South African elite athletes will be vaccinated through the Sisonke Study ahead of international sporting events including the Tokyo Games kicking off in July.
This comes after the approval granted by the South African Health Product Regulatory Authority (SAHPRA) to make available a “modest” number of the remaining COVID-19 Johnson & Johnson (J&J) vaccine doses to support the nation before they expire.
According to the South African Medical Research Council (SAMRC), the vaccination of these athletes, although not compulsory will take place at various vaccination sites throughout the country.
“After concluding the phase 3B open-label components of the healthcare worker study, the Sisonke investigators made an urgent application to SAHPRA requesting them to waiver the eligibility criteria to include persons of high priority to the nation, including the Olympic and Paralympic team to be allowed access to the Ad26 SARS-CoV-2 investigational vaccine,” said the council on Tuesday.
The SAMRC said the move to inoculate elite athletes was announced by the Minister of Health, Dr Zweli Mkhize, when he launched the national vaccination rollout programme and supported by the Director-General, Dr Sandile Buthelezi.
SAMRC President and Chief Executive Officer, Professor Glenda Gray said, the athletes would have received the Pfizer vaccine.
However, Gray, who is also the national co-principal investigator of the Sisonke Study, said there was not enough time before their departure to complete the vaccination course of two doses.
“By them receiving the Sisonke vaccine, the Pfizer doses allocated to them will go to ordinary citizens of our country and thus will free up additional doses for our country,” said Gray, adding that all conditions of registration of the J&J vaccine will be observed for the vaccinated athletes.
“These include safety monitoring and reporting of the relevant safety outcomes to SAHPRA at specified intervals.”
Co-national principal investigator, Professor Linda Gail Bekker said they are glad to be of assistance.
“At the end of the day these individuals are ambassadors for our country, they have to travel to do their jobs and they need to be vaccinated,” Bekker added.
Sisonke enabled government to make the J&J jab immediately available to healthcare workers using a research programme ahead of the third wave.
As part of the initial phase of the national vaccination rollout, 479 768 healthcare workers were vaccinated at 122 sites nationwide.
“This was necessary to safeguard the health system to deal with the third wave of COVID-19 infections and admissions and to vaccinate the rest of the nation.”
The SAMRC said sub-studies are ongoing to evaluate the vaccine further in pregnant and lactating women, in health workers living with HIV, older health workers and those with other co-morbidities.