MFDA approves the Serum Institute's Covishield vaccine for emergency use

The Maldives Food and Drug Authority (MFDA) has announced approval for the Oxford-AstraZeneca Covishield vaccine as manufactured by India's Serum Institute for emergency use in the Maldives at a special press briefing held on Thursday night.

Spokesperson for the Health Emergency Operations Center Dr. Nazla Rafeeq was accompanied by Director of Pharmaceuticals at MFDA Aishath Jaleela and member of the Maldives Technical Advisory Group on Immunization (MTAGI) member Dr. Mohamed Ali on Thursday's press, where they jointly announced that the MFDA had granted approval to use the Covishield vaccine for restricted use in emergency situation of Covid-19. The approval was granted as per the powers vested in that Authority under the Health Services Act (No.: 29/2015) and the Medicine's Regulation (2014/R-6) with technical advice from the National Pharmaceutical Board based on information submitted by the Serum Institute regarding Covishield vaccines.

The Director General of Public Health is reserved the right to define the "emergency situation" under which the vaccines may be administered as per the powers afforded to them under the Public Health protection Act (No.: 7/2012), and the MFDA's approval explicitly states that the vaccines may only be used under the context of government use.

Designated immunization centers are to be established in the country under immunization programs through which the vaccines will be supplied and administered to the public. While the MFDA requires all vaccine recipients to be monitored for at least 30 minutes for adverse effects after receiving the shot, no persons under the age of 18 are to be administered the vaccine under the current approval.

Answering a question by a member of the public on Wednesday's "Jazeera Salla" Covid-19 Q&A program hosted by spokesperson for the President's Office Mabrook Azeez, Spokesperson for the Health Emergency Operations Center Dr. Nazla Rafeeq said that it was impossible to say for sure when vaccination efforts could be concluded in the country as things stand. She added that expat workers and foreigners living in the Maldives would also be entitled to free vaccines from the Maldivian government, irrespective of nationality, as they were also individuals who contributed to the society, whose health and safety was just as important as a Maldivians.

Healthcare professionals experiencing the brunt of the pandemic were quick to express their relief at the announcement of the vaccine's emergency approval, and urged authorities to expedite vaccination procedures for vulnerable groups and high-risk frontline workers as soon as possible.

HPA announced that the vaccine approval was a huge step in controlling the Covid-19 pandemic in the Maldives. Thursday was the fifth day in a row that the number of new daily infection reported in the country had topped one hundred. As of now, there are 1,410 active cases of Covid-19 in the country, with 116 persons reported as receiving in-hospital care for the infection by sundown on Thursday.

Maldives received 100,000 doses of the Oxford-AstraZeneca Covishield vaccine manufactured by India's Serum Institute on 20 January. President Ibrahim Mohamed Solih has announced that the government's Covid-19 response plan is to provide free vaccines to all those living in the Maldives in the coming months.