The government is working to “ensure” that 67% of the population will be vaccinated by the end of 2021.
In other words, in a period of nine months, the government expects to procure, distribute, and arrange for 40 million citizens to be vaccinated.
Government is the sole purchaser of Covid-19 vaccines. However, the vaccines must first be authorised for use by the SA Health Products Regulatory Authority (Sahpra). Sahpra is tasked with regulating all health products and clinical trials in South Africa.
Sahpra reported that as at December 2, 2020, only 58 Covid-19 vaccine candidates were in clinical research in the world. Of these, 43 are in Phase I–II trials, 15 are in Phase II–III trials, and no vaccine has yet fully completed a Phase III trial.
Authorisations for the various vaccines to be used in SA are outlined below.
Covishield/ Oxford-AstraZeneca vaccine
On January 22, 2021 Sahpra granted a Section 21 (unregistered drug) authorisation to the Department of Health for Covishield. Covishield is manufactured by the Serum Institute of India, and is the local name for the Oxford-AstraZeneca vaccine that was developed in the UK.
In January one million doses arrived, and another 500 000 doses will arrive in February.
However, use of the AstraZeneca vaccine has been temporarily suspended until such time that its effectiveness against the new Covid-19 501Y.V2 variant has been determined.
Recent reports summarised in The Lancet indicate that the vaccine is more effective if the second dose is given 12 weeks after the first.
As the doses obtained by South Africa have an expiry date of April 16, it will only be possible to administer one dose.
Health Minister Dr Zweli Mkhize tweeted on February 10: “What will happen to the current doses of AstraZeneca vaccine already in SA will depend on the advice from leading scientists.”
Johnson & Johnson vaccine
South Africa has procured nine million doses of the Johnson & Johnson (J&J) vaccine, and 80 000 doses arrived on February 16. An additional 500 000 doses are expected to arrive over the next four weeks.
Sahpra granted Emergency Use Authorisation to the J&J vaccine, 300 000 doses of which had already been tested and approved by the SA Health Products Regulatory Authority (Sahpra) for use under study conditions.
“The vaccine will proceed in the form of an implementation study through a partnership between the SA Medical Research Council and the National Department of Health,” according to a Ministry of Health media statement dated February 16.
Other possible vaccines
Mkhize, in his address at the debate on the president’s State of the Nation Address (Sona21), said that: “As government we are actively engaging manufacturers and suppliers of the Covid-19 vaccines through different but interrelated channels.”
He added: “These include the Covax facility, bilateral arrangements with pharmaceutical manufacturers and other mechanisms such as the African Union’s Vaccines Financing Strategy and the Vaccine Acquisition Task Team. These initiatives have to date allowed us to engage with the manufacturers of multiple vaccines, namely AstraZeneca, Pfizer, Johnson & Johnson, Moderna, Sinopharm, Sinovac, and the Sputnik V.
“Recently, we have been in discussion with Cuba to engage them on the development of their candidate vaccine.”
Mkhize also said the government has committed to procuring 20 million doses of the Pfizer vaccine, which are expected to arrive at the end of March. No information was given regarding the authorisation for the use of this vaccine.
Sahpra confirmed in a press release dated February 18 that it has not received any documentation for the Sputnik V vaccine developed by the Gamaleya Institute in Russia.
Sisonke Early Access Programme
The batch of 80 000 J&J vaccines was approved by Sahpra under the Sisonke protocol, with the objective of gaining an understanding of the impact of mass vaccination.
The Sisonke Early Access Programme was launched on February 17 (per a media statement issued by the Department of Health on February 21, 2021).
By February 21, 10 000 healthcare workers had been vaccinated with the J&J vaccine, which “provides 57% protection against moderate-severe disease, 85% protection against severe disease and 100% protection against death, based on evidence from the clinical trials that included South African participants”.
Sahpra approved the protocol amendment of the J&J implementation study targeted at Health Care Workers (HCW) for the inclusion of the president and the deputy president, explaining in a press release dated February 18: “While they are not classified as HCW, this initiative would assist greatly in encouraging vaccine uptake and reduce vaccine hesitancy.”
President’s response to Sona debate
President Cyril Ramaphosa, in his response to the debate on Sona21, acknowledged the world-leading capabilities of South Africa’s scientists, research institutions, universities, agencies and public entities.
Credit was given to the South African scientists, engineers and manufacturers who were able to “design and produce personal protective equipment and thousands of medical ventilators within a matter of months”.
The president also acknowledged the scientists from the University of KwaZulu-Natal, who, “working with other laboratories, were at the forefront of the genomic surveillance work that has led to the identification of new Covid-19 variants”. He added: “South African scientists and researchers at a number of world-class institutions have been involved in the management of vaccine trials in the country.”
Recognising that pandemics may become more frequent, the president proposed that South Africa develop its scientific capabilities and “prepare for the future”.
Ramaphosa mentioned that he had asked the minister of higher education and innovation to “put together a team of scientists to begin the process of developing our own vaccines to deal with this and future pandemics”.
The latest information on Covid-19 can be obtained from the SA coronavirus webpage run by the Department of Health. This also includes Mkhize’s address to the debate on Sona21.
The latest information on the authorisation of Covid-19 vaccines can be found on Sahpra’s website.
Detailed budgetary allocations for the procurement of Covid-19 vaccines will be announced in the 2021 National Budget on Wednesday (February 24).