Health authorities at the National Medicines Regulatory Authority (NMRA) have granted Emergency Use Authorization for the Oxford-AstraZeneca COVID-19 vaccine.
Pharmaceutical Production and Regulation Minister Prof. Channa Jayasumana said the British/Swedish vaccine has been approved for emergency use, the first such vaccine to be approved in Sri Lanka, while several other vaccine candidates are in the pipeline for approval at the National Medicines Regulatory Authority.
State Minister Prof. Jayasumana that this is the first vaccine that the country will deploy against COVID-19. The vaccine will be available very soon in Sri Lanka. The first batches will probably be shipped from India, where it is manufactured by the Serum Institute of India (SII) under license as “Covishield”.
The vaccine developed by Oxford University and manufacturing partner AstraZeneca has been approved for emergency use in the UK and several other countries including India, with the first doses being released on December 30 last year.
Clinical trials revealed the vaccine was 62 to 90 percent effective, depending on the initial dosage. Despite some uncertainty over trial results, Britain authorised the vaccine for emergency use in December, and India authorised a version of the vaccine on January 3, 2021.
Researchers at the University of Oxford’s Jenner Institute begin work on a Coronavirus vaccine almost immediately after Chinese scientists published the Virus genome online in January 2020.
The vaccine was created by modifying a harmless adenovirus that causes the common cold in chimpanzees. It can generate a strong immune response and is not a replicating virus, so cannot cause an infection.
On March 27, 2020, Oxford researchers begin screening volunteers for a human trial and on April 23 Oxford began a Phase 1/2 trial in Britain.
On April 30, Oxford partnered with AstraZeneca to develop, manufacture and distribute the vaccine.
On May 28, a Phase 2/3 trial of the vaccine began in Britain. Some of the volunteers accidentally received half of the intended dose. In June, 23, a Phase 3 trial began in Brazil. On August 18, a Phase 3 trial of the vaccine began in the United States, with 40,000 participants.
On November 23, AstraZeneca announced clinical trial data that shows an initial half dose of the vaccine appears more effective than a full dose. But irregularities and omissions prompted many questions about the results. On December 7, the Serum Institute of India announced that it has applied to the Indian Government for emergency use authorization of the vaccine, known as Covishield in India.
On December 11, AstraZeneca announced that it will collaborate with Gamaleya, the Russian creators of the Sputnik V vaccine, which is also made from adenoviruses.
AstraZeneca expects to produce up to two billion doses this year. Each vaccinated person will require two doses, at an expected price of US$ 3 to US$ 4 per dose (approx Rs.600-800). Orders have been received from many countries around the world and AstraZeneca will also partner with the UN/WHO COVAX facility to give the vaccine to developing countries.