Assistant Director of the Pan American Health Organization (PAHO), Dr. Jarbas Barbosa, says the World Health Organization (WHO) is sourcing information from regulatory authorities in Russia regarding that country’s development of a coronavirus (COVID-19) vaccine, which was announced on Tuesday (August 11).
He said that it is only after analysing all of the data, guaranteeing its safety, that the vaccine can have the WHO’s recommendation, and it can be procured through PAHO’s Revolving Fund for member countries.
“That vaccine must be prequalified by WHO, and in order to prequalify, they have to undergo this entire review on how safe it is and the quality of the vaccine,” he noted.
Dr. Barbosa was speaking during PAHO’s COVID-19 digital brieifng on Tuesday.
The Russian administration announced that the country has become the first to approve a vaccine – ‘Sputnik K’ – designed to offer “sustainable immunity” against COVID-19.
WHO spokesman, Tarik Jasarevic, speaking at a digital press briefing in Geneva, Switzerland, said that discussions are ongoing with the Russian health authorities regarding possible WHO prequalification of the vaccine.
“Prequalification of any vaccine includes rigorous review and assessment of all the safety and efficacy data,” he pointed out.
Dr. Barbosa explained that newly manufactured vaccines, drugs or medications must undergo three stages of clinical trials, noting that this is a globally standardised stipulation.
He noted that the manufacturer must also request and receive authorisation from the regulatory health authorities in the country of origin and target markets.
“The regulatory authority analyses the records [pertaining to] the registration of the vaccine, assesses the [integrity] of the manufacturer, and reviews the data of all clinical trials. This is a guarantee that assures us if this is an effective, efficient and safe vaccine,” he said.
Responding to questions from journalists pertaining to at least two PAHO member countries that have expressed interest in either producing the vaccine locally or acquiring it from Russia, Dr. Barbosa said that the technical review “must be followed very carefully in order to make sure that the product is safe and effective”.
The latest WHO overview, dated July 31, indicates that a total of 165 candidate vaccines are being worked on around the world.
Of these, 139 are in preclinical evaluation, while the other 26 are in the various phases of testing on humans. Six of the latter have reached stage three of that process.