Maldives approves emergency use of Janssen, Moderna Covid-19 vaccines

Maldives has approved the emergency use of Moderna and Janssen 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 Moderna Covid-19 vaccine to be used in the Maldives as the fifth vaccine approved for use, with the technical advice from National Pharmaceutical Board. The same is to be followed for the Janssen vaccine, approved as the sixth vaccine against Covid-19.

Making the announcement on Sunday, the authority listed conditions to be met when administering both vaccinations.

Manufactured by Moderna Biotech Spain, Moderna, and Janssen, manufactured by Janssen Pharmaceutical Companies of Johnson and Johnson 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.

However, MFDA’s statement revealed that the vaccinations may be administered to other categories and age groups based on availability and recommendations from medical professional groups, so long as they are monitored for a longer period of time and undergo routine check-ups in every three months.

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 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 doses of Moderna and Janssen, 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.

Both the Moderna and Janssen vaccines are required to be stored at -25 to -15 Degrees Celcius and Moderna’s second dose is to be administered after four weeks or 28 days after administering the first dose.

MFDA revealed that a sufficient stock of the Moderna vaccines must be secured in order for authorities to utilize second doses in consideration that the vaccine is administered in two dosages.

The authority has also urged relevant facilities handling the dosages to report any suspected quality defects or product issues to MFDA. These products must not be used and separated, properly labeled and stored appropriately to be handed over to MFDA for more evaluation.

MFDA also has the power to take necessary actions to recall the products and the approval is subject to change. MFDA revealed that they may revise or revoke the authorization based on safety concerns and new scientific findings to justify such changes.

Janssen vaccination doses are administrated as a single-dose of 0.5ml in intramuscular injections.

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.

Maldives is using the Oxford AstraZeneca Covishield vaccination, Sinopharm as well as Pfizer vaccines in its inoculation programme and the Russia-produced Sputnik V vaccine was the fourth addition to the vaccination drive. The newest additions total six Covid-19 vaccinations approved for use in Maldives.