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03 May 2021

Delay in J&J shots after mistakes by US firm could slow start of vaccine rollout

Business Day 03 May 2021 - The release of SA’s first commercial shipment of Johnson & Johnson’s (J&J’s) Covid-19 vaccine from Aspen Pharmacare’s Gqeberha facility is being delayed as a “precautionary” safety measure after problems at a US company contracted by J&J to make a key vaccine ingredient, health minister Zweli Mkhize announced on Sunday.

While Pfizer’s planned deliveries are still on track, with the first shipment of 325,260 doses expected on Sunday night, the delay in the J&J shots could slow the start of the vaccine rollout, which begins on May 17. The government has ordered 31-million doses of J&J’s single-shot vaccine, which it is banking on to be the workhorse of its national inoculation drive since it is easier to administer and handle than Pfizer’s double-dose vaccine, which requires ultracold storage. Aspen has 1.1-million doses of J&J’s Covid-19 vaccine ready for dispatch, but cannot release the stock until medicine regulators in the US and Europe give the nod to J&J stock worldwide after mistakes by its US contract manufacturer, Emergent BioSolutions, Mkhize said. The government expects Aspen’s stock will be released by mid-May, he said. 


Risk remains after first Pfizer Covid-19 shot, UK study finds

Business Day 30 April 2021 - The immune response after just the first dose was weaker in people who had not previously been infected, leaving them at risk from new variants

A single dose of Pfizer’s Covid-19 vaccine may not generate a sufficient immune response to protect against dominant new variants, except in people who have already been infected with Covid-19, according to a UK study published on Friday. The Imperial College-led study, which looked at immune responses among healthcare workers in Britain after their first dose of the Pfizer shot, found that those who had previously had mild or asymptomatic infection had enhanced protection against more infectious mutated variants that emerged in Britain and SA. But the immune response after a first dose of the shot was weaker in people who had not previously been infected, potentially leaving them at risk from such variants, researchers leading the work said. “This study highlights the importance of getting second doses of the vaccine rolled out to protect the population,” said Rosemary Boyton, a professor of immunology and respiratory medicine at Imperial who co-led the study. 

 

Pregnant women face vaccine hurdle as regulator reviews safety data

Business Day 28 April 2021 - Some of the most vulnerable are at risk of being left out of SA’s vaccination drive

Pregnant and breastfeeding women, who are among the groups most at risk from Covid-19, face being left out of SA’s vaccination drive after the medicines regulator said it was reviewing data for both Johnson & Johnson (J&J) and Pfizer’s shots, which are central to the government’s plans. Pregnant women are considered a particularly vulnerable group, as they are at increased risk of pre-term birth, severe illness and death from Covid-19. The mass vaccination programme is due to start in about three weeks. The development comes hard on the heels of Sahpra’s surprise exclusion of pregnant and lactating women from the Sisonke Covid-19 vaccine study aimed at health workers. Sahpra suspended the Sisonke study, which aims to vaccinate 500,000 healthcare workers with J&J’s shot, over safety concerns flagged by the US health authorities two weeks ago in the wake of extremely rare blood clots among vaccine recipients. US regulators recommended on Friday that vaccinations resume, while EU authorities have said the benefits outweigh the risks. 


Vaccine discrimination likely to delay restart of global travel

Business Day 28 April 2021 - Selective guidelines around which vaccines are recognised means travel may be restricted

With the resumption of global travel on the horizon, some people are discovering that their choice of vaccine could determine where they’re allowed to go. Already, the EU is planning to allow Americans vaccinated with shots approved by their drug agency to enter over the summer, European Commission president Ursula von der Leyen suggested in a New York Times interview on Sunday. This means that those who have shots by Chinese makers such as Sinovac Biotech and Sinopharm are likely to be barred from entry for the foreseeable future, with stark consequences for global business activity and the revival of international tourism. 


Medical schemes regulator boosts patients’ rights to choose their pharmacy

Business Day 27 April 2021 - The medical schemes regulator has banned the imposition of excessive co-payments on patients who choose health-care providers outside the networks chosen by their medical schemes.                 

While the move potentially has implications across the private health-care sector, it will bring particular relief to independent pharmacies shut out of these networks and give patients greater choice in where they purchase their medicines. Some schemes have also drawn fire for levying stiff penalties of up to 40% of the total cost of a prescription on members who opt to use pharmacies that do not belong to a DSP, according to the Independent Community Pharmacy Association (ICPA). These practices have limited patient choice and hurt the businesses of independent pharmacies that draw a significant portion of their income from the fees they charge for dispensing medicines. The notice, which came into immediate effect, bans schemes from levying penalties greater than the difference between the rate charged by a health-care provider belonging to their approved network and one that does not. It also prohibits the appointment of a DSP without engaging in a procurement process that is “fair, equitable, transparent, competitive and cost-effective”, according to the gazette. 


Vaccine rollout, including J&J, to resume this week

Business Day 26 April 2021 - The medicines regulator has given the J&J vaccine the greenlight with 1.1-million doses ready to be dispatched from Aspen Gqeberha

The Sisonke vaccine trial of health workers will start again on Wednesday, health minister Zweli Mkhize has announced, and the sites offering vaccinations will be expanded to 95 from 18. Mkhize said in a statement, “It has since been established there is a one-in-a-million chance of getting a clot after the Johnson & Johnson (J&J) vaccine, and it appears that women between the ages of 18 and 48 are at risk.” He said there were far more cases of blood clots related to Covid-19 itself and urged people to get vaccinated.  The blood clot condition, known as vaccine-induced thrombotic thrombocytopenia (VITT), caused both a blood clot in the brain and abdomen, as well as a low platelet count. Eight people in the US developed this after 6.8-million J&J vaccinations. 


J&J vaccine must be used, says CDC, as US uptake seen slowing

Business Day 26 April 2021 - As the US says the J&J vaccine is good to go with benefits far outweighing risks, some in the US seem OK being half-vaccinated against Covid-19

For Americans wary of the Johnson & Johnson (J&J)  Covid-19 vaccine as it returns to use after the investigation of a rare but potentially deadly side effect, health experts have a message: the system worked. A recommended hold on the vaccine was lifted on Friday by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration after a 10-day review of rare but serious blood clots in some people who had received the shot. The small risk of clots from the shot is far outweighed by its protection against the coronavirus, an advisory panel said. In the next six months, the shot could prevent some 1,435 Covid-19 deaths and 2,236 hospitalisation, compared with a projected 26 possible clot cases, according to a presentation by the CDC. 

 

Covid-19 vaccine claimants to give upright to sue government over injury

Business Day 23 April 2021 - Gazetted rules follow J&J and Pfizer insisting on a no-fault compensation scheme run by the government

South Africans who claim from a Covid-19 vaccine injury fund will give up rights to approach the courts to sue the government or health workers should they suffer severe injury from taking the injection. This is in terms of new regulations for the compensation fund in the event a person is severely injured by a Covid-19 vaccine. Minster of co-operative governance Nkosazana Dlamini-Zuma gazetted the regulations after allowing four days for comments, leading to an outcry by activists. The government has secured millions of doses of vaccines from drug companies Johnson & Johnson (J&J) and Pfizer, who both insisted on a no-fault compensation scheme run by the government as a prerequisite for supplying the vaccines. The companies will not be liable for any costs should the vaccines cause injury or death but instead the government will take on liability. 


The risk of blood clots may be higher with Covid than after vaccine

Business Day 23 April 2021 - The risk of blood clots among those who’ve been diagnosed with Covid-19 is higher than among those who’ve received vaccines against the disease, according to a new study from the University of Oxford.

Covid patients saw a clot risk of 39 in a million. That compared with four in a million in mRNA vaccines such as those developed by Pfizer and BioNTech or Moderna, and five in a million people after AstraZeneca’s vaccine. Though the analyses for the three vaccines are based on different data sets, making comparisons difficult, the study suggests that the risk of a clot among those with the disease is about eight to 10 times higher than after vaccination. It was hard to compare the baseline risk of clotting in the general population without Covid because incidence is rare and varies across age groups, the authors said in a media briefing. 


Malaria vaccine trial results may indicate a ‘game-changer’

Business Day 23 April 2021 - The disease kills about 400,000 people a year, largely in Sub-Saharan Africa, with most being children under five

The first malaria vaccine to meet a World Health Organization (WHO)  specified goal of more than 75% efficacy has been developed by scientists at the University of Oxford, a potentially significant step toward defeating the disease. Finding more effective inoculations against the mosquito-borne disease has been a critical goal in fighting an infection that kills about 400,000 people a year, largely in Sub-Saharan Africa, with most being children under five. “Even before Covid-19, progress in the global fight against malaria had stalled,” said Simon Bland, CEO of the Global Institute for Disease Elimination. “This new vaccine could be a game-changer toward the elimination of malaria, a disease that has killed more people than any other since the beginning of humankind.” 


African countries urged not to destroy vaccines after expiry confusion

Business Day 22 April 2021 - States receiving donations of Covid-19 vaccines told they could use the shots up to July 13

The AU’s disease control body and World Health Organisation on Thursday urged African countries not to waste Covid-19 vaccines donated to them, after confusion in Malawi and South Sudan about whether doses they received had expired. “My appeal to member states is: if we are doing our part to mobilise these vaccines, you do your part and use the vaccines,” John Nkengasong, director of the Africa Centres for Disease Control and Prevention (Africa CDC), told a news conference. Malawi has said it plans to destroy more than 16,000 doses of AstraZeneca’s vaccine manufactured by the Serum Institute of India because the shots were not administered before the April 13 expiry date on the packaging. The doses were supplied via the AU thanks to a donation from telecoms group MTN. South Sudan has set aside 59,000 doses supplied by the AU and is not using them because of the same expiry issue, a government official told Reuters last week. 


Government overrode scientific advice at times ‘to balance lives with the economy’

Business Day 22 April 2021 - The documents show that the government took a softer stance than the MAC’s recommendations ahead of the Easter period

The government has departed at times from scientific advice on managing the coronavirus pandemic, as it sought to balance the need to protect lives and livelihoods, spokesperson Phumla Williams said on Thursday.

A series of documents detailing the recommendations made by scientists to health minister Zweli Mkhize have been released by the government, revealing how it has overridden or only partly implemented much of their counsel on contentious issues such as alcohol restrictions and school closures. These ministerial advisories, initially published on the health department’s website, are now located on the government’s official coronavirus site. The documents show the government took a softer stance than the MAC’s recommendations ahead of the Easter period, when it advised tightening lockdown restrictions and moving the country from level 1 to level 2, including limiting alcohol sales for off-site consumption to weekdays. Instead, the government imposed only a four-day prohibition on alcohol sales from shops over the Easter long weekend and relaxed rules on mass gatherings. 


Imperial Logistics gets piece of vaccine action as state awards contracts

Business Day 22 April 2021 - Imperial to provide importation services

The government has awarded contracts for importing and distributing Covid-19 vaccines, a vital step in preparing for its mass vaccination drive, which is due to begin on May 17. State-backed vaccine manufacturer Biovac is to play a central role, but contracts have also been awarded to JSE-listed Imperial Logistics and DSV Healthcare. According to the contract circular announcing the award, Biovac and Imperial Logistics have been appointed to provide importation services, while the job of transporting, warehousing and distributing the vaccines has been split between Biovac and DSV Healthcare. Biovac will cover all the cold chain requirements for vaccines that require storage at 2°C to 8°C, at -20°C and -70°C. DSV Healthcare will only provide services for vaccines requiring storage at -70°C. A third company is expected to be appointed shortly to assist with the -20°C services, according to the circular. 


Mkhize: Pfizer backs down over ‘unreasonable demands’

Medical Brief 21 April 2021 - Pfizer has backed down over its controversial demand that the South African government put up sovereign assets guaranteeing an indemnity against the cost of any future legal cases

During COVID-19 vaccine negotiations, the company sought indemnity against civil claims from citizens who had experienced adverse vaccine effects – meaning that the government would have to cover the costs instead. The report says last week South African Health Minister Zweli Mkhize, voiced frustrations about “difficult and sometimes unreasonable” terms his countryʼs government had been presented with during contract negotiations with vaccine manufacturers, including Pfizer.