Maldives Food and Drug Authority (MFDA), on Thursday night, approved the Oxford AstraZeneca's COVISHIELD vaccines, gifted to Maldives by India, under a specific set of conditions.
In a statement released by MFDA, the authority stated that the approval is exclusively issued for restricted use in "emergency situation", defined by the Health Protection Agency (HPA), for the ongoing COVID-19 pandemic, subjected to various regulatory provisions.
Further, the vaccines are allowed to be used under to context of "government use" alone and vaccination must only be carried out in designated immunization centres equipped to handle anaphylactic reactions.
As per MFDA, prior to receiving the vaccine, the patient must be informed of the vaccine's side effects and other possible reactions. The vaccine can only be administered by trained medical staff, well-equipped of handling any complications that may arise.
Since the vaccine is administered in two doses, with a duration of four to six weeks between the first and second dose, MFDA also mandated sufficient stock to be secured for the second dose, before the first dose is injected.
The vaccine is strictly not to be administered for persons below 18 years of age and pregnant women.
MFDA further asserted that all the technical aspects of the vaccine were thoroughly investigated, and the counsel of National Pharmaceutical Board was taken into account, prior to the approval of COVISHIELD
Maldives currently stocks 100,000 doses of the aforementioned vaccine, and the government has now signed an agreement with AstraZeneca's Singaporean company for an additional 700,000 doses.
COVISHIELD was manufactured by the world's largest vaccine producer Serum Institute of India, using a formula prepared in a collaborative effort by Oxford University and AstraZeneca. British Medicine and Healthcare Products Regulatory Agency approved the vaccine on December 30, 2020.
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