Shangula procures unapproved Covid vaccines

16 March 2021 | Health



The health ministry is forging ahead with plans to allow the importation of vaccines not approved by the Namibia Medicines Regulatory Council (NMRC) as well as with the procurement of vaccines worth N$535 million from middlemen.

Health minister Dr Kalumbi Shangula has granted exemption to some vaccines, with the exception of one, that are not currently approved for emergency use by the World Health Organisation (WHO).

The WHO’s emergency use listing allows countries to accelerate their own regulatory approval processes to import and administer the vaccine.

NMRC’s council chairperson Hendrina Gideon explained that countries are free to use and procure any product they want, but as a country that aligns itself with WHO, Namibia must adhere to WHO standards.

Namibian Sun understands NMRC and Shangula had a heated meeting last month where the council advised the minister not to grant an exemption to unapproved manufacturers due to the potential health implications.

Council members, sources privy to the meeting said, allegedly told Shangula to halt the process, but their pleas fell on deaf ears.

“The minister told the council members that the law only requires him to consult NMRC and not necessarily take their advice,” the source said.

Not untoward

Days after meeting the council members, Shangula on 9 March issued a gazette exempting certain medicines from NMRC approval.

“Under section 45 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), after consultation with the Namibia Medicines Regulatory Council, I exclude the Covid-19 vaccines, specified in the schedule, from the operation of section 18(1) of that Act, subject to the following conditions,” the Gazette reads.

Shangula yesterday said there is nothing wrong with what he has done, pointing out that the NMRC operates within the confines of the Medicines and Related Substance Act.

“I have acted within the power given by the same Act. There is no contradiction here. The legislators foresaw an emergency situation like the Covid-19 and made provision for that in the Act,” he said.

New route

Under normal circumstances, importers of medicine into Namibia must be in possession of a licence to import such medicine, issued by NMRC, and the vaccine’s labelling and package insert must be written or translated into English.

This is no longer necessary following Shangula’s gazette.

The exempted vaccines include Vero Cell, Sputnik V, Ad26.COV2.S, AZD1222 (AstraZeneca) and mRNA-1273 (Moderna).

A day after the gazette was issued publicly, NMRC issued a press release in which it listed the market authorisation status of different vaccines for which applications for registration have been lodged with the medicine regulator.

NMRC received six vaccine applications for emergency use between 3 and 18 February. These are Covishield, Vero Cell, Sputnik V, AZD1222 and BNT162b2/Comirnaty. Only Covishield was approved by NMRC.


When the health ministry on 18 February applied to the finance ministry for an exemption to procure Covid-19 vaccines and services needed for the roll-out of the vaccine on an emergency basis, one of the reasons given was that the procurement of the vaccines will be from approved manufacturers and pooled procurement agencies such as the United Nations International Children's Emergency Fund and manufacturer representatives who are duly approved.

An exemption to seek bids from local suppliers through the open bidding process was also sought.

Shiimi granted the exemption on 2 March.

Upon enquiry, Shiimi said his ministry had advised the health ministry to go for emergency procurement using direct procurement.

“We take note of the invitation that was sent out to procure from all potential suppliers. We are currently engaging the ministry of health to ensure that the procurement process is done in the public interest and that government gets value for money,” Shiimi said.

[email protected]

Similar News


US government donates equipment for Covid-19 testing

1 day - 15 April 2021 | Health

NAMPAWINDHOEKThe United States government has donated laboratory equipment to the Namibia Institute of Pathology (NIP) to support the ministry of health and social services in...

Covid-19 hits Rehoboth school hard

1 day - 15 April 2021 | Health

JEMIMA BEUKESThe Rehoboth High School (RHS) hostel, where more than 62 learners are quarantined, has reportedly turned into a breeding ground for Covid-19 due to...

Mpora villagers still without ambulance

2 days ago - 14 April 2021 | Health

Kenya Kambowe RUNDUThe health ministry has not lived up to its promise to allocate an ambulance to...

Govt splashes millions on isolation opulence

3 days ago - 13 April 2021 | Health

JEMIMA BEUKES WINDHOEKGovernment has spent N$165 million to accommodate Covid-19 patients at guest...

New 'triple pill' could eliminate high blood pressure

3 days ago - 13 April 2021 | Health

In a recent clinical trial led by researchers from the George Institute for Global Health — with branches in the United Kingdom, Australia, and India...

Covid-19: Namibia records five new deaths

4 days ago - 12 April 2021 | Health

NAMPA WINDHOEKHealth minister Dr Kalumbi Shangula on Saturday announced that the country recorded 130 new Covid-19 positive cases and five deaths....

Only 2 300 vaccinated against Covid so far

1 week ago - 09 April 2021 | Health

JEMIMA BEUKES WINDHOEKAfter a slow start, the distribution of Covid-19 vaccines has gradually accelerated, with over 2 300 people vaccinated in just...

N$53m Rundu maternity ward closed

1 week ago - 08 April 2021 | Health

Kenya Kambowe RUNDU Just four months after health minister Dr Kalumbi Shangula inaugurated...

Living with endometriosis: A warrior’s story

1 week ago - 08 April 2021 | Health

TUYEIMO HAIDULA ONGWEDIVALea Nampala lived with chronic pain for years before being diagnosed with...

Sexual and reproductive rights are rights – Gawanas

1 week ago - 08 April 2021 | Health

JEMIMA BEUKES WINDHOEKAdvocate Bience Gawanas, former special advisor on Africa for the United...

Latest News

Trans-Zambezi railway extension studied

8 hours ago | Economics

Government has commenced with a feasibility study to help determine the viability of developing and extending the Trans-Zambezi railway to link Namibia with other member...

‘I won’t humiliate ministers’

8 hours ago | Government

STAFF REPORTERWINDHOEKPresident Hage Geingob yesterday said he will not humiliate ministers accused of corruption by firing them, as questions mount against his administration’s preference to...

DJ Omzala falls on hard...

8 hours ago | People

TUYEIMO HAIDULAOSHAKATI Former radio personality DJ Omzala, who graced the NBC airwaves in the 1990s, is a broken man.Off the airwaves, divorced and having had...

High-level panel members land plum...

8 hours ago | Government

OGONE TLHAGEWINDHOEKSeveral of the individuals who served on the High-Level Panel on the Namibian Economy (HLPNE) have been landed cushy government jobs since playing advisor...

Jobless Kenyans tackle illegal logging

8 hours ago | Economics

Kagondu Njagi - Standing under a thick green canopy in coastal Kenya's Shim Hills, Mohamed Mwaramuno squints at his fellow forest ranger's smartphone.With about a...

Another uninspiring SONA

8 hours ago | Opinion

President Hage Geingob’s State of the Nation Address (Sona) yesterday was as empty as the state coffers. Off the script, he offered better soundbites to...

Rehoboth Basters fight over Kaptein

8 hours ago | Cultural

JEMIMA BEUKESREHOBOTHA group of disgruntled Rehoboth Baster Community members yesterday protested the "irregular" election process of the Rehoboth Baster Kaptein slated for 24 April.The group,...

SSA to see world's slowest...

8 hours ago | Economics

JOHANNESBURG - Sub-Saharan Africa is set to record the slowest economic growth of any world region this year as the continent struggles to bounce back...

Plots handed over to residents

8 hours ago | Economics

OTJIWARONGO – Eighty residents of Otjiwarongo in the Otjozondjupa region on Wednesday received plots where they are expected to build houses through the Build Together...

Load More