KUALA LUMPUR, Dec 23 — AstraZeneca said it estimated the first deliveries of its Covid-19 vaccine to Malaysia in the first six months of next year, amid ongoing clinical trials.
The Malaysian government and the UK pharmaceutical company have entered a supply agreement for 6.4 million doses of the coronavirus vaccine by AstraZeneca and Oxford University, AZD1222, covering 10 per cent of the Malaysian population.
“AstraZeneca is proud to reinforce our commitment to Malaysia and support the government’s Covid-19 vaccine strategy by providing 6.4 million doses of the AstraZeneca/University of Oxford’s potential vaccine, AZD1222, at no profit during the period of the pandemic,” AstraZeneca Malaysia country president Dr Sanjeev Panchal said in a statement.
Under its agreement with the Malaysian government, AstraZeneca said it will expand its global manufacturing capacity to ensure dedicated supply of its Covid-19 vaccine for Malaysia, parallel to ongoing clinical trials in the United States, United Kingdom, Brazil, South Africa, Japan, and Russia.
AstraZeneca-Oxford University’s Covid-19 vaccine showed 62 per cent efficacy for participants who received two full doses at least a month apart, as well as 90 per cent efficacy for the minority of participants who received a half dose first, according to an interim analysis of its Phase 3 trial published in the Lancet on December 8.
The New York Times reported December 8 AstraZeneca and Oxford researchers as saying in the Lancet that they were still unsure why their vaccine worked much better when participants received a half-strength first dose. Also, some participants who received the initial half dose didn’t get their second jab until at least three months later; they were supposed to get a booster shot about a month after the first dose.
The US’ Food and Drug Administration (FDA) reportedly requires late-stage data from at least 30,000 trial participants in order to authorise a vaccine.
However, AstraZeneca was only halfway to its goal of enrolling 30,000 people in its US trial as of early December, according to the New York Times, after the US trial restarted in late October following a 47-day suspension over safety issues in the UK study.
AstraZeneca executives reportedly said they did not expect to get FDA approval for their vaccine until after results from the US trial, which could happen in January.
It is unclear if the Malaysian government will accept delivery of AstraZeneca’s Covid-19 vaccine before FDA approval. FDA approval is one of the prerequisites by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) to authorise vaccines here.
