THERE were no serious safety incidents reported from clinical trials of AstraZeneca-Oxford University’s Covid-19 vaccine, the pharmaceutical company told The Malaysian Insight.

The company, which will be supplying vaccine to Malaysia early next year, said interim analysis of clinical trials of the AZD1222 vaccine in the UK and Brazil shows that it is safe and highly effective in preventing Covid-19.

There are no reports of hospitalisations or severe allergies among participants, it said.

A total of 131 Covid-19 cases were reported in the interim analysis.

“We are pleased with the positive high-level results (HLR). The results showed high efficacy against Covid-19 and that it successfully prevented severe cases and hospitalisations in late-stage trial participants including older adults,” it said.

“Following the recent HLR announcement, an independent data safety monitoring board determined there were no serious safety events related to the vaccine,” it added.

Oxford University conducted the interim analysis of the phase III clinical trials.

Delivery to Malaysia

Asked on the timeline for deliveries of the vaccines to Malaysia, the company said partial deliveries can be expected as early as the first half of 2021.

“AstraZeneca is committed to providing the vaccine as soon as possible, without compromising on the scientific process and with the highest standards for patient safety.”

The timing of the first delivery is dependent on a number of factors, including regulatory approval and import permit.

“All efforts are made to accelerate this process without cutting corners in collaboration with relevant authorities.”

However, it did not reveal when the company will submit its dossiers to the National Pharmaceutical Regulatory Division (NPRA) for approval.

Malaysia bought 12.8 million doses from the company – whereby 6.4 million doses will be purchased via the Covax facility while the remaining is through direct negotiations with the British-Swedish pharmaceutical company.

This will provide vaccine coverage for 20% of the population, or for 6.4 million people.

The adenovirus-based coronavirus vaccine is developed by AstraZeneca and Oxford University

Adenoviruses are common viruses that typically cause colds or flu-like symptoms.

The vaccine was developed using a modified version of a chimpanzee adenovirus, known as ChAdOx1.

Unlike the Pfizer-BioNTech vaccine, which requires ultra-cold storage at -70° Celsius, AstraZeneca’s vaccine is easier to store, as it only requires a temperature of 2-8° Celsius.

According to The Guardian, the vaccine will be available on a non-profit basis “in perpetuity” to low- and middle-income countries in the developing world.

Free vaccination

Malaysia will spend RM2.05 billion on Covid-19 vaccines to inoculate 82.8% of the population.

Science, Technology and Innovation Minister Khairy Jamaluddin said recently that this would provide free vaccination coverage to 26.5 million people.

The cost includes the agreements inked with Covax, Pfizer and AstraZeneca along with three other deals still being finalised.

Putrajaya is also in talks with China-based Sinovac and CanSinoBIO as well as Russia’s Gamaleya National Centre for the procurement of vaccines.

Last month, Putrajaya struck a deal with Pfizer Inc to procure 12.8 million doses of the Pfizer-BioNTech vaccine.

The vaccine is a joint development by US pharmaceutical corporation Pfizer and Germany’s BioNTech.

Under the deal, Pfizer will deliver the first one million doses in the first quarter of 2021, with 1.7 million, 5.8 million and 4.3 million doses to follow in subsequent quarters. – December 28, 2020.