KUALA LUMPUR (Dec 22): The Covid-19 vaccine produced by US pharmaceutical giant Pfizer will have to go through a five-phase evaluation process in Malaysia before it can be approved for use by the public, Health director-general Tan Sri Dr Noor Hisham Abdullah told reporters yesterday.
And just the first phase of this process, which involves checking the documentation submitted by Pfizer, may, shockingly, take between 90 and 120 days.
This means that while countries like Britain, the US and Canada have already approved the Pfizer-BioNTech vaccine and are now carrying out vaccination exercises on their citizens, Malaysians, from the looks of it, will need to wait at least a few more months before anyone can get their shots.
In the meantime, our neighbour Singapore has joined the list of countries — including the European Union — which have approved the vaccine for use. Yesterday evening, it received its first shipment of Covid-19 vaccines.
In Malaysia, Dr Noor Hisham said Pfizer's application to register its vaccine for use here was received by the National Pharmaceutical Regulatory Agency (NPRA) last Tuesday (Dec 15).
“We have five phases. We may take around 90-120 days to scrutinise everything and make sure it is safe to use. That is the first phase,” Dr Noor Hisham explained, adding the NPRA has identified 11 medical experts to look into this.
“The second is to make sure we can procure these vaccines and have the logistics to handle it. The third step is prioritise certain groups such as front liners and vulnerable groups,” said Dr Noor Hisham.
The fourth stage involves checking the after-effects of the vaccine, while the final step is to assess its effectiveness in curbing the spread of Covid-19, he added.
It is uncertain at this point, however, how long the entire five-phase process will take, or if any of the phases or steps can be undertaken concurrently.
There is no disputing the fact that the vaccines' safety and efficacy need to be checked thoroughly, especially given some concerns that they may be rushed jobs. However, if certain steps can be undertaken simultaneously to cut short the waiting time, then it must be done instead of doggedly following a step-by-step process.
On Nov 24, the government through the Health Ministry signed a preliminary purchasing agreement with Pfizer to obtain 12.8 million doses of its Covid-19 vaccine to meet the immunisation needs of 20% or 6.4 million Malaysians.
Under this agreement, Pfizer has pledged to deliver one million doses of its vaccine in the first quarter of 2021, 1.7 million doses in the second quarter, 5.8 million doses in the third quarter, and 4.3 million doses in the final quarter.
The Malaysian government also has, on Dec 19, announced an agreement with the United Kingdom’s AstraZeneca to purchase Covid-19 vaccines to meet the immunisation needs of 20% of the people in the country.
Health Minister Datuk Seri Adham Baba said it was the third agreement after the government signed with Covax to buy 10% of its vaccine needs and with Pfizer to cover 20% of Malaysia’s requirements last month.
Malaysia yesterday reported 2,018 new Covid-19 cases, bringing its nationwide tally of confirmed infections to 95,327.