Maldives has approved the emergency use of Sputnik V Vaccine in its battle against Covid-19.
Under the Health Services Act and under the Medicines Regulation, Maldives Food and Drug Authority (MFDA) authorized the use of Sputnik V Covid-19 vaccination to be used in the Maldives, with the technical advice from National Pharmaceutical Board.
Making the announcement on Wednesday, the authority listed conditions to be met when administering the Russia-produced vaccine.
Manufactured by Gamaleya National Center of Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Sputnik V is only to be used for active immunization to prevent Covid-19 caused by severe acute respiratory syndrome in individuals over 18 years of age.
MFDA revealed that the approval is only exclusive for restricted use in emergency situations and is subject to regulatory provisions.
As such, the authorization will only be valid for 60 days in an event that authorities revoke the state of public health emergency Maldives has been in, since 12 March 2020. Further use of the vaccine requires registration in compliance with the Medicines Regulation.
Only the Director General of Public Health Maimoona Aboobakuru is vested with the power to revoke the state of public health emergency, under the Public Health Protection Act. As such, during the state of public health emergency, the Director General may determine the need for vaccination in the Maldives.
Highlighting that the Sputnik V vaccines may only be administered under the context of government use, MFDA revealed that doses will be supplied to the ongoing inoculation drive to be used in accordance with Health Protection Agency (HPA) guidelines and standards.
When administering the Sputnik V doses, patients must be briefed on all information on the vaccine as well as side effects and probable adverse effects. Only trained healthcare workers must handle the vaccine doses and patients are to be monitored for immediate reactions for 15 – 30 minutes.
Maldives is using the Oxford AstraZeneca Covishield vaccination, Sinopharm as well as Pfizer vaccines in its inoculation programme and the Russia-produced vaccine is the fourth addition to the vaccination drive.
The Russia-produced vaccine which is required to be stored at -18 degree Celcius, is approved for emergency use across 66 countries currently.
President Ibrahim Mohamed Solih launched the “Covid-19 Dhifaau” inoculation drive on February 1 with the Oxford AstraZeneca Covishield vaccinations produced by India’s Serum Institute. After temporarily discontinuing the first round of vaccinations on March 15, the public health authorities resumed administering the first doses of vaccination on March 22 with the Sinopharm vaccination. HPA began administering the second Covishield vaccination doses on April 3 and the second doses of Sinopharm are also being administered currently for those who have completed four weeks since receiving the first jab.
Healthcare authorities halted administering the India-sourced Covishield vaccinations at a time there have been reports that the Maldives is low on Covishield supply. However, authorities have since revealed that they expect to receive a shipment of the Covishield vaccination within a fortnight, and that efforts are currently underway to procure supplies.