Maldives Food and Drug Authority (MFDA), on Monday, approved the Pfizer-BioNTech vaccine and the Sinopharm vaccine for use in Maldives under a specific set of conditions.
In a statement released by MFDA, the authority stated that the approval for both vaccines 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.
As per the authority, the Pfizer-BioNTech vaccine will only be administered to individuals above the age of 16 while the Sinopharm vaccine will only be administered to those between the ages of 18 and 60.
Furthermore, 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, the patient must be informed of any possible side effects prior to receiving the vaccine and must be kept for observation for a minimum of 15 to 30 minutes following vaccination. Vaccines can only be administered by trained medical staff that are trained to handle any complications that may arise.
MFDA also stipulated that Adverse Events Following Immunization (AEFI) reporting mechanisms must be established to identify and treat any potential side effects.
While Maldives has received 18,000 doses of the Sinopharm vaccine and is expected to receive Pfizer dozes through the COVAX Facility.
The COVAX Facility, which aims to ensure rapid, fair and equitable access to COVID-19 vaccines worldwide, accepted Maldives' application to secure vaccines for 20 percent of the country's population in December 2020.
Furthermore, the Maldivian government also signed an agreement with AstraZeneca's Singaporean company to secure additional 700,000 doses.
Maldives officially commenced its vaccine roll-out on February 1 after receiving the initial donation of 100,000 doses of the COVISHIELD vaccine from the Indian government. An additional donation of 100,000 doses was granted on February 20.
Currently, the island nation records a total of 21,666 virus cases of which 2,350 are active cases, in addition to 19,245 recoveries and 64 deaths.
On March 12, 2020, WHO classified the spread of COVID-19 as a global pandemic. To date, the new strain of novel coronavirus has infected over 120.4 million people and claimed over 2.6 million lives around the world. However, out of those infected, more than 20.7 million people have recovered.
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