First batch of Astrazeneca vaccine expected to arrive in second quarter of 2021

AstraZeneca Malaysia country president Dr Sanjeev Panchal said the company will continue to fulfil their commitment to provide broad and equitable access at no profit.

"We are working closely with the Malaysian government to help stem the pandemic, enable people to return to normalcy and pave way for the country’s economic recovery," he said in a statement here yesterday.

Yesterday, the AstraZeneca COVID-19 vaccine (AZD1222) has been granted conditional registration approval in Malaysia by the National Pharmaceutical Regulatory Agency (NPRA), for active immunisation of individuals 18 years and above for the prevention of COVID-19.

Dr Sanjeev said the approval marks another important milestone following a landmark agreement with the Malaysian government and aims to supply 6.4 million doses of AstraZeneca COVID-19 Vaccine to millions of Malaysians.

He said the approval decision was anchored on rolling submissions which included results of an interim analysis of the Phase III programme conducted by the University of Oxford and published in The Lancet on Dec 8 last year.

He added the Malaysia authorisation is for the two standard dose regimen of AstraZeneca COVID-19 Vaccine, which was shown in the clinical trials to be well tolerated and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations of more than 14 days after the second dose.

"Today is a day we have all been anticipating... this conditional registration will provide millions of Malaysians with access to AstraZeneca’s effective, well-tolerated and simple-to-administer vaccine once supply becomes available," he said.

Dr Sanjeev said clinical trials found that it was 100 per cent protective against severe disease, hospitalisation and death, more than 22 days after the first dose, where a single dose of the vaccine has an efficacy of 76 per cent against symptomatic COVID-19 in the first 90 days after vaccination.

He said vaccine efficacy after the second dose was higher in those with a longer interval, reaching 81.3 per cent in those with a dosing interval of 12 weeks or more, and research also indicates that it reduces transmission of the disease by 67 per cent.

"The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months... it is easily administered within existing healthcare settings," he said.

He added the AstraZeneca COVID-19 Vaccine has been granted authorisation for use in the European Union (EU), United Kingdom, Argentina, Dominican Republic, El Salvador, Mexico, Saudi Arabia, UAE, Kuwait, Bahrain, Oman, Egypt, Algeria, Morocco and in Asia such as India, Taiwan, Philippines, Thailand, Vietnam as it continues to seek approval worldwide.