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Tuesday, February 16, 2021

NPRA looks into three more Covid-19 vaccines, mulls conditional registration

 


COVID-19 | The National Pharmaceutical Regulatory Agency (NPRA) has received applications to register three more Covid-19 vaccines for use in the country, said the Health director-general.

Dr Noor Hisham Abdullah said that the vaccines may also be given conditional registration, which would allow for their quick registration.

"So far three more companies have sent their dossier to the NPRA. These are for the Sinovac, Sputnik V, and Astrazeneca vaccines. 

"The NPRA is still conducting tests to see the effectiveness of the vaccines, and if they have side effects. The focus is especially on the vaccines' third phase of clinical trials.

"We have given some feedback so that they can reply and present (to us) for approval. There is a possibility that conditional registration can be given to these vaccines too," he told reporters at a press conference in Putrajaya today.

So far, only one Covid-19 vaccine - developed by Pfizer and BioNTech - has received such conditional approval from the NPRA for use in the country.

Noor Hisham added that conditional registration would allow pharmaceutical companies to submit the latest data they have on a vaccine from time-to-time for evaluation.

He gave the example of a research on Covid-19 vaccines that can be given to individuals aged 12 and above.

"We will see if there is evidence of effectiveness on 12-year-olds and above, and if there are side effects. 

"Until we get strong evidence, then only we would recommend vaccine use on the group," he said.  - Mkini

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