Namibia: Sinopharm Vaccine Awaits WHO Approval
THE Sinopharm Covid-19 vaccine, which the Chinese government promised to Namibia as a donation, has not received emergency use clearance from the World Health Organisation (WHO).
China will be donating 100 000 doses of the vaccine to Namibia.
WHO programme area manager on immunisation and vaccine development Dr Richard Mihigo confirmed yesterday that the Sinopharm vaccine has not yet been given the WHO emergency use listing (EUL) authorisation.
“The review of data is still ongoing and we are expecting a decision point by mid to end March,” he said.
This means the rollout of the Sinopharm vaccine in the country might only start after March.
Vaccines undergo EUL assessments to evaluate quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements.
According to health minister Kalumbi Shangula, the efficacy of Sinopharm is 79,8%, which is more than that of the AstraZeneca/Oxford vaccine.
These EUL assessments will allow countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
Namibia is set to receive 30 000 doses of Covid-19 vaccines from the Serum Institute of India, 100 000 doses of the Sinopharm vaccine from China, and 127 700 AstraZeneca/Oxford vaccine doses through the Covax Facility.
The earliest arrival of any vaccine, according to Shangula, from the Covax Facility is sometime this month.
ABOUT SINOPHARM
The vaccine, also known as BIBP-CorV, is named after the Chinese state-owned manufacturer, Sinopharm and it is created from an inactivated coronavirus strain.
The inactivated coronavirus strains in the vaccine are dead and therefore they can be injected into the arm without resulting in Covid-19 infection.
According to the The Lancet medical journal, the Sinopharm vaccine is safe and well-tolerated at all tested doses in two age groups.
The Lancet indicated that Sinopharm results in rapid induction of immune responses against Covid-19, and would be valuable in preventing or limiting the Covid-19 pandemic.
However, further clinical studies are warranted to evaluate the potential of this vaccine in clinical application.
The article suggested that the two-dose immunisation can be administered 21 or 28 days apart.
During its trial phases, Sinopharm was administered to two age groups 18-59 years and older than 60 years and induced neutralising antibodies in 100% of vaccine recipients.
“We found that the inactivated Covid-19 vaccine BBIBP-CorV is tolerable and immunogenic in healthy people,” medical researchers stated in the article.
The Lancet further stated that mild adverse reactions, including pain and fever, were observed but no severe adverse reaction was reported in all groups.
TRIAL RESULTS
According to the results of phase 1 and 2 trials, they observed a 100% seroconversion rate was reached earlier in the group aged 18 to 59 years than in the group aged 60 years and older.
The seroconversion is the time during which a specific antibody develops and becomes detectable in the blood.
More than 75% of vaccine recipients in the group aged 18 to 59 years seroconverted after the first vaccine dose (day 14).
The remaining vaccine recipients seroconverted on day 28. For the group aged 60 years and older, the seroconversion rate only reached 100% on day 28.
The magnitude of neutralising antibodies in the group aged 60 years and older was lower than in the group aged 18-59 years.
The company has yet to publish detailed results of their phase 3 trial.
According to international media, the United Arab Emirates gave full approval to Sinopharm, announcing it has an efficacy rate of 86%, however, the government did not release any details with their announcement, leaving it unclear how they had come to their conclusions.
Egypt and Bahrain have also authorised the vaccine for emergency use.
by Namibian.
