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My mother’s friend, a single woman in her 60s, has been withdrawing funds from her Employee Provident Fund (EPF) account to pay her bills, as she has been unable to find work as a freelance graphic designer. You only see your medical specialist for a certain condition when you cannot bear the pain.
My mother, a retired kindergarten director, thanks God that she has a pension that allows her not to touch her EPF; my late father was a civil servant. The Covid-19 pandemic has disproportionately affected the bottom 40 percent (B40) and middle-class workers in the private sector. Civil servants, on the other hand, have not been affected economically because most did not lose their jobs or suffer pay cuts.
Despite government assurances that the Conditional Movement Control Order (CMCO) allows economic activity, people on the ground are suffering. Legislators and high-ranking civil servants, who enjoy high and uninterrupted monthly salaries, must keep this in mind when crafting 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 signed a preliminary purchase agreement with Pfizer to purchase 12.8 million doses of its Covid-19 vaccine it was very welcome news. The 12.8 million doses of Pfizer’s mRNA vaccine, a two-dose regimen, will cover 20 percent of Malaysia’s population, or 6.4 million Malaysians.
A vaccine is not a silver bullet solution to the pandemic, especially as the doses will be distributed over the next year, and Pfizer will only deliver 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 COVAX’s portfolio it will buy) will cover another 10 percent of Malaysia’s population.
Thus, by the end of 2021, just under a third of Malaysia’s population may be vaccinated against Covid-19, still a long way 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 authorization (US) application to the United States Food and Drug Administration (FDA) for their coronavirus vaccine candidate. The FDA will meet on December 10 to discuss the application. An EUA from the FDA is not the same as a full approval; FDA determines whether the “known and potential benefits of a product outweigh its known and potential risks” by 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, dubbed BNT162b2, showed it to be 95% effective in preventing symptomatic Covid-19 infection. Their study, which began in the United States on July 27, had enrolled 43,661 volunteers; approximately 42 percent of global participants and 30 percent of American participants were of diverse ethnic and racial origins. And 41 percent of global participants and 45 percent of Americans were between 56 and 85 years old.
Pharmaceutical companies said that of the 43,661 volunteers in the Phase 3 study, 170 people developed a 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 the US health news site. STAT, suggested that Pfizer’s vaccine protects against severe illness Covid-19, in addition to mild illness. Pfizer and BioNTech said they planned to submit efficacy and safety data from their study to a scientific journal for peer review after the data analysis was complete.
While efficacy and safety are prerequisites for a vaccine, clinicians and politicians, while rightly asking for safety data and local regulatory approval, should avoid contributing to vaccine vacillation in Malaysia or using pseudoscience in his criticism of the Pfizer vaccine.
A vaccine usually takes more than 10 years to develop. Typically, countries would wait for full regulatory approval, not mere press releases from drug companies, before deciding to buy and use new vaccines or drugs. But we don’t live in normal times.
The Malaysian government is not rushing to purchase Pfizer’s Covid-19 vaccine by signing a preliminary purchase agreement even before the US FDA issues emergency use approval. If anything, I am amazed that it took us so long to reach our first vaccine agreement in the midst of the global race to secure a vaccine.
The government has made the right decision to reserve Covid-19 vaccines for Malays before global supplies are likely to run out by the end of the year. Other countries have already reserved millions of doses of Pfizer-BioNTech’s experimental vaccines; Modern; 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. Pre-orders for coronavirus vaccines around the world have allowed developers, creating their vaccines at record speed, to take the financial risk of clinical trials without knowing whether their experimental vaccines will be successful.
Canada, Japan, the UK and the US will be able to vaccinate more than 100 percent of their entire population, based on their pre-orders, should these three candidate vaccines gain regulatory approval. Indonesia has also reserved 100 million doses of the AstraZeneca vaccine. COVAX, of which Malaysia is a part, has reserved 300 million doses of the AstraZeneca vaccine.
There may be no more doses left to buy if Malaysia waits for approval from its National Drug Regulatory Agency (NPRA) before placing an order for a Covid-19 vaccine.
Muhyiddin has already said that regulatory approval from the US FDA and the Malaysian NPRA will be required before Pfizer’s Covid-19 vaccine can be used here.
We don’t have the luxury of waiting for other countries to test a Covid-19 vaccine as “guinea pigs” (the real guinea pigs were the volunteers in the Phase 3 trials), before we decide to buy one. It’s not like Malaysia records fewer than 100, or even a few hundred, Covid-19 cases a day. Malaysia reported 1,387 average daily cases of Covid-19 in the last week of November 23-29.
Our public health response has failed to reduce the number of Covid-19 cases, even as New Zealand, Australia, and neighboring countries such as Singapore, Thailand, and Vietnam appear to have successfully contained their epidemics. Malaysia’s official fatality rate is low, but data on the number of deaths and excess mortality, which could indicate the true extent of the epidemic, are scarce.
As new groups emerge on a daily basis across the country, based on opportunistic, rather than widespread, evidence, we seem to be unaware of our epidemic as our public health response is primarily firefighting at this time. Malaysia appears to have run out of options, as the government says the CMCO may be extended until the end of the year, even though state shutdowns have clearly failed to cut Covid-19 transmission.
I do not wish to engage in a blame game, suffice it to say that the government was already warned months ago, when Malaysia was officially recording a few dozen coronavirus infections a day (amid selective testing), about potential and repeat outbreaks in vulnerable populations. such as prisons and migrant workers. These warnings were ignored.
What solution is there, when it seems that we are losing control of the coronavirus epidemic, besides a vaccine? The government also deserves praise for acquiring a Covid-19 vaccine directly from the foreign manufacturer, rather than using bidding agents from Bumiputera which has been the typical procurement practice in the public health sector. The prime minister’s surprise announcement about the purchase of the ultra-cold Covid-19 vaccine from Pfizer must have upset several intermediaries who hoped to profit from the acquisition of a coronavirus vaccine.
Pfizer’s unfounded vaccine propaganda risks causing the Malaysian public to stop receiving all Covid-19 vaccines, as many may not know the difference between each vaccine in development.
There are valid questions about Pfizer’s vaccine, including costly logistics and distribution problems due to its storage requirement of minus 70 degrees Celsius, that MPs must raise in Parliament. However, reducing the Covid-19 vaccine narrative to a “political” debate is simplistic at best and damaging at worst.
Malaysia’s health care policy is not exclusive to the political administration or legislators; It also exists in the civil service that has its own vested interests that, although not necessarily dire, exert a significant and furtive influence on health policies.
At this stage, Malaysia has only one chance to end the acute phase of the Covid-19 epidemic: through vaccines. While we wait for the scientific data, the government must begin to prepare the infrastructure and mass communications, in a joint effort with the medical fraternity and elected representatives in the political corridor, on the vaccines that we obtain.
These are extraordinary times. Extraordinary times require changes and a break with conventional practice. If we treat the pandemic as normal, Malaysia will be isolated while other countries reopen and return to pre-Covid normalcy.
Boo Su-Lyn is the editor-in-chief of CodeBlue. She is a libertarian, or classical liberal, who believes in minimal state intervention in the economy and in socio-political affairs.
