, private sectors, civil societies and philanthropists crystallize to ensure equitable access to diagnostic tests, therapies, and vaccines regardless of national income level.
They are at the forefront of vaccine research, development, manufacturing and pricing. Their motto is: “No one is safe unless everyone is safe.” They strive to ensure equitable access to Covid-19 vaccines in all countries.
This is probably the best investment and insurance policy for any nation to ensure an adequate supply of vaccines at affordable prices for its citizens. Therefore, 78 high-income countries and 92 low- and middle-income countries have signed the agreement.
We are still not sure about the situation in Malaysia. The ministers have been very ambivalent in their responses. As an investment, Malaysia must deposit US $ 10 per dose (two doses per pax) for 20 percent of its population as starters. I doubt that any payment has been made for this purpose.
And we rakyat could miss out on a golden opportunity to have access to 18 potential Covax vaccines at the best and most affordable prices.
Instead, we have seen politicians and business leaders rub shoulders and sign deals with Chinese vaccine manufacturers. This limits us to just one type of vaccine, which may not be effective or safe in the long term compared to the 18 potential vaccines in the Covax portfolio.
Let’s be honest and call things by name. In my opinion, many politicians and business leaders hope to reap massive benefits from the many vaccine deals that are being negotiated in parallel.
Let us be clear that our national coffers are drying up. We must secure the best deals directly with Covax or directly from the vaccine manufacturers, without the interference of intermediaries who will go to the bank with millionaire profits.
We can analyze the numbers to make it more obvious:
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Malaysian population = 32 million
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The first deal is to immunize 20 percent of our population (healthcare workers / elderly / high risk with comorbidities) = 6.4 million
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If the middle party sells the vaccine to the government at a profit of RM 10 per dose, then the middle party will make a profit of 12.8 million X RM 10 = RM 128 million!
This is the kind of rent-seeking and escape the nation can do without, especially when its fiscal circumstances are in dire straits and where GDP has contracted 17 percent in the second quarter.
The Incorporated Ministry of Finance should directly negotiate the agreements with Covax or the vaccine manufacturers, without the interference of intermediaries.
An advisory board of experts, key opinion leaders, economists, and scientists can advise the government on the best vaccine options with the best deals to better protect the nation and the interests of the rakyat.
DR MUSA MOHD NORDIN is a consultant pediatrician and neonatologist and clinical professor of pediatrics at KPJ University College. Email: [email protected]
The opinions expressed here are those of the author / contributor and do not necessarily represent the views of Malaysiakini.
