The authority approved the use of Johnson and Johnson last
week saying the vaccine had passed quality, safety and efficacy checks.
The American vaccine is the fifth to be approved in
Zimbabwe after the Chinese Sinopharm and Sinovac, the Russian Sputnik V and the
Indian Covaxin.
During clinical trials, the J&J vaccine was 66,3
percent effective in efficacy at preventing laboratory-confirmed infection in
people who received the vaccine and had no evidence of being previously
infected.
The vaccine had high efficacy at preventing hospitalisation
and death in people who did get sick.
In a statement, MCAZ acting director general Mr Richard
Rukwata said the Emergency Use Authorisation (EUA) for the vaccine is valid for
12 months or when the public health emergency ends, whichever is shorter.
“MCAZ reviewed the technical documentation and clinical
studies conducted and issued EUA for the Ministry of Health and Child Care to
consider adding Johnson and Johnson to the vaccines for use in Zimbabwe.
“This EUA is subject to a number of considerations which
include ensuring there is adequate cold storage capacity to store the vaccines
and also ensuring there is robust side effect monitoring in place,” he said.
Mr Rukwata said the Ministry will decide whether to deploy
the vaccines in Zimbabwe or not as the authority’s duty was only to ensure that
risk-benefit analysis is conducted.
“Based on the review of the submitted quality, safety and
efficacy data and upon performing a benefit-risk assessment thereof, emergency
use authorisation has been granted for Ad26.Sars-Cov-S manufactured by Johnson
and Johnson. This authorisation was issued on the basis of section 75 of the
Medicines and Allied Substances Control Act (Chapter 15:03),” said the MCAZ.
“In line with the recommendations made by regulators (EMA,
US-FDA and Health Canada) in other countries that are using the Johnson and
Johnson Ad26Cov2-S, vaccine, healthcare professionals should be alerted to the
signs and symptoms of thromboembolism and thrombocytopenia.”
Mr Rukwata added that those being vaccinated should be
instructed to seek immediate medical attention if they develop symptoms.
“The symptoms include shortness of breath, chest pain, leg
swelling, or persistent abdominal pain following vaccination. Additionally,
anyone with neurological symptoms including severe or persistent headaches or
blurred vision after vaccination, or who experiences skin bruising (petechial)
beyond the site of vaccination after a few days, should seek prompt medical
attention.”
As of July 27, 2021, Zimbabwe had recorded 101 711 Covid-19
cases including 70 496 recoveries and 3 280 deaths.
A total of 1 552 150 had received their first dose of the
Covid-19 vaccines. Chronicle
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