Malaysia Moves Closer To Pfizer Vaccine Approval After EU Greenlight

By CodeBlue | 22 December 2020

A Covid-19 vaccine must be first registered by the US’ FDA and the European Medicines Agency (EMA), among the National Pharmaceutical Regulatory Agency’s (NPRA) requirements for vaccine approval in Malaysia.

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KUALA LUMPUR, Dec 22 — The European Union’s (EU) drug authority has approved Pfizer-BioNTech’s Covid-19 vaccine, moving Malaysia’s regulatory process closer to greenlighting the shot that is scheduled to arrive here in February.

Yesterday, the European Medicines Agency (EMA) and the European Commission, the executive arm of the EU, approved the vaccine by US pharmaceutical company Pfizer and its German partner BioNTech, DW reported, paving the way for the first Covid-19 vaccine available in the EU to be distributed across the region.

Prime Minister Muhyiddin Yassin said earlier today that the first million doses of the Pfizer-BioNTech shot will be delivered to Malaysia in February 2021. The Malaysian government has procured 12.8 million doses of the Pfizer-BioNTech vaccine to immunise 20 per cent of the population, or 6.4 million people, on its two-dose regimen.

According to the Ministry of Health (MOH) Malaysia, any vaccines or medications that are brought into Malaysia will have to be approved by the National Pharmaceutical Regulatory Agency (NPRA) first.

On December 14, Pfizer sent clinical trial data on its Covid-19 vaccine to NPRA. Health director-general Dr Noor Hisham Abdullah said yesterday that it will take between 90 and 120 days for NPRA to study the data and approve the vaccine after receiving Pfizer’s application on December 15 to register its shot in Malaysia.

Health Minister Dr Adham Baba told CodeBlue that there are various criteria that MOH will look into before approving a coronavirus vaccine, among which include safety, efficacy, quality, as well as if the vaccine has been registered by the United States’ Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as registration in the country of the manufacturer.

On December 11, the FDA issued an emergency use authorisation (EUA) to the Pfizer-BioNTech two-dose vaccine that was found to be 95 percent effective in preventing symptomatic Covid-19.

With the approval from the EMA yesterday and previous approval from the FDA, Malaysia now moves one step closer in approving the Covid-19 vaccine from Pfizer-BioNTech.

DW reported that the EMA has recommended for the vaccine to be used in those aged 16 years and older. Meanwhile, for pregnant women, the decision on whether or not they should be vaccinated should be assessed on a case-by-case basis, as only limited data is available on the safety of the vaccine on pregnant women.

German Health Minister Jens Sphan said that by end of this year, a total of over 1.3 million vaccine doses should be delivered to Germany’s 16 states. From December 27, those over the age of 80, nursing home staff and residents, as well as health care workers who are at high risk of infection will be given the vaccine first.

Besides that, EMA officials were quoted saying that the Pfizer-BioNTech vaccine “is very likely” to work against the new variant of the coronavirus that is circulating around the United Kingdom, as antibodies generated by the vaccine can neutralise different variants with mutations. The new variant of the virus is 70 per cent more transmissible than existing strains.

Public health officials from the UK also found no evidence that the mutated virus causes more severe illness or that vaccines will be less effective against it.

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