Malaysia Only Has One Shot To End Covid-19

By Boo Su-Lyn | 30 November 2020

The government has made the right decision to book Covid-19 vaccines for Malaysians before global supplies likely get snapped up by year end.

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My mother’s friend, a single woman in her 60s, has been withdrawing from her Employees’ Provident Fund (EPF) account to pay for the bills, as she has been unable to get jobs as a freelance graphic designer. She only goes to see her medical specialist for a certain condition whenever she absolutely can’t take the pain.

My mother, a retired kindergarten principal, thanks God that she has a pension, which allows her not to touch her EPF; my late father was a civil servant. The Covid-19 pandemic has disproportionately affected the bottom 40 per cent (B40) and middle class workers in the private sector. Civil servants, on the other hand, have not been financially affected because most did not lose their jobs or suffer pay cuts.

Despite the government’s assurances that the Conditional Movement Control Order (CMCO) allows economic activity, people on the ground are suffering. Lawmakers and high-ranking civil servants – who enjoy large and uninterrupted monthly salaries – must keep this in mind when they make Covid-19 policies and regulations from their ivory towers in Parliament and Putrajaya.

So, Prime Minister Muhyiddin Yassin’s announcement – one day after Budget 2021 passed the policy stage in Parliament – that Malaysia has signed a preliminary purchasing agreement with Pfizer to buy 12.8 million doses of its Covid-19 vaccine was very welcome news. The 12.8 million doses of Pfizer’s mRNA vaccine, a two-dose regimen, will cover 20 per cent of Malaysia’s population, or 6.4 million Malaysians.

A vaccine isn’t a silver bullet to the pandemic, especially since doses will be spread out throughout next year, with Pfizer only delivering one million doses (for 500,000 people) to Malaysia by the first quarter of 2021. Malaysia has also signed an agreement with the COVAX Facility, whose vaccines (the government has not indicated which vaccine in the COVAX portfolio that it will purchase) will cover another 10 per cent of Malaysia’s population.

Hence, by the end of 2021, just under a third of Malaysia’s population may be vaccinated against Covid-19, still a long shot from herd immunity. However, a Covid-19 vaccine is still light at the end of the tunnel for Malaysia.

Pfizer and its German partner BioNTech have submitted an emergency-use authorisation (EUA) application to the United States’ Food and Drug Administration (FDA) for their coronavirus vaccine candidate. The FDA will meet December 10 to discuss the application. An EUA from the FDA is not the same as full approval; the FDA determines whether a product’s “known and potential benefits outweigh its known and potential risks” when issuing an EUA for emergency situations.

Pfizer and BioNTech said in a press release that a final analysis of the Phase 3 trial of their coronavirus vaccine, named BNT162b2, showed it was 95 per cent effective in preventing symptomatic Covid-19 infection. Their study, which started in the US on July 27, had enrolled 43,661 volunteers; about 42 per cent of global participants and 30 per cent of US participants were from racially and ethnically diverse backgrounds. And 41 per cent of global and 45 per cent of US participants were aged between 56 and 85 years.

The pharmaceutical companies said that of the 43,661 volunteers in the Phase 3 study, 170 people developed symptomatic Covid-19 infection. Of these 170 people, 162 had received placebos, while only eight had received the vaccine. The clinical trial reported 10 cases of severe Covid-19 infection, nine of which were in the placebo arm. This, according to US health news site STAT, suggested that Pfizer’s vaccine protected against serious Covid-19 disease, besides mild illness. Pfizer and BioNTech said they planned to submit efficacy and safety data from their study to a scientific journal for peer review upon completion of data analysis.

While efficacy and safety are prerequisites for a vaccine, medical practitioners and politicians – while rightly calling for safety data and local regulatory approval – must avoid contributing to vaccine hesitancy in Malaysia or use pseudoscience in their criticism of Pfizer’s vaccine.

A vaccine usually takes more than 10 years to develop. Typically, countries would wait for full regulatory approval, not mere press releases by pharmaceutical companies, before deciding to purchase and use new vaccines or medicines. But we are not living in normal times.

The Malaysian government is not rushing to buy Pfizer’s Covid-19 vaccine by signing a preliminary purchasing agreement even before the US FDA issues emergency-use approval. If anything, I’m surprised it took us this long to make our first vaccine agreement amid the global race to secure a vaccine.

The government has made the right decision to book Covid-19 vaccines for Malaysians before global supplies likely get snapped up by year end. Other countries have already pre-ordered millions of doses of the experimental vaccines from Pfizer-BioNTech; Moderna; and AstraZeneca-Oxford. In total, as of November 27, individual nations and the European Union have already ordered 2.8 billion doses of these three potential coronavirus vaccines. The worldwide pre-orders of coronavirus vaccines have allowed developers, creating their vaccines in record speed, to take the financial risk of clinical trials without knowing if their experimental vaccines will be be successful.

Canada, Japan, the UK, and the US will be able to vaccinate more than 100 per cent of their entire population, based on their pre-orders, should these three vaccine candidates get regulatory approval. Indonesia has also pre-ordered 100 million doses of AstraZeneca’s vaccine. COVAX, which Malaysia is a part of, has booked 300 million doses of AstraZeneca’s vaccine.

There might be no more doses left to buy if Malaysia were to await approval from its National Pharmaceutical Regulatory Agency (NPRA) before placing an order for a Covid-19 vaccine.

Muhyiddin has already said regulatory clearance from the US FDA and Malaysia’s NPRA will be required before Pfizer’s Covid-19 vaccine can be used here.

We do not have the luxury of time to wait for other countries to try a Covid-19 vaccine as “guinea pigs” (the real guinea pigs were the volunteers in Phase 3 trials), before we decide to purchase one. It’s not as if Malaysia is recording below 100, or even a few hundred Covid-19 cases daily. Malaysia reported 1,387 daily average Covid-19 cases in the past week from November 23 to 29.

Our public health response has failed to reduce the number of Covid-19 cases, even as New Zealand, Australia, and neighbouring countries like Singapore, Thailand, and Vietnam, appear to have successfully contained their epidemics. Malaysia’s official case fatality rate is low, but data on the number of brought-in-dead cases and excess mortality – which could signify the true extent of the epidemic – is scant.

As new clusters pop up nationwide daily – based on opportunistic, rather than widespread testing – we do not seem to know our epidemic as our public health response is mostly fire-fighting at this point. Malaysia appears to have run out of options, as the government says the CMCO may be extended till the end of the year, even though state-wide lockdowns have clearly failed to cut Covid-19 transmission.

I do not wish to engage in a blame-game, suffice to say that the government was already warned months ago – when Malaysia was officially recording a few dozen coronavirus infections daily (amid targeted testing) – about potential and repeated outbreaks in vulnerable populations like prisons and migrant workers. These warnings were ignored.

What solution is there – when we seem to be losing control of the coronavirus epidemic – other than a vaccine? The government also deserves praise for procuring a Covid-19 vaccine directly from the foreign manufacturer, as opposed to using Bumiputera tender agents that has been the typical procurement practice in the public health sector. The prime minister’s surprise announcement about purchasing Pfizer’s ultra-cold Covid-19 vaccine must have upset a number of middlemen who had hoped to profit from the procurement of a coronavirus vaccine.

Baseless fear-mongering about Pfizer’s vaccine risks turning the Malaysian public off all Covid-19 vaccines, as many may not know the difference between each vaccine under development.

There are valid questions about Pfizer’s vaccine, including costly logistics and distribution issues due to its minus 70 degrees’ Celsius storage requirement, which MPs must raise in Parliament. However, reducing the Covid-19 vaccine narrative to a “political” debate is simplistic at best and harmful at worst.

The politics of Malaysian health care is not exclusive to the political administration or lawmakers – it also exists in the civil service that have their own vested interests which, while not necessarily nefarious, exert a significant and furtive influence on health policies.

At this stage, Malaysia only has one shot to end the acute phase of the Covid-19 epidemic – through vaccines. While we await scientific data, the government should start preparing infrastructure and mass communications, in a joint effort with the medical fraternity and elected representatives across the political aisle, on whichever vaccines we procure.

These are extraordinary times. Extraordinary times demand change and a break from conventional practice. If we treat the pandemic like business as usual, then Malaysia will be left isolated as other countries reopen and return to pre-Covid normality.

Boo Su-Lyn is CodeBlue editor-in-chief. She is a libertarian, or classical liberal, who believes in minimal state intervention in the economy and socio-political issues.

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