Members of the public wait to receive the AstraZeneca Covid-19 jab at Universiti Malaya, Kuala Lumpur May 5, 2021. — Picture by Yusof Mat Isa
Subscribe to our Telegram channel for the latest updates on news you need to know.
KUALA LUMPUR, May 25 — The National Pharmaceutical Regulatory Agency (NPRA) today denied that it was slow with the evaluation process for complete Covid-19 vaccine applications as alleged by the Opposition.
The government agency said the regular review period taken to evaluate Covid-19 vaccine applications has been shortened to 120 days now, nearly half the 245 working days it took previously.
“We have taken note of some views which claim the rise in cases in the country is due to the delay in approving Covid-19 vaccines, which is untrue,” it said in a statement.
Malaysia broke another record with 7,289 Covid-19 cases today. Public health facilities are heavily strained with more patients entering the intensive care units. There are currently 726 patients in ICU.
The NPRA said the Drug Control Authority (PBKD) under the Health Ministry implemented the conditional fast-track registration for Covid-19 vaccines last December 14 which enabled it to better prioritise review applications.
“This is meant to expedite approval and subsequently grant immediate access to vaccine usage in the country, without ignoring the quality, safety and efficacy aspects via the risk-based approach.
“The NPRA’s references and standards for evaluating Covid-19 vaccine dossiers is based on the guidelines issued by the national regulatory authority in other nations, including the World Health Organisation, the European Medicines Agency, the United States’ Food and Drug Administration, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, among others,” it said.
It explained that complete vaccine dossier applications that have been fully evaluated will be immediately presented to the PBKD for conditional approval for registration.
“The agency is working closely with companies and manufacturers to ensure they immediately forward complete information for all applications. Without the complete data and information, the vaccine’s quality, efficacy, and safety cannot be determined, prior to conditional approval for registration from the PBKD.
“To date, six Covid-19 vaccines have been evaluated by the NPRA within the set timeframe, and have obtained conditional approval for registration from the PBKD. The NPRA is also evaluating several new applications for the conditional registration at this time, which will be expedited using the same method,” it said.
The six vaccines which have been approved include the ones by Pfizer-BioNTech, Astra-Zeneca, and Sinovac, as well as the Sinovac vaccine being processed in Malaysia by Pharmaniaga LifeScience Sdn Bhd, a subsidiary of Pharmaniaga Berhad.
Last Thursday, the Pakatan Harapan Covid-19 Vaccination Committee urged the NPRA to accelerate its review and registration of vaccines, especially for those already approved by the World Health Organisation.
Earlier on March 26, Science, Technology and Innovation Minister Khairy Jamaluddin was reported as saying that the country could end up losing 6.4 million pre-ordered doses of the Russian Sputnik V vaccine, if domestic regulators fail to quickly approve it.