Gov’t disapproves some vaccines’ extensions
Despite announcing that the shelf life of certain COVID-19 vaccines has been extended for another three months, government has admitted to declining a request to extend the Shelf-Life of some COVID-19 vaccines.
The Ministry of Health has been under fire recently for allegedly using expired vaccines on people, something the ministry has dismissed as untrue. Although he declined to state the names of the rejected vaccines, BoMRA CEO Dr Stephen Ghanie said this week during a media briefing that they didn’t approve requests for extension from some vaccine manufacturers because there was insufficient data. “In most cases we require Phase 1-3 studies.
We had manufacturers who presented only Phase 1 studies and we couldn’t approve that,” he said. He said manufacturers have different batches and at certain intervals before the vaccine expires they test the vaccine for potency. Ghanie also said as BoMRA once they have established that the vaccine is potent in terms efficacy and quality, they approve extension.
Ghanie further indicated that the ShelfLife extension is a well-known practice in the pharmaceutical industry it is accepted globally if the provided stability data is adequate to demonstrate that a medical product retained its quality attributes throughout the proposed period. When the Shelf-Life extension is approved, it will apply to the current and all future batches. Ghanie also assured the public that the decision was supported by essential performance data and science to determine the quality, safety and efficacy of the vaccines. Most COVID-19 vaccines assessed by BoMRA initially had around three to six months accelerated and long-term stability data, as such were approved with a Shelf- Life of six months.
As additional stability data (from subsequent testing points) became available and submitted to regulators worldwide, and the assessment outcome remained favourable, the Shelf-Life of the vaccines was extended accordingly. For his part, Health Minister Edwin Dikoloti emphasised that under no circumstances can the government ever use expired vaccines. “This will be unethical and irresponsible, to say the least. I want to assure Batswana that all vaccines used in this country are potent and safe for the human body.
I wish to emphasise that vaccines are valid and safe until their last day of expiry. This will be further emphasised by my follow up speakers in this press briefing today,” he highlighted. Dikoloti further assured the public that after the manufacturer had communicated its decision to extend the Shelf-Life of certain vaccine batches, the BoMRA conducted due diligence on those vaccines before they could proceed to use them.
“I therefore wish to take this opportunity to assure all Batswana that all vaccines used in this country are safe and internationally acceptable. I further advise that Batswana should always disregard misleading information coming from other sources other than the ministry,” he concluded.