THE four Covid-19 vaccines that were approved for use by Cabinet last week underwent rigorous assessment by the country’s medicines regulatory authority to ascertain their safety and efficacy prior to receiving certification.
The Government, through the Medicines Control Authority of Zimbabwe (MCAZ), granted emergency use authorisation to Sinovac from China, Covaxin from India and Sputnik V from Russia ahead of commencement of the second phase of the country’s vaccination programme.
The Sinopharm vaccine, also from China, is already in use following the launch of the first phase of the vaccination programme earlier this month.
MCAZ projects and public relations officer Mr Shingai Gwatidzo told The Sunday Mail that the three vaccines went through requisite Emergency Use Authorisation Assessment (EUA) procedures. He said the vaccines’ manufacturers fulfilled all of the authority’s emergency use authorisation guidelines.
“The four vaccines (Sinopharm, Sinovac, Sputnik V and Covaxin) went through the MCAZ Emergency Use Authorisation Assessment procedure after the manufacturers approached the authority with submissions which fulfil the requirements in our EUA guidelines, demonstrating potential benefit in the fight against Covid-19,” said Mr Gwatidzo.
“The EUA assessment is carried out by a team of regulatory experts from our key technical divisions, who conducted a benefit-risk assessment of these vaccines that had undergone Phase I and II clinical trials and had started Phase III studies but were already showing favourable safety and efficacy in preventing Covid-19.
“The four vaccines were deemed to have a favourable benefit-risk balance.” He said it was standard practice for vaccines undergoing phase three clinical trials to be approved for use while further tests are ongoing.
Three of the approved vaccines – Sinopharm, Covaxin and Sinovac – are undergoing phase three clinical trials.
Results of Russia’s Sputnik V phase three trials were published earlier this month and showed that the jab has 91.6 percent efficacy and no unusual side effects.
“Within the context of Covid-19 vaccine research, Phase three clinical trials are primarily conducted to assess effectiveness of the vaccines, and determine their therapeutic value in prevention of Covid-19.
“Due to the urgency brought about by the pandemic, and the need for therapies with some potential value in prevention of Covid-19, it is not uncommon for Phase three trials to be ongoing whilst a regulatory decision is being made, that is Emergency Use Authorisation,” said Mr Gwatidzo.
“This will provide access to potentially life-saving vaccines as additional data on efficacy and safety is being generated through these usually large, multicentre clinical trials.
“Data obtained from Phase three trials often provides valuable information as these try to mimic routine clinical practice while providing definitive assessment of how effective and safe the vaccines are.”
He said MCAZ is working with the Ministry of Health and Child Care to monitor any adverse effects following immunisation to ensure that the vaccines maintain a favourable benefit-risk balance.
The country’s Covid-19 vaccination programme was launched recently using a consignment of 200 000 doses of Sinopharm vaccines.
Frontline workers are being immunised under the first phase, while vulnerable groups among them people with chronic illnesses such as cancer, TB and diabetes will be inoculated during the second phase.