NO NEED TO WORRY
The shelf life of some Covid-19 vaccines including Moderna, Johnson & Johnson and Pfizer has been extended by manufacturers.
Minister of Health and Wellness, Dr Edwin Dikoloti said this week that this has unfortunately led some people, including those in the health profession, to misinterpret this to mean that the vaccines had expired.
Dikoloti clarified that contrary to misleading information spread across social media platforms that the ministry is using expired vaccines on members of the public, the ministry would under no circumstances use expired vaccines.
“This would 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,” he said.
Dr Dikoloti, who is also MP for Mathethe/Molapowabojang explained that the extension of shelf life of vaccines and medicines is a normal and acceptable practice in medicine, and does not mean that the vaccines or medicines have expired.
He added that after the manufacturers had communicated their decision to extend the shelf life of certain vaccine batches, the local medicines regulator, Botswana Medicines Regulatory Authority (BoMRA) conducted due diligence on the vaccines before they were used.
BoMRA CEO, Stephen Ghanie echoed the minister that shelf life extensions are not a new phenomenon, especially for newly-developed vaccines and medicines. Ghanie explained that when Covid-19 broke out, not much was known about it nor vaccines.
He said BoMRA through their technical team of experts drawn from the private sector, pharmaceutical sector and universities among other institutions, independently assess information and decides to approve or not to approve based on the quality and safety of the vaccines among other factors.
World Health Organisation (WHO) Representative, Dr Josephine Namboze said data from vaccine manufacturers for any extension of shelf life would be reviewed and the outcomes disseminated to all countries’ national regulatory authorities for regulatory decision making. Approvals of regulatory authorities would be based on the assessment of vaccine stability data from vaccine manufacturers.
She added that vaccines were initially awarded shorter shelf life pending the final stability data coming in. According to her, the decision to extend the shelf life especially of the Pfizer biotech was based on scientific evidence, vaccine stability and whether it does not compromise the safety of vaccines.
“For example, WHO has reviewed all available data on Pfizer and determined that the shelf life may be extended. This was done based on the approval by the Food and Drug Administration of the US, which had approved the extension. Originally, the shelf life was set for nine months,” she said.
Dr Namboze explained that as the pandemic progressed, more data on vaccine stability has become available. The vaccines are deemed potent for a longer time frame than initially indicated because of new data.
“The decision to approve the Pfizer shelf life is not unique to Botswana.
Regulatory authorities of other countries have made similar recommendations and their populations have benefited from vaccines with longer shelf life, which reduces vaccine wastage and provides more opportunities to immunise more individuals especially those vulnerable,” she said.
She added that WHO will continue to work with BoMRA to ensure the safety of all the vaccines that are currently used in the country and continue monitoring adverse effects following immunisation.
Minister of Health and Wellness, Dr Edwin Dikoloti said this week that this has unfortunately led some people, including those in the health profession, to misinterpret this to mean that the vaccines had expired.
Dikoloti clarified that contrary to misleading information spread across social media platforms that the ministry is using expired vaccines on members of the public, the ministry would under no circumstances use expired vaccines.
“This would 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,” he said.
Dr Dikoloti, who is also MP for Mathethe/Molapowabojang explained that the extension of shelf life of vaccines and medicines is a normal and acceptable practice in medicine, and does not mean that the vaccines or medicines have expired.
He added that after the manufacturers had communicated their decision to extend the shelf life of certain vaccine batches, the local medicines regulator, Botswana Medicines Regulatory Authority (BoMRA) conducted due diligence on the vaccines before they were used.
BoMRA CEO, Stephen Ghanie echoed the minister that shelf life extensions are not a new phenomenon, especially for newly-developed vaccines and medicines. Ghanie explained that when Covid-19 broke out, not much was known about it nor vaccines.
He said BoMRA through their technical team of experts drawn from the private sector, pharmaceutical sector and universities among other institutions, independently assess information and decides to approve or not to approve based on the quality and safety of the vaccines among other factors.
World Health Organisation (WHO) Representative, Dr Josephine Namboze said data from vaccine manufacturers for any extension of shelf life would be reviewed and the outcomes disseminated to all countries’ national regulatory authorities for regulatory decision making. Approvals of regulatory authorities would be based on the assessment of vaccine stability data from vaccine manufacturers.
She added that vaccines were initially awarded shorter shelf life pending the final stability data coming in. According to her, the decision to extend the shelf life especially of the Pfizer biotech was based on scientific evidence, vaccine stability and whether it does not compromise the safety of vaccines.
“For example, WHO has reviewed all available data on Pfizer and determined that the shelf life may be extended. This was done based on the approval by the Food and Drug Administration of the US, which had approved the extension. Originally, the shelf life was set for nine months,” she said.
Dr Namboze explained that as the pandemic progressed, more data on vaccine stability has become available. The vaccines are deemed potent for a longer time frame than initially indicated because of new data.
“The decision to approve the Pfizer shelf life is not unique to Botswana.
Regulatory authorities of other countries have made similar recommendations and their populations have benefited from vaccines with longer shelf life, which reduces vaccine wastage and provides more opportunities to immunise more individuals especially those vulnerable,” she said.
She added that WHO will continue to work with BoMRA to ensure the safety of all the vaccines that are currently used in the country and continue monitoring adverse effects following immunisation.
