The muddled acquisition AstraZeneca vaccine from India, found on delivery to have an April expiry date and not the normal six-month one, continues, writes MedicalBrief. After India refused to exchange the vaccine or give a refund, the Health Department said it would on-sell the consignment to the African Union (AU) at cost but now, reports the Mail & Guardian, it appears that South Africa is having to sell at half-price.
Contradicting official accounts that South Africa would on-sell the AstraZeneca vaccine to the AU "at no cost to the fiscus", Mail & Guardian reported that that government is planning to sell its AstraZeneca COVID-19 vaccine consignment to the AU or an associated body on the cheap, at almost half the price it originally paid for it.
M&G's Lizeka Tandwa and Chris Bateman write that "two sources with knowledge of the discussions say that President Cyril Ramaphosa has been in talks with the AU to offload the vaccines at a cheaper rate. Another source from the Treasury has also confirmed that the government has asked for advice. "
South Africa plans to share 1m AstraZeneca COVID-19 vaccine doses with other African countries, Reuters reports a senior official said. The country paused the rollout of AstraZeneca doses this month, after preliminary trial data showed they offered minimal protection against mild to moderate illness from the country’s dominant coronavirus variant.
It has been consulting with scientists about what to do with the AstraZeneca vaccine, switching to a plan to start inoculating healthcare workers with Johnson & Johnson's (J&J’s) alternative in a research study. The South African Medical Association (SAMA) said if the first shots arrived Tuesday as expected, then vaccinations could start on Wednesday. Eighty thousand J&J shots are expected initially, and up to 500,000 health workers could be immunised in total in the study.
SAMA chair Angelique Coetzee said vaccinations would happen at hospitals in each of the country’s nine provinces. Roughly two-thirds of the doses would go to public-sector health workers, and one-third to those in the private sector.
Anban Pillay, deputy director-general at the Health Department, said South Africa planned to share the 1m AstraZeneca doses it received at the start of the month from the Serum Institute of India (SII) via the AU. “The doses are going to be shared with countries on the continent … via the AU,” Pillay is quoted by Reuters as saying, adding that the government would look to recover money spent on the AstraZeneca vaccine but was still finalising how to do that.
He said it was not true that South Africa had asked the Serum Institute to take back the doses, as reported by Indian newspaper The Economic Times.
The AU’s disease control body said last week it was not “walking away” from AstraZeneca’s vaccine but would target its use in countries that have not reported cases of the more contagious 501Y.V2 variant first identified in South Africa late last year. The AU said six countries other than South Africa had confirmed the variant was circulating, but there are concerns it has spread elsewhere.
AstraZeneca says it believes its two-dose vaccine protects against severe COVID-19 and that it has started adapting it to be more effective against the 501Y.V2 variant. J&J’s vaccine is administered in a single shot, an advantage given how complex a logistical exercise it will be for the government to reach its target of vaccinating 40m people.
South Africa’s health ministry said the manufacturers of Russia’s Sputnik V vaccine had submitted documentation to local medicines regulator the South African Health Products Regulatory Agency (SAHPRA) for registration. According to Reuters, the ministry said it was “continuously engaging” with the manufacturers of Sputnik V and that it had signed a non-disclosure agreement with China’s Sinopharm to receive more information about its vaccine.
It added that scientists were conducting detailed analyses on Sputnik V, following concerns about the effects of its Ad5 component on communities with a high prevalence of HIV.
SAHPRA did not immediately respond to a request for comment, the report said.
The government has been under immense pressure to decide what to do with the consignment because it expires on 30 April, leaving little time to administer the vaccines either in South Africa or elsewhere, reports Business Day.
Meanwhile, Pillay is quoted as saying that the 1m doses already received would be shared with other African nations via the AU at no cost to the fiscus. "We plan to recover our costs," he said.
The government also hopes to exchange millions more doses of AstraZeneca shots earmarked for South Africa in separate deals with the international vaccine financing mechanism COVAX and the AU, but has yet to finalise these plans.
"We will try to swap them for other doses," said Pillay.
Speaking during the debate on the State of the Nation Address on Tuesday, Health Minister Zweli Mkhize reiterated: “We would also like to categorically refute the speculation in the media that we have returned the stock to India, we have not.
“The AstraZeneca doses we purchased have been offered to the AU platform, of which we are part of, and the AU will distribute to those countries who have already expressed interest in acquiring the stock. Therefore please be assured there will be no wasteful and fruitless expenditure.”
IoL reports that Mkhize said they would continue with efforts to ensure they reach herd immunity.
City Press had reported that there was a tense standoff brewing between South Africa and India over the refusal by the SII to replace the consignment of COVID-19 vaccines that were delivered to South Africa at the beginning of the month with new ones that have an appropriate expiry date.
The report says the it can be confirmed that the relationship between the South African Health Department and the SII has now deteriorated to such an extent that the department has indicated that the second consignment of 500,000 Oxford-AstraZeneca vaccines, which the SII would have delivered to South Africa next month, can stay in India.
South Africa paid about R78m for the first consignment. The report quotes reliable sources as saying that deputy director-general of health Anban Pillay was apparently so annoyed with the SII that he told it bluntly that South Africa would not pay the $5.20 (R75) per dose for the remaining consignment.
Meanwhile, government has decided not to give the Oxford-AstraZeneca vaccine to the countryʼs approximately 1.2m health workers because it does not provide adequate protection against the 501Y.V2 variant, a more transmissible mutation of COVID-19. Plans to use it elsewhere have been thwarted by the expiry date.
Professor Willem Hanekom, head of the Africa Health Research Institute, says, in the report, that pharmaceutical companies are “conservative” with expiry dates. “There is usually some leeway, where they can test the products in their warehouses close to the expiry date and adjust it before labelling and shipping them,” says Hanekom. However, he says it is problematic if the product has already been labelled and shipped because such products are subject to strict rules and regulations.
Government and scientists are trying to decide what to do with the SII vaccines, City Press reports.
Professor Francois Venter, an expert in contagious diseases at Wits University, said: “It would be a disaster if the vaccines were lost. We are not looking for perfection. We want to prevent people from going to hospital and dying, and (the Oxford-AstraZeneca vaccine) can still help with that.”
The report says about 75% of health workers are not in the high-risk category in terms of age and underlying comorbidities, and therefore they would most likely derive less value from the vaccine than older or sick people. It is not known how much protection the vaccine provides against hospitalisation and death, and experts believe the consignment could be used to help answer that question.
“But the expiry date complicates this option because a study will basically have to start next week,” says a source with insight into the ministerial advisory committee meetings.
It was reported earlier that South Africa has reportedly asked India's Serum Institute to take back the AstraZeneca vaccines that arrived earlier this month. Eyewitness News reports that the request comes off the back of a small local study which found that the vaccine provided minimal protection against mild to moderate COVID-19 in patients infected with the second variant of the virus.
Just last week, Mkhize said that government had been contacted by other countries who were interested in swopping or buying the jabs from South Africa.
According to the Eyewitness News report, The Economic Times in India has reported that the South African government has approached the Serum Institute of India asking it to take back the 1m AstraZeneca vaccines.
The report says Minister Mkhize last week met with the World Health Organisation (WHO) to discuss the way forward after the findings of the small study were made public.
This is what he had to say then: "What happens to the money used to buy AstraZeneca? We don't intend to claim it back. We intend to use the vaccine based on the advice of our experts."
As noted in a TimesLIVE report in the MedicalBrief last week, Pillay said that South Africa was speaking to the Serum Institute of India for an extension of the (vaccine expiry) date, if that’s possible, alternatively an exchange of the stock.
Mkhize announced on Tuesday that 80,000 J&J vaccines are en route to South Africa and will be used in this week’s roll-out of government’s national vaccination programme, reports Polity. Another 500,000 doses are expected over the next four weeks.
Mkhize revealed that government had secured a total of 9m doses of the J&J vaccine and 20m doses of the Pfizer vaccine, which are expected in the country at the end of March.
Meanwhile, government is also engaging with COVID-19 vaccine manufacturers and suppliers, following calls by the public for South Africa to develop and manufacture its own vaccines. Mkhize added that government would continue to be the sole buyer of vaccines for the country.
Polity reports that he lauded South African scientists for their discovery of the 501Y.V2 variant and for guiding pharmaceutical companies in their adaption of vaccines against emerging variants.
“As a matter of fact, we are one of very few countries that is so precise in its vaccination approach by implementing the guidance from the genomics surveillance expertise,” Mkhize said.
The WHO has listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” said Dr Mariângela Simão, WHO assistant-director general for access to medicines and health products.
“But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things – a scale-up of manufacturing capacity, and developers’ early submission of their vaccines for WHO review.”
The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.
In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took under four weeks.
The vaccine was reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines’ use in populations (recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and above.
The AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S (recombinant). It is being produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09% efficacy and is suitable for low- and middle-income countries due to easy storage requirements.
The EUL procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.
WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020.
[link url="https://www.reuters.com/article/health-coronavirus-safrica/update-1-south-africa-says-documentation-on-russian-covid-19-vaccine-sent-to-regulator-idUSL8N2KM1CY"]Full Reuters report (Open access)[/link]
[link url="https://www.businesslive.co.za/bd/national/health/sas-astrazeneca-shots-will-go-to-au-at-no-cost-to-fiscus/"]Full Business Day report (Open access)[/link]
[link url="https://www.iol.co.za/news/politics/sa-is-not-returning-the-astrazeneca-vaccines-says-mkhize-91d4bbcd-5e52-447e-bd93-a33d647ef2ba"]Full IoL report (Open access)[/link]
[link url="https://www.news24.com/citypress/news/south-africa-and-india-in-battle-over-vaccines-20210214-2"]Full City Press report (Open access)[/link]
[link url="https://ewn.co.za/2021/02/16/sa-asks-serum-institute-to-take-back-1m-astrazeneca-vaccines-report"]Full Eyewitness News report (Open access)[/link]
[link url="https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/south-africa-asks-sii-to-take-back-1-m-covid-vaccines/articleshow/80947580.cms"]Full Economic Times report (Restricted access)[/link]
[link url="https://www.polity.org.za/article/vaccination-with-jj-doses-to-begin-this-week-mkhize-2021-02-16"]Full Polity report (Open access)[/link]
[link url="https://www.who.int/news/item/15-02-2021-who-lists-two-additional-covid-19-vaccines-for-emergency-use-and-covax-roll-out"]World Health Organisation material[/link]
See also MedicalBrief archives:
[link url="https://www.medicalbrief.co.za/archives/sa-changes-course-in-vaccine-rollout/"]SA changes course in vaccine rollout[/link]