SA changes course in vaccine rollout

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Faced with its first-choice Oxford/AstraZeneca vaccine showing showing low efficacy against the South African variant of the coronavirus, the Department of Health has responded swiftly, writes MedicalBrief. The Johnson & Johnson vaccine may be administered to health workers from as early as next week and the Russian Sputnik vaccine is also currently being tested for local efficacy.

The new plan is for the J&J vaccine to be rolled out to health workers and further evaluated in the field. SA Medical Research Council CEO and president, and principal investigator for the Johnson & Johnson vaccine in SA, Professor Glenda Gray said that a rolling submission for approval, where investigators constantly add data, has been submitted to the South African Health Products Regulatory Authority (SAHPRA). The company has also applied for emergency use approval from the Food and Drug Administration in the United States and with other regulators.

Results from the vaccine have shown that it is 57% efficacious against the local 501Y.V2 variant for the prevention of moderate Covid-19 and 85% for the prevention of severe Covid-19, hospitalisation, and death.

The South African variant was first identified in November 2020 and at present more than 90% of positive local cases of coronavirus infections are caused by this variant, which is more contagious than the original virus. In SA clinical trials the Oxford/AstraZeneca had shown only a 22% lower risk of Covid-19 in the vaccinated group and although SA study was not designed to test whether the vaccine will protect against severe COVID-19, in other international trials it proved efficacious against these when testing against the original coronavirus

Lead investigator in the Oxford/AstraZeneca trial, the University of the Witwatersrand's Professor Shabir Madhi, told a Daily Maverick webinar that the vaccine does have a place in the vaccination schedule. “This vaccine will be the cheapest and the most readily available. The toss-up might be between no vaccine and a vaccine that likely will protect against death and hospitalisation.” Gray agreed, saying if it could stop deaths and stop health facilities from being overrun, the vaccine should be given to high-risk patients.

Since the Oxford/AstraZeneca is very similar to the Johnson & Johnson vaccine and the immune responses triggered by the two vaccines were similar, there is no reason to think that it would not also protect against severe Covid-19, Madhi said. The other clinical trial where Madhi is the principal investigator, the Novavax vaccine trial, had shown a 60% efficacy in protecting against mild and moderate infections with the South African variant.

 

Bloomberg reports that SA plans to accelerate the arrival of other products to vaccinate health workers. The government has secured 9 million doses from Johnson & Johnson and 20 million doses from Pfizer, which were initially expected to arrive from June and May respectively. Vaccines for health workers from both drugmakers should now arrive within four weeks, according to Health Minister Dr Zweli Mkhize.

Pfizer's vaccine needs to be stored and distributed at about -70°C, requiring countries importing it to have ultra-cold chain capabilities. However, Pfizer said it would enabling direct shipment to the point of vaccination SA in a thermal shipper, to maintain the ultra-low temperature required for up to 10 days unopened.

SA has also secured an additional 4.3 million vaccines from the Covax facility, which are due in March. The program has allocated about three to five million doses of the Astra shot to the nation, the SA DoH said, with supply starting in mid-February. The country expects a resurgence of infections in winter, which starts in June.

The start of South Africa’s vaccination program is only likely to be slightly delayed but it may be rolled out slower than initially planned, Prof Salim Abdool Karim, co-chair of the nation’s Covid-19 ministerial advisory committee, told a World Health Organization briefing. The country may consider issuing AstraZeneca shots in stages until a clearer picture of its efficacy emerges, he said.

 

The Guardian reports that leading vaccine scientists are calling for a rethink of the goals of vaccination programmes, saying that herd immunity through vaccination is unlikely to be possible because of the emergence of variants like that in South Africa.

The UK vaccines minister, Nadhim Zahawi, said the British public should maintain confidence in the Oxford jab, saying that the vaccines being deployed “appear to work well against the COVID-19 variants currently dominant in the UK”. He continued: “In terms of other variants, not in the UK, we need to be aware that even where a vaccine has reduced efficacy in preventing infection there may still be good efficacy against severe disease, hospitalisation, and death.”

And, the report says, Pollard emphasised the value of the vaccines in reducing the burden on health systems. “This study confirms that the pandemic coronavirus will find ways to continue to spread in vaccinated populations, as expected, but, taken with the promising results from other studies in South Africa using a similar viral vector, vaccines may continue to ease the toll on health care systems by preventing severe disease,” he said.

Ravi Gupta, professor of clinical microbiology at the University of Cambridge, said that it was pragmatic to adopt the approach that vaccines will prevent severe disease and death rather than enabling herd immunity in countries like South Africa. To stop transmission – if it were possible – would mean delivering huge numbers of vaccine doses, which are not working so well, very rapidly. “We probably need to switch to protecting the vulnerable, with the best vaccines we have which, although they don’t stop infection, they probably do stop you dying,” he said.

 

Polity quotes the European head of the WHO as saying that he is “concerned” over whether COVID-19 vaccines will prove effective against new virus variants. Kluge’s comments came after the UK, a global leader in the field of genomic sequencing, said the world now faces about 4,000 variants of the virus.

The report says it remains unclear how long it will take to vaccinate the world. Many of those vaccinated to date have received only one of two doses required. About 65% of all jabs given so far have been delivered in high-income countries, according to World Bank criteria. Israel is currently ahead of the rest of the world on vaccinations per head of population, followed by the United Arab Emirates, the UK, Bahrain, the US, and then EU member states Spain, Italy and Germany.

Kluge reiterated the WHO’s call for rich countries to show solidarity towards poorer nations unable to buy vaccines, urging wealthy ones to share their doses. “We know that in the EU, Canada, UK, US, they all ordered and made deals for four to nine times more doses than they need,” Kluge said.

 

TimesLIVE reports, meanwhile, that the Oxford/AstraZeneca vaccines delivered to South Africa last week have an expiry date of April, rather than the normal six-week expiry. The admission was made during a question-and-answer session following a press briefing on the effectiveness of the vaccine against the current dominant COVID-19 variant in South Africa, known as 501. V2 or B. 1.351. Health department deputy director-general Anban Pillay said that SA was now speaking to the Serum Institute of India for an extension of the date, if that's possible, alternatively an exchange of the stock.

 

Business Insider reports that a SA pharmaceutical company says it is ready to bring 15m doses of Russia’s Sputnik V vaccine to the country immediately, as soon as it gets emergency approval from local health authorities. The DoH presented cabinet with a proposal for vaccines that includes as many as 23m Sputnik doses, provided to South Africa via two pharmaceutical companies.

One of the companies, Lamar International, said that it has already been allocated 15 million doses of the Sputnik vaccine by the Gamaleya Institute, which developed the vaccine and is part of Russia’s ministry of health. According to a Lamar spokesperson, the doses could be flown to South Africa as soon as SAHPRA registers it for emergency use.

A peer-reviewed study published in the international science journal The Lancet has shown the vaccine to be 92% effective after two doses (three weeks apart), in a trial of 20,000 people. This is among the highest efficacy rates reported for COVID vaccines. However, Business Insider reports, there are as yet no findings to prove whether Sputnik would be effective against the 501Y.V2 variant.

The Lamar spokesperson said the Gamaleya Institute is currently testing the efficacy against the variant in its laboratories, and additional data is expected this week. This will be presented to SAHPRA.

While Africa Health Research Institute director and vaccinology expert Professor Willem Hanekom is quoted as saying that the Sputnik results were rigorous, he noted the lack of diversity in its trial – only white males were included and there is no mention of its efficacy in those with HIV.

 

The Times reports that health officials around the world are giving their backing to the AstraZeneca vaccine against COVID-19. “It is vastly too early to be dismissing this vaccine,” said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, a foundation that co-leads the global Covax programme to provide vaccine doses in poor countries.

More than 330m doses of AstraZeneca’s vaccine form the overwhelming majority of doses Covax aims to begin rolling out in a first phase in poor countries beginning as soon as this month. “Obviously the world is full of the wild type virus that this AstraZeneca vaccine is known to work against,” Hatchett said.

Several global health officials noted the South African study was small and had tested the vaccine using a short four-week interval between the first and second doses, despite evidence having since emerged that it works better if there is a longer wait. It was becoming “more and more clear that the longer the interval between the two doses the higher the efficacy,” said Kate O’Brien, head of immunisations at WHO.

 

Eyewitness News reports that Madhi said that scientists needed more time to interrogate the data. “I think it would be highly reckless for us to discard the vaccine. We paid a high price for it and so the vaccines do have a role in protecting from severe disease. I think an important feature in all the vaccines is that generally, vaccines work much better in preventing severe disease.”

Eyewitness News writes that this is not an unusual way to roll out vaccines either: “Similar programmes in South Africa have been used for drugs to treat extensively-drug resistant TB, balancing the need for patients to have access with the need for more data.”

Madhi said that there were other options to put the vaccine to good use. “If we're strategic in terms of the rollout, we might still be able to get the vaccine used, not two doses per individual but at least a single dose and we could possibly follow it up then with another vaccine and a few vaccines that might come online in the next two or three months.”

 

SABC News reports that the head of the WHO Tedros, Adhanom Ghebreyesus, expressed concern over South Africa’s decision temporarily halt the rollout of the AstraZeneca vaccine. Ghebreyesus said as the trial from which this data emanated was small and involved young participants, more research needs to be done on the efficacy of the vaccine in older age groups that have a higher risk of more severe infection.

“This is clearly concerning news however there are some important caveats. Given the limited sample size of the trial and the younger healthier profile of the participants, it is important to determine whether or not the vaccine remains effective in preventing more severe illness. Several countries are succeeding in suppressing transmission including those where new variants are circulating. It also seems increasingly clear that manufacturers will have to adjust to the evolution of the virus taking into account the latest variant for future shots including boosters.”

Addressing a WHO briefing, Karim explained the approach government is considering. “We are just not confident about its efficacy against the 501yv2 variant and so we are proposing an alternative approach to roll out the vaccine and one proposal that is currently being considered is to roll it out initially just in a set manner where the first step includes about 100 000 individuals that are vaccinated in which we monitor the hospitalisation rates. All that has been suggested at this point is to delay the rollout of the AstraZeneca vaccine until we have the processes in place to undertake this kind of kind if step-wise implementation approach.”

 

Full Daily Maverick webinar report (Open access)

 

Wits University full report on Oxford/AstraZeneca trial results

 

Full Bloomberg report (Open access)

 

Full Business Day report (Restricted access)

 

Full report in The Guardian (Open access)

 

Full Polity report (Open access)

 

Full report in The Times (Open access)

 

Full Business Insider report (Open access)

 

Full report in The Times (Open access)

 

Full Eyewitness News report (Open access)

 

Full SABC News report (Open access)

 

 

 

See also MedicalBrief archives:

Russia’s Sputnik V vaccine is 91.6% effective — Phase 3 results

 


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